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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12 January 2026 has been entered.
Claims 1-20 are pending in the application, and claims 1, 13 and 18 are amended.
Response to Arguments
Applicant's arguments filed 12 January 2026 with respect to the rejections claims 1-20 under 35 U.S.C. 112(a) have been fully considered but they are not persuasive. The applicant argues on pages 9-10 of the remarks that the disclosure of “categorical risk values” would sufficiently describe the invention to those of ordinary skill in the art. The Office respectfully disagrees. The applicant’s disclosure does not identify the categories and risk values that are used to practice the invention but rather merely indicates that categories and risk values may be identified as high risk or low risk. Applicant points to paragraphs [0052] and [0053] which provides examples that may be used to define high or low risk. Some examples relate to quartiles, means or medians. However, the applicant’s disclosure does not identify any particular categories or risk values and there corresponding definitions. Similarly, the applicant argues the “weighted combination of physiological information” using weighting coefficients a, b, c, d, and e is adequately described because generic “statistical analysis” and “machine learning techniques” are mentioned in the disclosure. Specifically, applicant argues paragraphs [0057] and [0058] provide and equation and list known statistical analysis techniques that would inform one of ordinary skill in the art. The examiner respectfully disagrees because the disclosure does not demonstrate a particular analysis or learning technique to determine the coefficients of the equation for any type of data. The example equation is providing examples of what data could potentially be used but does not specifically disclose equations for the physiological measures presented din the claims.
Applicant's arguments filed 12 January 2026 with respect to the rejections claims 1-8, 10-11 and 13-19 under 35 U.S.C. 101 have been fully considered but they are not persuasive. The applicant argues the limitation “wherein the assessment circuit is configured to control, based on the determined mortality risk metric, at least one resource of the medical device system, the at least one resource including at least one of a storage resource of physiologic information, a sensing resource of physiologic information, a processing resource of physiologic information or a communication resource to communicate physiologic information of the patient” along with the previous limitations provide a concrete technical solution to a recognized technical problem in ambulatory medical devices resource and power management. The examiner respectfully disagrees. The invention does not integrate the abstract idea of data gathering and processing into a practical application. The abstract idea itself cannot be the practical application. The newly added limitation provides generic, nonspecific, control over various resources. The communication resource is broad enough to read on an alert which does not take the claim as a whole beyond the abstract idea. Should the applicant include more specific definitions of “control” in the claims, the rejection could be overcome.
Applicant’s arguments with respect to claims 1-20 under 35 U.S.C. 102/103 have been considered but are not persuasive. The amended claims add the limitation “physiologic information” to each of the resources. The previously recited communication resource is a communication resource to communicate physiologic information of the patient i.e. a worsening cardiac event. Applicant argues a worsening cardiac event is not a risk metric indicative of a risk of patient mortality. The examiner maintains that one of skill in the art would understand that a worsening cardiac event indicates a greater risk of patient mortality. The applicant appears to be arguing specific limitations that are not claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Objections
Claims 1-20 objected to because of the following informalities: claims 1, 13 and 18 recite the limitation “a communication resource to communication physiologic information of the patient” which is interpreted to be “a communication resource to communicate physiologic information of the patient.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1-2, the limitation “risk values satisfying a pre-determined condition” in claim 1 and “wherein the predetermined condition comprises determined categorical risk values indicating the high risk” in claim 2 lack sufficient written description. The original disclosure does not define the “pre-determined condition” beyond the limitation in claim 2 presented above and paragraph [0020] of the specification, which also states “wherein the predetermined condition comprises determined categorical risk values indicating the high risk.” There is no definition of a “condition … indicating the high risk.” Thus, the disclosure does not provide sufficient disclosure of the pre-determined condition. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved (MPEP § 2161.01).
Regarding claims 13-14, the limitation “risk values satisfying a condition” in claim 13 and “wherein the condition comprises determined categorical risk values indicating the high risk” in claim 14 lack sufficient written description. The original disclosure does not define the “condition” beyond the limitation in claim 2 presented above and paragraph [0020] of the specification, which states “wherein the predetermined condition comprises determined categorical risk values indicating the high risk.” There is no definition of a “condition … indicating the high risk.” Thus, the disclosure does not provide sufficient disclosure of the pre-determined condition. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved (MPEP § 2161.01).
Regarding claim 18, the limitation “determine a mortality risk metric using a weighted combination of physiological information” lacks sufficient written description. The original disclosure does not explain how to determine the weighting of the physiological information. The only disclosure of determining weights is found in paragraph [0057] of the specification, which states: “For example, the function can be illustrated as: M = (a*HL-+- b*RR + c*S3/SJ)/(d*TI-+- e*Activity), where M is the mortality risk metric, HL is the HeartLogic™ index (described above), RR is respiratory rate information (e.g., daily median respiratory rate), S3/SJ is the S3 normalized by changes in S1, TI is thoracic impedance, Activity is commensurate with time active by the patient, and a, b, c, d, and e are coefficients representing weights for respective measures.” While this disclosure provides an equation, the disclosure does not describe how the weight coefficients a, b, c, d, and e are determined. Original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved (MPEP § 2161.01).
All remaining claims are rejected based on their dependency on a claim lacking sufficient written description.
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 1-8, 10-11 and 13-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. law of nature, natural phenomenon, or an abstract idea) without significantly more. The claims recite a system and method of determining a mortality risk metric using a variety of physiological information gathered from a patient. This is a mental process that can be performed in the mind of a diagnostician.
Regarding claims 1, 13 and 18, the limitations of obtaining of determining a mortality risk based on a weighted combination of physiological measures constitutes a mental process. This is a mental process that can be performed in the mind of a diagnostician by reviewing the information and making a determination of mortality risk based on prior knowledge and experience. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements: a signal receiver circuit and an assessment circuit. The circuits are recited at a high-level of generality and the specification does not disclose any specific structure or algorithms to be performed by the circuits. The assessment circuit is configured to control, based on the determined mortality risk metric, at least one resource of the medical device system, the at least one resource including at least one of a storage resource, a sensing resource, a processing resource or a communication resource but this amounts to generic, nonspecific control over various resources. The communication resource is broad enough to read on an alert which does not take the claim as a whole beyond the abstract idea. Thus, the recitation of the circuits represents mere data gathering and pre-solution activity that is necessary for use of the recited judicial exception (mental diagnostic process). Accordingly, this additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above the recitation of the signal receiver circuit for obtaining information is mere data gathering, and the recitation of these assessment circuit is merely generic computer structure. Therefore the circuits remain insignificant extra-solution activity even upon reconsideration, and do not amount to significantly more. The claim is not patent eligible.
Claims 2 and 14 describe indicating a high risk or a low risk and adjusting weightings of physiological measures, which may be performed in the human mind.
Claims 3-4 and 15 indicate third heart sound (S3), first sound information (S1), and the ratio of S3/S1 are used to determine the mortality risk metric, which is pre-solution data gathering.
Claims 5 and 19 describe the assessment circuit adjusts a weight or combination of the weighted combination, which can be performed by the human mind.
Claims 6 and 17 describe using clinical information to inform the determination of the mortality risk metric, which can be performed by the human mind.
Claims 7 and 16 describe determining an alert state of the patient based on the mortality risk metric and a threshold to inform adjust the mortality risk metric according, which can be performed by the human mind.
Claim 8 describes setting a schedule to determine the mortality risk metric which can be performed by the human mind.
Claim 10 describes determining a trend in the mortality risk metric and outputting the result to a user interface or other circuit. Determining a trend is a task that may be performed in the human mind, and outputting information to a user interface or circuit is insignificant extra-solution activity.
Claim 11 describes determining the mortality risk metric based on a relative difference between mortality risks measured at different times, which can be performed by the human mind.
Claim Rejections - 35 USC § 102
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.
Claims 1-11 and 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thakur et al. (US 2017/0281097).
[Claims 1, 13] Thakur discloses a medical device system comprising:
a signal receiver circuit (signal processor circuit, #220) configured to receive physiologic information from a patient [pars. 0054, 0055]; and
an assessment circuit (risk stratifier circuit, #230, 400) configured to:
determine a risk value for each of a plurality of physiologic measures, the plurality of physiologic measures determined using the received physiologic information (risk indication is determined by analyzing physiological signals using one or more signal metrics) [pars. 0058-0059]; and
determine a mortality risk metric (composite cardiac risk indication, cR) indicative of a risk of patient mortality (indicative of worsening heart failure, WHF) as a weighted combination of the plurality of physiologic measures having risk values satisfying a pre-determined condition [pars. 0079, 0082],
wherein the plurality of physiologic measures includes one or more of impedance information (intrathoracic and/or intracardiac impendence), activity information (physical activity or exertion level), respiratory rate information (respiration), and heart sound information (intensities and/or ratios between heart sound components) [pars. 0048, 0055], and
wherein the assessment circuit is configured to control, based on the determined mortality risk metric, at least one resource of the medical device system, the at least one resource including at least one of a storage resource of physiologic information, a sensing resource of physiologic information, a processing resource of physiologic information or a communication resource to communicate physiologic information of the patient (an output circuit generates an alert in response to the detection of the worsening cardiac event by the risk stratifier circuit) [par. 0072; claim 1].
[Claims 2, 14] Thakur discloses the risk value includes a categorical risk value, the categorical risk value indicating one of a high risk or a low risk [par. 0058], wherein the pre-determined condition comprises a determined indicating the high risk, wherein the assessment circuit is configured to adjust a weighting or the combination of the weighted combination of physiologic measures based on the determined categorical risk values indicating the high risk [pars. 0081-0082].
[Claim 3] Thakur discloses the heart sound information comprises a combination of third heart sound (S3) information and first heart sound (S2) information [pars. 0066, 0097].
[Claim 4] Thakur discloses the combination of S3 information and S1 information comprises a ratio of S3/S1 [pars. 0066, 0097].
[Claims 5, 15] Thakur discloses the assessment circuit is configured to adjust a weighting or combination of the weighted combination of the plurality of physiologic measures based on a combination of third heart sound (S3) information, the respiratory rate information, and the activity information, wherein the combination of physiologic measures includes at least two of first heart sound (S1) information, the third heart sound (S3) information, the impedance information, the respiratory rate information, or the activity information [pars. 0048, 0055, 0066, 0097].
[Claims 6, 17] Thakur discloses the signal receiver circuit is configured to receive clinical information about the patient separate from the received physiologic information, the clinical information including at least one of: patient demographic information; diagnosed comorbidities; previous treatment or hospitalization; or a type of implanted device, wherein the assessment circuit is configured to determine the mortality risk metric indicative of the risk of patient mortality using the weighted combination of the plurality of physiologic measures and the received clinical information about the patient separate from the received physiologic information (the risk stratifier circuit may determine the risk indication using information including clinical health assessments and current/historical disease states) [pars. 0060, 0085].
[Claims 7, 16] Thakur discloses the assessment circuit is configured to determine an alert state of the patient using the determined mortality risk metric and a threshold, and to further adjust the determined mortality risk metric as a function of a time that the determined mortality risk metric is above the threshold (produce time-varying weight factors decaying with time elapsed from a historical medical event, and apply the time-varying weight factors to at least one of the primary or secondary risk indications R1 or R2; maintain elevated risks of R1 or R2 above a baseline risk score within a specified timeframe following a historical medical event, and resume to the baseline risk score beyond the specified timeframe) [par. 0086].
[Claim 8] Thakur discloses the assessment circuit is configured to schedule determinations of the mortality risk metric at a default time period, and to adjust the default time period as a function of a value of the determined mortality risk metric (a sampling circuit 322 may sample the second signal metric X2n only when the risk indication R satisfies the specified condition, such as when the signal metric used for risk assessment falls within a specified range) [pars. 0057, 0075].
[Claim 9] Thakur discloses the system comprises an implantable medical device (ambulatory medical device (AMD), #110, may include an implantable device) comprising the assessment circuit [par. 0046], wherein the assessment circuit is configured to alter or adjust one or more modes or functions of the implantable medical device based on the determined mortality risk metric, wherein the one or more modes or functions includes at least one of: an active state of a sensor of the implantable medical device; a sampling frequency or resolution of a sensor of the implantable medical device [par. 0075]; an amount of data storage of physiologic information; or a time of communication of stored information outside of the implantable medical device.
[Claim 10] Thakur discloses the assessment circuit is configured to determine a trend of the determined mortality risk metric over time (composite signal metric trend) [pars. 0074, 0090] and to provide an output of the determined mortality risk metric trend to a user interface for display to a user (user interface, #260, including an output module) [par. 0072] or to another circuit to control or adjust a process or function of the system (therapy circuit, #270) [par. 0073].
[Claim 11] Thakur discloses the assessment circuit configured to determine the mortality risk metric indicative of the risk of patient mortality as a relative difference between respective determined mortality risk metrics at different times (time varying weight indicators and/or relative differences between metrics) [par. 0086, 0092].
[Claim 18] Thakur discloses a system, comprising:
a signal receiver circuit (signal processor circuit, #220) configured to receive physiologic information from a patient, including:
heart sound information, including first heart sound (S1) information and third heart sound (S3) information [pars. 0066, 0097];
respiration information, including respiratory rate information (respiration) ; and
activity information (physical activity or exertion level), including an indication of activity above a threshold [pars. 0048, 0055]; and
an assessment circuit (risk stratifier circuit, #230, 400) configured to determine a mortality risk metric using a weighted combination of physiologic information (risk indication is determined by analyzing physiological signals using one or more signal metrics) [pars. 0058-0059], including the third heart sound (S3) information and the first heart sound (S1) information [pars. 0066, 0097],
wherein the assessment circuit is configured to adjust a weighting or combination of the physiologic information based on a combination of the third heart sound (S3) information, the respiration information, and the activity information [pars. 0079, 0082],
wherein the assessment circuit is configured to control, based on the determined mortality risk metric, at least one resource of the medical device system, the at least one resource of physiologic information including at least one of a storage resource of physiologic information, a sensing resource of physiologic information, a processing resource of physiologic information or a communication resource to communicate physiologic information of the patient (an output circuit generates an alert in response to the detection of the worsening cardiac event by the risk stratifier circuit) [par. 0072; claim 1].
[Claim 19] Thakur discloses the assessment circuit is configured to adjust the weighting or combination of the physiologic information to determine the mortality risk metric to include one or more of impedance information, the respiratory rate information, or the activity information based on the combination of the third heart sound (S3) information, the respiration information, and the activity information, and wherein the assessment circuit is configured to determine the mortality risk metric using the weighted combination of physiologic information and to adjust the weighting or combination of the physiologic information without using heart rate information [pars. 0048, 0055, 0066, 0097].
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.
Claims 12 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (US 2017/0281097) as applied to claims 1 and 18 above, in view of Sharma et al. (US 2019/0069851).
[Claim 12, 20] Thakur discloses the system comprises an implantable medical device comprising the assessment circuit and battery but does not disclose wherein the assessment circuit is configured to determine an estimated remaining battery status of the implantable medical device, wherein the assessment circuit is configured to alter or adjust one or more modes or functions of the implantable medical device based on the determined mortality risk metric and the determined estimated remaining battery status of the implantable medical device.
Sharma discloses an analogous system comprising wherein an estimated remaining battery status (battery status/projected battery life) of the implantable medical device, wherein an assessment circuit (processing circuitry) is configured to alter or adjust one or more modes or functions of the implantable medical device based on the determined mortality risk metric and the determined estimated remaining battery status of the implantable medical device (heart failure risk status is determined by a HF risk score, if the HF risk score is high then a high risk monitoring protocol is implemented depending on battery status/projected battery life) [par. 0250].
It would have been obvious to one of ordinary skill in the art at the effective filing date to modify the assessment circuit taught by Thakur to factor in the mortality risk metric and battery status as taught by Sharma in order to increase the frequency on monitoring in response to a high risk of a cardiac event so long as the battery life is sufficient.
Conclusion
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN J JENNESS whose telephone number is (571)270-5055. The examiner can normally be reached M-F 8:00-5:00 EST.
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/NATHAN J JENNESS/Supervisory Patent Examiner, Art Unit 3733 7 April 2026
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