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 Objections
Claims 10, 12, 14, 16, 18 objected to because of the following informalities: Claims 10, 12, 14, 16 line 2; claim 18, line 3; typographical error, “an increased the likelihood the patient.” Appropriate correction is required.
Claim 11 objected to because of the following informalities: line 10, typographical error; “first posture angle during based on”. Appropriate correction is required.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless 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 second device external to the patient to measure the second measurements” in claim 2.
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.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter of abstract ideas under the mental processes and mathematical concepts groupings, without significantly more.
The framework for establishing a prima facie case of lack of subject matter eligibility requires that the Examiner determine: (1) Does the claim fall within the four categories of patent eligible subject matter; (2a) prong 1: Does the claim recite an abstract idea, law of
nature, or natural phenomenon and (2a) prong 2: Does the claim recite additional elements
that integrate the judicial exception into a practical application; and (2b) Does the claim recite additional elements that amount of significantly more than the judicial exception.
Under Step 1:
Independent claims 1, 21, and 22 are directed to a system and a method, and thus, the claims all fall under one of the four patent eligible categories.
Under Step 2A, Prong 1:
Claims 1, 21, 22 recite steps to determine one or more first measurements comprising subcutaneous tissue impedance measurements; obtain second measurements; determine a first respective one or more values for each of a plurality of first physiological parameters; determine a second respective one or more values for each of a plurality of second physiological parameters; identify a first diagnostic state for each of the first physiological parameters based on the first respective values; identify a second diagnostic state for each of the second physiological parameters based on the second respective values; determine, from the probability model, a probability score.
Under broadest reasonable interpretation, these limitations appear to be directed to mental processes because they concern observing, evaluating, and comparing signal data using mathematical formulas which can be performed in the mind or with pen and paper. A trained clinician can evaluate a set of signal data from a patient; observe first subcutaneous tissue impedance measurements; observe second measurements; identify first respective values for each of first physiological parameters; identify second respective values for each of second physiological parameters; evaluate patient diagnostic states for first and second physiological parameters from their respective values; and perform statistical analysis on first and second diagnostic states to determine a probability score. Accordingly, claims 1, 21, 22 are directed to a judicial exception including one or more abstract ideas under mental processes.
Dependent claim 2 recites an additional limitation to measure the second measurements but appears to be directed to mental processes because it further limits an abstract process and concerns observations and mental judgements which can be performed in the mind or with pen and paper.
Dependent claim 3 recites an additional limitation of the second device includes one or more of a smartphone, scale, bed sensor, biochemical sensor, camera, smart device, wearable computing device, continuous glucose monitor but appears to be directed to mental processes because it further limits an abstract process.
Dependent claim 4 recites an additional limitation to determine, from the probability model, a probability score indicating a likelihood that the patient is likely to experience the adverse health event within a predetermined amount of time but appears to be directed to mental processes because it further limits an abstract process and concerns observations, judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 5 recites an additional limitation of the physiological status of the patient includes one or more of: heart rate, respiratory rate, fluid status, sympathetic tone, heart rate variability (HRV), blood pressure, fluid redistribution, tissue perfusion, pulse oxygenation, or sleep disordered breathing but appears to be directed to mental processes because it further limits an abstract process.
Dependent claim 6 recites an additional limitation of one or more of the second physiological parameters indicates the precipitating condition of the patient, and the precipitating condition includes one or more of: current clinical status, clinical history, weight, pneumonia, sepsis, respiratory infection, chronic obstructive pulmonary disease (COPD), atrial fibrillation with rapid ventricular rate, anemia, hypoxemia, hyperglycemia, hypoglycemia, panic attack, physical exertions, dietary non-compliance, medication non-compliance, dietary change, medication change, reduction in urinary output, sleep apnea, Cheyenes Stokes breathing, sleep apnea burden, premature ventricular contractions (PVC) burden, or increased fluid consumption but appears to be directed to mental processes because it further limits an abstract process and concerns observations and mental judgements which can be performed in the mind or with pen and paper.
Dependent claim 7 recites an additional limitation of one or more of the second physiological parameters indicates the symptom of the patient, and the symptom of the patient includes one or more of respiratory rate, respiratory effort, rales through lung sounds, symptom app, coughing, cough frequency, chronotropic incompetence, hematocrit, and peripheral perfusion of incident infection but appears to be directed to mental processes because it further limits an abstract process and concerns observations and mental judgements which can be performed in the mind or with pen and paper.
Dependent claim 8 recites an additional limitation of one or more of the second physiological parameters indicates the functional capacity of the patient, and the functional capacity of the patient includes one or more of: activity, voice pattern, sleep posture, gait, speech pattern, and sit-to-stand time but appears to be directed to mental processes because it further limits an abstract process and concerns observations and mental judgements which can be performed in the mind or with pen and paper.
Dependent claim 9 recites an additional limitation of the first measurements include heart rate measurements, and the second measurements patient activity measurements; collate the heart rate measurements and activity measurements over a period of time; apply a line fit to the collated measurements to determine a rate of change of heart rate as a function of change in activity over the period time; determine a slope of the applied line fit; compare the determined slope to a threshold; and determine the second diagnostic state based on the comparison but appears to be directed to mental processes because it further limits an abstract process and concerns observations, mental judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 10 recites an additional limitation of the determined second diagnostic state is chronotropic incompetence to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event but appears to be directed to mental processes because it further limits an abstract process and concerns observations, mental judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 11 recites an additional limitation of the second measurements include posture angle measurements and patient activity measurements; determine a first period of time when the patient is active based on the activity measurements; determine a second period of time when the patient is at rest based on the activity measurements; collate the plurality of posture angle measurements during the first period of time; collate the plurality of posture angle measurements during the second period of time; determine a first posture angle during based on the plurality of posture angle measurements during the first period of time; determine a second posture angle based on the plurality of posture angle measurements during the second period of time; compare the determined first posture angle to the determined second posture angle; and determine the second diagnostic state based on the comparison but appears to be directed to mental processes because it further limits an abstract process and concerns observations, mental judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 12 recites an additional limitation of the determined second diagnostic state is a low posture difference to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event but appears to be directed to mental processes because it further limits an abstract process and concerns observations, mental judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 13 recites an additional limitation of the second measurements include short-term heart rate variability (HRV) measurements; determine HRV metrics based on the HRV measurements; collate the determined HRV metrics over a period of time; compare collated HRV metrics to a respective threshold; and determine the second diagnostic state based on the comparison but appears to be directed to mental processes because it further limits an abstract process and concerns observations, mental judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 14 recites an additional limitation of the determined second diagnostic state is a high mode-sum value to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event but appears to be directed to mental processes because it further limits an abstract process and concerns observations, mental judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 15 recites an additional limitation of the first measurements include interstitial impedance measurements, and the second measurements include patient activity measurements; collate the measured interstitial impedance over a first period of time; determine a second period of time when the patient is inactive based on the activity measurements, the second period of time being within the first period of time; and determine the second diagnostic state based on the measured interstitial impedances over the second period of time but appears to be directed to mental processes because it further limits an abstract process and concerns observations, mental judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 16 recites an additional limitation of the determined second diagnostic state is sleep disordered breathing to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event but appears to be directed to mental processes because it further limits an abstract process.
Dependent claim 17 recites an additional limitation of the first measurements include an electrocardiogram (ECG) signal; collate R-wave features based on R-waves of the ECG signal;
compare collated R-wave features to a respective threshold; and determine the second diagnostic state based on the comparison but appears to be directed to mental processes because it further limits an abstract process and concerns observations, mental judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 18 recites an additional limitation of the determined second diagnostic state is one or more of decreasing R-wave amplitude, increasing QRS complex duration, and increasing QRS width to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event but appears to be directed to mental processes because it further limits an abstract process and concerns observations, mental judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 19 recites an additional limitation of the implantable medical device comprises an insertable cardiac monitor; determine the subcutaneous tissue impedance measurements via the first electrode and the second electrode but appears to be directed to mental processes because it further limits an abstract process and concerns observations, mental judgements, and calculations which can be performed in the mind or with pen and paper.
Dependent claim 20 recites an additional limitation of communicate with the implantable medical device but appears to be directed to mental processes because it further limits an abstract process.
Under Step 2A, Prong 2:
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (2) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. MPEP 2106.04(d).
Claims 1, 21, 22 fail to include any additional elements that integrate the abstract idea into a practical application. Claim 1 includes an implantable medical device comprising a plurality of electrodes, processing circuitry, storage devices, and the steps of determine one or more first measurements and obtain second measurements wherein the implantable medical device and electrodes generally link the use of the judicial exception to a particular field of use; and processing circuitry and storage devices are generic computer structures for implementing the abstract ideas on a computer; determine and obtain are insignificant pre-solution activity (data gathering). The processing circuitry and storage devices include additional steps of determine a first respective one or more values, determine a second respective one or more values, identify a first diagnostic state, identify a second diagnostic state, and determine a probability score wherein the processing circuitry and storage devices are generic computer structures for implementing the abstract ideas on a computer; identify is insignificant pre-solution activity (data gathering); PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) (assessing or measuring data derived from an ultrasound scan, to be used in a diagnosis).
Claims 2-3 include a second device external to the patient wherein the second device is a generic computer structure for implementing the abstract ideas on a computer and/or generally links the use of the judicial exception to a particular technological environment or field of use.
Claim 4 includes a step of determine, from the probability model, a probability score indicating a likelihood that the patient is likely to experience the adverse health event within a predetermined amount of time wherein the processing circuitry is a generic computer structure for implementing the abstract idea on a computer.
Claim 9 includes steps of collate the heart rate measurements and activity measurements over a period of time, apply a line fit to the collated measurements to determine a rate of change of heart rate as a function of change in activity over the period time, determine a slope of the applied line fit, compare the determined slope to a threshold, and determine the second diagnostic state based on the comparison wherein the processing circuitry is a generic computer structure for implementing the abstract ideas on a computer; apply and determine are pre-solution activity (data gathering).
Claim 11 includes steps of determine a first period of time when the patient is active based on the activity measurements, determine a second period of time when the patient is at rest based on the activity measurements, collate the plurality of posture angle measurements during the first period of time, collate the plurality of posture angle measurements during the second period of time, determine a first posture angle during based on the plurality of posture angle measurements during the first period of time, determine a second posture angle based on the plurality of posture angle measurements during the second period of time, compare the determined first posture angle to the determined second posture angle, and determine the second diagnostic state based on the comparison wherein the processing circuitry is a generic computer structure for implementing the abstract ideas on a computer.
Claim 13 includes steps of determine HRV metrics based on the HRV measurements, collate the determined HRV metrics over a period of time, compare collated HRV metrics to a respective threshold, and determine the second diagnostic state based on the comparison wherein the processing circuitry is a generic computer structure for implementing the abstract ideas on a computer.
Claim 15 includes steps of collate the measured interstitial impedance over a first period of time, determine a second period of time when the patient is inactive based on the activity measurements, the second period of time being within the first period of time, and determine the second diagnostic state based on the measured interstitial impedances over the second period of time wherein the processing circuitry is a generic computer structure for implementing the abstract ideas on a computer.
Claim 17 includes steps of collate R-wave features based on R-waves of the ECG signal, compare collated R-wave features to a respective threshold, and determine the second diagnostic state based on the comparison wherein the processing circuitry is a generic computer structure for implementing the abstract ideas on a computer.
Claim 19 includes an insertable cardiac monitor, a housing, and a step to determine the subcutaneous tissue impedance measurements via the first electrode and the second electrode wherein the insertable cardiac monitor and housing links the use of the judicial exception to a particular field of use; determine is pre-solution activity (data gathering).
Despite the fact that the abstract ideas claimed are performed on a generic computer, the courts do not distinguish between claims that recite mental processes performed by humans and claims that recite mental processes performed on a computer. As the Federal Circuit has explained, “[c]ourts have examined claims that required the use of a computer and still found that the underlying, patent-ineligible invention could be performed via pen and paper or in a person’s mind.” Versata Dev. Group v. SAP Am., Inc., 793 F.3d 1306, 1335, 115 USPQ2d 1681, 1702 (Fed. Cir. 2015). See also Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318, 120 USPQ2d 1353, 1360 (Fed. Cir. 2016) (‘‘[W]ith the exception of generic computer-implemented steps, there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper.’’); Mortgage Grader, Inc. v. First Choice Loan Servs. Inc., 811 F.3d 1314, 1324, 117 USPQ2d 1693, 1699 (Fed. Cir. 2016) (holding that computer-implemented method for “anonymous loan shopping” was an abstract idea because it could be “performed by humans without a computer”). See MPEP 2106.04(a)(2)(III).
Furthermore, generic computer components that perform abstract ideas are still abstract mental processes unless the claim limitation cannot be practically performed in the mind. As such, “processing circuitry”, “storage devices”, and “second external device” appear to amount to nothing more than a suggestion to “apply it” on a computer; Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983. See also 573 U.S. at 224, 110 USPQ2d at 1984.
Under Step 2b:
Claims 1, 21, 22 fail to include any additional elements that, alone or in combination, amount to significantly more than the judicial exception. As discussed above with respect to integration of the judicial exception into a practical application, the additional elements of “IMD comprising a plurality of electrodes”, “processing circuitry”, “storage devices”, “second external device”, and “housing” are well-understood, routine, and conventional activities previously known in the field of electrostimulation as indicated in the following references:
US 2021/0106253 A1:
See [0030] for IMD comprising a plurality of electrodes
See [0068], (50, Fig. 3) for processing circuitry
See [0072], (56, Fig. 3) for storage device
See [0078], (12, Fig. 5) for second external device
See [0036] for housing
WO 2021/061688 A1:
See [0013] for IMD comprising a plurality of electrodes
See [0009] for processing circuitry
See [0051], (84, Fig. 3) for storage device
See [0051], (12, Fig. 4) for second external device
See [0139] for housing
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 4-8, 11-18, 20-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sarkar et al (International Publication WO 2021/061688 A1).
Regarding claim 1, Sarkar teaches a system comprising:
an implantable medical device (IMD) (10, Fig. 9) comprising a plurality of electrodes (at least two of 16A-16N, Fig. 9) and configured for subcutaneous implantation in a patient [0144], wherein the IMD is configured to determine one or more first measurements ([0144]; impedance values of interstitial fluid) comprising subcutaneous tissue impedance measurements via the electrodes ([0144-0145]; IMD 10 determines impedance values and other physiological parameters); and
processing circuitry (98, Fig. 2) coupled to one or more storage devices (96, Fig. 2), and configured to:
obtain second measurements, the second measurements being different than the first measurements ([0147]; EGM (ECG) signals);
determine a first respective one or more values for each of a plurality of first physiological parameters ([0146]; subcutaneous impedance), wherein each of the plurality of first physiological parameters indicates a physiological status of the patient ([0146]; fluid index), the plurality of first physiological parameters determined from the one or more first measurements (implicit; necessarily determined from first measurements);
determine a second respective one or more values for each of a plurality of second physiological parameters, wherein each of the plurality of second physiological parameters indicates at least one of a precipitating condition of the patient, a symptom of the patient, or a functional capacity of the patient ([0151]; tachyarrhythmia), the plurality of second physiological parameters determined from the one or more second measurements (implicit);
identify a first diagnostic state for each of the first physiological parameters based on the first respective values ([0145], [0176]; impedance scores determine low, medium, high risk) and identify a second diagnostic state for each of the second physiological parameters based on the second respective values ([0160], [0175]; heart rate values e.g. HRV determine heart failure risk), the first and second diagnostic states defining a plurality of inputs for a probability model (19, Fig. 3) ([0120], [0128], Fig. 4; diagnostic states determine evidence nodes 8 which are inputs to probability model 19); and
determine, from the probability model, a probability score indicating at least one of a likelihood that the patient (a) is experiencing an adverse health event of a chronic condition of the patient (optional limitation) or (b) is to experience the adverse health event ([0128]; probability score from probability model indicates likelihood patient will experience adverse health event).
Regarding claim 4, Sarkar teaches the system of claim 1, and further teaches wherein the processing circuitry is configured to determine, from the probability model, a probability score indicating a likelihood that the patient is likely to experience the adverse health event within a predetermined amount of time ([0013]; “…and determine, from the probability model, a probability score indicating a likelihood that the patient (a) is experiencing an adverse health event or (b) is likely to experience the adverse health event within a predetermined amount of time.”).
Regarding claim 5, Sarkar teaches the system of claim 1, and further teaches wherein the physiological status of the patient includes one or more of: heart rate, respiratory rate, fluid status, sympathetic tone, heart rate variability (HRV), blood pressure, fluid redistribution, tissue perfusion, pulse oxygenation, or sleep disordered breathing ([0050]; physiological parameters include heart rates).
Regarding claim 6, Sarkar teaches the system of claim 1, and further teaches wherein one or more of the second physiological parameters indicates the precipitating condition of the patient, and the precipitating condition includes one or more of: current clinical status, clinical history, weight, pneumonia, sepsis, respiratory infection, chronic obstructive pulmonary disease (COPD), atrial fibrillation with rapid ventricular rate, anemia, hypoxemia, hyperglycemia, hypoglycemia, panic attack, physical exertions, dietary non-compliance, medication non-compliance, dietary change, medication change, reduction in urinary output, sleep apnea, Cheyenes Stokes breathing, sleep apnea burden, premature ventricular contractions (PVC) burden, or increased fluid consumption ([0008]; probability model can input other known clinical risk stratifiers such as COPD, sleep apnea).
Regarding claim 7, Sarkar teaches the system of claim 1, and further teaches wherein one or more of the second physiological parameters indicates the symptom of the patient, and the symptom of the patient includes one or more of respiratory rate, respiratory effort, rales through lung sounds, symptom app, coughing, cough frequency, chronotropic incompetence, hematocrit, and peripheral perfusion of incident infection ([0005]; physiological parameters include respiration rate).
Regarding claim 8, Sarkar teaches the system of claim 1, and further teaches wherein one or more of the second physiological parameters indicates the functional capacity of the patient, and the functional capacity of the patient includes one or more of: activity, voice pattern, sleep posture, gait, speech pattern, and sit-to-stand time ([0005]; physiological parameters include activity parameters).
Regarding claim 11, Sarkar teaches the system of claim 1, and further teaches,
wherein the second measurements include posture angle measurements and patient activity measurements [0077], and the processing circuitry is further configured to:
determine a first period of time (implicit) when the patient is active based on the activity measurements ([0005]; daytime active angle);
determine a second period of time (implicit) when the patient is at rest based on the activity measurements ([0005]; nighttime rest angle);
collate (implicit) the plurality of posture angle measurements during the first period of time (time series measurements necessitate collated data);
collate (implicit) the plurality of posture angle measurements during the second period of time (time series measurements necessitate collated data);
determine a first posture angle (implicit) during based on the plurality of posture angle measurements during the first period of time ([0005]; daytime active angle);
determine a second posture angle (implicit) based on the plurality of posture angle measurements during the second period of time ([0005]; nighttime rest angle);
compare (implicit) the determined first posture angle to the determined second posture angle ([0098]; nighttime rest vs daytime active body angle); and
determine the second diagnostic state based on the comparison [0098].
Regarding claim 12, Sarkar teaches the system of claim 11, and further teaches wherein the determined second diagnostic state is a low posture difference ([0161]; posture changes) to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event ([0161]; posture changes used to determine probability of a health event which indicates likelihood of adverse health event occurring or will occur).
Regarding claim 13, Sarkar teaches the system of claim 1, and further teaches wherein the second measurements include short-term heart rate variability (HRV) measurements [0092], and the processing circuitry is further configured to:
determine HRV metrics based on the HRV measurements ([0092]; minimum HRV);
collate ([0092]; determining diagnostic states utilizes threshold comparisons in the last X number of days implies HRV data is combined in an ordered state) the determined HRV metrics over a period of time (time series measurements necessitate collated data);
compare collated HRV metrics to a respective threshold ([0092]; minHRV less than 55 ms); and
determine the second diagnostic state based on the comparison ([0092]; maxRR data satisfies threshold, then RR diagnostic state used as input to probability model; HRV diagnostic state implied as input to probability model when minHRV satisfies threshold).
Regarding claim 14, Sarkar teaches the system of claim 13, and further teaches wherein the determined second diagnostic state is a high mode-sum value ([0135], Fig. 6B; sum of scores) to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event ([0136], Table 3; high diagnostic evidence score more likely to have heart failure event in the next 30 days).
Regarding claim 15, Sarkar teaches the system of claim 1, and further teaches wherein
the first measurements include interstitial impedance measurements ([0162]; subcutaneous impedance indicative of fluid in interstitium 28), and the second measurements include patient activity measurements ([0161]; sensor 62 (Fig. 8) includes accelerometers that indicate activity level), and
the processing circuitry is further configured to:
collate (implicit) the measured interstitial impedance over a first period of time (interstitial measurements necessitate collated time series data);
determine a second period of time when the patient is inactive based on the activity measurements [0161], the second period of time being within the first period of time ([0113]; interstitial impedance measurements common to inactive time frames necessitates second period of time to be within the first period of time, [0172]; impedance measurements set to occur when certain conditions satisfied e.g. activity level); and
determine the second diagnostic state based on the measured interstitial impedances over the second period of time [0172-0175]; impedance score compared to risk threshold for diagnostic state e.g. heart failure risk).
Regarding claim 16, Sarkar teaches the system of claim 15, and further teaches wherein the determined second diagnostic state is sleep disordered breathing ([0172]; adverse diagnostic state for respiration parameters taken during sleep includes sleep disordered breathing) to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event ([0190]; high fluid based on impedance scores indicates possible or predicted heart failure decompensation).
Regarding claim 17, Sarkar teaches the system of claim 1, and further teaches wherein the first measurements include an electrocardiogram (ECG) signal ([0084]; R-R intervals derived from ECG measurements), and the processing circuitry is further configured to:
collate (implicit) R-wave features based on R-waves of the ECG signal ([0115]; processing circuitry 98 identifies parameter features that encode R-wave amplitude, out-of-normal range values, and temporal changes; ECG measurements necessitate collated time series data);
compare collated R-wave features to a respective threshold ([0115]; compares features to absolute threshold); and
determine the second diagnostic state based on the comparison ([0115]; high heart rate determined by expected heart rate values).
Regarding claim 18, Sarkar teaches the system of claim 17, wherein the determined second diagnostic state is one or more of decreasing R-wave amplitude, increasing QRS complex duration, and increasing QRS width ([0008], [0012]; metrics that indicate worsening heart failure include increased ventricular filling pressures or other morbidities associated with worsening heart failure; systolic (ventricular) heart failure necessitates reduced R-wave amplitude, increased QRS duration, and/or increasing QRS width) to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event ([0013]; diagnostic states define evidence nodes for a probability model; probability score associated with decreasing R-wave amplitude, increasing QRS complex duration, and/or increasing QRS width necessarily indicates increased likelihood patient will experience adverse health event).
Regarding claim 20, Sarkar teaches the system of claim 1, and teaches a system further comprising one or more computing devices configured to communicate with the implantable medical device, wherein the one or more computing devices comprise the processing circuitry ([0011]; medical device transmits data to external device for further processing).
Regarding claim 21, Sarkar teaches a method comprising:
determining a first respective one or more values for each of a plurality of first physiological parameters ([0146]; subcutaneous impedance), wherein each of the plurality of first physiological parameters indicates a physiological status of the patient ([0146]; fluid index), the plurality of first physiological parameters being determined from one or more first measurements ([0144]; impedance values of interstitial fluid; first physiological parameters necessarily determined from first measurements) comprising subcutaneous tissue impedance measurements ([0144-0145]; IMD 10 determines impedance values and other physiological parameters);
determining a second respective one or more values for each of a plurality of second physiological parameters, wherein each of the plurality of second physiological parameters indicates at least one of a precipitating condition of the patient, a symptom of the patient, or a functional capacity of the patient ([0151]; tachyarrhythmia), the plurality of second physiological parameters determined from one or more second measurements (implicit), the second measurements being different than the first measurements ([0147]; EGM (ECG) signals);
identifying a first diagnostic state for each of the first physiological parameters based on the first respective values ([0145], [0176]; impedance scores determine low, medium, high risk);
identifying a second diagnostic state for each of the second physiological parameters based on the second respective values ([0160], [0175]; heart rate values e.g. HRV determine heart failure risk), the first and second diagnostic states defining a plurality of inputs for a probability model (19, Fig. 3) ([0120], [0128], Fig. 4; diagnostic states determine evidence nodes 8 which are inputs to probability model 19); and
determining, from the probability model, a probability score indicating at least one of a likelihood that the patient (a) is experiencing an adverse health event of a chronic condition of the patient or (b) is to experience the adverse health event ([0128]; probability score from probability model indicates likelihood patient will experience adverse health event).
Regarding claim 22, Sarkar teaches a non-transitory computer-readable storage medium having stored thereon instructions that, when executed, cause one or more processors to at least:
determine a first respective one or more values for each of a plurality of first physiological parameters ([0146]; subcutaneous impedance), wherein each of the plurality of first physiological parameters indicates a physiological status of the patient ([0146]; fluid index), the plurality of first physiological parameters being determined from one or more first measurements ([0144]; impedance values of interstitial fluid; first physiological parameters necessarily determined from first measurements) comprising subcutaneous tissue impedance measurements ([0144-0145]; IMD 10 determines impedance values and other physiological parameters);
determine a second respective one or more values for each of a plurality of second physiological parameters ([0147]; EGM (ECG) signals), wherein each of the plurality of second physiological parameters indicates at least one of a precipitating condition of the patient, a symptom of the patient, or a functional capacity of the patient ([0151]; tachyarrhythmia), the plurality of second physiological parameters determined from one or more second measurements (implicit), the second measurements being different than the first measurements;
identify a first diagnostic state for each of the first physiological parameters based on the first respective values ([0145], [0176]; impedance scores determine low, medium, high risk);
identify a second diagnostic state for each of the second physiological parameters based on the second respective values ([0160], [0175]; heart rate values e.g. HRV determine heart failure risk), the first and second diagnostic states defining a plurality of inputs for a probability model (19, Fig. 3) ([0120], [0128], Fig. 4; diagnostic states determine evidence nodes 8 which are inputs to probability model 19); and
determine, from the probability model, a probability score indicating at least one of a likelihood that the patient (a) is experiencing an adverse health event of a chronic condition of the patient or (b) is to experience the adverse health event ([0128]; probability score from probability model indicates likelihood patient will experience adverse health event).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarkar et al (International Publication WO 2021/061688 A1), in view of Gunderson (US Pre Grant Publication 2021/0106253 A1).
Regarding claim 19, Sarkar teaches the system of claim 1, and further teaches wherein the implantable medical device comprises an insertable cardiac monitor ([0142]; Reveal LINQ Insertable Cardiac Monitor) comprising:
a housing (15, Fig.9) configured for subcutaneous implantation in the patient [0186],
a first electrode (16A, Fig. 9) of the plurality of electrodes at or proximate to the first end; and
a second electrode (16N, Fig. 9) of the plurality of electrodes at or proximate to the second end,
wherein the insertable cardiac monitor is configured to determine the subcutaneous tissue impedance measurements via the first electrode and the second electrode [0141].
Sarkar does not disclose,
the housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end, a width less than the length, and a depth less than the width,
as claimed.
However, Gunderson teaches,
the housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end ([0056]; length of about 40-60 mm), a width less than the length ([0056]; width 10mm), and a depth less than the width ([0056]; depth 5mm).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Sarkar with the housing having a length between 40 millimeters (mm) and 60 mm between a first end and a second end, a width less than the length, and a depth less than the width as taught by Gunderson. One of ordinary skill in the art would have been motivated to make these modifications to improve ease of implantation and patient comfort by altering IMD geometry and size (Gunderson, [0057]).
Claim(s) 9, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarkar et al (International Publication WO 2021/061688 A1), in view of Gunderson (US Pre Grant Publication 2021/0106253 A1), and in further view of Tognetti et al (Internation Publication WO 2021/212112 A1).
Regarding claim 9, Sarkar teaches the system of claim 1, and further teaches wherein the first measurements include heart rate measurements ([0160]; processing circuitry 50 determines heart rate values e.g. night heart rate), and the second measurements patient activity measurements ([0161]; sensor 62 (Fig. 8) includes accelerometers that indicate activity level), and the processing circuitry (50, Fig. 8) is further configured to:
collate the heart rate measurements and activity measurements over a period of time ([0113]; processing circuitry 98 may determine diagnostic states for different parameters such as tissue impedance and respiration rate over distinct timeframes for each (ie 30-day timeframe for impedance and 60-day timeframe for respiration; a common timeframe between heart rate and activity measurements necessitate collated time series data);
Sarkar does not disclose processing circuitry is further configured to:
apply a line fit to the collated measurements to determine a rate of change of heart rate as a function of change in activity over the period time;
determine a slope of the applied line fit;
compare the determined slope to a threshold; and
determine the second diagnostic state based on the comparison,
as claimed.
Gunderson teaches a system and a method for detecting patient coughs based on EGM (ECG) and accelerometer signals. Gunderson is analogous to the claimed invention because it is reasonably pertinent to the problem of determining diagnostic states from multimodal physiological signals.
Gunderson further teaches,
collate (implicit) the heart rate measurements and activity measurements over a period of time ([0029], Fig. 8; IMD 10 continuously records a plurality of physiological signals);
apply a line fit to the collated measurements ([0041]; second sequence of EGM samples represents derivative of first sequence of EGM samples; derivative determination has equivalent result to the slope of a line of fit);
determine a slope of the applied line fit ([0041]; second sequence of EGM samples represents derivative of first sequence of EGM samples; examiner notes this limitation is an intended result from application of a line fit to the measurements);
compare the determined slope to a threshold ([0042]; derivative threshold indicates slope reversal or slope change event); and
determine the second diagnostic state based on the comparison ([0042]; r-wave not slope reversal, then not related to muscle contractions relating to cough).
Gunderson does not disclose,
apply a line fit to the collated measurements to determine a rate of change of heart rate as a function of change in activity over the period time,
as claimed.
However, Tognetti teaches a system and a method for detecting and monitoring of viral infections using patient physiological data. Tognetti is analogous to the claimed invention because it is reasonably pertinent to the problem of predicting diagnostic states from patient data.
Tognetti further teaches,
apply a line fit to the collated measurements to determine a rate of change of heart rate as a function of change in activity over the period time ([0092]; “For example, one or more of the skin conductance and heart rate may be normalized by one or more of temperature and activity level.” (i.e. heart rate is a function of activity level), [0097]; linear regression necessarily applies a line of best fit).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Sarkar with the processing circuitry further configured to determine a slope of the applied line fit, compare the determined slope to a threshold, determine the second diagnostic state based on the comparison, as taught by Gunderson, and apply a line fit to the collated measurements to determine a rate of change of heart rate as a function of change in activity over the period time, as taught by Tognetti. One of ordinary skill in the art would have been motivated to make these modifications to determine baseline values by adjusting physiological data with respect to different subgroups (Tognetti, [0092]).
Regarding claim 10, Sarkar in view of Tognetti teaches the system of claim 9, and further teaches wherein the determined second diagnostic state is chronotropic incompetence [0098] to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event [0105].
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system, as taught by Sarkar and Tognetti, with a second diagnostic state that is chronotropic incompetence to indicate an increased the likelihood the patient (a) is experiencing the adverse health event or (b) is to experience the adverse health event. One of ordinary skill in the art would have been motivated to make these modifications to provide warnings for heart conditions by determining the likelihood of an adverse health condition such as chronotropic incompetence (Sarkar, [0004-0005]).
Claim(s) 2, 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sarkar et al (International Publication WO 2021/061688 A1), in view of Tognetti et al (International Publication WO 2021/212112 A1).
Regarding claim 2, Sarkar teaches the system of claim 1, but does not disclose wherein the system further includes a second device external to the patient to measure the second measurements, as claimed.
However, Tognetti teaches wherein the system further includes a second device external to the patient to measure the second measurements ([0038], Fig. 1; user device 110 configured to be a wearable device with 1-lead ECG sensor).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Sarkar with a second device external to the patient to measure the second measurements as taught by Tognetti. One of ordinary skill in the art would have been motivated to make these modifications to monitor physiological data by continuously measuring patient data with a portable device (Tognetti, [0035]).
Regarding claim 3, Sarkar teaches the system of claim 2, but does not disclose wherein the second device includes one or more of:
smartphone, scale, bed sensor, biochemical sensor, camera, smart device, wearable computing device, continuous glucose monitor ([0012]; pulse oximeters are wearable computing devices),
as claimed.
However, Tognetti teaches wherein the second device includes one or more of:
smartphone, scale, bed sensor, biochemical sensor, camera, smart device, wearable computing device, continuous glucose monitor ([0038], Fig. 1; user device 110 configured to be a wearable device with 1-lead ECG sensor).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Sarkar with the second device includes one or more of a smartphone, scale, bed sensor, biochemical sensor, camera, smart device, wearable computing device, continuous glucose monitor as taught by Tognetti. One of ordinary skill in the art would have been motivated to make these modifications to monitor physiological data by continuously measuring patient data with a portable device (Tognetti, [0035]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Imran et al (US 2021/0338103 A1) discloses a multimodal system and a method for detecting and predicting respiratory infections [0019]; predicting likelihood based on biomarkers or parameters ([0026], [0044]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWANE COLLARD/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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