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 .
Notice to Applicant
Receipt of Applicant’s Amendment filed August 6, 2026 is acknowledged.
Response to Amendment
Claims 1, 3, 7, 9-10, 12, 17, and 19 are currently amended. Claims 2, 4-6, 8, 11, 13-16, 18, and 20 have not been modified. Claims 1-20 are pending and are provided to be examined upon their merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 6, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments with respect to Remarks filed on July 22, 2026 have been considered but are not persuasive. Response has been provided below.
Applicant argues 35 U.S.C. §112 Rejection, starting pg. 9 of Remarks:
Examiner acknowledges Applicant amendment and withdraws the §112 Rejection.
Applicant argues 35 U.S.C. §101 Rejection, starting pg. 9 of Remarks:
Examiner acknowledges Applicant amendment and withdraws the §101 Rejection. Please see explanation below.
Applicant argues 35 U.S.C. §103 Rejection, starting pg. 10 of Remarks:
Applicant argues that the combination of Perschbacher in view of Hamilton fails to teach the limitations of the independent claim for the following reasons:(1) an overall weight as Perschbacher assesses a single event against a historical events while the claimed subject matter aggregates multiple current events to assess the patient’s present state, (2) Perschbacher’s determination of the overall clinical priority is the reverse of the claimed system as the patient priority is increased in response to the sum of severity-weighted increases also increasing, and (3) neither Perschbacher nor Hamilton teach the amended claim limitation of pushing the corrective action.
Regarding (1), Examiner notes that the claimed language does not delineate between multiple events that occur over time and multiple events that occur simultaneously as the claimed language only recites:
“determining, by the processing system, that at least one event experienced by the patient is at least one critical event, each of the at least one critical event being one of a plurality of predefined critical events;
determining, by the processing system, a severity of each of the at least one critical event, and;
weighting, by the processing system, each of the at least one critical event based on the determined severity to provide a corresponding at least one weighted critical event;
summing, by the processing system, the at least one weighted critical event to provide a sum of at least one weighted critical event;”
The claims do not recite any mention of the timing of received events as alleged by Applicant’s arguments. Applicant specification does not support such an interpretation either, as [0088] of Applicant specification recites: “At 855, one or more weighted events are summed together. The weighted critical event(s) may correspond to an observation window of time. The observation window may be a moving window, such that all weighted events that fall within the window are summed together. By way of example and not limitation, the observation window may be a two-week (e.g., 14 day) period of time that refreshes every day such that the period of time is over days 1-14 on the 14th day, and is over days 2-15 on the 15th day, and the like. Other periods of time (e.g., number of days, hours, minutes, etc.) may be used to provide an observation window in which the weighted critical events are summed.”
As the only limitation on timing for events that are processed are that they may correspond to an observation window of time, under the broadest reasonable interpretation, this may include historical event data. Examiner notes that Perschbacher’s historical event data is in line with Applicant’s example above ([0089] of Perschbacher, “the composite similarity measure D may be computed using only a portion of historical medical alerts occurring during a specified period of time, such as within a week, a month, or a year prior to the detected medical event.”).
Thus, under the broadest reasonable interpretation, Examiner maintains that the multiple events of Perschbacher encompass the claimed subject matter.
Regarding (2), Examiner notes that the claimed language does not specify the way in which the calculated sum of the at least one weighted critical event affects the overall clinical priority as the claimed language only recites:
“determining, by the processing system, an overall clinical priority for the patient based at least in part on the sum, and weighting, by the processing system, the patient based on the determined overall clinical priority to provide a weighted patient priority;”
As the claims provide no specific relationship between the sum and the overall clinical priority, Examiner maintains that the multiple events of Perschbacher encompass the claimed subject matter.
Regarding (3), Examiner agrees that neither Perschbacher nor Hamilton teach the amended claim limitation. However, Applicant argument is moot as new art is introduced to teach the amended claim limitation.
Regarding Srivastava, Applicant arguments are moot as Srivastava is no longer relied upon as new art is applied based on Applicant’s amendments.
Regarding Daniel and Stahmann, Applicant arguments are moot as these references were not and still are not applied to teach the contended claim limitations.
Regarding 35 USC § 101
The claims recite abstract ideas of organizing human activity as managing personal behaviors of medical staff by determining clinical priorities of patients based on severities of critical events by patients and performing therapy via a deep brain stimulator (DBS), which is a human activity typically performed by neurologists (Step 2A, Prong One: Yes). However, the claims also recite concrete steps that use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment (Step 2A, Prong Two: Yes). Specifically, the abstract steps of determining clinical priorities of patients based on severities of critical events by patients and performing therapy are integrated into a specific practical application of pushing a corrective action to the DBS device encompassing a revision, reversion, replacement, or toggling of a therapy program on the DBS device that is delivered to the patient, which is a specific, technical improvement to the functioning of DBS devices.
Thus, the claims qualify as eligible subject matter under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 8, 11-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Perschbacher (US 20180310892) in view of Zenisek (US 20220230743).
Regarding claim 1, Perschbacher teaches a method, comprising:
delivering, by a medical device, a therapy to a patient to treat a condition, wherein the therapy is at least partially defined using a parameter set ([0003], “Implantable medical devices (IMDs) have been used for monitoring patient health condition or disease states and delivering therapies. For example, implantable cardioverter-defibrillators (ICDs) are used to monitor certain abnormal heart rhythms... In addition to diagnostic capabilities, the IDs may also provide therapies to treat or alleviate certain medical conditions, such as cardiac electrostimulation therapies to treat cardiac arrhythmias or to rectify cardiac desynchrony in CHF patients.” [0064], “The detector circuit 220 may detect the cardiac arrhythmia using heart rates, heart rate statistics such as heart rate stability or variability, atrioventricular activation patterns (e.g., timing relationship between atrial activation and ventricular activation within a cardiac cycle), morphologies of cardiac electrical or mechanical signals, or hemodynamic parameters.”); and
determining, by the processing system, that at least one event experienced by the patient is at least one critical event, each of the at least one critical event being one of a plurality of predefined critical events ([0008], “a detector circuit to detect medical events in a patient.” [0009], “The system comprises a receiver circuit configured to receive a medical event detected from a patient and information of historical medical alerts associated with the patient” [0024], “a machine-readable storage medium, comprising a plurality of instructions that, responsive to being executed with processor circuitry of a computing device, cause the computing device to:”);
determining, by the processing system, a severity of each of the at least one critical event, and weighting, by the processing system, each of the at least one critical event based on the determined severity to provide a corresponding at least one weighted critical event ([0034], “alerts associated with device-detected physiological events from a patient (e.g., cardiac arrhythmias or worsening heart failure events) may represent different degrees of severities. Alerts may be prioritized according to their degrees of severities before being presented to a clinician for evaluation… If a device-detected arrhythmia episode resembles a historical TP detection, then the detected arrhythmia episode is more likely a true target arrhythmia. As such, a higher severity is indicated and a higher priority is designated. However, if the device-detected arrhythmia episode resembles a historical FP detection, then it is less likely a true target arrhythmia event. As such, a lower severity is indicated, and a lower priority is designated.” [0084], “the similarity metric and the event prioritization may be further using the quality of the physiological data, such as a signal to noise ratio (SNR), of one or more physiological signals used for detecting the target medical event. In an example where the similarity metric is a Euclidean distance d(Y, X.sub.i) between Y and X.sub.i, the squared differences of individual signal characteristics, such as (Y(j)−X.sub.i(j)).sup.2, may each be weighted by the respective SNRs associated with the signal characteristics”);
summing, by the processing system, the at least one weighted critical event to provide a sum of at least one weighted critical event ([0103], “The composite similarity measure may be computed using the event analyzer circuit 300A. In an example, the composite similarity measure may be computed as a weighted combination of the distance measures {d(Y, X.sub.1), d(Y, X.sub.2), . . . , d(Y, X.sub.N)}. The weight factors may be determined according to the temporal proximity to the detected medical event, as previously discussed with reference to FIG. 3A.”);
determining, by the processing system, an overall clinical priority for the patient based at least in part on the sum, and weighting, by the processing system, the patient based on the determined overall clinical priority to provide a weighted patient priority ([0035], “The alert prioritization discussed in this document may timely direct medical attention to patients likely having more severe events than those likely having frequent false positive detections. This might help better align the medical resources to serve the need of more patients, but may also help save the operational cost in the healthcare facilities. For example, by identifying patients with lower priority alerts (such as PAPs), fewer unnecessary medical interventions, such as drugs, procedures, or device therapies, may be scheduled, prescribed, or provided to such patients.” [0058], “System users, such as clinicians or other qualified medical specialists, may use the clients to securely access stored patient data assembled in the database in the server, and to select and prioritize patients and alerts for health care provisioning.” [0103], “The composite similarity measure may be computed using the event analyzer circuit 300A. In an example, the composite similarity measure may be computed as a weighted combination of the distance measures {d(Y, X.sub.1), d(Y, X.sub.2), . . . , d(Y, X.sub.N)}. The weight factors may be determined according to the temporal proximity to the detected medical event, as previously discussed with reference to FIG. 3A.”). Examiner interprets the selection and prioritizing specific patients who have more severe events, based on a total sum exceeding a threshold value and adjusting the priority of their medical events based on the weight factors (noted above with regards to [0103] of Perschbacher) to encompass an overall clinical priority (selecting and prioritizing patients) and a weighted patient priority (adjusting alert priority). Note that [0013] of Applicant specification recites: “the weighted patient priority is determined to be high based on a single weighted critical event”, which is fully encompasses by the priority of the detected medical event used to prioritize patients as taught by Perschbacher.
communicating, by the processing system, the critical event using the selected communication technique ([0058], “the remote device 124, including the server and the interconnected clients, may also execute a follow-up scheme by sending follow-up requests to the AMD 110, or by sending a message or other communication to the patient 102, clinician or authorized third party as a compliance notification.” [0057], “alert notifications may include a Web page update, phone or pager call, E-mail, SMS, text or “Instant” message, as well as a message to the patient and a simultaneous direct notification to emergency services and to the clinician. Other alert notifications are possible. The server may include an alert prioritizer circuit configured to prioritize the alert notifications. For example, an alert of a detected medical event may be prioritized using a similarity metric between the physiological data associated with the detected medical event to physiological data associated with the historical alerts.”).
Perschbacher does not teach wherein the medical device includes a deep brain stimulator (DBS) and the therapy includes a DBS therapy; selecting, by the processing system, a communication technique from a plurality of available communication techniques for use to communicate the at least one critical event, the communication technique being selected based on the weighted patient priority; and performing, by the processing system, a corrective action to address the at least one critical event by pushing the corrective action to the DBS device to adjust the DBS therapy delivered to the patient, wherein the corrective action includes at least one of revising a current program for the DBS device, reverting to a prior program for the DBS device, replacing the current program with another program for the DBS device, or toggling programs for the DBS device.
However, Perschbacher in view of Zenisek does teach wherein the medical device includes a deep brain stimulator (DBS) and the therapy includes a DBS therapy (Zenisek, [0003], “An electrical stimulation device may deliver electrical stimulation therapy via electrodes, e.g., carried by one or more leads, positioned proximate to target locations associated with the brain, the spinal cord, pelvic nerves, tibial nerves, peripheral nerves, the gastrointestinal tract, or elsewhere within a patient. Stimulation proximate the spinal cord, proximate the sacral nerve, within the brain, and proximate peripheral nerves is often referred to as spinal cord stimulation (SCS), sacral neuromodulation (SNM), deep brain stimulation (DBS), and peripheral nerve stimulation (PNS), respectively.”);
selecting, by the processing system, a communication technique from a plurality of available communication techniques for use to communicate the at least one critical event, the communication technique being selected based on the weighted patient priority (Zenisek, [0017], “External programmer 150 may determine a severity level for patient information. For example, each communication mode of a plurality of communication modes may be assigned a respective range of severity levels. In this example, external programmer 150 may select the communication mode that comprises a range of severity level that includes the severity level for the patient information. For instance, patient information may be associated with a severity level of 3, which may be assigned to a text message.”); and
performing, by the processing system, a corrective action to address the at least one critical event by pushing the corrective action to the DBS device to adjust the DBS therapy delivered to the patient, wherein the corrective action includes at least one of revising a current program for the DBS device, reverting to a prior program for the DBS device, replacing the current program with another program for the DBS device, or toggling programs for the DBS device (Zenisek, [0028], “External programmer 150 may transmit therapy stimulation programs, program groups, stimulation parameter adjustments, therapy stimulation program selections, user input, or other information to control the operation of IMD 110, e.g., by wireless telemetry or wired connection.” [0029], “External programmer 150 may perform a stimulation parameter adjustment that changes a set of stimulation parameters of an existing program. For example, external programmer 150 may automatically, semi-automatically, or based on a user selection, may determine or more stimulation parameter adjustments for an existing program.” [0061], “Processing circuitry 352 may be configured to control IMD 110 with a program to provide stimulation. For example, processing circuitry 352 may automatically or semi-automatically set or adjust programs at IMD 110 by transmitting, with telemetry circuitry 358, instructions to IMD 110. For instance, in response to a change (e.g., a change indicated by user input, a change sensed by IMD 110, etc.) in activity of a patient (e.g., standing, walking, voiding, etc.), processing circuitry 352 may automatically or semi-automatically set or adjust programs at IMD 110.” Perschbacher, [0034], “alerts associated with device-detected physiological events from a patient (e.g., cardiac arrhythmias or worsening heart failure events) may represent different degrees of severities.”). Under the broadest reasonable interpretation, Examiner interprets a physiological event to encompass a change. Thus, combining the adjustment of a DBS therapy device’s program in response to a change encompasses the claim limitation.
Perschbacher in view of Zenisek are considered analogous to the claimed invention because they are in the field of patient monitoring. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perschbacher with Zenisek for the advantage of “improv[ing] a therapy provided to the patient” (Hamilton; [0099]).
Regarding claim 2, Perschbacher in view of Zenisek teaches the system of method of claim 1. Perschbacher does not teach wherein the processing system is further used to adjust the weighted patient priority based on whether corrective action is successfully performed by the medical device to address the at least one critical event, and
the communication technique is selected based on the adjusted weighted patient priority.
However, Zenisek does teach wherein the processing system is further used to adjust the weighted patient priority based on whether corrective action is successfully performed by the medical device to address the at least one critical event ([0107], “Remote client 472 may set the severity level specified by the tag based on feedback from one or more of the medical device or a user interaction.” [0023], “Stimulation parameters may be programmed prior to delivery of the stimulation pulses, manually adjusted based on user input, or automatically controlled during delivery of the stimulation pulses, e.g., based on sensed conditions.” [0109], “It is to be recognized that depending on the example, certain acts or events of any of the techniques described herein can be performed in a different sequence, may be added, merged, or left out altogether (e.g., not all described acts or events are necessary for the practice of the techniques).”), and
the communication technique is selected based on the adjusted weighted patient priority ([0017], “External programmer 150 may determine a severity level for patient information. For example, each communication mode of a plurality of communication modes may be assigned a respective range of severity levels. In this example, external programmer 150 may select the communication mode that comprises a range of severity level that includes the severity level for the patient information. For instance, patient information may be associated with a severity level of 3, which may be assigned to a text message… changes to a therapy easier for low risk changes using simple and/or non-intrusive communication modes (e.g., an e-mail, a text message, an in-app notification, etc.) and that may alert or prioritize changes to a therapy that may be relatively risky and would most likely benefit from a clinician review using relatively complex communication modes (e.g., a telephone call, a virtual visit, an in-person visit, etc.)”).
Perschbacher in view of Zenisek are considered analogous to the claimed invention because they are in the field of patient monitoring. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perschbacher with Zenisek for the advantage of “allow[ing] a clinician to more quickly review therapy changes, which may help to reduce an amount of time a clinician spends reviewing patient information.” (Zenisek; [0005]).
Regarding claim 3, Perschbacher in view of Zenisek teaches the system of method of claims 1 and 2. Perschbacher further teaches wherein the at least one critical event is determined from analyzing at least one of a heart rate, tremor, rigidity, or bradykinesia ([0109], “the lead system 108 and the associated electrodes may alternatively be positioned on other parts of the body to sense a physiological signal containing information about patient heart rate or pulse rate.” [0053], “the medical event includes a specific cardiac arrhythmia. Examples of cardiac arrhythmias may include atrial or ventricular brady- or tachy-arrhythmia, such as atrial fibrillation, atrial flutter, atrial tachycardia, supraventricular tachycardia, ventricular tachycardia, or ventricular fibrillation, among others.”).
Regarding claim 4, Perschbacher in view of Zenisek teaches the system of method of claim 1. Perschbacher does not teach wherein the medical device includes a deep brain stimulator (DBS) and the therapy includes a DBS therapy.
However, Zenisek does teach wherein the medical device includes a deep brain stimulator (DBS) and the therapy includes a DBS therapy ([0192], “A system may also include at least one medical device that is configured to deliver a therapy such as an electrical or drug therapy. A non-limiting example of a medical device to deliver a drug therapy is an insulin pump, and non-limiting examples of a medical device configured to deliver electrical therapy muscle stimulators, cardiac rhythm devices such as pacemakers and defibrillators, and neurostimulators. Examples of neuromodulation include Spinal Cord Stimulation (SCS), Deep Brain Stimulation (DBS), Peripheral Nerve Stimulation (PNS), and Functional Electrical Stimulation (FES).”).
Perschbacher in view of Zenisek are considered analogous to the claimed invention because they are in the field of patient monitoring. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perschbacher with Zenisek for the advantage of “treat[ing] a variety of symptoms or conditions such as chronic pain, tremor, Parkinson's disease, epilepsy, or other neurological disorders,” (Zenisek; [0003]).
Regarding claim 5, Perschbacher in view of Zenisek teaches the system of method of claims 1 and 4. Perschbacher further teaches wherein the at least one critical event is specific to the condition of the patient, specific to the DBS therapy, or specific to the medical device used to deliver the therapy ([0003], “implantable cardioverter-defibrillators (ICDs) are used to monitor certain abnormal heart rhythms. Some IMDs may be used to monitor progression of a chronic disease, such as worsening of cardiac performance due to congestive heart failure (CHF). In addition to diagnostic capabilities, the IDs may also provide therapies to treat or alleviate certain medical conditions, such as cardiac electrostimulation therapies to treat cardiac arrhythmias or to rectify cardiac dyssynchrony in CHF patients.”).
Regarding claim 6, Perschbacher in view of Zenisek teaches the system of method of claim 1. Perschbacher wherein the severity of each of the at least one critical event is determined using a plurality of weight factors that include at least two of the following:
whether the corresponding critical event is due to a newly recommended stimulation setting that the patient applied remotely;
whether the corresponding critical event is potentially life threatening ([0034], “the present inventors have recognized that alerts associated with device-detected physiological events from a patient (e.g., cardiac arrhythmias or worsening heart failure events) may represent different degrees of severities. Alerts may be prioritized according to their degrees of severities before being presented to a clinician for evaluation. For example, an AMD patient may have device-detected cardiac arrhythmia events in his/her medical history. The device-detected cardiac arrhythmia events may be designated as true positive (TP) detections or false positive (FP) detections. The TP detections are detected arrhythmia episodes that are truly the target arrhythmia type, and the FP detections are detected arrhythmia episodes that are indeed non-arrhythmic event or belong to other types of arrhythmia different from the target arrhythmia. If a device-detected arrhythmia episode resembles a historical TP detection, then the detected arrhythmia episode is more likely a true target arrhythmia. As such, a higher severity is indicated and a higher priority is designated.”). Examiner notes that [0105] of Applicant specification indicates cardiac events as potentially life threatening (“Critical events that may be life threatening (blood pressure, cardiac, falls, depression, etc.) may be considered independently.”).
whether the corresponding critical event is anticipated;
the regularity of an occurrence for the corresponding critical event based on a pre-assessed normal occurrence of the critical event for the patient ([0013], “a patient identifier circuit configured to identify a prolific alert patient, the prolific alert patient having a quantity of historical medical alerts exceeding a threshold value (e.g., a threshold quantity value) during a specified time period. The output circuit may be configured to adjust the priority of the detected medical event using the identification of the prolific alert patient.”); or
a comparison of a severity score for the corresponding critical event to a pre-assessed normal for the patient.
Regarding claim 8, Perschbacher in view of Zenisek teaches the system of method of claim 1. Perschbacher wherein the weighted patient priority is determined to be high based on a single weighted critical event or based on a combination of two or more weighted critical events ([0103], “the composite similarity measure may be computed as a weighted combination of the distance measures {d(Y, X.sub.1), d(Y, X.sub.2), . . . , d(Y, X.sub.N)}. The weight factors may be determined according to the temporal proximity to the detected medical event, as previously discussed with reference to FIG. 3A.” [0015], “generate the event priority indicator using the similarity metric” [0013], “a patient identifier circuit configured to identify a prolific alert patient, the prolific alert patient having a quantity of historical medical alerts exceeding a threshold value (e.g., a threshold quantity value) during a specified time period. The output circuit may be configured to adjust the priority of the detected medical event using the identification of the prolific alert patient. The output circuit may be configured to schedule the presentation of the detected medical event using the identification of the prolific alert patient.” [0058], “System users, such as clinicians or other qualified medical specialists, may use the clients to securely access stored patient data assembled in the database in the server, and to select and prioritize patients and alerts for health care provisioning.”).
Regarding claim 11, Perschbacher in view of Zenisek teaches the system of method of claim 1. Perschbacher does not teach wherein the plurality of available communication techniques for use to communicate the at least one critical event includes at least two techniques selected from a phone call, a text message, an email message, phone alerts including at least one of badges, banners or sound, a patient-connected app, a device rep portal and a clinician/physician portal.
However, Zenisek does teach wherein the plurality of available communication techniques for use to communicate the at least one critical event includes at least two techniques selected from a phone call, a text message, an email message, phone alerts including at least one of badges, banners or sound, a patient-connected app, a device rep portal and a clinician/physician portal ([0010], “one or more processors arranged in an external clinician programmer device and/or a cloud (e.g., using a web interface of the cloud) may be configured to select the communication mode to include one or more of a browser presentation, an e-mail, a text message, a telephone call, a virtual visit, or an in-person visit… In this way, a system may help to provide risk control measures that simplify or make changes to a therapy easier for low risk changes using simple and/or non-intrusive communication modes (e.g., an e-mail, a text message, an in-app notification, etc.) and that may alert or prioritize changes to a therapy that may be relatively risky and would most likely benefit from a clinician review using interactive communication modes (e.g., a telephone call, a virtual visit, an in-person visit, etc.), which may improve a therapy provided to the patient.”).
Perschbacher in view of Zenisek are considered analogous to the claimed invention because they are in the field of patient monitoring. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perschbacher with Zenisek for the advantage of utilizing “different communication modes, such that one scenario may be handled with less urgent, less intrusive communication while another may be handled with different, more intrusive modalities” (Zenisek; [0094]).
Regarding claims 12, 13, 14, 15, 16, 18, 19, and 20, these claims are rejected for claims 1, 2, 4, 5, 6, 8, 1, and 2, respectively. Perschbacher further teaches a non-transitory machine-readable medium including instructions, which when executed by a machine, cause the machine to perform a method ([0125], “a massed machine readable medium comprises a machine readable medium with a plurality of particles having invariant (e.g., rest) mass. Accordingly, massed machine-readable media are not transitory propagating signals. Specific examples of massed machine readable media may include: non-volatile memory, such as semiconductor memory devices (e.g., Electrically Programmable Read-Only Memory (EPROM), Electrically Erasable Programmable Read-Only Memory (EEPROM)) and flash memory devices; magnetic disks, such as internal hard disks and removable disks; magneto-optical disks; and CD-ROM and DVD-ROM disks.”).
Further regarding Claim 19, Examiner notes that [0109] of Zenisek recites: “It is to be recognized that depending on the example, certain acts or events of any of the techniques described herein can be performed in a different sequence, may be added, merged, or left out altogether (e.g., not all described acts or events are necessary for the practice of the techniques).” Thus, the combination of Perschbacher in view of Zenisek teaches claim limitations of claim 19 for the same reasons as claim 1.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Perschbacher (US 20180310892) in view of Zenisek (US 20220230743) further in view of Daniel (US 20140129250) and Hatlestad (US 20040122487).
Regarding claim 7, Perschbacher in view of Zenisek teaches the system of method of claim 1. Perschbacher in view of Zenisek does not teach wherein the overall clinical priority for the patient is determined using a combination of the sum as well as at least one of: a determination that one or more of the at last one critical event is likely related to a change in medication or stimulation; and when the patient is scheduled for a clinical visit.
However, Perschbacher in view of Daniel does teach wherein the overall clinical priority for the patient is determined using a combination of the sum (Perschbacher, [0103], “the composite similarity measure may be computed as a weighted combination of the distance measures {d(Y, X.sub.1), d(Y, X.sub.2), . . . , d(Y, X.sub.N)}. The weight factors may be determined according to the temporal proximity to the detected medical event, as previously discussed with reference to FIG. 3A.” [0015], “generate the event priority indicator using the similarity metric”),
when the patient is scheduled for a clinical visit (Daniel, [0058], “In assigning a priority to a patient, additional criteria may also be taken into account, for example, the next scheduled examination appointment or the like.” [0053], “Joint analysis 209 of the treatment-related data transmitted originally and the additional treatment-related data may also be performed in such a manner that it is performed for a number of patients, such that there is a correlation of a value number or a priority and a priority is assigned with respect to a need for intervention and/or a need for a check on a treatment by a caregiver and/or a visual observation of a certain patient by a caregiver or the severity of the deviation found or of a symptom cluster is indicated.”). Examiner notes that Daniel supports combining severity levels, which may be determined using weighted combinations as taught by Perschbacher, with “additional criteria”, as indicated. Thus, it would be obvious to one of ordinary skill in the art to combine the sum of Perschbacher with additional criteria, including a patient’s next scheduled visit.
Perschbacher in view of Zenisek further in view of Daniel are considered analogous to the claimed invention because they are in the field of patient monitoring. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perschbacher in view of Zenisek with Daniel for the advantage of utilizing a system wherein “additional criteria may also be taken into account” (Daniel; [0058]).
Perschbacher in view of Zenisek further in view of Daniel does not teach a determination that one or more of the at least one critical event is likely related to a change in medication or stimulation.
However, Hatlestad does teach a determination that one or more of the at least one critical event is likely related to a change in medication or stimulation ([0128], “At 1777, predetermined events are defined. In various embodiments, predetermined events are significant health-related events, such as events that are clinically important in themselves, events that trigger a change, and/or events that explain a change. Examples of predetermined events includes device (e.g. IMD) therapy changes initiated by the device and/or clinician, a drug therapy change initiated by the device and/or clinician, arrhythmic events, changes in trended parameters, and autonomously-identified parameter correlations.” [0174], “This ranking is used to prioritize the processing of the predetermined events and respond in an appropriate manner. For example, the system can be designed such that a modest increase in heart rate holds a lower priority and is related to the clinician at a next patient followup; whereas a sudden increases in weight (which may be associated with acute decompensation in a heart failure patient) may be assigned a higher priority and immediately be communicated to the clinician through various communication means.”).
Perschbacher in view of Zenisek further in view of Daniel and Hatlestad are considered analogous to the claimed invention because they are in the field of patient monitoring. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perschbacher in view of Zenisek further in view of Daniel with Hatlestad for the advantage of “triag[ing] predetermined events for use in managing a patient's health” (Hatlestad; [01785]).
Regarding claim 17, this claim is rejected for the same reasons as claim 7.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Perschbacher (US 20180310892) in view of Zenisek (US 20220230743) further in view of Stahmann (US 20110275942).
Regarding claim 9, Perschbacher in view of Zenisek teaches the system of method of claim 1. Perschbacher in view of Zenisek does not teach the method further comprising monitoring for the at least one event within an observation window to set for a time after a treatment change.
However, Stahmann does teach the method further comprising monitoring for the at least one event within an observation window to set for a time after a treatment change ([0195], “If an increase in the HR/VE ratio is detected following a change in therapy, it is indicative of worsening of CHF and suggests that the therapy was ineffective. Likewise, should the V.sub.t/RR ratio decrease, it suggests that the patient's condition has worsened and that the therapy should be modified accordingly.”).
Perschbacher in view of Zenisek further in view of Stahmann are considered analogous to the claimed invention because they are in the field of patient monitoring. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perschbacher in view of Zenisek with Stahmann for the advantage of providing a “clinical trajectory [that] can also be used to provide diagnostic information to a physician when a new therapy (e.g., either a device-based therapy or a drug) is prescribed” (Stahmann; [0201]).
Regarding claim 10, Perschbacher in view of Zenisek teaches the system of method of claim 1. Perschbacher in view of Zenisek does not teach wherein the determined overall clinical priority is attributable to: a treatment change and a determination whether the at least one critical event is life threatening or non-life-threatening; patient deterioration rather than the treatment change or an acute event; or a need for replacing the medical device.
However, Perschbacher in view of Stahmann does teach wherein the determined overall clinical priority is attributable to: a treatment change and a determination whether the at least one critical event is life threatening or non-life-threatening; patient deterioration rather than the treatment change or an acute event; or a need for replacing the medical device (Stahmann, [0195], “If an increase in the HR/VE ratio is detected following a change in therapy, it is indicative of worsening of CHF and suggests that the therapy was ineffective.” [0205], “the system can be designed such that a modest increase in heart rate holds a lower priority and is related to the clinician at a next patient followup; whereas a sudden increases in weight (which may be associated with acute decompensation in a heart failure patient) may be assigned a higher priority and immediately be communicated to the clinician through various communication means.” Perschbacher, [0035], “The alert prioritization discussed in this document may timely direct medical attention to patients likely having more severe events than those likely having frequent false positive detections. This might help better align the medical resources to serve the need of more patients, but may also help save the operational cost in the healthcare facilities. For example, by identifying patients with lower priority alerts (such as PAPs), fewer unnecessary medical interventions, such as drugs, procedures, or device therapies, may be scheduled, prescribed, or provided to such patients.” [0058], “System users, such as clinicians or other qualified medical specialists, may use the clients to securely access stored patient data assembled in the database in the server, and to select and prioritize patients and alerts for health care provisioning.”). It would be obvious to one of ordinary skill in the art that combining the selection and prioritization of patients based on alerts as taught by Perschbacher and indicating priority for alerts that that occur after treatment is implemented as taught by Stahmann would result in the above claim limitation.
Perschbacher in view of Zenisek further in view of Stahmann are considered analogous to the claimed invention because they are in the field of patient monitoring. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Perschbacher in view of Zenisek with Stahmann for the advantage of generating indications that “suggests that the therapy was ineffective” (Stahmann; [0195]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to whose telephone number is 571-272-3931. The examiner can normally be reached M-Th: 10:30-8:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached on (571)270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.C./Examiner, Art Unit 3684
/KENNETH BARTLEY/Primary Examiner, Art Unit 3684
Prosecution Insights