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 .
Status of Claims
This Nonfinal Office Action is in response to the Remarks filed on 04/02/2026. Claim 12 is amended. Claim 13 is cancelled. Claim 21 is new. Claims 1-12 and 14-21 are currently pending and considered below.
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 1-12 and 14-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without practical application and without significantly more than the abstract idea.
Claim 1 recites the following, wherein the abstract limitations are not emboldened:
A medical device system, comprising: a signal receiver circuit configured to receive physiologic information of a patient; and an assessment circuit configured to determine a health index for the patient as a function of the received physiologic information, wherein the signal receiver circuit is configured to receive chemical information of the patient, and wherein the assessment circuit is configured to determine an alert state of the patient using the determined health index and the received chemical information.
Independent claim 11 recites similar limitations. The claimed invention is broadly directed to the abstract idea of collecting patient information, analyzing the information, and determining different results based on the analyses using a data processing system.
The claims recite subject matter within a statutory category as a machine (claims 1-10) and process (claims 11-20), which recite steps to “receive physiologic information of a patient; and to determine a health index for the patient as a function of the received physiologic information, to receive chemical information of the patient, and to determine an alert state of the patient using the determined health index and the received chemical information,” that as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity including following rules or instructions. The claim recites as a whole a method of organizing human activity because the limitations include analyzing patient health information including physiologic and chemical and determine an alert state based on the analyses. This is a method of managing interactions between people. The mere nominal recitation of a generic computer system, signal receiver circuit and assessment circuit does not take the claims out of the method of organizing human interactions grouping. The limitations seem to monopolize the abstract idea of patient/caregiver analysis and care coordination and general diagnostic techniques between a clinician and her patient. Thus, the claims recite an abstract idea.
Additionally, the limitations of the independent claims could be considered an abstract idea including mental processes, whereby the steps of the claimed invention could be performed in the mind by manually obtaining patient physiologic and chemical information and determining statuses. For example, but for the generic computing device, signal receiver circuit and assessment circuit, a method for alerting if the chemical and physiological data is beyond a certain threshold, in the context of this claim encompasses one skilled in the pertinent art to manually determine those details. Other than reciting a generic computer system, signal receiver circuit and assessment circuit nothing in the claim elements precludes the step from practically being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of a medical device system, signal receiver circuit and assessment circuit, and the devices in these steps are recited at a high-level of generality (i.e., as a generic processor/server/storage/display/sensor performing a generic computer function of receiving inputs and displaying selected information) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, the additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application because the additional elements amount to mere instructions to apply an exception. See MPEP 2106.05(f)-(g). The claim is thus directed to an abstract idea.
Furthermore, the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of a medical device system, signal receiver circuit and assessment circuit amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. Claims 2-6 and 12, 14-16 recite alert states, health indexes and thresholds which are recited at a high level of generality and do not integrate the abstract idea into a practical application and do not amount to significantly more than the abstract idea itself. Claims 7-9 and 17-19 recite providing a control signal to a chemical in response to an alarm, which are recited at a high level of generality and even in combination do not provide a practical application or significantly more than the abstract idea. Claims 10 and 20 further define a heart failure index and limits the abstract idea. Claim 21 describes further how an assessment circuit would function, which is recited at a high level of generality such that it amounts no more than mere instructions to apply the judicial exception using a generic computer component and cannot provide an inventive concept. Even in combination, the assessment circuit and its alert state and received information does not integrate the abstract idea into a practical application and does not amount to significantly more than the abstract idea itself.
For at least the reasons as stated above, the claims are not patent eligible under 35 U.S.C. 101.
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.
Claims 1-4, 11-12, 14 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 2019/0029567 A1 to Stahmann et al., hereinafter “Stahmann.”
Regarding claim 1, Stahmann discloses A medical device system, comprising: a signal receiver circuit configured to receive physiologic information of a patient (See Stahmann at least at Abstract; Paras. [0004], [0059]-[0063] (Posture sensors, activity sensors, accelerometers for a patient.), [0070], [0113]; Figs. 3-7, 10. The Specification at Paras. [0048] (includes posture information as physiologic information) and at [0055] (accelerometer sensors), [0075]-[0076] (more physiologic sensors/information), [0110] (“The medical systems embodied herein can detect a physiological parameter in conjunction with posture determination. Exemplary physiological parameters can include cardiac, pulmonary, renal, nervous, etc. In some embodiments, a physiological parameter can be used in conjunction with a posture determination of a patient to determine a course of treatment or a modification of treatment using targeted therapies.”), wherein the signal receiver circuit is configured to receive chemical information of the patient (See id. at least at Abstract; Paras. [0005], [0094]-[0096] (“Physiological analytes that can be measured in accordance with chemical sensors of embodiments herein can include physiological analytes such as, but not limited to, electrolytes, proteins, sugars, hormones, peptides, amino acids, metabolites, and the like.”), [0113] (“The method can also include an operation of making a preliminary posture determination of a patient using data measured by an accelerometer at 1004. The method can also include measuring chemical data of a patient using a chemical sensor at 1006. The method can also include making a final posture determination of a patient using data measured by an accelerometer and data measured by a chemical sensor, using a controller at 1008. In some embodiments, methods herein can also include reporting the posture of the patient and/or providing the posture of the patient to a different circuit or component as an input for further processing.”); Figs. 3-7, 10.); and an assessment circuit configured to determine a health index for the patient as a function of the received physiologic information (See id. at least at Paras. [0059]-[0063] (Posture sensors, activity sensors, accelerometers for a patient and health index, i.e., posture status, is based on received physiologic information), [0070], [0105]-[0113]; Figs. 3-7, 10. The Specification at Paras. [0048] (includes posture information as physiologic information) and at [0049] (“Health indexes can include single-feature health indexes determined using a single feature or measure of a single type of physiologic information, or separately a composite health index determined using a combination of physiologic information, such as two or more separate features of different physiologic measures.”), and wherein the assessment circuit is configured to determine an alert state of the patient using the determined health index and the received chemical information (See id. at least at Paras. [0041]-[0044], [0105]-[0112] (“In some embodiments, the normalization circuitry will suspend chemical sensor data collection or not use the chemical sensor data for a predetermined length of time after a posture change, activity level change, or respiration change (i.e., health index) […] The alert can regard the levels of physiological analytes measured by the chemical sensor(s). However, in some embodiments, the issuance of an alert can be dependent on the postural and/or positional data corresponding to the chemical sensor data. In some embodiments, the issuance of an alert can also include data regarding the posture determination of a patient such that the alert can be acted upon or not in consideration of the corresponding posture determination of a patient.” Chemical sensors and physiological information independently calculated and changing alert states […] the physiological parameter can be displayed as a function of the posture determination of a patient.”), [0113] (“The method can also include measuring chemical data of a patient using a chemical sensor at 1006. The method can also include making a final posture determination of a patient using data measured by an accelerometer and data measured by a chemical sensor, using a controller at 1008. In some embodiments, methods herein can also include reporting the posture of the patient and/or providing the posture of the patient to a different circuit or component as an input for further processing.”); Figs. 3-7, 10).
Regarding claim 2, Stahmann discloses the limitations of claim 1 and further discloses wherein the health index includes a composite health index, wherein the assessment circuit is configured to determine the composite health index for the patient as a function of at least two features of the received physiologic information (See id. at least at Abstract; Paras. [0041]-[0044], [0059]-[0063] (Medical sensors, respiration sensors, posture and heart electrical activity being sensed as a health index of physiological information received); Figs. 3-7, 10).
Regarding claim 3, Stahmann discloses the limitations of claim 2 and further discloses wherein, to determine the alert state of the patient, the assessment circuit is configured to: determine a first alert state of the patient using a value of the determined health index and a health index alert threshold; and determine a second alert state based on the determined first alert state and the received chemical information of the patient (See id. at least at Paras. [0041]-[0044],[0080]-[0085], [0105]-[0112] (“In some embodiments, the normalization circuitry will suspend chemical sensor data collection or not use the chemical sensor data for a predetermined length of time after a posture change, activity level change, or respiration change (i.e., health index) […] The alert can regard the levels of physiological analytes measured by the chemical sensor(s). However, in some embodiments, the issuance of an alert can be dependent on the postural and/or positional data corresponding to the chemical sensor data. In some embodiments, the issuance of an alert can also include data regarding the posture determination of a patient such that the alert can be acted upon or not in consideration of the corresponding posture determination of a patient.” Chemical sensors and physiological information independently calculated and changing alert states […] the physiological parameter can be displayed as a function of the posture determination of a patient.”), [0113] (“The method can also include measuring chemical data of a patient using a chemical sensor at 1006. The method can also include making a final posture determination of a patient using data measured by an accelerometer and data measured by a chemical sensor, using a controller at 1008. In some embodiments, methods herein can also include reporting the posture of the patient and/or providing the posture of the patient to a different circuit or component as an input for further processing.”); Figs. 3-7, 10).
Regarding claim 4, Stahmann discloses the limitations of claim 1 and further discloses wherein, to determine the alert state of the patient, the assessment circuit is configured to: determine a first alert state of the patient using a value of the determined health index and a health index alert threshold; and determine a second alert state based on the determined first alert state and the received chemical information of the patient (See id.).
Regarding claims 11 and 14, the claims recite substantially the same limitations as claims 1 and 4, respectively. Thus, claims 11 and 14 are rejected under the same grounds of objection and for the same reasoning as applied to claims 1 and 4, above.
Regarding claim 12, claim 12 recites substantially the same limitations as claims 2 and 3. Thus, claim 12 is rejected under the same grounds of objection and for the same reasoning as applied to claims 2 and 3, above.
Regarding claim 21, Stahmann discloses the limitations of claim 1 and further discloses wherein the health index does not include any features based on the received chemical information and is determined as a function of the received physiologic information not including the received chemical information, and wherein the assessment circuit is configured to determine the alert state by adjusting or augmenting, using the received chemical information as a separate input, a first alert state determined using the determined health index (See Stahmann at least at Paras. [0105]-[0113] (“In some embodiments, the normalization circuitry will suspend chemical sensor data collection or not use the chemical sensor data for a predetermined length of time after a posture change, activity level change, or respiration change […] The alert can regard the levels of physiological analytes measured by the chemical sensor(s). However, in some embodiments, the issuance of an alert can be dependent on the postural and/or positional data corresponding to the chemical sensor data. In some embodiments, the issuance of an alert can also include data regarding the posture determination of a patient such that the alert can be acted upon or not in consideration of the corresponding posture determination of a patient.” Chemical sensors and physiological information independently calculated and changing alert states […] the physiological parameter can be displayed as a function of the posture determination of a patient.”), [0113] (“The method can also include measuring chemical data of a patient using a chemical sensor at 1006. The method can also include making a final posture determination of a patient using data measured by an accelerometer and data measured by a chemical sensor, using a controller at 1008. In some embodiments, methods herein can also include reporting the posture of the patient and/or providing the posture of the patient to a different circuit or component as an input for further processing.”); Figs. 3-4, 6-7, 10).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 5-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Stahmman, in view of U.S. 2019/0008467 A1 to Averina et al., hereinafter “Averina,” and further in view of U.S. 2020/0305713 A1 to Sipe et al., hereinafter “Sipe.”
Regarding claim 5, Averina as modified by Stigen discloses the limitations of claim 4 and Averina further discloses wherein the assessment circuit is configured to provide an output of the determined alert state to a user interface for display to a user or to a control circuit to control or adjust a process or function of the medical device system (See Averina at least at Abstract; Paras. [0008]-[0014] (control circuit), [0026], [0045]-[0047] (RCT), [0057] (delivering therapy and control circuit), [0058]-[0061] (“Examples of the physiological signals may include […] blood panel, sodium and potassium levels, glucose level and other biomarkers and bio-chemical markers, among others. The sensor circuit may include one or more sub-circuits to digitize, filter, or perform other signal conditioning operations on the received physiological signal.”), [0064], [0068] (“[T]he medical event detector circuit 240 may generate a composite signal index using a combination of signal metrics derived from the one or more physiological signals.”), [0084]; Figs. 1-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Stahmann to incorporate the teachings of Averina and provide displaying on a user interface. Averina is directed to systems and methods for medical alert management. Incorporating the medical alert management of Averina and the accelerometers and chemical sensors to alert a patient is in a particular state as in Stahmann would thereby improve the applicability, efficacy, and accuracy of an alert state on a display.
The references may not specifically describe but Sipe teaches wherein the second alert state is one of a plurality of guideline-directed medical therapy (GDMT) alert states associated with a therapy adjustment (See Sipe at least at Paras. [0153] (alerts in accordance with GDMT), [0240]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Stahmann and Averina to incorporate the teachings of Sipe and provide alerts and related to GDMT. Sipe is directed to providing drug prescription information with monitored patient information. Incorporating the drug and monitored patient information of Sipe with the medical alert management of Averina and the accelerometers and chemical sensors to alert a patient is in a particular state as in Stahmann would improve the alert state and provision of proper therapy.
Regarding claim 6, Stahmann as modified by Averina and Sipe discloses the limitations of claim 5 and Stahmann further discloses wherein the assessment circuit is configured to determine first and second chemical parameters using the received chemical information (See Stahmann at least at Paras. [0085]-[0095] (“Chemical sensors herein can include at least two functional elements: a receptor and a transducer. It will be appreciated that other elements can also be included. The receptor part of a chemical sensor can transform chemical information into a form of energy or signal that can be measured by the transducer. The transducer can transform and/or convey the energy or signal carrying the chemical information so as to provide a useful analytical signal […] Examples of physiological analytes that can be measured in accordance with chemical sensors of embodiments herein can include physiological analytes such as, but not limited to, electrolytes, proteins, sugars, hormones, peptides, amino acids, metabolites, and the like. In some embodiments, the electrolytes that can be measured can include potassium, calcium, sodium, magnesium, hydrogen phosphate, chloride, bicarbonate, and the like […] Chemical sensors herein can be directed at a specific physiological analyte or a plurality of different physiological analytes. In an embodiment, the physiological analyte sensed can be one or more physiological analytes relevant to cardiac health. In an embodiment, the physiological analyte sensed can be one or more analytes indicative of renal health. In an embodiment, the physiological analyte sensed can be one or more analytes indicative of pulmonary health. In an embodiment, the physiological analyte sensed can be one or more analytes indicative of neuronal health.”); wherein the received chemical information comprises at least one of potassium information or creatinine information of the patient (See id. at least at Paras. [0005] (Potassium, creatinine), [0043], [0080]-[0082] (Changes in analyte concentration.), [0085], [0096], [0108] (Hypo and hyperkalemia, analyte levels too high or low), wherein the first and second chemical parameters comprise indications of relative high or low values of the received chemical information with respect to one or more thresholds (See id.), wherein to determine the first alert state, the assessment circuit is configured to determine that the value of the determined health index is above the health index alert threshold, and wherein the assessment circuit is configured to determine the second alert state based on the determined first alert state and at least one of the determined first and second chemical parameters (See id. at least at Paras. [0105]-[0113] (“In some embodiments, the normalization circuitry will suspend chemical sensor data collection or not use the chemical sensor data for a predetermined length of time after a posture change, activity level change, or respiration change […] The alert can regard the levels of physiological analytes measured by the chemical sensor(s). However, in some embodiments, the issuance of an alert can be dependent on the postural and/or positional data corresponding to the chemical sensor data. In some embodiments, the issuance of an alert can also include data regarding the posture determination of a patient such that the alert can be acted upon or not in consideration of the corresponding posture determination of a patient.” Chemical sensors and physiological information independently calculated and changing alert states […] the physiological parameter can be displayed as a function of the posture determination of a patient.”), [0113] (“The method can also include measuring chemical data of a patient using a chemical sensor at 1006. The method can also include making a final posture determination of a patient using data measured by an accelerometer and data measured by a chemical sensor, using a controller at 1008. In some embodiments, methods herein can also include reporting the posture of the patient and/or providing the posture of the patient to a different circuit or component as an input for further processing.”); Figs. 3-4, 6-7, 10).
Regarding claims 15-16, the claims recite substantially the same limitations as claims 5-6, respectively. Thus, claims 15-16 are rejected under the same grounds of objection and for the same reasoning as applied to claims 5-6, above.
Claims 7, 9, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann, in view of Averina, in view of Sipe, and further in view of U.S. 2010/0016423 A1 to Claudel et al., hereinafter “Claudel.”
Regarding claim 7, Stahmann as modified by Averina and Sipe discloses the limitations of claim 6 and Stahmann further discloses wherein to determine the second alert state includes to determine that the potassium information of the patient is below a potassium threshold (See Stahmann at least at Paras. [0005] (Potassium, creatinine), [0043], [0080]-[0085], [0096], [0108] (Hypo and hyperkalemia, analyte levels too high or low, threshold values), the creatinine information of the patient is below a creatinine threshold (See id.).
The references may not specifically describe but Claudel teaches wherein the assessment circuit is configured to provide a control signal to provide or increase a potassium sparing diuretic in response to determining the second alert state (See Claudel at least at Paras. [0019]-[0030], [0047]-[0056] (“If the serum creatinine levels increases above the reference level, temporarily interrupting treatment with dronedarone, while maintaining treatment with compound B (i.e., potassium sparing diuretics)); Claims 8, 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Stahman, Averina and Sipe to incorporate the teachings of Claudel and provide increase in potassium sparing diuretic. Claudel is directed to treating patients using potassium sparing diuretics. Incorporating the use of potassium sparing diuretics as in Claudel with the drug and monitored patient information of Sipe, the medical alert management of Averina and the accelerometers and chemical sensors to alert a patient is in a particular state as in Stahmann would improve the alert state and provision of proper therapy for a patient.
Regarding claim 9, Stahmann as modified by Averina and Sipe discloses the limitations of claim 6. The references may not specifically describe but Claudel teaches wherein to determine the second alert state includes to determine that the creatinine information of the patient is above a creatinine threshold, and wherein the assessment circuit is configured to provide a control signal to provide or increase a vasodilator in response to determining the second alert state (See Claudel at least at Paras. [0001], [0009]-[0024] (“If the increase in the serum creatinine level above the reference level is due to dronedarone, then the treatment with dronedarone and compound B can be pursued.”), [0047]-[0056] (“If the serum creatinine levels increases above the reference level, temporarily interrupting treatment with dronedarone, while maintaining treatment with compound B (i.e., ACE inhibitor vasodilator); Claims 8, 9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Stigen, Averina and Sipe to incorporate the teachings of Claudel and provide ACE inhibitor when creatinine is high. Claudel is directed to treating patients using potassium sparing diuretics. Incorporating the use of potassium sparing diuretics as in Claudel with the drug and monitored patient information of Sipe, the medical alert management of Averina and the accelerometers and chemical sensors to alert a patient is in a particular state as in Stahmann would improve the alert state and provision of proper therapy for a patient.
Regarding claim 17, claim 17 recites substantially the same limitations as claim 7 and is rejected under the same grounds of objection and for the same reasoning as applied to claim 7, above.
Regarding claim 19, claim 19 recites substantially the same limitations as claim 9 and is rejected under the same grounds of objection and for the same reasoning as applied to claim 9, above.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Averina, in view of Stigen, in view of Sipe, and further in view of U.S. 2025/0239348 A1 to Halpert et al., hereinafter “Halpert.”
Regarding claim 8, Stahmann as modified by Averina and Sipe discloses the limitations of claim 6 and Stahmann further discloses wherein to determine the second alert state includes to determine that the potassium information of the patient is above a potassium threshold (See Stahmann at least at Paras. [0005] (Potassium, creatinine), [0043], [0080]-[0085], [0096], [0108] (Hypo and hyperkalemia, analyte levels too high or low, threshold values); See also Halpert at least at Paras. [0030], [0110], [0202]; Figs. 1-2, 5-14), and the creatinine information of the patient is below a creatinine threshold (See id. at least at Paras. [0005] (Potassium, creatinine), [0043], [0080]-[0085], [0096], [0108] (Hypo and hyperkalemia, analyte levels too high or low, threshold values); See also Halpert at Paras. [0037], [0110]).
The references may not specifically describe but Halpert teaches wherein the assessment circuit is configured to provide a control signal to provide or increase a thiazide diuretic in response to determining the second alert state (See Halpert at least at Paras. [0030]-[0035] (“Methods for fluid therapy based on patient data, including managing fluid levels of the patient based at least partially in response to data received from the patient before and/or during the fluid therapy. In some embodiments, the systems, devices, and methods described herein are used to treat a patient for fluid overload. To treat fluid overload, patients can be administered a diuretic drug.”), [0044]-[0047], [0110], [0124], [0129], [0153] (excess levels), [0159], [0202]; Figs. 1-3, 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Stahmann, Averina and Sipe to incorporate the teachings of Halpert and provide control of diuretics. Halpert is directed to fluid therapy based on patient data. Incorporating the fluid therapy of Halpert with the drug and monitored patient information of Sipe, the medical alert management of Averina and the accelerometers and chemical sensors to alert a patient is in a particular state as in Stahmann would improve the provision of proper therapy for a patient.
Regarding claim 18, claim 18 recites substantially the same limitations as claim 8 and is rejected under the same grounds of objection and for the same reasoning as applied to claim 8, above.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stahmann, in view of Averina.
Regarding claim 10, Stahman discloses the limitations of claim 4. Stahmann may not specifically describe but Averina teaches wherein the health index includes a heart failure index and the health index alert threshold includes a heart failure alert threshold (See Averina at least at Abstract; Paras. [0003]-[0004], [0017], [0031], [0048]-[0050], [0059], [0068]; Fig. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Stahmann to incorporate the teachings of Averina and provide a heart failure index. Averina is directed to systems and methods for medical alert management. Incorporating the medical alert management of Averina with the accelerometers and chemical sensors to alert a patient is in a particular state as in Stahmann would thereby improve the alert threshold for a heart failure event.
Regarding claim 20, claim 20 recites substantially the same limitations as claim 10 and is rejected under the same grounds of objection and for the same reasoning as applied to claim 10, above.
Response to Arguments
Applicant’s remarks filed April 2, 2026 have been fully considered, but they are not entirely persuasive. The following explains why:
Applicant’s arguments pertaining to subject matter eligibility are not persuasive. The claims have been addressed with regard to the updated 35 U.S.C. §101 rejection discussed above in this Second Nonfinal Office Action, and considered under relevant sections of the MPEP. The arguments at pages 7-11 of Applicant’s Remarks are not persuasive. At pages 7-9 the Examiner disagrees that there is not an abstract idea, that there is any practical application thereof or there is a technological improvement in the claims. Here the data and assessment and signal receiver circuits act as a computer tool used to employ the abstract idea. That it may be tedious or laborious to perform analyses in the mind or manually is not of consequence in the eligibility analysis. The current claims are included as a mental process(es) for the judicial exception as well as organizing human activity. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. There is no clear technological improvement that is described in the claims for the underlying computer technology. For at least these reasons and those stated above, the claims are not patent eligible.
Applicant’s arguments pertaining to prior art rejections are not entirely persuasive. The arguments are moot in light of the Second Nonfinal Office Action and the claims have been addressed with regard to the 35 U.S.C. §103 rejection discussed above. The arguments pertaining to prior art references of the Applicant’s Remarks at Pages 12-24 are moot or not persuasive in light of the updated rejections. The Examiner respectfully notes that the broadly worded claim limitations versus the narrow interpretation of the specification used throughout each of the arguments to scrutinize the cited prior art does not limit the claims. However, it is noted the newly cited prior art reads on the claim limitations as they are broadly recited in the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/WILLIAM T. MONTICELLO/Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682
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