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
Claims 1-20 are pending and have been examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 28, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of the claim are indefinite as claim 1 recites a method. However, no steps of the claim are positively recited (ie. “determine that at least one…; determine a severity…”). The claims are presently directed towards systems and devices that are configured to perform steps as opposed to actively performing the claimed steps.
Claims 2-11 are rejected by virtue of their dependency on claim 1.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a system and a method (1-20). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP §2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and /or c) mathematical concepts. MPEP §2106.04(a).
The Examiner has identified system claim 19 as the claim that represents a claimed invention for analysis and is similar to method Claim 1 and product claim 12.
Claim 1:
A system, comprising:
at least one medical device configured to treat a condition by delivering a therapy to a patient, wherein the therapy is at least partially defined using a parameter set, the medical device includes a deep brain stimulator (DBS) and the therapy includes a DBS therapy; and
a processing system configured for use to:
determine 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, wherein the at least one critical event is specific to the condition of the patient, specific to the DBS therapy, or to the medical device used to deliver the therapy;
determine a severity of each of the at least one critical event, and weight each of the at least one critical event based on the determined severity to provide a corresponding at least one weighted critical event;
sum the at least one weighted critical event to provide a sum of at least one weighted critical event;
determine an overall clinical priority for the patient based at least in part on the sum, and weight the patient based on the determined overall clinical priority to provide a weighted patient priority;
adjust the weighted patient priority when corrective action is successfully performed to address the at least one critical event, wherein the corrective action is performed by revising a current program for the medical device, reverting to a prior program for the medical device, replacing the current program with another program for the medical device, or toggling programs for the medical device;
select 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
communicate the critical event using the selected communication technique..
These above limitations, not in bold, under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activities. The claim elements are directed towards “determin[ing] that at least one event experienced by the patient is at least one critical event”, “determin[ing] a severity of each of the at least one critical event, and weight each of the at least one critical event”, “sum[ming] the at least one critical event”, “determine an overall clinical priority for the patient”, “adjust[ing] the weighted patient priority when corrective action is successfully performed”, “select[ing] a communication technique”, and “communicat[ing] the critical event”, which encompasses managing personal behaviors of patient care providers as these activities are typically performed by nurses managing and triaging patients who may then communicate patient care escalations to other care providers based on patient priority.
Accordingly, the claim recites an abstract idea.
Claims 1 and 12 are also abstract for similar reasons.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether the claim as a whole integrates the idea into a practical application. As noted at MPEP §2106.04 (ID)(A)(2), it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” MPEP §2106.05(I)(A).
Additional elements cited in the Claims:
Medical device (1-2,4-5,10,12-15,19-20); processing system (1-2,19-20); communication technique (1-2,11-13,19-20); revising a current program (3,19); reverting to a prior program (3,19); replacing the current program with another program (3,19); toggling programs (3,19); deep brain stimulator (4,14,19); phone call (11); text message (11); email message (11); phone alerts (11); patient-connected app (11); device rep portal (11); clinician/physician portal (11); non-transitory machine readable medium (12-18); a machine (12);
Any computing systems that would be able to perform the method (processing system, machine) and associated elements (non-transitory machine readable medium) are taught at a high level of generality such that the claim elements amounts to no more than mere instructions to apply the exception using any generic component capable of performing the claim limitations. [0058] of Applicant specification recites: “Various devices may function as the CP 104. Such devices may include portable devices such as a lap-top personal computer, mini-computer, personal digital assistant (PDA), tablets, phones, or a remote control (RC) with expanded functionality. Thus, the programming methodologies can be performed by executing software instructions contained within the CP 104. Alternatively, such programming methodologies can be performed using firmware or hardware.” No specific, technical improvements are being made to the technology of computing devices as any generic server may be applied to perform the abstract idea of determining patient priorities based on severity of clinical events and communicating information about the patients to other care professionals.
Communication techniques (phone call, text message, email message, phone alerts, patient-connected app, device rep portal, clinician/physician portal) are also taught at a high level of generality. [0089] recites: “As illustrated at 965 a communication technique is selected based on the weighted patient priority. Different communication techniques may include different audiences for the communication (e.g., patient, doctor or clinician, caregiver, and/or device), may include different channels of communication to a person (e.g., phone call. text, email, portal messages or reports, app messages, phone alerts such as badges, banners, sounds)”. No specific, technical improvements are being made to communication techniques as a wide variety of generic communication techniques are applied to perform the abstract idea of communicating information to another person.
Treatment machines (medical device, deep brain stimulator) are also taught at a high level of generality. [0083] recites: “The medical device may be configured to provide sensing functions and/or therapy functions. For example, the medical device may include a device configured to use a parameter set to deliver an electrical stimulation therapy. The medical device may be an implantable medical device such as an implantable neurostimulator. The implantable medical device may be configured to deliver SCS or DBS therapy. The medical device may include more than one medical device. The processing system may be within a single device, or may be a distributed system across two or more devices including local and/or remote systems. According to various embodiments, the medical system may include at least one medical device configured to treat a condition by delivering a therapy to a patient.” No specific, technical improvements are being made to the technology of treatment devices as the treatment is incidental to the abstract idea of determining patient priorities based on severity of clinical events and communicating information about the patients to other care professionals.
Corrective actions (revising a current program, reverting to a prior program, replacing the current program with another program, toggling programs) are also taught at a high level of generality. [0094] recites: “The corrective action may include adjusting a current program, reverting to the settings originally (or more generally previously) programmed on a given program, replacing a program, or switching to another program. Corrective action may be performed by revising a current program for the medical device, reverting to a prior program for the medical device, replacing the current program with another program for the medical device, or toggling programs for the medical device.” Under the broadest reasonable interpretation of the claim language, modifying program settings through a corrective action does not effect actual treatment or change in the medical device; see Examiner suggestion below. Instead, the corrective actions are claimed such that they are only applied to the processing system, which is incidental to the claimed abstract idea instead of integrating the judicial exception into a practical idea.
Looking at the additional elements as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above -noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID)(A)(2).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set forth below:
Claims 2, 13, and 20: These claims recite 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; which only serves to limit the abstract ideas of determining clinical priority for a patient and selection of the communication technique.
Claim 3: This claim recites the method further comprising performing the corrective action to address the at least one critical event, wherein the corrective action includes revising a current program, reverting to a prior program, replacing the current program with another program, or toggling programs; which merely describes corrective actions at a high level of generality, such that they are incidental to the abstract idea and does not integrate the abstract idea into a practical application.
Claims 4 and 14: These claims recite wherein the medical device includes a deep brain stimulator (DBS) and the therapy includes a DBS therapy; which teaches the deep brain stimulator at a high level of generality, such that no improvements are being made to the deep brain stimulators.
Claims 5 and 15: These claims recite 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; which only serves to limit the type of critical event happening to the patient.
Claims 6 and 16: These claims recite 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; 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; or a comparison of a severity score for the corresponding critical event to a pre-assessed normal for the patient; which only serves to limit the abstract idea of determining severity of a patient’s critical event.
Claims 7 and 17: These claims recite 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; which only serves to limit the abstract idea of determining clinical priority for a patient.
Claims 8 and 18: These claims recite 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; which only serves to limit the abstract idea of determining clinical priority for a patient.
Claim 9: This claim recites the method further comprising monitoring for the at least one event within an observation window to set for a time after a treatment change; which teaches an abstract idea of certain methods of organizing human activities by choosing timing for monitoring a patient, which is typically performed by healthcare providers of a patient.
Claim 10: This claim recites 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; which only serves to limit the abstract idea of determining clinical priority for a patient.
Claim 11: This claim recites 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; which teaches a variety of communication techniques at a high level of generality such that they are only applied to perform the abstract idea of communicating with another person.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
These claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
Amount to elements that have been recognized as activities in particular fields (such as Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), MPEP §2106.05(d)(II)(i);storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv)).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-11, 13-18, and 20, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 2-11, 13-18, and 20, e.g., performing repetitive calculations, Flook, MPEP §2106.05(d)(II)(ii); claims 2-11, 13-18, and 20, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP §2106.05(d)(II)(iv). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-20 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Regarding the 35 U.S.C. 101 Rejection
Examiner suggests including an implementation step to the claim wherein the corrective action performed by the processing system is pushed to the medical device to perform an adjustment to actual therapy that is delivered to the patient based upon the determinations by the processing system. Such an amendment would be similar to Diamond v. Diehr, which recited meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment by installing rubber in a press, closing the mold, constantly measuring the temperature in the mold, and automatically opening the press at the proper time. These steps were found to be meaningful because they sufficiently limited the use of the mathematical equation to the practical application of molding rubber products. 450 U.S. at 184, 187, 209 USPQ at 7, 8.
In the present case, pushing a corrective action (including revising a program, reverting to a prior program, replacing the current program with another program, or toggling programs) to the deep brain stimulator would cause a similar meaningful limitation by improving deep brain stimulator treatments. Support for such an amendment exists in [0073] of Applicant specification, which recites: “In some examples, the computing device 426 may detect, or otherwise receive as input, patient clinical responses to electrostimulation such as DBS, and determine or update stimulation parameters using a closed-loop algorithm based on the patient clinical responses. Examples of the patient clinical responses may include physiological signals (e.g., heart rate) or motor parameters (e.g., tremor, rigidity, bradykinesia). The computing device 426 may communicate with the CP 104, RC 103, ETM 105, or IPG 102 and direct the changes to the stimulation parameters to one or more of those devices.”
Examiner further notes that Claim 19 is the closest to overcoming the 35 U.S.C. 101 rejection as it identifies a particular device/technological environment (deep brain stimulator; please see MPEP 2106.05(b), which describes the particularity of a machine being an important consideration: “The particularity or generality of the elements of the machine or apparatus, i.e., the degree to which the machine in the claim can be specifically identified (not any and all machines). ”) and actions that, if pushed to the medical device and implemented, could transform the judicial exception into a practical application of improving brain stimulator treatments (revising a current program for the medical device, reverting to a prior program for the medical device, replacing the current program with another program for the medical device, or toggling programs for the medical device).
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, 11-12, 16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Perschbacher (US 20180310892) in view of Hamilton (US 20170308662).
Regarding claim 1, Perschbacher teaches a method, comprising:
using a medical device configured to treat a condition by delivering a therapy to a patient, 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 dyssynchrony 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
using a processing system ([0066], “the microprocessor circuit may be a general purpose processor that may receive and execute a set of instructions of performing the functions, methods, or techniques described herein.”) to:
determine 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”);
determine a severity of each of the at least one critical event, and weight 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”);
sum 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.”);
determine an overall clinical priority for the patient based at least in part on the sum, and weight 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.
communicate 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 using a processing system to:
select 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.
However, Hamilton does teach using a processing system to:
select 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 ([0017], “different threshold criticality levels may be contemplated, where exceeding each threshold may trigger different types of electronic notifications and/or may cause electronic notifications to be transmitted to different medical experts. For example, the threshold criticality level may be a first threshold criticality level and the electronic notification data generated as a result of exceed the first threshold criticality level may convey a notification of a first type. The operations performed at the programmable system may further comprise selectively transmitting electronic notification data conveying a notification of a second type over the data network in connection with the particular obstetrics patient following the criticality level associated with the particular obstetrics patient exceeding a second threshold criticality level distinct from the first threshold criticality level.” [0010], “the computing device associated with the particular medical expert may include a smartphone, a tablet, a general purpose computer and/or any other suitable computing device and the electronic notification data may convey an e-mail message, an SMS message and/or or any other suitable electronic message”).
Perschbacher in view of Hamilton 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 Hamilton for the advantage of “selectively transmitting electronic notification data over the data network in connection with a particular… patient at least in part by processing a criticality level.” (Hamilton; [0009]).
Regarding claim 6, Perschbacher in view of Hamilton 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 Hamilton 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 Hamilton 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, Hamilton 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], “the computing device associated with the particular medical expert may include a smartphone, a tablet, a general purpose computer and/or any other suitable computing device and the electronic notification data may convey an e-mail message, an SMS message and/or or any other suitable electronic message” [0017], “different threshold criticality levels may be contemplated, where exceeding each threshold may trigger different types of electronic notifications and/or may cause electronic notifications to be transmitted to different medical experts. For example, the threshold criticality level may be a first threshold criticality level and the electronic notification data generated as a result of exceed the first threshold criticality level may convey a notification of a first type. The operations performed at the programmable system may further comprise selectively transmitting electronic notification data conveying a notification of a second type over the data network in connection with the particular obstetrics patient following the criticality level associated with the particular obstetrics patient exceeding a second threshold criticality level distinct from the first threshold criticality level.”).
Perschbacher in view of Hamilton 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 Hamilton for the advantage of “selectively transmitting electronic notification data over the data network in connection with a particular… patient at least in part by processing a criticality level.” (Hamilton; [0009]).
Regarding claims 12, 16, and 18, these claims are rejected for claims 1, 6, and 8, 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.”).
Claims 2-5, 13-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Perschbacher (US 20180310892) in view of Hamilton (US 20170308662) further in view of Srivastava (US 20240127927).
Regarding claim 2, Perschbacher in view of Hamilton 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, Hamilton does teach wherein the communication technique is selected based on the adjusted weighted patient priority ([0168], “the GUI 900 is caused to be dynamically adapted over time to present the user with adapted versions of the ordered list adjusted over time, the adjusted versions of the ordered list being derived at least in part by processing the criticality levels for the obstetrics patients adjusted over time.” [0017], “different threshold criticality levels may be contemplated, where exceeding each threshold may trigger different types of electronic notifications and/or may cause electronic notifications to be transmitted to different medical experts. For example, the threshold criticality level may be a first threshold criticality level and the electronic notification data generated as a result of exceed the first threshold criticality level may convey a notification of a first type. The operations performed at the programmable system may further comprise selectively transmitting electronic notification data conveying a notification of a second type over the data network in connection with the particular obstetrics patient following the criticality level associated with the particular obstetrics patient exceeding a second threshold criticality level distinct from the first threshold criticality level.” [0010], “the computing device associated with the particular medical expert may include a smartphone, a tablet, a general purpose computer and/or any other suitable computing device and the electronic notification data may convey an e-mail message, an SMS message and/or or any other suitable electronic message”).Examiner notes that criticality levels that are adjusted over time based on changing patient values would result in an adjustment in the notification type, if a corresponding threshold is passed.
Perschbacher in view of Hamilton 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 Hamilton for the advantage of “selectively transmitting electronic notification data over the data network in connection with a particular… patient at least in part by processing a criticality level.” (Hamilton; [0009]).
Perschbacher in view of Hamilton 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.
However, Srivastava 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 ([0155], “a patient may be given a lower priority if the patient therapy is already efficacious and/or already is interacting with the system.” [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 Hamilton further in view of Srivastava 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 Hamilton with Srivastava for the advantage of “escalating the patients in need of immediate intervention” (Srivastava; [0111]).
Regarding claim 3, Perschbacher in view of Hamilton further in view of Srivastava teaches the system of method of claims 1 and 2. Perschbacher does not teach the method further comprising performing the corrective action to address the at least one critical event, wherein the corrective action includes revising a current program, reverting to a prior program, replacing the current program with another program, or toggling programs ([0109], “The method 500 may include the optional step 556 of delivering a therapy to the patient in response to the detection of the medical event, such as via the optional therapy circuit 260 as illustrated in FIG. 2. Examples of the therapy may include electrostimulation therapy delivered to the heart, a nerve tissue, other target tissues, a cardioversion therapy, a defibrillation therapy, or drug therapy including delivering drug to a tissue or organ. In some examples, an existing therapy may be modified such as by adjusting a stimulation parameter 2-4, 13-14, and 20.”). Examiner notes that adjusting a stimulation parameter is analogous to revising a current program, as supported by [0073] of Applicant specification (“the computing device 426 may detect, or otherwise receive as input, patient clinical responses to electrostimulation such as DBS, and determine or update stimulation parameters using a closed-loop algorithm based on the patient clinical responses.”).
Regarding claim 4, Perschbacher in view of Hamilton teaches the system of method of claim 1. Perschbacher in view of Hamilton does not teach wherein the medical device includes a deep brain stimulator (DBS) and the therapy includes a DBS therapy.
However, Srivastava 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 Hamilton further in view of Srivastava 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 Hamilton with Srivastava for the advantage of “deliver[ing] modulation energy and sens[ing] electrical activity” (Srivastava; [0103]).
Regarding claim 5, Perschbacher in view of Hamilton further in view of Giftakis 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 13, 14, 15, and 20, these claims are rejected for the same reason as claims 2, 4, 5, and 2, respectively.
Claim 19 is rejected for the same reasons as claims 1-5.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Perschbacher (US 20180310892) in view of Hamilton (US 20170308662) further in view of Daniel (US 20140129250).
Regarding claim 7, Perschbacher in view of Hamilton teaches the system of method of claim 1. Perschbacher in view of Hamilton alone do 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”),
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 (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 combiantions 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 Hamilton 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 Hamilton with Daniel for the advantage of utilizing a system wherein “additional criteria may also be taken into account” (Daniel; [0058]).
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 Hamilton (US 20170308662) further in view of Stahmann (US 20110275942).
Regarding claim 9, Perschbacher in view of Hamilton teaches the system of method of claim 1. Perschbacher in view of Hamilton 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 Hamilton 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 Hamilton 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 Hamilton teaches the system of method of claim 1. Perschbacher in view of Hamilton 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 Hamilton 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 Hamilton with Stahmann for the advantage of generating indications that “suggests that the therapy was ineffective” (Stahmann; [0195]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Patient Event Indication (US 20090082641) teaches that an indication that a patient event occurred may be used to evaluate the efficacy of at least one therapy program and/or adjust therapy delivery to the patient. In some examples, the patient event indication includes patient input that may be received via an event indication button of a programming device. In addition to or instead of the patient input, the patient event indication may be generated based on a physiological parameter of the patient. In some examples, therapy delivery may be adjusted by adjusting at least one therapy parameter value, switching therapy programs or therapy program groups or restarting a therapy cycle of a medical device. The patient input via an event indication button may also help evaluate whether a therapy system is useful for the patient.
Tactical Clinical Evaluation Of Patient Monitor Events (US 20160171865) teaches a method and accompanying system for evaluating alarm events generated by patient monitors includes the steps of receiving a plurality of alarm events and associated alarm event data from one or more patient monitors at a central control unit, storing the alarm event data in an electronic storage medium, calculating an acuity score for the patient monitor from the alarm event data and a customizable rule set input into and stored in the control unit, the rule set applied to the alarm event data and comparing the calculated acuity score to a threshold value for the acuity score.
Medical Device Management Using Risk Control Measures (US 20220230743) teaches a device comprising memory and processing circuitry coupled to the memory. The processing circuitry is configured to receive patient information for a medical device associated with the patient and select a communication mode for the patient based on the patient information. The processing circuitry is further configured to cause an output of the indication of the patient information using the selected communication mode.
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/D.C./Examiner, Art Unit 3684
/Shahid Merchant/Supervisory Patent Examiner, Art Unit 3684
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