US2021012873A1PendingUtilityA1

Applied Artificial Intelligence Technology for Hormone Therapy Treatment

Assignee: NORMAN JAMES GLENNPriority: Oct 15, 2018Filed: Sep 28, 2020Published: Jan 14, 2021
Est. expiryOct 15, 2038(~12.2 yrs left)· nominal 20-yr term from priority
G16H 20/10G16H 10/40C07K 14/61A61K 38/27G16H 40/67G16H 50/20G16H 10/60G16H 50/30
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Claims

Abstract

Disclosed herein are a number of techniques that systematically integrate a person's biochemical, symptomatic, and genetic status to generate recommended hormone therapy treatment prescriptions.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A system for applying computer technology that systematically integrates a person's biochemical, symptomatic, and genetic status to generate a recommended hormone therapy treatment prescription for the person, the system comprising:
 a processor; and   a memory;   wherein the memory is configured to store (1) data representative of a measured level of a first hormone in a person, (2) data representative of a measured level of a second hormone in the person, (3) symptom experience data for a plurality of symptoms experienced by the person that relate to a plurality of conditions associated with deficiencies of the first and second hormones, and (4) genetic profile data for the person; and   wherein the processor configured to:
 access the memory; 
 perform an analysis of the first hormone measured level data, the second hormone measured level data, the symptom experience data, and the genetic profile data; and 
 based on the analysis, generate a recommended hormone therapy prescription to treat a hormone deficiency condition experienced by the person, wherein the prescription comprises (1) a formulation comprising (i) the first hormone, a biologically active form thereof, an analog thereof, a precursor thereof, and/or a metabolite thereof, and (ii) the second hormone, a biologically active form thereof, an analog thereof, a precursor thereof, and/or a metabolite thereof, and (2) a dosage for the formulation. 
   
     
     
         2 . The system of  claim 1  wherein the processor and memory are for use in conjunction with a biological sample assay that measures (1) a level of the first hormone in the person and (2) a level of the second hormone in the person based on an analysis of a bodily fluid sample from the person, wherein the first hormone measured level data and the second hormone measured level data are derived from the first and second hormone levels that are measured by the biological sample assay. 
     
     
         3 . The system of  claim 2  wherein the memory further comprises a data structure that associates a plurality of different prescriptions of the formulation with (1) a first factor associated with the first hormone (2) and a second factor associated with the second hormone; and
 wherein the analysis translates the first hormone measured level data, the second hormone measured level data, the symptom experience data, and the genetic profile data into values for the first and second factors; and 
 wherein the processor is further configured to generate the recommended hormone therapy prescription based on a selection from the data structure of the prescription associated with the translated first and second factor values. 
 
     
     
         4 . The system of  claim 2  wherein the processor is further configured to provide a user interface for display on a display screen, the user interface configured to receive input that defines the symptom experience data. 
     
     
         5 . The system of  claim 4  wherein the user interface includes a plurality of slider bars, each slider bar corresponding to a different symptom relating to a condition associated with a deficiency of the first and/or second hormone, and wherein the slider bar is adjustable in response to input to define a value within a range of values for severity of its corresponding symptom, and wherein the symptom experience data comprises the input-defined severity values. 
     
     
         6 . The system of  claim 2  wherein the processor comprises a first processor and a second processor, the first processor being resident in a user computer, the second processor being resident in a server, wherein the first processor is configured to collect the symptom data from the user interface, and wherein the second processor is configured to perform the analysis. 
     
     
         7 . The system of  claim 2  wherein the memory is further configured to store medical information about the person, and wherein the analysis is also performed on the medical information, wherein the medical information comprises a body fat composition characteristic for the person and/or a surgical history for the person. 
     
     
         8 . The system of  claim 2  wherein the genetic profile data comprises gene data about whether the person has an allele of a gene which affects a person's metabolism of the first and/or second hormones. 
     
     
         9 . The system of  claim 2  wherein the genetic profile data comprises gene data about whether the person has an allele of a gene linked to an adverse health risk for a human if the human is treated with the first and/or second hormones. 
     
     
         10 . The system of  claim 2  wherein the memory is further configured to store (1) data representative of a measured level of a third hormone in the person obtained from the biological sample assay, and (2) symptom experience data for a plurality of symptoms experienced by the person that relate to a plurality of conditions associated with a deficiency of the third hormone, and wherein the processor is further configured to:
 perform an analysis of the first hormone measured level data, the second hormone measured level data, the third hormone measured level data, the symptom experience data for symptoms experienced by the person that relate to conditions associated with deficiencies of the first, second, and third hormones, and the genetic profile data; and 
 based on the analysis, generate a recommended hormone therapy prescription for the person to treat a hormone deficiency condition experienced by the person, wherein the prescription comprises (1) a formulation comprising any combination of (i) the first hormone, a biologically active form thereof, an analog thereof, a precursor thereof, and/or a metabolite thereof, (ii) the second hormone, a biologically active form thereof, an analog thereof, a precursor thereof, and/or a metabolite thereof, and (iii) the third hormone, a biologically active form thereof, an analog thereof, a precursor thereof, and/or a metabolite thereof and (2) a dosage for the formulation. 
 
     
     
         11 . The system of  claim 2  further comprising the biological sample assay. 
     
     
         12 . The system of  claim 11  wherein the biological sample assay comprises a plurality of biological assays. 
     
     
         13 . The system of  claim 2  wherein the processor is further configured to repeat its operations for the person over time;
 wherein the processor and memory are further configured to (1) track the measured first and second hormone level data for the person over time, and (2) track the symptom experience data for the person over time; and 
 wherein the processor is further configured to adjust the analysis based on the tracked measured first and second hormone level data and the tracked symptom experience data. 
 
     
     
         14 . The system of  claim 2  wherein the processor is further configured to repeat its operations for a plurality of different persons over time such that the processor and memory (1) track the measured first and second hormone level data for the persons over time, (2) track the symptom experience data for the persons over time, and (3) track the recommended prescriptions for the persons over time;
 wherein the processor is further configured to adjust the analysis based on the tracked measured first and second hormone level data and the tracked symptom experience data for the persons over time in combination with the tracked recommend prescriptions for the persons over time. 
 
     
     
         15 . The system of  claim 14  wherein the memory further comprises a data structure that associates a plurality of different prescriptions of the formulation with a first factor associated with the first hormone and a second factor associated with the second hormone; and
 wherein the analysis translates the first hormone measured level data, the second hormone measured level data, the symptom experience data, and the genetic profile data into values for the first and second factors; and 
 wherein the processor is further configured to (1) generate the recommended hormone therapy prescription based on a selection from the data structure of the prescription associated with the translated first and second factor values, and (2) adjust an assignment of prescriptions to first and second factors in the data structure based on the tracked measured first and second hormone level data and the tracked symptom experience data for the persons over time in combination with the tracked recommend prescriptions for the persons over time. 
 
     
     
         16 . The system of  claim 15  wherein the processor, as part of the analysis, is further configured to compute a measured deficiency value for the first hormone based on the measured first hormone level data such that the measured first hormone deficiency value has an inverse relationship with the measured first hormone level data. 
     
     
         17 . The system of  claim 16  wherein the symptom experience data comprises first symptom data for symptoms experienced by the person that relate to conditions associated with deficiencies of the first hormone; and
 wherein the processor, as part of the analysis, is further configured to (1) compute a symptomatic deficiency value for the first hormone based on the first symptom experience data such that the symptomatic deficiency value exhibits larger values for relatively more severe symptoms for the conditions associated with deficiencies of the first hormone and smaller values for less severe symptoms for the conditions associated with deficiencies of the first hormone, and (2) compute a deficiency factor for the first hormone based on a combination of the computed first hormone measured deficiency value and the computed first hormone symptomatic deficiency value. 
 
     
     
         18 . The system of  claim 17  wherein the processor, as part of the analysis, is further configured to (1) compute a metabolism adjustment factor for the first hormone deficiency factor based on the genetic profile data for the person, and (2) adjust the first hormone deficiency factor based on the computed metabolism adjustment factor. 
     
     
         19 . The system of  claim 18  wherein the first hormone comprises progesterone, wherein the second hormone comprises estrogen, wherein the genetic profile data comprises a presence indicator for the person with respect to allelic status of one or more Cytochrome P450 (CP450) family genes, and wherein the processor is further configured to compute the metabolism adjustment factor for the first hormone deficiency factor such that the first hormone deficiency factor will be upwardly adjusted if the genetic profile data indicates the presence of an allele of a CP450 family of genes in the person linked to an increased rate of steroid metabolism in a human. 
     
     
         20 . The system of  claim 17  wherein the memory is further configured to store a body fat composition characteristic value for the person; and
 wherein the processor, as part of the analysis, is further configured to (1) compute a body fat composition characteristic adjustment factor for the first hormone deficiency factor based on the body fat composition characteristic value for the person, and (2) adjust the first hormone deficiency factor based on the computed body fat composition characteristic adjustment factor. 
 
     
     
         21 . The system of  claim 17  wherein the processor, as part of the analysis, is further configured to (1) compute a risk adjustment factor for the first hormone deficiency factor based on the genetic profile data for the person, and (2) adjust the first hormone deficiency factor based on the computed risk adjustment factor. 
     
     
         22 . The system of  claim 21  wherein the first hormone comprises progesterone, wherein the second hormone comprises estrogen, wherein the genetic profile data comprises a presence indicator for the person with respect to allelic status of BRCA1 and BRCA2 genes, and wherein the processor is further configured to compute the risk adjustment factor for the first hormone deficiency factor such that the first hormone deficiency factor will be zero if the genetic profile data indicates the presence of either the BRCA1 or BRCA2 gene alleles in the person linked to an increased risk of breast cancer associated with hormone replacement therapy. 
     
     
         23 . The system of  claim 2  wherein the processor, as part of the analysis, is further configured to (1) compute a value for a first hormone deficiency factor based on the measured first hormone level data and the symptom experience data, and (2) compute a value for a second hormone deficiency factor based on the measured second hormone level data and the symptom experience data;
 wherein the memory further comprises a data structure that associates a plurality of different prescriptions of the formulation with different values for the first and second hormone deficiency factors; and 
 wherein the processor is further configured to generate the recommended hormone therapy prescription based on a selection from the data structure of the prescription associated with the computed first and second hormone deficiency factor values. 
 
     
     
         24 . The system of  claim 23  wherein the data structure represents a grid of cells, each cell corresponding to different prescriptions of the first and second hormones and being indexed in a coordinate space by a pair of values for the first and second hormone deficiency factors, wherein the grid has a first axis and a second axis that define the coordinate space, wherein the first axis has a range of values for the first hormone deficiency factor, and wherein the second axis has a range of values for the second hormone deficiency factor. 
     
     
         25 . The system of  claim 24  wherein the different prescriptions are a set of X different prescriptions, and wherein the data structure associates the different members of the X descriptions with the cells that are deemed clinically appropriate for the person based on the cell's associated first and second hormone deficiency factor values. 
     
     
         26 . The system of  claim 25  wherein the first hormone comprises progesterone, wherein the second hormone comprises estrogen, and wherein X is a value between 3 and 5. 
     
     
         27 . The system of  claim 25  wherein prescriptions with a higher dose of the first hormone, biologically active form thereof, analog thereof, precursor thereof, and/or metabolite thereof relative to the second hormone, biologically active form thereof, analog thereof, precursor thereof, and/or metabolite thereof in the formulation are associated with cells of the grid that are associated with first hormone deficiency factor values above a first threshold and second hormone deficiency factor values below a second threshold;
 wherein prescriptions with a higher dose of the second hormone, biologically active form thereof, analog thereof, precursor thereof, and/or metabolite thereof relative to the first hormone, biologically active form thereof, analog thereof, precursor thereof, and/or metabolite thereof in the formulation are associated with cells of the grid that are associated with second hormone deficiency factor values above a third threshold and first hormone deficiency factor values below a fourth threshold; and 
 wherein prescriptions with doses of the first and second hormone, biologically active forms thereof, analogs thereof, precursors thereof, and/or metabolites thereof that are of relatively equal clinical strengths in the formulation are associated with cells of the grid that are associated with first hormone deficiency factor values between the first and fourth thresholds and second hormone deficiency factor values between the second and third thresholds. 
 
     
     
         28 . The system of  claim 25  wherein the recommended prescription further comprises a third hormone, biologically active form thereof, analog thereof, precursor thereof, and/or metabolite thereof;
 wherein the first hormone comprises progesterone; 
 wherein the second hormone comprises estrogen; 
 wherein the third hormone comprises testosterone; and 
 wherein X is a value between 9 and 11. 
 
     
     
         29 . The system of  claim 1  further comprising:
 a plurality of different formulations of the first and second hormones, biologically active forms thereof, analogs thereof, precursors thereof, and/or metabolites thereof; and 
 wherein the processor is further configured to, based on the analysis, select a formulation from among the different formulations for use in the recommend hormone therapy prescription. 
 
     
     
         30 . The system of  claim 1  wherein the processor comprises a plurality of processors. 
     
     
         31 . The system of  claim 1  wherein the memory comprises a plurality of memories. 
     
     
         32 . A computer program product for applying computer technology that systematically integrates a person's biochemical, symptomatic, and genetic status to generate a recommended hormone therapy treatment prescription for the person, the computer program product comprising:
 a memory configured to store (1) data representative of a measured level of a first hormone in a person, (2) data representative of a measured level of a second hormone in the person, (3) symptom experience data for a plurality of symptoms experienced by person user that relate to a plurality of conditions associated with deficiencies of the first and second hormones, and (4) genetic profile data for the person; and   a plurality of processor-executable instructions that are resident on a non-transitory computer-readable storage medium, wherein the instructions are configured for execution to cause a processor to:
 access the memory; 
 perform an analysis of the first hormone measured level data, the second hormone measured level data, the symptom experience data, and the genetic profile data; and 
 based on the analysis, generate a recommended hormone therapy prescription to treat a hormone deficiency condition experienced by the person, wherein the prescription comprises (1) a formulation comprising (i) the first hormone, a biologically active form thereof, an analog thereof, a precursor thereof, and/or a metabolite thereof, and (ii) the second hormone, a biologically active form thereof, an analog thereof, a precursor thereof, and/or a metabolite thereof, and (2) a dosage for the formulation. 
   
     
     
         33 . A method for generating a recommended hormone therapy treatment prescription based on a systematic analysis of a person's biochemical, symptomatic, and genetic status, the method comprising:
 storing data in memory that represents a measured progesterone level and a measured estrogen level in a female person, wherein the stored data representing the measured progesterone and estrogen levels are derived from a biological sample assay with respect to a bodily fluid sample from the female person;   storing data in memory that represents experiences for the female person with respect to a plurality of symptoms that relate to a plurality of conditions associated with deficiencies of progesterone and/or estrogen in a human female;   storing data in memory that represents a genetic profile for the female person;   storing data in memory that represents a body fat composition characteristic for the female person;   storing a data structure in memory that associates a plurality of different hormone therapy treatment prescriptions with different progesterone deficiency factor values and different estrogen deficiency factor values, each prescription comprising a formulation and dosage of progesterone and estrogen, biologically active forms thereof, analogs thereof, precursors thereof, and/or metabolites thereof,   a processor processing the measured progesterone level data, the measured estrogen level data, the symptoms experience data, the genetic profile data, and the body fat composition characteristic data according to a computer program that computes a progesterone deficiency factor value and an estrogen deficiency factor value as a function of the measured progesterone level data, the measured estrogen level data, the symptoms experience data, the genetic profile data, and the body fat composition characteristic data; and   a processor selecting the prescription that is associated by the data structure with the computed progesterone deficiency factor value and the computed estrogen deficiency factor value, wherein the selected prescription serves as the recommended hormone therapy treatment prescription for the female person.   
     
     
         34 . The method of  claim 33  wherein the symptoms experience data comprises (1) progesterone deficiency symptoms experience data that quantifies a severity of a plurality of symptoms experienced by the female person that relate to a plurality of conditions associated with deficiencies of progesterone in a human female, and (2) estrogen deficiency symptoms experience data that quantifies a severity of a plurality of symptoms experienced by the female person that relate to a plurality of conditions associated with deficiencies of estrogen in a human female, and wherein the processing step comprises:
 a processor computing a progesterone deficiency value according to a formula where the computed progesterone deficiency value has an inverse relationship with the measured progesterone level; 
 a processor computing a symptomatic progesterone deficiency value based on the progesterone deficiency symptoms experience data such that the symptomatic progesterone deficiency value exhibits larger values for relatively more severe symptoms for the conditions associated with progesterone deficiencies and smaller values for less severe symptoms for the conditions associated with progesterone deficiencies; 
 a processor scaling the computed progesterone deficiency value based on the computed symptomatic progesterone deficiency value; 
 a processor computing an estrogen deficiency value according to a formula where the measured estrogen level has an inverse relationship with the computed estrogen deficiency value; 
 a processor computing a symptomatic estrogen deficiency value based on the estrogen deficiency symptoms experience data such that the symptomatic estrogen deficiency value exhibits larger values for relatively more severe symptoms for the conditions associated with estrogen deficiencies and smaller values for less severe symptoms for the conditions associated with estrogen deficiencies; 
 a processor scaling the computed estrogen deficiency value based on the computed symptomatic estrogen deficiency value; 
 a processor computing a metabolism adjustment factor based on the genetic profile data; 
 a processor computing a body fat composition characteristic adjustment factor based on the body fat composition characteristic data; 
 a processor computing the progesterone deficiency factor value by adjusting the scaled progesterone deficiency value based on the computed metabolism adjustment factor and the computed body fat composition characteristic adjustment factor; and 
 a processor computing the estrogen deficiency factor value by adjusting the scaled estrogen deficiency value based on the computed metabolism adjustment factor and the computed body fat composition characteristic adjustment factor.

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