Office Action 2: Final Rejection (2024-11-21)
Rejection types: 101 - Patent-Eligible Subject Matter, 102 - Lack of Novelty

CLAIMS:
SVG {EMBED HERE} 0.506.75INTHECLAIMS Please amend the claims as follows:

1\. (Currently Amended) A medical-device system, comprising:a risk stratification circuit configured to:
receive physiological information sensed from \[\[the\]\]a patient;
generate distinct first, second, and third signal metrics using the received physiological information;
calculate a primary pulmonary risk score using the first signal metric, and
calculate a secondary pulmonary risk score using the second and the third signal metrics, the primary pulmonary risk score and the secondary pulmonary risk score each taking a numerical value; andcalculate a composite pulmonary risk score using the primary and the secondary pulmonary risk scores; and
an output circuit configured to provide the calculated composite pulmonary risk to a user or a process.
2\. (Original) The medical-device system of claim 1, comprising a physiological event detector circuit configured to automatically detect a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score.
3\. (Original) The medical-device system of claim 2, wherein to automatically detect the cardiorespiratory event, the physiological event detector circuit is configured to:
calculate a cardiorespiratory event score using one or more physiological signals sensed from the patient;
determine or adjust an alert threshold based at in part on the calculated composite pulmonary risk score; and
generate an alert of the cardiorespiratory event when the cardiorespiratory event score exceeds the alert threshold.AMENDMENT AND RESPONSE UNDER 37 C.F.R. § 1.111 Page 3 Application Number: 18/097,348 Dkt: 279.N69US2 Filing Date: January 16, 2023 Title: MULTI-DISEASE PATIENT MANAGEMENT
4\. (Original) The medical-device system of claim 2, wherein the cardiorespiratory event includes at least one of worsening heart failure (WHF), chronic obstructive pulmonary disease (COPD), asthma, or pulmonary edema.
5\. (Original) The medical-device system of claim 1, wherein the first, the second, and the third signal metrics are each selected from the group consisting of:
a respiration rate;
a ratio of respiration rate to tidal volume;
a third heart sound (S3) intensity;
a ratio of the S3 intensity to a reference heart sound intensity;
a heart rate;
a thoracic impedance; and
a physical activity level.
6\. (Original) The medical-device system of claim 1, wherein the risk stratification circuit is configured to calculate the secondary pulmonary risk score using measurements of the second signal metric obtained at times when the third signal metric satisfies a specified condition.
7\. (Original) The medical-device system of claim 6, wherein the second signal metric include a respiratory rate and the third signal metric incudes a physical activity intensity or duration,
wherein the measurements of the second signal metric include respiratory rates measured during a time period when the physical activity intensity or duration exceeds a threshold.
8\. (Original) The medical-device system of claim 1, wherein the risk stratification circuit is configured to calculate the secondary pulmonary risk score using the second signal metric weighted by the third signal metric.
9\. (Original) The medical-device system of claim 1, wherein the risk stratification circuit is configured to calculate the composite pulmonary risk score using a linear or a nonlinear combination of the primary and secondary pulmonary risk scores.AMENDMENT AND RESPONSE UNDER 37 C.F.R. § 1.111 Page 4 Application Number: 18/097,348 Dkt: 279.N69US2 Filing Date: January 16, 2023 Title: MULTI-DISEASE PATIENT MANAGEMENT

10\. (Original) The medical-device system of claim 1, wherein the risk stratification circuit is configured to calculate the composite pulmonary risk score using a neural network taking the primary and the secondary pulmonary risk scores as input.

11\. (Canceled)

12\. (Original) The medical-device system of claim 1, comprising a therapy circuit configured to initiate or adjust a therapy to treat a cardiorespiratory disease in accordance with the calculated composite pulmonary risk score.

13\. (Currently Amended) A method, comprising:receiving physiological information sensed from \[\[the\]\]a patient;
generating, via a risk stratification circuit of a medical-device system, distinct first, second, and third signal metrics using the received physiological information;
calculating, via the risk stratification circuit, a primary pulmonary risk score using the first signal metric, and calculate a secondary pulmonary risk score using the second and the third signal metrics, the primary pulmonary risk score and the secondary pulmonary risk score each taking a numerical value;
calculating, via the risk stratification circuit, a composite pulmonary risk score using the primary and the secondary pulmonary risk scores; and
providing, via an output circuit, the calculated composite pulmonary risk to a user or a process.

14\. (Original) The method of claim 13, further comprising automatically detecting a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score, the cardiorespiratory event including at least one of worsening heart failure (WHF), chronic obstructive pulmonary disease (COPD), asthma, or pulmonary edema.AMENDMENT AND RESPONSE UNDER 37 C.F.R. § 1.111 Page 5 Application Number: 18/097,348 Dkt: 279.N69US2 Filing Date: January 16, 2023 Title: MULTI-DISEASE PATIENT MANAGEMENT

15\. (Original) The method of claim 14, wherein automatically detecting the cardiorespiratory even includes:calculating a cardiorespiratory event score using one or more physiological signals sensed from the patient;
determining or adjusting an alert threshold based at in part on the calculated composite pulmonary risk score; and
generating an alert of the cardiorespiratory event when the cardiorespiratory event score exceeds the alert threshold.

16\. (Original) The method of claim 13, wherein calculating the secondary pulmonary risk score includes using measurements of the second signal metric obtained at times when the third signal metric satisfies a specified condition.

17\. (Original) The method of claim 13, wherein calculating the secondary pulmonary risk score includes using the second signal metric weighted by the third signal metric.

18\. (Original) The method of claim 13, wherein calculating the composite pulmonary risk score includes using a neural network taking the primary and the secondary pulmonary risk scores as input.

19\. (Canceled)

20\. (Original) The method of claim 13, further comprising initiating or adjusting a therapy to treat a cardiorespiratory disease in accordance with the calculated composite pulmonary risk score.

21\. (New) A medical-device system, comprising:a risk stratification circuit configured to:
receive physiological information sensed from a patient;
generate distinct first, second, and third signal metrics using the received physiological information;AMENDMENT AND RESPONSE UNDER 37 C.F.R. § 1.111 Page 6 Application Number: 18/097,348 Dkt: 279.N69US2 Filing Date: January 16, 2023 Title: MULTI-DISEASE PATIENT MANAGEMENT calculate a primary pulmonary risk score using the first signal metric, and calculate a secondary pulmonary risk score using the second and the third signal metrics, the primary pulmonary risk score and the secondary pulmonary risk score each taking a numerical value;
and calculate a composite pulmonary risk score using the primary and the secondary pulmonary risk scores; and
a physiological event detector circuit configured to detect a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score.

22\. (New) The medical-device system of claim 21, wherein the physiological event detector circuit is configured to determine or adjust a detection threshold based at in part on the calculated composite pulmonary risk score, and to detect the cardiorespiratory event using the determined or adjusted detection threshold.

OFFICE ACTION:
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 .
Interview Request in Reply Filed August 12, 2024
Examiner acknowledges the request for interview in the reply filed August 12, 2024. Where a complete reply to a first action includes a request for an interview, the examiner, after consideration of the reply, should grant such an interview request if it appears that the interview would result in expediting the allowance of the application. MPEP 713.01. After consideration of the reply, it does not appear that an interview would expedite allowance given the nature of the rejections of both Sections 101 and 103.
Election/Restrictions
Newly submitted claims 21-22 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
I. Claims 1-10 and 12, drawn to a medical device system for calculating and providing a pulmonary risk score, classified in 600/529.
II. Claims 13-18, drawn to a method of calculating and providing a pulmonary risk score, classified in 600/529.
III. Claims 21-22, drawn to a medical device system for calculating a pulmonary risk score and detecting a cardiorespiratory risk, classified in 600/484.
Invention I and III are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants.  See MPEP § 806.05(j). In the instant case, the inventions have a materially different effect in that no specific event is determined in Invention I. In addition, there is nothing that is output in invention III.  Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-22 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA  35 U.S.C. 103(a) of the other invention.
Claim Objections
Claims 1 and 13 are objected to because of the following informalities: In the penultimate line of each claim, “pulmonary risk” should be changed to “pulmonary risk score.”
Claim 3 is objected to because of the following informalities: In line 5 of the claim, it appears that “based at in part” should be changed to “based at least in part.”  Appropriate correction is required.
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, 5-6, 8-13, and 16-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) the process of using a mathematical formula to output a pulmonary risk score. This judicial exception is not integrated into a practical application because the calculation is merely output such as the case in Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as discussed above, the inputs to this formula are well-known and conventional metrics, further analogous to Electric Power. Evidence that such additional elements are well-known and convention is shown by the publications cited herein. The use of a neural network as claimed in claim 18 is insufficient to transform the abstract idea into eligible subject matter given that this neural network is still another calculation using well-known and conventional techniques to arrive at a mathematical answer that is a pulmonary risk score.  Moreover, simply providing therapy based on a calculated metric is no more than routine and conventional techniques that fail to integrate the abstract idea into a practical application given that there does not appear to be any language in the claim that particularly links the abstract idea to the further limitations.
In keeping with the requirement that all claims be considered as a whole, Examiner notes that several claims have not been rejected under Section 101. As an example, claim 3 is not rejected because it includes the limitation wherein the physiological detection circuit is configured to determine or adjust an alert threshold based at least in part on the calculated composite pulmonary risk score. This has an effect of technological improvement as one of ordinary skill in the art would appreciate that the composite pulmonary risk score is being used to adjust the operation of the machine itself by determining or adjusting alert thresholds. This has the effect of making the device more responsive to the needs of the user by at least reducing false positive alerts. Moreover, such a configuration must take in as an input the current state of the user, much like the rubber molding press in Diamond v. Diehr, 450 U.S. 175 (1981) (holding patentable a process that iteratively computed a cure time using a mathematical formula to control the physical process of transforming rubber). These additional elements in, for example, claim 3 amount to significantly more than the judicial exception such that it is integrated into a practical application.
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.
Claim(s) 1-2, 4, 12-14, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2011/0040713 A1 to Colman et al. (“Colman”).
As to claim 1, Colman discloses a medical-device system, comprising:
a risk stratification circuit configured to:
receive physiological information sensed from a patient;
generate distinct first, second, and third signal metrics using the received physiological information (see Fig 4A, elements 170A, 170B, and 176 and [0105], [0115]-[0116] – “According to some exemplary embodiments, the parameters used may include, for example, parameters, such as: EtCO2, Respiratory Rate (RR), Heart Rate (HR), SpO2, blood pressure, spirometry, relative flow parameters, CO2 waveform patterns, blood gas, and the like.” See also [0135] --  “The additional parameters (factors) may include various patient specific parameters that may be characteristic of the patient, such as, for example, blood pressure, age, medical condition, sedation, patient awake, patient asleep, and the like. For example, an additional parameter (factor), such as, for example, additional parameter (factor) 176 may enter into one or more of the characterization processes and may thus control/tune the membership functions and membership value for each Output Characteristic Group that result from the characterization process.”);
calculate a primary pulmonary risk score using the first signal metric, and calculate a secondary pulmonary risk score using the second and the third signal metrics (see Fig 4A, elements 170A-B, 172A-B, 176), the primary pulmonary risk score and the secondary pulmonary risk score each taking a numerical value (see [0135] – “In the characterization process, the respective membership value to each characteristic group (such as groups 173A-C) is calculated/computed/assigned. The characteristic groups may be labeled, for example, as: “Normal”, “High”, “Low”, “Very High”, “Very Low”, and the like [Examiner notes that such processes, by their nature, will be given numerical values given that computers process data numerically] The same process may be applied onto any number of input main parameters, such as, for example, input parameter 170B, which may be characterized by characterization process 172B, where the respective membership value to each characteristic group (such as groups 173D-F) is calculated.”); and
calculate a composite pulmonary risk score using the primary and the secondary pulmonary risk scores (see Fig 4A, element 175 and [0135]); and
an output circuit configured to provide the calculated composite pulmonary risk to a user or a process (see [0142], [0146] and Fig 6A, elements 204, 206).
As to claim 2, Colman further discloses a physiological event detector circuit configured to automatically detect a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score (see [0096]).
As to claims 4 and 14, Colman further discloses wherein the cardiorespiratory event includes at least one of worsening heart failure (WHF), chronic obstructive pulmonary disease (COPD), asthma, or pulmonary edema (see [0102]).
As to claim 12 and 20, Colman further discloses a therapy circuit configured to initiate or adjust a therapy to treat a cardiorespiratory disease in accordance with the calculated composite pulmonary risk score (see [0036]).
Claim 13 is rejected for the reasons provided in treatment of claim  1.
Claim(s) 3, 8-10, 15, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colman in view of  US 2013/0116578 A1 to An et al. (“An”).
As to claims 3 and 15, Colman does not appear to disclose wherein to automatically detect the cardiorespiratory event, the physiological event detector circuit is configured to:
calculate a cardiorespiratory event score using one or more physiological signals sensed from the patient;
determine or adjust an alert threshold based at in part on the calculated composite pulmonary risk score; and
generate an alert of the cardiorespiratory event when the cardiorespiratory event score exceeds the alert threshold.
However, in a related invention, An discloses wherein the physiological event detector circuit is configured to:
calculate a cardiorespiratory event score using one or more physiological signals sensed from the patient (see [0193] – “The risk analysis module 3005 may adjust the detection threshold criterion to make the detection more sensitive or less sensitive to detection according to the determined HF risk score.”);
determine or adjust an alert threshold based at in part on the calculated composite pulmonary risk score (see [0193]); and
generate an alert of the cardiorespiratory event when the cardiorespiratory event score exceeds the alert threshold (see [0193]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the pulmonary risk score and event detection of Colman with the threshold modification based on a calculated composite pulmonary risk score in order to achieve the predictable result of increasing sensitivity of the event detection.
As to claims 8 and 17, it does not appear that Colman discloses wherein the risk stratification circuit is configured to calculate the secondary pulmonary risk score using the second signal metric weighted by the third signal metric.
However, in a similar invention, An teaches that a first signal metric may be used to influence (i.e., weight) of another signal metric when combining the two to signal an alert (i.e. a score that reaches a particular threshold for sounding an alarm) (see, e.g., [0194] – “In an illustrative example, the first physiological parameter may be the amplitude of the S3 heart sound and the second physiological parameter may be fluid status of the subject that is derived from intrathoracic impedance. Decreasing intrathoracic impedance may indicate fluid retention. Based on the measured S3 amplitude, the risk analysis module 3005 may assign a higher risk to the subject. The risk analysis module 3005 may then lower the value of an intrathoracic impedance threshold used by the WHF detection module 3010 to increase the sensitivity of prediction of a WHF event. If the risk analysis module 3005 does not identify an S3 heart sound in the heart sound signal, the risk analysis module 3005 may raise the value of an intrathoracic impedance threshold used by the WHF detection module 3010 to decrease the sensitivity of prediction of an HF event.”)(emphasis added).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the calculation of the second pulmonary risk score of Colman as taught by An in order to achieve the predictable result of lowering false positives and/or reducing false negatives by adjusting the weights to better reflect a user’s health condition as taught by An.
As to claim 9, Colman fails to disclose wherein the risk stratification circuit is configured to calculate the composite pulmonary risk score using a linear or a nonlinear combination of the primary and secondary pulmonary risk scores.
However, An discloses such a combination for calculating a related composite health score (see [0061]-[0065]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the linear combination as taught by An given that An teaches that such a composite score allows its user to weight symptoms and signs in such a way as to emphasize those factors that are most important to patient health.
As to claims 10 and 18, Colman fails to disclose wherein the risk stratification circuit is configured to calculate the composite pulmonary risk score using a neural network taking the primary and the secondary pulmonary risk scores as input.
However, An discloses such a risk stratification circuit that uses a neural network in a similar fashion (see [0174]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the teachings of Colman with the neural network of An given that neural networks were well-known for the advantage of automatically learning and extracting relevant features from raw sensor data, reducing the need for manual feature engineering.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colman in view of  US 2012/0157799 A1 to Patangay et al. (“Patangay”).
As to claim 5, while Colman discloses that many of the claimed parameters (see [0007] – “In addition to CO2 concentration, various other parameters may be indicative (directly or indirectly) of the ventilation (respiratory) status of a patient. Such parameters may include, for example, saturation of oxygen in the blood cells and other organs, heart rate, respiration rate, breath flow rate, blood pressure, and the like. Combinations of various parameters may yield an improved indication of the clinical condition of the patient, in general, and of the ventilatory status of the patient, in particular.”), it is not clear that the first, the second, and the third signal metrics are each selected from the group consisting of: a respiration rate; a ratio of respiration rate to tidal volume; a third heart sound (S3) intensity; a ratio of the S3 intensity to a reference heart sound intensity; a heart rate; a thoracic impedance; and a physical activity level.
However, in a related cardiorespiratory metric determination invention, Patangay discloses these metrics (see [0042]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the respiratory metric determination of Colman with the parameters disclosed by Patangay given that Patangay teaches that they are indicative of patient cardiorespiratory health.
Claim(s) 6-7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Colman in view of US 2014/0243690 A1 to Dumont et al. (“Dumont”).
As to claims 6 and 16, it does not appear that either Colman discloses wherein the risk stratification circuit is configured to calculate the secondary pulmonary risk score using measurements of the second signal metric obtained at times when the third signal metric satisfies a specified condition.
However, in a related disclosure, Dumont teaches that decision trees may be constructed that operate in a Boolean decision tree that calculates risk scores (see Fig 1 – alert/no alert is a binary score, but still a score) using measurements of one metric obtained at time when another metric satisfies a specified condition (see Fig 1 and [0058]-[0063]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the teachings of Dumont in the systems of Colman to calculate the secondary pulmonary risk score using measurements of the second signal metric obtained at times when the third signal metric satisfies a specified condition in order to achieve the predictable result of reducing false positives and increasing true negatives by finding the proper combinations of thresholds and signal metrics that are most powerful.
As to claim 7, Dumont further discloses wherein the second signal metric include a respiratory rate and the third signal metric incudes a physical activity intensity or duration, wherein the measurements of the second signal metric include respiratory rates measured during a time period when the physical activity intensity or duration exceeds a threshold (see Fig 1 and [0058]-[0063]).
Response to Arguments
Applicant's arguments filed August 12, 2024 have been fully considered but they are not persuasive.
As to the arguments in favor of eligibility under Section 101, Applicants argue that the inventions of claims 1, 5-6, 8-13, and 16-20 amount to an improvement in technology and are therefore eligible under the Alice/Mayo test. Applicants argue that the improvement is in the field of computerized, device-based patient monitoring and pulmonary risk management. Applicants describe the features of the invention as allowing the device to be turned off when the patient as low pulmonary risk as well as back on when the patient has high pulmonary risk. A more accurate composite pulmonary risk assessment would lead to improved accuracy of risk-based pulmonary disease detection. Further, because pulmonary disease detection can be turned on when high pulmonary risk is indicated, using the pulmonary risk assessment can help save battery power and conserve computing resources, thereby improving the functionality of the medical-device system.
These arguments are respectfully found not persuasive for at least two reasons.
First, a more accurate composite risk assessment is an insufficient reason to convey subject matter eligibility. Examiner has concluded that the judicial exception in the inventions of claims 1, 5-6, 8-13, and 16-20 is the computation of a pulmonary risk score. That such a score results in an improvement in the assessment of pulmonary risk that is sufficient to confer patentability is at odds at least in the conclusion reached in Parker v. Flook, 437 U.S. 584, 598, n. 18 (“…[the patentee’s] process patent rests solely on the claim that his mathematical algorithm, when related to a computer program, will improve the existing process for updating alarm units. Very simply, our holding today is that a claim for an improved method of calculation, even when tied to a specific end use, is unpatentable subject matter under § 101”) (emphasis added). Here, Applicants have failed to identify a technological problem that the claimed invention addresses that is of the type that has been found eligible by the courts.
In reviewing the pertinent precedent out of the Federal Circuit, the “technological improvement” argument has been successful in very different scenarios than at issue here. In DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014), the problem was unique to e-commerce in that it concerned the tendency for users to “click-away” from a merchant’s site. The eligible patent solved this problem by modifying the website interface to retain consumers. In BASCOM Global Internet Services, Inc. v. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016), the problem was unique to content filtering over the internet and allowed for customizable filtering at a specific network location, such as a particular ISP, that would be less susceptible to circumvention by a user. By making the filter more dynamic and efficient, the software-based invention improved the performance of the computer itself. In Data Engine Technologies LLC v. Google LLC, 906 F.3d 999 (Fed. Cir. 2018), the problem was unique to navigation through prior art three-dimensional or multipage electronic spreadsheets. The eligible patent solved the problem in a particular way by providing an intuitive, user-friendly interface with familiar notebook tabs for navigating the three-dimensional worksheet environment.
As summarized above, Applicants argue that the technology improvement is in the field of computerized, device-based patient monitoring and pulmonary risk management. A more accurate composite pulmonary risk assessment, Applicants further argue, would lead to improved accuracy of risk-based pulmonary disease detection. The problem with this framing of the issue is that the benefits of the composite pulmonary indicator are independent of any technological use case. In other words, whether or not the pulmonary risk score was used in a patient monitor, its salient benefit would still be the same. A doctor could independently calculate this score based on medical records alone and the result would still be the same—an assessment of medical risk for the patient. For at least this reason, the claims cannot be said to be a technological improvement of the type that would confer patent eligibility.
Second, while there are several examples offered by Applicants as to why the claimed invention is a technological improvement, none of these benefits are commensurate with the scope of claims 1, 5-6, 8-13, and 16-20. For example, Applicants argue that the device may be turned off or on depending on the patient risk. Setting aside the question of how the patient risk can be calculated by the monitor when it is turned off, these features are nowhere to be found in the text of claims 1 and 13. Claim 1 is illustrative of this point. It comprises two circuits. One to calculate the risk and another to output it. There is little in the text of the claims that would realize the advantages proposed by Applicants. Applicants further argue that the score uses a unique combination of primary and secondary risk scores each computed using distinct signal metrics. But close scrutiny of the claims finds little “distinct” or “unique” about the metrics or risks scores claimed here. Given that they are only tethered to “physiological information,” the metrics embrace almost any information related to patient health. Similarly, it is difficult to understand how these scores may be unique without any distinguishing text. In short, the claims are insufficiently aligned with the features pointed out in Applicants’ remarks. For at least this reason, the arguments are found not persuasive to finding patent eligibility. Accordingly, the rejection of claims 1, 5-6, 8-13, and 16-20 under Section 101 are maintained.
As to the art rejections, Applicants’ arguments are moot in view of the newly applied rejections.
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 extension fee 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 date of this final action.

APPLICANT REBUTTAL: REMARKS
This responds to the Final Office Action dated November 21, 2024.
Claims 1-6, 13-16, and 21-22 are presently amended. Claims 11 and 19 were canceled
previously. Claims 21-22 are withdrawn. No new claim is added. As a result, claims 1-10, 12-18, and 20-22 are now pending in this application.
Applicant respectfully submits that no new matter has been introduced, and that the
amendment is supported by, for example,    [0075]-[0078] and FIG. 4 of the Application as filed.
Interview Summar
y
Applicant thanks Examiner Eric Messersmith for the courtesy of a helpful telephone
interview on January 9, 2025, with Applicant's representative Dan Li, during which the Restriction Requirement, the rejections of claim 1 under § § 101 and 102, and distinctions between the claimed subject matter and the cited art (Colman) were discussed. The Examiner was provided with an Interview Agenda, in which Applicant's representative proposed amending claim 1 to incorporate the cardiorespiratory event detector from claim 2, and further to require the first signal metric be generated using respiration information and the second or the third signal metric be generated using heart sound information (proposal 1), or sampling of measurements of the second signal metric only when the third signal metric satisfies a specific condition (proposal 2). The Examiner indicated that incorporating claim 2 into claim 1 would appear to overcome the 101 rejection, and amendment proposals 1 and 2 would appear to overcome the current art rejection subject to further consideration and supplemental search in view of a formal response.
Claim Ob
j
ections
Claims 1 and 13 were objected to because of the following informalities: In the penultimate line of each claim, "pulmonary risk" should be changed to "pulmonary risk score." Applicant has amended said claims accordingly, and respectfully requests withdrawal such objection.
Claim 3 was objected to because of the following informalities: In line 5 of the claim, it
appears that "based at in part" should be changed to "based at least in part." Applicant has amended said claim accordingly. Similar amendment was also made to claims 15 and 22. Applicant respectfully requests withdrawal such objection.
Affirmation of Election
The Office Action asserts that claims 21-22 are directed to an invention that is independent or distinct from the invention originally claimed, and restricts the claims to one of the following under 35 U.S.C. 121:
I.   Claims 1-10 and 12, drawn to a medical device system for calculating and providing
a pulmonary risk score, classified in 600/529.
II.   Claims 13-18, drawn to a method of calculating and providing a pulmonary risk
score, classified in 600/529.
III.   Claims 21-22, drawn to a medical device system for calculating a pulmonary risk
score and detecting a cardiorespiratory risk, classified in 600/484.
Applicant provisionally elects, with traverse, Group I, claims 1-10 and 12.
The Office Action asserts that "invention I and III ... have a materially different effect in that no specific event is determined in Invention I. In addition, there is nothing that is output in invention III. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-22 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03." (Office Action 2-3.)
As Applicant explained in the Response dated August 12, 2024, claim 21 incorporates the limitations of original claim 1 (except for the "output circuit") and original claim 2, and the requirement of the primary pulmonary risk score and the secondary pulmonary risk score each taking a numerical value, as similarly made to claim 1. The Office Action asserts that "no specific event is determined in Invention I." Claim 2 of Invention I, however, explicitly recites a physiological event detector circuit configured to automatically detect a cardiorespiratory event, a limitation similarly recited in claim 21. The Office Action further asserts that "the inventions [I and III] as claimed do not encompass overlapping subject matter." Claim 1 (of Invention I) and claim 21 (of Invention III) both recite a risk stratification circuit performing substantially identical functions.
Furthermore, although claim 21 does not explicitly recite an "output circuit" (as recited in
claim 1), claim 21 recites a physiological event detector circuit to detect a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score. This suggests that the calculated composite pulmonary risk score is output to the physiological event detector circuit, which then detects a cardiorespiratory event based on said risk score. Detecting a cardiorespiratory event is clearly a variant of "providing the calculated composite pulmonary risk score to a user or a process," as required by claim 1.
Finally, because original claims 1 and 2 have both been examined on the merit, and claim 21 incorporates the limitations of original claim 1 (except for the "output circuit") and original claim 2, no serious burden of search and examination is believed required.
For at least the foregoing reasons, Applicant respectfully submits that the restriction between Inventions I and III is improper.
Additionally, Applicant has amended claim 1 to incorporate the limitation from claim 2. As such, claim 1 of Group I and claim 21 of Group III both require a physiological event detector circuit configured to detect a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score. Claim 13 of Group II has been amended similarly to recite automatically detecting, via a physiological event detector circuit, a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score. In view of such amendment, the asserted basis of restriction no longer applies; and no serious search and examination burden appears required. Accordingly, Applicant respectfully requests coherent, efficient, and expeditious examination of claims 1-10, 12-18, and 20-22.
To the extent that the provisionally non-elected claims are deemed withdrawn by the Office, Applicant reserves the right to request rejoinder or to reintroduce such provisionally non-elected claims later during prosecution in the present application, or to present the non-elected claims in one or more continuation or divisional applications at a later date.
The Re
j
ection of Claims Under
?
Claims 1, 5-6, 8-13 and 16-20 were rejected under 35 U.S.C. § 101 as allegedly being directed to non-statutory subject matter.
The Office Action asserts that said claims are directed to an abstract idea without
significantly more, and that the claims recite the process of using a mathematical formula to output a pulmonary risk score. (Office Action at 4.) Without acquiescing to such assertions, Applicant has amended claim 1, among other things, to incorporate the limitation of original claim 2 ("a physiological event detector circuit configured to detect a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score.") Claim 2 was not rejected on the ineligibility basis. Detecting a cardiorespiratory event based on the pulmonary risk score amounts to significantly more than the alleged judicial exception (mathematical formula to compute a pulmonary risk score), such that it is integrated into a practical application.
Applicant further submits that claim 1 is patent eligible in view of Federal Circuit's decision on CardioNet, LLC v. InfoBionic, Inc., No. 19-1149 (Fed. Cir. 2020). Claim 1 of CardioNet, reproduced below, is directed to a device to detect an event relevant to atrial fibrillation or atrial flutter based on variability in the beat-to-beat timing.
A device, comprising:
a beat detector to identify a beat-to-beat timing of cardiac activity; a ventricular beat detector to identify ventricular beats in the cardiac activity; variability determination logic to determine a variability in the beat-to-beat timing of a collection of beats;
relevance determination logic to identify a relevance of the variability in the beat-to-beat timing to at least one of atrial fibrillation and atrial flutter; and
an event generator to generate an event when the variability in the beat-to- beat timing is identified as relevant to the at least one of atrial fibrillation and atrial
flutter in light of the variability in the beat-to-beat timing caused by ventricular beats
identified by the ventricular beat detector.
The Federal Circuit held that, when read as a whole and in light of the written description, claims directed to an improvement in cardiac monitoring technology are not directed to an abstract idea. See id. at p. 13. Similar to the "event generator" of the CardioNet claim that generates an event of atrial fibrillation or atrial flutter based on variability in the beat-to-beat timing, Applicant's claim 1 recites a "physiological event detector" to detect a cardiorespiratory event based on the calculated composite pulmonary risk score. With respect to the disclosures, similar to CardioNet patent's disclosure that the claimed invention achieves more accurate and clinically significant detection of atrial fibrillation and atrial flutter which constitutes an improvement to cardiac monitoring technology, Applicant's disclosure describes improved cardiorespiratory event detection guided by
the composite pulmonary risk score, including more timely detection with increased accuracy (e.g., lower false positive detections). For example, as described in Applicant's specification, pulmonary disease detection may be turned off or temporarily withhold if the patient has a low pulmonary risk, and turned back on when the patient has a high pulmonary risk. (See Application at   [0095] and FIG. 6.) Table 1 further shows examples of various cardiorespiratory event detection algorithms corresponding to different pulmonary risk levels. Accordingly, a more accurate composite pulmonary risk assessment, such as in accordance with the claimed invention, would lead to improved accuracy of risk-based cardiorespiratory event detection. Furthermore, using the pulmonary risk assessment as described in Applicant's specification can help save battery power and conserve computing resources, thereby improving the functionality of the medical-device system.
Because Applicant's claim 1 includes similar limitations to those of the eligible claim 1 of CardioNet, said claim is submitted to be patent-eligible for similar reasons set forth in the CardioNet decision.
Accordingly, Applicant respectfully requests withdrawal of such rejection and allowance of claims 1, 5-6, 8-13 and 16-20.
The Re
j
ection of Claims Under
?
Claims 1-2, 4, 12-14 and 20 were rejected under 35 U.S.C. § 102(a) over Colman (U.S. 2011/0040713). Applicant respectfully traverses.
Applicant has amended claim 1 to more distinctly recite certain aspects of the present subject matter, including, among other things, a risk stratification circuit configured to receive physiological information including respiration information and heart sound information sensed from a patient, and generate distinct first, second, and third signal metrics using the received physiological information, the first signal metric generated using the received respiration information, the second or the third signal metric generated using the received heart sound information, and a physiological event detector circuit configured to detect a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score.
Colman mentions various signal metrics being used for generating a pulmonary index
output, but is silent on a first signal metric generated using respiration information, the second or the third signal metric generated using heart sound information, as required by claim 1. Because
Colman fails to disclose each and every claim limitation in claim 1, a primafacie case of anticipation has not been established with respect to claim 1.
Claim 13 has been similarly amended claim 1, and is submitted to be patentable for the same reason set forth above with respect to claim 1.
Claims 2, 4, and 12 are dependent from base claim 1. Claims 14 and 20 are dependent form base claim 13. Such dependent claims each include patentable subject matter beyond that recited in their respective base claims, and are believed to be patentable for at least the reasons stated above with respect to the respective base claims.
Accordingly, Applicant respectfully requests reconsideration and withdrawal of this basis of rejection and allowance of claims 1-2, 4, 12-14 and 20.
The Re
j
ection of Claims Under
?
Claims 3, 8-10, 15 and 17-18 were rejected under 35 U.S.C. § 103 over Colman in view of An (U.S. 2013/0116578); Claim 5 was rejected under 35 U.S.C. § 103 over Colman in view of Patangay (U.S. 2012/0157799); Claims 6-7 and 16 were rejected under 35 U.S.C. § 103 over Colman in view of Dumont (U.S. 2014/0243690).
Applicant respectfully traverses the above rejections under § 103. The combination of
Colman with any of An, Patangay, or Dumont, as suggested in the Office Action, does not rectify the deficiency of Colman, as stated above with respect to claims 1 and 13, such that a primafacie case of obviousness has not been established with respect to said claims because all claimed features have not been disclosed or suggested by the combined references.
Furthermore, regarding claims 6 and 16 (which have been amended to clarify that the
measurements of the second signal metric used for the calculating the secondary pulmonary risk score are sampled only at times when the third signal metric satisfies a specified condition), the Office Action relies on Dumont to teach such "conditional sampling" feature. Dumon refers to a decision tree that employs activity V1 and average respiratory frequency V2 to decide whether to issue an alert or not. (FIG. 1 and    [0058]-[0063].) Dumon, however, does not teach or suggest sampling measurements of one signal metric (e.g., respiratory frequency data V2) only at times when another signal metric (e.g., activity V1) satisfies a specific condition. Checking the activity V1 against a specific condition (above or below the threshold T1, e.g., 1 hr/day) is merely used for
setting different thresholds (T2 or T3) for the respiratory frequency data V2. Dumon is silent on using activity V1 satisfying a specific condition to trigger or gate sampling of respiratory frequency data V2. Instead, the activity V1 and respiratory frequency V2 data appear to be independently collected and applied to the decision tree that logically decides whether to issue an alert or not. Nothing in Dumon teaches or suggests that the comparison of the activity to the threshold T1 would affect the sampling of respiratory frequency data.
For at least the foregoing reasons, Dumon fails to rectify the deficiency of Colman, such that aprimafacie case of obviousness has not been established with respect to each of claims 6 and 16. Accordingly, Applicant respectfully requests reconsideration, withdrawal of this basis of rejection, and allowance of claims 6-7 and 16.
Previously withdrawn claim 21 has been amended to include such "conditionalsampling"
features similar to claim 6 (calculating a secondary pulmonary risk score using measurements of the second signal metric sampled only at times when the third signal metric satisfies a specific condition). For at least the same reasons set forth above with respect to claim 6, Applicant respectfully submits that claim 21 is patentable over Colman in view of Dumont.
Reservation of
Rig
hts
In the interest of clarity and brevity, every assertion made in the Office Action may not have been equally addressed. Silence regarding any such assertion does not constitute any admission or acquiescence. All rights not exercised in connection with this response, such as the right to challenge or rebut any tacit or explicit characterization of any reference or of any of the present claims, the right to challenge or rebut any asserted factual or legal basis of any of the rejections, the right to swear behind any cited reference such as provided under 37 C.F.R. § 1.131 or otherwise, or the right to assert co-ownership of any cited reference, are reserved. It is not admitted that any of the cited references or any other references of record are relevant to the present claims, or that they constitute prior art. To the extent that any rejection or assertion is based upon the Examiner's personal knowledge, rather than any objective evidence of record as manifested by a cited prior art reference, timely objection to such reliance on Official Notice is made, and all rights to request that the Examiner provide a reference or affidavit in support of such assertion, as required by MPEP § 2144.03, are reserved. All rights to pursue any cancelled claims in a subsequent patent application
claiming the benefit of priority of the present patent application, and to request rejoinder of any
withdrawn claim, as required by MPEP § 821.04, are likewise reserved.
CONCLUSION

NEXT OFFICE ACTION: 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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection.  Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.  Applicant's submission filed on January 15, 2025 has been entered.
Election/Restrictions
Examiner has considered the arguments against the restriction of claims 21-22 and has found them persuasive. The restriction requirement has been withdrawn.
Allowable Subject Matter
Claims 1-10, 12-18, and 20-22 are allowed.
The following is an examiner’s statement of reasons for allowance:
Consistent with the opinion in CardioNet, LLC v. Infobionic, Inc., 955 F.3d 1358, 2020 U.S.P.Q.2d 10367 (Fed. Cir. 2020), Examiner finds that the claims are directed to an improved cardiopulmonary monitoring device and not an abstract idea.
Independent claims 1, 13, and 21 recite, or similarly recite, inter alia,
“…a risk stratification circuit configured to:
receive physiological information including respiration information and heart sound information sensed from a patient;
generate distinct first, second, and third signal metrics using the received physiological information, the first signal metric generated using the received respiration information, the second or the third signal metric generated using the received heart sound information;
calculate a primary pulmonary risk score using the first signal metric, and calculate a secondary pulmonary risk score using the second and the third signal metrics, the primary pulmonary risk score and the secondary pulmonary risk score each taking a numerical value; and
calculate a composite pulmonary risk score using the primary and the secondary pulmonary risk scores; and
a physiological event detector circuit configured to detect a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score.”
The closest reference found during Examiner’s search of the prior art were US 2011/0040713 A1 to Colman, US 2013/0116578 A1 to An et al., and US 2012/0041279 A1 to Freeman et al.
None of these references, alone or in combination with one another or any other art reference, anticipates or renders obvious the inventions of claims 1, 13, and 21 including, inter alia,
“…a risk stratification circuit configured to:
receive physiological information including respiration information and heart sound information sensed from a patient;
generate distinct first, second, and third signal metrics using the received physiological information, the first signal metric generated using the received respiration information, the second or the third signal metric generated using the received heart sound information;
calculate a primary pulmonary risk score using the first signal metric, and calculate a secondary pulmonary risk score using the second and the third signal metrics, the primary pulmonary risk score and the secondary pulmonary risk score each taking a numerical value; and
calculate a composite pulmonary risk score using the primary and the secondary pulmonary risk scores; and
a physiological event detector circuit configured to detect a cardiorespiratory event of the patient based at least in part on the calculated composite pulmonary risk score.”
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee.  Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion

CITED REFERENCE SUMMARIES: Ref US20110040713A1: Claims:
- 102 . (canceled)
An apparatus for generating an index value indicative of a condition of a patient, said apparatus comprising: a port adapted to receive two or more measured patient parameters, wherein the measured patient parameters originate from one or more sensing devices; and processing logic adapted to: (a) characterize a first measured patient parameter based on a comparison of the first measured patient parameter against a first reference value; (b) characterize a second measured patient parameter based on a comparison of the second measured patient parameter against a second reference value; and (c) computing the index value based on values associated with each of the characterized first and second measured parameters, wherein a weighting factor applied to the value associated with the second characterized measured parameter is influenced by the characterization of the first measured patient parameter.
a port adapted to receive two or more measured patient parameters, wherein the measured patient parameters originate from one or more sensing devices; and
processing logic adapted to: (a) characterize a first measured patient parameter based on a comparison of the first measured patient parameter against a first reference value; (b) characterize a second measured patient parameter based on a comparison of the second measured patient parameter against a second reference value; and (c) computing the index value based on values associated with each of the characterized first and second measured parameters, wherein a weighting factor applied to the value associated with the second characterized measured parameter is influenced by the characterization of the first measured patient parameter.
The apparatus according to claim 103 , wherein said processing logic is adapted to apply a mathematical model reflecting medical expert considerations, literature, clinical data, medical experience or any combination thereof.
The apparatus according to claim 103 , wherein said processing logic is adapted to apply a fuzzy logic, a Bayesian network, a decision tree, a neural network, a radial base function, a linear regression model, a non-linear regression model, an expert system, or any combination thereof.
The apparatus according to claim 103 , wherein said processing logic is adapted to average measured patient parameters over a period of time.
The apparatus according to claim 106 , wherein the period of time is predetermined.
The apparatus according to claim 106 , wherein the period of time is determined based on one or more patient characteristics, on the stability of one or more measured patient parameters, or both.
The apparatus according to claim 103 , wherein the two or more measured parameters comprise a CO 2 related parameter and one or more measured parameters selected from the group consisting of: a CO 2 related parameter respiration rate, an O 2 related parameter, heart rate, an electrocardiogram (ECG), an encephalogram (EEG), blood pressure, and spirometry.
The apparatus according to claim 109 , wherein the CO 2 related parameter comprises a CO 2 waveform related parameter, an expired air CO 2 concentration, respiratory rate or any combination thereof.
The apparatus according to claim 110 , wherein the CO 2 waveform related parameter comprises EtCO 2 , changes in EtCO 2 , a slope of the increase in the CO 2 concentration, a change in a slope of the increase in the CO 2 concentration, time to rise to a predetermined percentage of a maximum value of CO 2 concentration, a change in time to rise to a predetermined percentage of a maximum value of CO 2 concentration, an angle of rise to a predetermined percentage of a maximum value of CO 2 concentration, a change in an angle of rise to a predetermined percentage of a maximum value of CO 2 concentration, breath to breath correlation, breath to breath correlation, a CO 2 duty cycle, a change in CO 2 duty cycle or any combination thereof.
The apparatus according to claim 103 , wherein said processing logic is adapted to apply a learning process, wherein the learning process increases reliability of the index value.
The apparatus according to claim 112 , wherein the learning process comprises neural network methods, a support vector machine (SVM), genetic algorithms, simulated annealing, expectation-maximization (EM), case based reasoning, or any combination thereof.
The apparatus according to claim 103 , wherein said processing logic is further adapted to compute the index value based on the two or more measured patient parameters and on one or more patient characteristics.
The apparatus according to claim 114 , wherein the one or more patient characteristics comprises age, weight, gender, medical condition, medication, ventilation, oxygen supply, lab tests results, blood pressure, medical history, intubation or any combination thereof.
The apparatus according to claim 115 , wherein the medical history comprises smoking, heart disease, lung disease, sleep apnea, a pacemaker, or any combination thereof.
The apparatus according to claim 103 , wherein the index-value is in the range of 1 to 10.
The apparatus according to claim 103 , wherein an increase in the index value is indicative of an improvement in the condition of the patient.
The apparatus according to claim 103 , wherein a decrease in the index value is indicative of a deterioration in the condition of the patient.
The apparatus according to claim 103 , wherein said processing logic is adapted to determine the index-value according to a medical significance of at least one of the parameters.
The apparatus according to claim 103 , wherein said processing logic is further adapted to compute a trend of the index-value.
The apparatus according to claim 103 , wherein said processing logic is further adapted to compute a reliability index of the index-value.
The apparatus according to claim 103 , wherein said processing logic is further adapted to provide a medical recommendation.
The apparatus according to claim 103 , further comprising a graphic display of the index value.
The apparatus according to claim 103 , further comprising a controller adapted to adjust at least one parameter related to a patient controlled analgesia (PCA) pump, a dosage management device, a ventilation device or any combination thereof.
The apparatus according to claim 103 , wherein the index value is a pulmonary index value.
Ref US20130116578A1: Claims:
A system comprising: a risk analysis module configured to: measure at least one first physiological parameter of a subject using a physiological sensor of an ambulatory medical device; and determine a heart failure (HF) risk score for the subject according to the at least one measured first physiological parameter, wherein the HF risk score indicates susceptibility of the subject to experiencing a worsening heart failure (WHF) event; and a WHF detection module configured to: measure at least one second physiological parameter of the subject using the same or different physiological sensor, wherein the at least one second physiological parameter is distinct from the at least one first physiological parameter; and generate an indication of prediction that the subject will experience a WHF event when the at least one second physiological parameter satisfies a WHF detection algorithm, wherein the risk analysis module is configured to adjust generation of the indication by the WHF detection algorithm according to the determined HF risk score, and wherein the WHF detection module is configured to generate the indication using the adjusted WHF detection algorithm and providing the indication to at least one of a user or process.
a risk analysis module configured to: measure at least one first physiological parameter of a subject using a physiological sensor of an ambulatory medical device; and determine a heart failure (HF) risk score for the subject according to the at least one measured first physiological parameter, wherein the HF risk score indicates susceptibility of the subject to experiencing a worsening heart failure (WHF) event; and
measure at least one first physiological parameter of a subject using a physiological sensor of an ambulatory medical device; and
determine a heart failure (HF) risk score for the subject according to the at least one measured first physiological parameter, wherein the HF risk score indicates susceptibility of the subject to experiencing a worsening heart failure (WHF) event; and
a WHF detection module configured to: measure at least one second physiological parameter of the subject using the same or different physiological sensor, wherein the at least one second physiological parameter is distinct from the at least one first physiological parameter; and generate an indication of prediction that the subject will experience a WHF event when the at least one second physiological parameter satisfies a WHF detection algorithm,
measure at least one second physiological parameter of the subject using the same or different physiological sensor, wherein the at least one second physiological parameter is distinct from the at least one first physiological parameter; and
generate an indication of prediction that the subject will experience a WHF event when the at least one second physiological parameter satisfies a WHF detection algorithm,
wherein the risk analysis module is configured to adjust generation of the indication by the WHF detection algorithm according to the determined HF risk score, and
wherein the WHF detection module is configured to generate the indication using the adjusted WHF detection algorithm and providing the indication to at least one of a user or process.
The system of claim 1 , wherein the WHF detection module is configured to generate the indication of prediction of a WHF event when the at least one second physiological parameter satisfies at least one detection criterion of the WHF detection algorithm, and wherein the risk analysis module is configured to adjust the at least one detection criterion of the WHF detection algorithm according to the determined HF risk score.
wherein the WHF detection module is configured to generate the indication of prediction of a WHF event when the at least one second physiological parameter satisfies at least one detection criterion of the WHF detection algorithm, and
wherein the risk analysis module is configured to adjust the at least one detection criterion of the WHF detection algorithm according to the determined HF risk score.
The system of claim 2 , wherein the risk analysis module is configured to continuously vary at least one parameter of the WHF detection algorithm as a function of the at least one first physiological parameter measurement.
The system of claim 1 , wherein the risk analysis module is configured to select a detection algorithm as the WHF detection algorithm from among a plurality of detection algorithms according to the determined HF risk score.
The system of claim 4 , wherein the risk analysis module is configured to: enable a logistic regression model as the WHF detection algorithm when the HF risk score is determined to be in a first HF risk score range; and enable a neural network model as the WHF detection algorithm when the HF risk score is determined to be in a second HF risk score range.
enable a logistic regression model as the WHF detection algorithm when the HF risk score is determined to be in a first HF risk score range; and
enable a neural network model as the WHF detection algorithm when the HF risk score is determined to be in a second HF risk score range.
The system of claim 1 , wherein the risk analysis module is configured to: compare the determined HF risk score with at least one risk score threshold; and assign a HF risk category to the subject according to the comparison.
compare the determined HF risk score with at least one risk score threshold; and
assign a HF risk category to the subject according to the comparison.
The system of claim 1 , including: one or more ambulatory medical devices, wherein at least one of the ambulatory medical devices include at least one of: a heart sound sensor and wherein the at least one first physiological parameter includes a measured amplitude of the S3 heart sound; a respiration sensor and wherein the at least one first physiological parameter includes a measured day-to-day variation in respiratory rate of the subject; a cardiac signal sensing circuit and wherein the at least one first physiological parameter includes a time interval measured between two fiducial features occurring in one or more cardiac cycles; a biomarker sensor configured to generate an indication or a surrogate indication of a biomarker indicative of a WHF event, and wherein the at least one first physiological parameter includes at least one of a direct measure or a surrogate measure of the biomarker; a jugular vein distention (JVD) sensor configured to generate an indication of JVD or a surrogate indication of JVD; and a counter circuit and a timer circuit, and wherein the at least one first physiological parameter includes a number of HF events detected for the subject within a specified time window.
one or more ambulatory medical devices, wherein at least one of the ambulatory medical devices include at least one of:
a heart sound sensor and wherein the at least one first physiological parameter includes a measured amplitude of the S3 heart sound;
a respiration sensor and wherein the at least one first physiological parameter includes a measured day-to-day variation in respiratory rate of the subject;
a cardiac signal sensing circuit and wherein the at least one first physiological parameter includes a time interval measured between two fiducial features occurring in one or more cardiac cycles;
a biomarker sensor configured to generate an indication or a surrogate indication of a biomarker indicative of a WHF event, and wherein the at least one first physiological parameter includes at least one of a direct measure or a surrogate measure of the biomarker;
a jugular vein distention (JVD) sensor configured to generate an indication of JVD or a surrogate indication of JVD; and
a counter circuit and a timer circuit, and wherein the at least one first physiological parameter includes a number of HF events detected for the subject within a specified time window.
The system of claim 1 , wherein the risk analysis module is configured to: measure a plurality of physiological parameters that are distinct from the at least one second physiological parameter; and determine the HF risk score using the plurality of physiological parameters.
measure a plurality of physiological parameters that are distinct from the at least one second physiological parameter; and
determine the HF risk score using the plurality of physiological parameters.
The system of claim 8 , including: a scoring module configured to determine individual reliability scores for each of the plurality of physiological parameters, wherein a higher reliability score is assigned to a physiological parameter having a more consistent measurement; and wherein the risk analysis module is configured to combine the individual HF risk scores according to the determined reliability scores to form a composite HF risk score.
a scoring module configured to determine individual reliability scores for each of the plurality of physiological parameters, wherein a higher reliability score is assigned to a physiological parameter having a more consistent measurement; and
wherein the risk analysis module is configured to combine the individual HF risk scores according to the determined reliability scores to form a composite HF risk score.
The system of claim 9 , wherein the scoring module is configured to discard a HF risk score for a physiological parameter measurement when a reliability score determined for the physiological parameter measurement falls below a specified reliability score threshold value.
The system of claim 1 , including: a user interface in electrical communication with the risk analysis module, wherein the risk analysis module is configured to: receive an indication of severity of an HF condition of the subject via the user interface; and determine the HF risk score according to the first physiological parameter measurement and the received indication of severity.
a user interface in electrical communication with the risk analysis module,
wherein the risk analysis module is configured to: receive an indication of severity of an HF condition of the subject via the user interface; and determine the HF risk score according to the first physiological parameter measurement and the received indication of severity.
receive an indication of severity of an HF condition of the subject via the user interface; and
determine the HF risk score according to the first physiological parameter measurement and the received indication of severity.
The system of claim 1 , including: the ambulatory medical device, wherein the ambulatory medical device includes the WHF detection module; an external medical device, wherein the external medical device includes the risk analysis module and a communication module in electrical communication with the risk analysis module, wherein the communication module is configured to communicate information with the ambulatory medical device, and wherein the risk analysis module is configured to communicate an adjustment to the WHF detection algorithm to the ambulatory medical device.
the ambulatory medical device, wherein the ambulatory medical device includes the WHF detection module;
an external medical device, wherein the external medical device includes the risk analysis module and a communication module in electrical communication with the risk analysis module, wherein the communication module is configured to communicate information with the ambulatory medical device, and
wherein the risk analysis module is configured to communicate an adjustment to the WHF detection algorithm to the ambulatory medical device.
A method comprising: measuring at least one first physiological parameter of a subject using a physiological sensor of an ambulatory medical device; determining a heart failure (HF) risk score of the subject according to the measured at least one first physiological parameter, wherein the HF risk score indicates susceptibility of the subject experiencing a worsening heat failure (WHF) event; measuring at least one second physiological parameter of the subject with the same or different physiological sensor, wherein the at least one second physiological parameter is distinct from the at least one first physiological parameter; generating an indication of prediction that the subject will experience a WHF event when the at least one second physiological parameter satisfies a device-based WHF detection algorithm; adjusting prediction by the WHF detection algorithm according to the determined HF risk score; and generating an indication of a predicted WHF event when predicting the WHF event using the adjusted WHF detection algorithm and providing the indication to at least one of a user or process.
measuring at least one first physiological parameter of a subject using a physiological sensor of an ambulatory medical device;
determining a heart failure (HF) risk score of the subject according to the measured at least one first physiological parameter, wherein the HF risk score indicates susceptibility of the subject experiencing a worsening heat failure (WHF) event;
measuring at least one second physiological parameter of the subject with the same or different physiological sensor, wherein the at least one second physiological parameter is distinct from the at least one first physiological parameter;
generating an indication of prediction that the subject will experience a WHF event when the at least one second physiological parameter satisfies a devic
[Truncated to input limit]