DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status: Claims 1-20 are pending; Claims 16-18 have been withdrawn from consideration as directed to non-elected invention.
Response to Arguments
Applicant's arguments filed on August 26, 2025 have been fully considered but they are not persuasive.
Re Claims 1 and 19, Applicant made an argument that there is a conditional logic in the claims where caloric restriction is recommended only when (1) there is sufficient risk of ischemia/hypoxia and (2) the patient’s metabolic state indicates that caloric restriction will be protective, not harmful. Applicant stated that present invention maximizes clinical utilization of caloric restriction only when caloric restriction stands a high likelihood of providing acute neuroprotection and just as importantly avoids caloric restriction in cases where caloric restriction may be harmful. Applicant argued that both Hodgdon and Hinman do not disclose only recommending caloric restriction when it is likely to be neuroprotective rather than harmful.
This argument has been considered but is not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., caloric restriction is recommended only when (1) there is sufficient risk of ischemia/hypoxia and (2) the patient’s metabolic state indicates that caloric restriction will be protective, not harmful) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Examiner would like to note that claim 1 is a device claim and only requires structures that corresponds to a means for evaluating the patient's risk of an ischemic event, at least one means for real-time physiologic diagnostic monitoring, and a means for evaluating a metabolic state of the patient. The claim languages “to determine the neuroprotective potential of caloric restriction of the patient” and “wherein combination of the patient's risk of an ischemic event and neuroprotective potential of caloric restriction allow for generation of the neuroprotective nutrition program” are merely an intended use and do not further narrow the above structures. Therefore, a conditional logic of recommending caloric restriction only when it is neuroprotective is not claimed.
Claim 19 recites the claim limitation “generating a neuroprotective nutrition program for the patient based on combination of the patient’s risk of the ischemic event and metabolic state”. However, this limitation does not recite “caloric restriction”; therefore, it is silent regarding the argued conditional logic.
Re Claims 1 and 19, Applicant further made an argument that Hodgdon and Hinman do not disclose real-time physiologic diagnostic monitoring.
Applicant’s arguments with respect to claims 1 and 14 have been considered but are moot because the new grounds of rejection have been made necessitated by amendments.
Response to Amendment
With respect to 112(b) rejection, Applicant’s amendment/argument has overcome each and every rejection.
Election/Restrictions
Claims 16-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on December 17, 2024.
Applicant's election with traverse of Invention I in the reply filed on December 17, 2024 is acknowledged. The traversal is on the ground(s) that there would not be a serious search and/or examination burden, because Applicant thinks any prior art searched for one group would be applicable to the other group. This is not found persuasive because the inventive groups are distinct as explained in the office action dated September 17, 2024. The inventive groups would require different keyword searches and search strategies. A prior art searched for one group would not necessarily be applicable to the other group.
The requirement is still deemed proper and is therefore made FINAL.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that uses the word “means,” and is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a means for evaluating the patient’s risk of an ischemic event” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Based on the review of the instant specification, the corresponding structure of means for evaluating the patient’s risk of an ischemic event is means for evaluating clinical signs and symptoms (e.g. chest pain), an oxygen saturation monitor (e.g. pulse oximetry), a blood pressure monitor, a heart rate monitor, a heart rhythm monitor (e.g. an electrocardiogram device), a serum laboratory profile (e.g. cardiac enzymes, blood sugar, inflammatory markers, lactate, renal function labs, coagulopathy labs, platelet function assays, etc), a coronary catherization or angiogram device, a chest x-ray device, an echocardiogram device, a computed tomography (CT) device, a magnetic resonance imaging (MRI) device, a diffuse optical spectroscopy device, a near infrared spectroscopy (NIRS) device, a perfusion monitoring device, a laser Doppler flowmetry device, a nuclear scan device, a genetic test, or a combination thereof (para. [0043]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes one or more claim limitations that uses the word “means,” and is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a means for evaluating a metabolic state of the patient” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Based on the review of the instant specification, the corresponding structure of a means for evaluating a metabolic state of the patient is an optical hemodynamic monitor, a blood sugar test using a rapid handheld glucometer, a rapid bedside testing of ketosis level via serum or urine samples (para. [0043]), a magnetic bead assay that determines serum concentrations of corticosterone, glucagon, and insulin simultaneously (para. [0090]), or a wearable device consisting of a miniaturized light source and detector and associated optics (e.g. MEMS/MOEMS technology) built into a patch or elastic band that attaches to the head, limb, or another part of the body and configured to detect the backscattered light at one or more wavelengths and modulation frequencies to obtain tissue optical properties such as absolute or relative blood flow, hemoglobin concentration, oxygenation, and cerebral metabolic rate of oxygen (or ratios of these parameters) (para. [0044]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
This application includes one or more claim limitations that uses the word “means,” and is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a means for evaluating clinical signs and symptoms” in claim 9.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Based on the review of the instant specification, the corresponding structure of a means for evaluating clinical signs and symptoms is at least some of the devices in para. [0043].
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hodgdon (US 2005/0228692) in view of Bayer et al. (US 2002/0133087).
Re Claim 1, Hodgdon discloses a system for generating a neuroprotective nutrition program for a patient, the system comprising:
a. a means for evaluating the patient's risk of an ischemic event (para. [0065], [0067], Health Scores and/or incentives are based on medical testing devices incorporating one or more tests, such as, for example, a hemoglobin A1c test, a blood-pressure test, a lipids test, a cholesterol test, a peak-flow test, an oxygen saturation test, a spirometer test, an exercise-based test, a heart-rate test, a body-fat test, a prescription-adherence test, a medical-laboratory test, a body-weight test, a chemotherapy-based test, a temperature-based test, a kidney-dialysis test, and/or a neuropathy test; para. [0029], restenosis, atherosclerosis, atherogenesis, angina (particularly chronic, stable angina pectoris), ischemic disease, congestive heart failure, pulmonary edema associated with acute myocardial infarction, thrombosis, controlling blood pressure in hypertension (for example, hypertension associated with cardiovascular surgical procedures), platelet aggregation, platelet adhesion, smooth muscle cell proliferation, vascular complications associated with the use of medical devices, wounds associated with the use of medical devices, and the like; para. [0053], incentives to modify or alter behavior (for example, implementing a heart-healthy diet or exercise regime) and/or implement pharmacotherapy are based upon having one or more risk factors for heart attack and may be further incentivized by the level of risk a particular risk factor is associated with in having a heart attack. Information to determine coronary heart disease and stroke risk is available at http://www.nhlbi.nih.gov/about/framingham/, which includes a description of the Framingham Coronary Heart Disease Risk Scoring System and the Framingham Stroke Risk Scoring System. Current methods for detecting a subject's susceptibility to stroke are well known, including, for example, positron emission tomography (PET) and sonogram technology to image capillaries in the brain. A stroke can also be preceded by changes in blood flow in the brain, and may occur well in advance of the stroke, sometimes appearing months beforehand. Other methods of detecting and/or assessing for the risk of stroke can also be found in U.S. Pat. Nos. 6,251,587; 6,280,393; and 6,466,816); and
b. a means for evaluating a metabolic state of the patient to determine the neuroprotective potential of caloric restriction of the patient (para. [0015], The health risks, the biometric parameters, and/or the biomedical parameters may also be scored based on the impact on excess health care claim. Illustratively, a health risk, a biometric parameter, and/or a biomedical parameter can include, for example, tobacco use, blood pressure, body weight, body-mass-index, body fat, total cholesterol level, high density cholesterol level, ratio of total cholesterol level to high density cholesterol level, low density cholesterol level, triglyceride level, glucose level, or gamma glutamyltransferase level);
wherein combination of the patient's risk of an ischemic event and neuroprotective potential of caloric restriction allow for generation of the neuroprotective nutrition program (para. [0015], implementing a healthy dietary change while a dietary change can include, for example, consuming food that is either higher or lower depending on the condition of the participant in at least one of salt, calories, carbohydrates, protein, fat, cholesterol, and/or triglycerides, improving serum cholesterol and triglyceride levels or ratios and/or a hemoglobin A1c score; para. [0018], one or more dietary changes can assist in bringing the health risk, the biometric parameter, and/or the biomedical parameter falling outside the medical index of normal range substantially into normal range; para. [0045], [0046], Incentives can also be offered to a participant to implement a dietary change, which includes, for example, increasing (or decreasing, depending on the health condition of the participant).
Hodgdon doesn’t explicitly express that the means for evaluating the patient’s risk of an ischemic event comprise at least one means for real-time physiologic diagnostic monitoring.
However, Bayer discloses patient monitor for determining a probability that a patient has acute cardiac ischemia (abstract) and teaches means for evaluating the patient’s risk of an ischemic event comprise at least one means for real-time physiologic diagnostic monitoring (abstract, para. [0008], [0009], detection of acute cardiac ischemia by continuous monitoring of ECG signals obtained by ECG lead; para. [0028]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hodgdon, by adding at least one means for real-time physiologic diagnostic monitoring to means for evaluating the patient’s risk of an ischemic event, as taught by Bayer, for the purpose of detection of acute cardiac ischemia and emergency room diagnosis (para. [0028]).
Re Claim 2, Hodgdon discloses that the ischemic event is cardiac arrest, a focal stroke, or another ischemic event (para. [0053], methods of detecting and/or assessing for the risk of stroke, para. [0015], [0043], [0067]).
Re Claim 3, Hodgdon discloses that the means for evaluating the metabolic state of the patient is configured to evaluate a cerebral metabolic state, a non-cerebral metabolic state, or a combination thereof (para. [0064], The time interval between each Health Care assessment needed to maintain and/or qualify for an incentive or benefit is based on a particular disease and/or disorder the individual is inflicted with or is prone to, and/or its degree or severity. For example, an individual with a score indicating a high propensity for diabetes (for example, family history, obesity, elevated glucose levels compared to non-diabetic individuals) or a high risk of complications caused from diabetes (such as, for example, heart attack, amputation, loss of eyesight) may require health-status testing on an hourly, twice-a-day, three-times-a-day, four-times-a-day, daily, weekly, or monthly basis after a baseline measurement is determined to maintain a benefit, while someone with a low propensity for diabetes may only require health-status testing on a yearly basis, or longer, after a baseline measurement is determined; para. [0015], [0043], [0067], The health risks, the biometric parameters, and/or the biomedical parameters may also be scored based on the impact on excess health care claim. Illustratively, a health risk, a biometric parameter, and/or a biomedical parameter can include, for example, tobacco use, blood pressure, body weight, body-mass-index, body fat, total cholesterol level, high density cholesterol level, ratio of total cholesterol level to high density cholesterol level, low density cholesterol level, triglyceride level, glucose level, or gamma glutamyltransferase level; para. [0053], incentives to modify or alter behavior (for example, implementing a heart-healthy diet or exercise regime) and/or implement pharmacotherapy are based upon having one or more risk factors for heart attack and may be further incentivized by the level of risk a particular risk factor is associated with in having a heart attack. Information to determine coronary heart disease and stroke risk is available at http://www.nhlbi.nih.gov/about/framingham/, which includes a description of the Framingham Coronary Heart Disease Risk Scoring System and the Framingham Stroke Risk Scoring System. Current methods for detecting a subject's susceptibility to stroke are well known, including, for example, positron emission tomography (PET) and sonogram technology to image capillaries in the brain. A stroke can also be preceded by changes in blood flow in the brain, and may occur well in advance of the stroke, sometimes appearing months beforehand. Other methods of detecting and/or assessing for the risk of stroke can also be found in U.S. Pat. Nos. 6,251,587; 6,280,393; and 6,466,816).
Re Claim 4, Hodgdon discloses that the system is configured to allow for comparison of a cerebral metabolic state and a non-cerebral metabolic state so as to assess autoregulation (para. [0043], Health risk screening can include a number of instruments known to those skilled in the art to address one or more parameters used to calculate a Health Score, including, for example, a self assessment survey, which parameters may include, for example, a participants exercise habits, motor skills, alcohol use, nutrition, self care, tobacco use, and/or safety habits; a medical history survey, which parameters may include, for example, a participant's family and personal medical history, prior healthcare utilization, symptoms of disease, blood pressure, height, and/or weight (biometric data); health status survey, which parameters may include, for example, health distress, health perception, musculo-skelatal condition, mental health, pain, social functioning, stress, anxiety, vitality, biometric data, body composition, and/or body fat; and/or blood chemistry analysis, which parameters may include, for example, organ functioning and/or possible onset of disease; para. [0067], a participant to determine the participant's health score completes a health survey. A health survey can include, for example, a health risk assessment questionnaire, a biometric measurement analysis, and/or a biomedical analysis of, for example, a biosample; the entire disclosure of para. [0043] and [0067]; para. [0099], Referring to FIG. 3, in yet another embodiment of the present invention, data coming from laboratory analysis 300 is parsed 301 and entered into a database 302. Such data includes, for example, biometric data, biomedical data, and/or vital organ chemistries data).
Re Claim 5, Hodgdon discloses that the neuroprotective nutrition program comprises a neuroprotective dietary limit (para. [0015], [0019], A behavioral change can include, for example, quitting smoking or use of tobacco, implementing an exercise program, while a dietary change can include, for example, consuming food that is either higher or lower depending on the condition of the participant in at least one of salt, calories, carbohydrates, protein, fat, cholesterol, and/or triglycerides; para. [0054], [0055], dietary change to prevent and/or treat the deficient function and/or lower the risk of developing a disease and/or disorder associated with the deficient function; para. [0067], [0071]).
Re Claim 6, Hodgdon discloses that the neuroprotective nutrition program is for a period of less than 72 hours (para. [0015], [0044], The incentive program can also provide for incentives for improving a Health Score over a period of time, maintaining a predetermined Health Score over a period of time, partaking in the incentive program at a future point in time, and/or improving an individual health parameter, such as, for example, quitting smoking, lowering alcohol consumption, implementing a healthy dietary change, implementing an exercise program, and/or improving serum cholesterol and triglyceride levels or ratios and/or a hemoglobin A1c score; para. [0066], the incentive program bases the incentive on the Health Score of the participant determined initially or after a period of time after the initial determination. For example, the period of time between an initial determination of a Health Score and a subsequent one can vary depending on the health condition of the participant, and, for example, can be about once, twice, three, four, five, six times a day, a day, a week, a month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, twelve months, or more; claim 27, the period of time comprises about one hour, two hours, six hours, eight hours, twelve hours, eighteen hours, one day, two days, three days, four days, five days, six days, one month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, twelve months, twenty-two months, thirty-six months, forty-eight months, or sixty months).
Re Claim 7, Hodgdon discloses that the neuroprotective nutrition program is for a period of less than 24 hours (para. [0015], [0044], The incentive program can also provide for incentives for improving a Health Score over a period of time, maintaining a predetermined Health Score over a period of time, partaking in the incentive program at a future point in time, and/or improving an individual health parameter, such as, for example, quitting smoking, lowering alcohol consumption, implementing a healthy dietary change, implementing an exercise program, and/or improving serum cholesterol and triglyceride levels or ratios and/or a hemoglobin A1c score; para. [0066], the incentive program bases the incentive on the Health Score of the participant determined initially or after a period of time after the initial determination. For example, the period of time between an initial determination of a Health Score and a subsequent one can vary depending on the health condition of the participant, and, for example, can be about once, twice, three, four, five, six times a day, a day, a week, a month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, twelve months, or more; claim 27, the period of time comprises about one hour, two hours, six hours, eight hours, twelve hours, eighteen hours, one day, two days, three days, four days, five days, six days, one month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, twelve months, twenty-two months, thirty-six months, forty-eight months, or sixty months).
Re Claim 8, Hodgdon discloses that the neuroprotective nutrition program includes a set ratio or amount of macronutrients (para. [0015], [0019], A behavioral change can include, for example, quitting smoking or use of tobacco, implementing an exercise program, while a dietary change can include, for example, consuming food that is either higher or lower depending on the condition of the participant in at least one of salt, calories, carbohydrates, protein, fat, cholesterol, and/or triglycerides; para. [0054], [0055], dietary change to prevent and/or treat the deficient function and/or lower the risk of developing a disease and/or disorder associated with the deficient function; para. [0071]).
Re Claim 9, Hodgdon discloses that the means for evaluating the patient's risk of an ischemic event comprises a means for evaluating clinical signs and symptoms, an oxygen saturation monitor, a pulse oximeter, a blood pressure monitor, heart rate monitor, a heart rhythm monitor, an electrocardiogram device, a serum laboratory profile, a serum laboratory profile including cardiac enzymes, a coronary catheterization or angiogram device, a chest x-ray device, an echocardiogram device, a computed tomography (CT) device, a magnetic resonance imaging (MRI) device, a diffuse optical spectroscopy device, a near infrared spectroscopy (NIRS) device, a perfusion monitoring device, a laser Doppler flowmetry device, a nuclear scan device, a genetic test, or a combination thereof (para. [0065], Health Scores and/or incentives are based on medical testing devices incorporating one or more tests, such as, for example, a hemoglobin A1c test, a blood-pressure test, a lipids test, a cholesterol test, a peak-flow test, an oxygen saturation test, a spirometer test, an exercise-based test, a heart-rate test, a body-fat test, a prescription-adherence test, a medical-laboratory test, a body-weight test, a chemotherapy-based test, a temperature-based test, a kidney-dialysis test, and/or a neuropathy test. Such tests and/or devices may be incorporated into the present methods and/or systems for monitoring and/or calculating Health Scores and/or incentives, including those devices described in, for example, U.S. Patent Application Publication No. 03/0050537; para. [0099], Referring to FIG. 3, in yet another embodiment of the present invention, data coming from laboratory analysis 300 is parsed 301 and entered into a database 302. Such data includes, for example, biometric data, biomedical data, and/or vital organ chemistries data).
Re Claim 10, Hodgdon discloses that the means for evaluating a metabolic state of the patient is configured to measure cerebral metabolic rate of oxygen (CMRO2), cerebral metabolic rate of glucose, cerebral blood flow (CBF), flow-metabolism ratio (CBF/CMRO2) tissue concentration of deoxy-hemoglobin (ctHb), tissue concentration of oxygenated hemoglobin (ctHbO2), tissue oxygenation (StO2), tissue water content, tissue lipid content, tissue reduced scattering coefficient, tissue scattering amplitude, tissue scattering slope, tissue reflectance, or a combination thereof (para. [0065], Health Scores and/or incentives are based on medical testing devices incorporating one or more tests, such as, for example, a hemoglobin A1c test, a blood-pressure test, a lipids test, a cholesterol test, a peak-flow test, an oxygen saturation test, a spirometer test, an exercise-based test, a heart-rate test, a body-fat test, a prescription-adherence test, a medical-laboratory test, a body-weight test, a chemotherapy-based test, a temperature-based test, a kidney-dialysis test, and/or a neuropathy test. Such tests and/or devices may be incorporated into the present methods and/or systems for monitoring and/or calculating Health Scores and/or incentives, including those devices described in, for example, U.S. Patent Application Publication No. 03/0050537).
Re Claim 11, Hodgdon discloses that the patient's metabolic state is evaluated based on most recent meal times, glucose levels, corticosterone levels, glucagon levels, insulin levels, ketone levels, or a combination thereof (para. [0121], a Health Score is scored, ranked, and/or graded based on a 100 point scale and can include health risks such as, for example, tobacco use (24/100), blood pressure (16/100), weight control (12/100), body fat (12/100), total cholesterol (4/100), high density lipoprotein cholesterol (4/100), total/high density lipoprotein cholesterol ratio (4/100), low density lipoprotein cholesterol (4/100), triglycerides (8/100), serum glucose level (8/100), and glutamyltransferase level (4/100); Table 1).
Re Claim 12, Hodgdon discloses that the means for evaluating the patient's metabolic state is configured to measure one or more analytes from a biological sample taken from the patient (para. [0121], a Health Score is scored, ranked, and/or graded based on a 100 point scale and can include health risks such as, for example, tobacco use (24/100), blood pressure (16/100), weight control (12/100), body fat (12/100), total cholesterol (4/100), high density lipoprotein cholesterol (4/100), total/high density lipoprotein cholesterol ratio (4/100), low density lipoprotein cholesterol (4/100), triglycerides (8/100), serum glucose level (8/100), and glutamyltransferase level (4/100); Table 1).
Re Claim 13, Hodgdon discloses that the biological sample is a blood, tissue, saliva, sweat, cerebral spinal fluid, respiratory gas, or urine sample (para. [0004], [0014], [0044], providing a biosample, for example, a blood, tissue, organ, saliva, hair, skin, fingernail, toenail, urine, and/or stool sample for biomedical analysis and/or completing a biometric measurement analysis).
Re Claim 14, Hodgdon discloses that the biological sample is evaluated using techniques comprising metabolomics, proteomics, and transcriptomics to obtain data on the concentrations of endogenous metabolites in the sample and quantify how these metabolite concentrations change as a result of caloric restriction (para. [0121], a Health Score is scored, ranked, and/or graded based on a 100 point scale and can include health risks such as, for example, tobacco use (24/100), blood pressure (16/100), weight control (12/100), body fat (12/100), total cholesterol (4/100), high density lipoprotein cholesterol (4/100), total/high density lipoprotein cholesterol ratio (4/100), low density lipoprotein cholesterol (4/100), triglycerides (8/100), serum glucose level (8/100), and glutamyltransferase level (4/100); para. [0056], [0059] discloses proteomics, and transcriptomics, para. [0061] discloses gene therapy, Table 1, para. [0043], [0015], [0044], The incentive program can also provide for incentives for improving a Health Score over a period of time, maintaining a predetermined Health Score over a period of time, partaking in the incentive program at a future point in time, and/or improving an individual health parameter, such as, for example, quitting smoking, lowering alcohol consumption, implementing a healthy dietary change, implementing an exercise program, and/or improving serum cholesterol and triglyceride levels or ratios and/or a hemoglobin A1c score, para. [0066])
Re Claim 19, Claim 19 is rejected under substantially the same basis as claim 1.
Re Claim 20, Hodgdon discloses re-evaluating the patient's metabolic state after a time period and amending the neuroprotective nutrition program based on a change in the patient's metabolic state (para. [0015], [0044], The incentive program can also provide for incentives for improving a Health Score over a period of time, maintaining a predetermined Health Score over a period of time, partaking in the incentive program at a future point in time, and/or improving an individual health parameter, such as, for example, quitting smoking, lowering alcohol consumption, implementing a healthy dietary change, implementing an exercise program, and/or improving serum cholesterol and triglyceride levels or ratios and/or a hemoglobin A1c score; para. [0066], the incentive program bases the incentive on the Health Score of the participant determined initially or after a period of time after the initial determination. For example, the period of time between an initial determination of a Health Score and a subsequent one can vary depending on the health condition of the participant, and, for example, can be about once, twice, three, four, five, six times a day, a day, a week, a month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, twelve months, or more; claim 27, the period of time comprises about one hour, two hours, six hours, eight hours, twelve hours, eighteen hours, one day, two days, three days, four days, five days, six days, one month, two months, three months, four months, five months, six months, seven months, eight months, nine months, ten months, eleven months, twelve months, twenty-two months, thirty-six months, forty-eight months, or sixty months).
Claims 1, 2, 3, 5, 9, 11, 12, 13, 14, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hinman et al. (US 2020/0057075A1) in view of Dambinova (US 2009/0181006 A1).
Re Claim 1, Hinman discloses a system for generating a neuroprotective nutrition program for a patient, the system comprising:
a. a means for evaluating the patient's risk of an ischemic event (para. [0006], An assay as described herein would be extremely useful to practicing clinicians of many specialties to identify patients at risk for the development of silent brain ischemia (SBI), para. [0007], Described herein are molecules that are produced by cerebral endothelial cells exposed to chronic vascular risk factors including obesity, hyperlipidemia, hypertension, and glucose intolerance. These stress molecules are produced by cerebral endothelial cells and detectable in the serum. These molecules serve as diagnostic indicators of brain-specific endothelial cell damage and correlate with MRI indicators of silent stroke and impaired cognitive function; para. [0008], [0009], Provided hereinbelow is a list of markers for this assay. Tier 1 molecules (CXCL5/6, IGFBP2, ITGB3, IL-17B) are preferred molecules and each can serve as an independent marker of silent cerebrovascular injury. Tier 2 molecules (IL-17A, GDF-15, FGF-23. MCP-1) provide additional markers. These Tier 2 markers, as well as other markers (such as TNFa, IL-18, IL-6, Fibrinogen, BDNF, ST2, SRAGE, MPO, and LpPLA2) can be used in combination with one or more Tier 1 markers. The combination of one or more of these markers with one or more Tier 1 markers will provide additional diagnostic accuracy above each any one assay component. The panel of markers provide longitudinal predictive value and can be modulated by various pharmacologic or lifestyle interventions; para. [0056], Provided below is a list of markers for this assay. Tier 1 molecules (Table 1) are our strongest candidate molecules and each can serve as an independent marker of silent cerebrovascular injury. Tier 2 molecules (Table 2) provide additional markers. The combination of these markers will provide additional diagnostic accuracy above each any one assay component. The panel of markers provide longitudinal predictive value and can be modulated by various pharmacologic or lifestyle interventions. Previously known markers of cardiovascular disease (CVD), such as those listed in Table 3, can be used in conjunction with one or more markers listed in Tables 1 and 2.); and
b. a means for evaluating a metabolic state of the patient to determine the neuroprotective potential of caloric restriction of the patient (para. [0056], Provided below is a list of markers for this assay. Tier 1 molecules (Table 1) are our strongest candidate molecules and each can serve as an independent marker of silent cerebrovascular injury. Tier 2 molecules (Table 2) provide additional markers. The combination of these markers will provide additional diagnostic accuracy above each any one assay component. The panel of markers provide longitudinal predictive value and can be modulated by various pharmacologic or lifestyle interventions. Previously known markers of cardiovascular disease (CVD), such as those listed in Table 3, can be used in conjunction with one or more markers listed in Tables 1 and 2; para. [0082], [0083], [0085], immunoassay techniques, such as enzyme immunoassays; para. [0093], Diet-induced obesity creates a metabolic syndrome serologic profile, as shown in the following table showing total cholesterol, HDL, triglycerides, LDL, glucose, and HgbAlc for control versus subjects with high fat; para. [0006], [0018], The method comprises administering to the subject aspirin therapy, blood pressure therapy, body weight management, and/or a program of diet and exercise when levels of two or more SBI markers are elevated. Treating the subject for metabolic syndrome and/or stroke. Examples of treatment include, but are not limited to, aspirin therapy, blood pressure therapy, body weight management, and/or a program of diet and exercise);
wherein combination of the patient's risk of an ischemic event and neuroprotective potential of caloric restriction allow for generation of the neuroprotective nutrition program (para. [0006], An assay as described herein would be extremely useful to practicing clinicians of many specialties to identify patients at risk for the development of silent brain ischemia (SBI). Described herein is a method of treating a subject having silent brain ischemia and/or metabolic syndrome. The method comprises administering to the subject aspirin therapy, blood pressure therapy, body weight management, and/or a program of diet and exercise when levels of two or more SBI markers are elevated; para. [0018]-[0028]).
Hinman further discloses that imaging is a means for evaluating the patient’s risk of an ischemic event (para. [0111], imaging evidence of silent stroke, imaging indicators of cerebral small vessel disease (CSVD), also referred to as small vessel ischemic disease (SVID); para. [0114], [0115], MRI imaging).
Hinman is silent regarding the means for evaluating the patient’s risk of an ischemic event comprising at least one means for real-time physiologic diagnostic monitoring.
However, Dambinova discloses emergency room diagnosis and teaches at least one means for real-time physiologic diagnostic monitoring (para. [0055], NR2 peptide or NMDA receptor fragments levels are elevated at a very fast and early stage of ischemic events and thus provide a real time indication of brain damage especially when measured in conjunction with NIHSS and CT or DWI//MRI.).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hinman, by adding at least one means for real-time physiologic diagnostic monitoring to the means for evaluating the patient’s risk of an ischemic event, as taught by Dambinova, for the purpose of emergency room diagnosis and rehabilitation prognosis (para. [0055]).
Re Claim 2, Hinman discloses that the ischemic event is cardiac arrest, a focal stroke, or another ischemic event (para. [0006], An assay as described herein would be extremely useful to practicing clinicians of many specialties to identify patients at risk for the development of silent brain ischemia (SBI)).
Re Claim 3, Hinman discloses that the means for evaluating the metabolic state of the patient is configured to evaluate a cerebral metabolic state, a non-cerebral metabolic state, or a combination thereof (para. [0055], Described herein are molecules that are produced by cerebral endothelial cells exposed to chronic vascular risk factors including obesity, hyperlipidemia, hypertension, and glucose intolerance. These stress molecules are produced by cerebral endothelial cells and detectable in the serum. These molecules serve as diagnostic indicators of brain-specific endothelial cell damage and correlate with MRI indicators of silent stroke and impaired cognitive function, [0056], Provided below is a list of markers for this assay. Tier 1 molecules (Table 1) are our strongest candidate molecules and each can serve as an independent marker of silent cerebrovascular injury. Tier 2 molecules (Table 2) provide additional markers. The combination of these markers will provide additional diagnostic accuracy above each any one assay component. The panel of markers provide longitudinal predictive value and can be modulated by various pharmacologic or lifestyle interventions. Previously known markers of cardiovascular disease (CVD), such as those listed in Table 3, can be used in conjunction with one or more markers listed in Tables 1 and 2; Tables 1, 2, and 3).
Re Claim 5, Hinman discloses that the neuroprotective nutrition program comprises a neuroprotective dietary limit (para. [0018], the method further comprises treating the subject for metabolic syndrome and/or stroke. Examples of treatment include, but are not limited to, aspirin therapy, blood pressure therapy, body weight management, and/or a program of diet and exercise.).
Re Claim 9, Hinman discloses that the means for evaluating the patient's risk of an ischemic event comprises a means for evaluating clinical signs and symptoms, an oxygen saturation monitor, a pulse oximeter, a blood pressure monitor, heart rate monitor, a heart rhythm monitor, an electrocardiogram device, a serum laboratory profile, a serum laboratory profile including cardiac enzymes, a coronary catherization or angiogram device, a chest x-ray device, an echocardiogram device, a computed tomography (CT) device, a magnetic resonance imaging (MRI) device, a diffuse optical spectroscopy device, a near infrared spectroscopy (NIRS) device, a perfusion monitoring device, a laser Doppler flowmetry device, a nuclear scan device, a genetic test, or a combination thereof (para. [0032], [0033], The methods can be performed using, for example, immunoassay techniques, such as enzyme immunoassays, multiplex assays; para. [0056], markers for assay, Table 1, 2, and 3; para [0093], a metabolic syndrome serologic profile,).
Re Claim 11, Hinman discloses that the patient's metabolic state is evaluated based on most recent meal times, glucose levels, corticosterone levels, glucagon levels, insulin levels, ketone levels, or a combination thereof (para. [0091], This Example describes the effects of metabolic syndrome on cerebral microvasculature and unveils the molecular mechanisms that regulate these changes. This syndrome in mice strongly mimics the human condition marked by obesity, elevated cholesterol, and impaired glucose tolerance; para. [0093], Diet-induced obesity creates a metabolic syndrome serologic profile, as shown in the following table showing total cholesterol, HDL, triglycerides, LDL, glucose, and HgbAlc for control versus subjects with high fat).
Re Claim 12, Hinman discloses that the means for evaluating the patient's metabolic state is configured to measure one or more analytes from a biological sample taken from the patient (Table 4 shows the list of analytes; para. [0063], Table 4 above lists markers that are both novel and previously reported, as indicated. In some embodiments, a combination of two or more of the markers listed in Table 4 is used in a method or assay as described herein.).
Re Claim 13, Hinman discloses that the biological sample is a blood, tissue, saliva, sweat, cerebral spinal fluid, respiratory gas, or urine sample (para. [0030], In typical embodiments, the sample is a serum sample, CSF sample, a urine sample, a blood sample, or other bodily fluid. For use in the methods described herein, representative examples of the sample include, but are not limited to, blood, plasma or serum, saliva, urine, cerebral spinal fluid, milk, cervical secretions, semen, and other bodily fluids).
Re Claim 14, Hinman discloses that the biological sample is evaluated using techniques including, but not limited to, metabolomics, proteomics, transcriptomics, and other related technologies, to obtain data on the concentrations of endogenous metabolites in the sample and quantify how these metabolite concentrations change as a result of caloric restriction (para. [0032], [0033], The methods can be performed using, for example, immunoassay techniques, such as enzyme immunoassays, multiplex assays; para. [0110], We have identified several important proteomic markers of cerebral endothelial dysfunction that can improve sensitivity to early SVD and serve as predictors of SVD progression; para. [0018]-[0028], adjusting treatment based on status score).
Re Claim 19, Claim 19 is rejected under substantially the same basis as claim 1.
Re Claim 20, Hinman discloses re-evaluating the patient's metabolic state after a time period and amending the neuroprotective nutrition program based on a change in the patient's metabolic state (para. [0018]-[0028], The method further comprises treating the subject for metabolic syndrome and/or stroke. Examples of treatment include, but are not limited to, aspirin therapy, blood pressure therapy, body weight management, and/or a program of diet and exercise. (a) contacting a sample obtained from the subject with reagents that specifically bind to at least one marker selected from Table 1 or Table 2; (b) measuring the level of binding to the marker; (c) assigning a status score that reflects the measured amount of marker relative to a normal control; (d) treating the subject for metabolic syndrome and/or stroke if the status score is significantly greater than 1; (e) repeating steps (a) to (c); and (f) adjusting the treatment when the status score is not trending toward 1).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hodgdon (US 2005/0228692), as modified by Bayer et al. (US 2002/0133087), and further in view of Rowe et al (US 2016/0310049).
Re Claim 15, Hodgdon as modified by Bayer discloses the claimed invention substantially as set forth in claim 1.
Hodgdon is silent regarding the means for evaluating the patient's cerebral metabolic state comprising a wearable device.
Rowe discloses a means for evaluating the patient's cerebral metabolic state comprising a wearable device (para. [0157], A wearable device comprising an ion selective field effect transistor in electrical communication with a reference electrode can advantageously be employed to measure characteristics associated with the presence of ions in a fluid at a user's skin surface. Other components secreted in sweat include glucose, pyruvate, lactate, cytokines, immunoglobulins, antimicrobial peptides (e.g. dermcidin), and the like; para. [0178], Additional physiological metrics can be measured and can be used in conjunction with the pH or ion measurements obtained by the ISFET sensor in the wearable device. These metrics can include, but are not limited to, user heart rate, user photoplethysmography, user blood pressure, user respiration rate, user skin conduction, user blood glucose levels, user blood oxygenation, user skin temperature, user body temperature, user electromyography, and user electroencephalography. Of interest for fitness tracking are CO2 chemical sensors and heart rate sensors integrated into the wearable device to detect anaerobic threshold if heart rate is in exercise zones. Capacitance sensors integrated into the wearable device may be useful in identifying measurements made on dry skin, or measurements made when the device is not in contact with skin, or when the device is immersed in water. A glucose sensor can be integrated into the wearable device, the glucose sensor being configured for use in conjunction with an electrochemical test strip).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Hodgdon as modified by Bayer, configuring the means for evaluating the patient's cerebral metabolic state to comprise a wearable device, as taught by Rowe, for enabling convenient measurement and/or monitoring of the pH and/or chemical composition of sweat and other body fluids originating from the skin or sweat (para. [0146]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/ Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, January 15, 2026Examiner, Art Unit 3792