DETAILED ACTION
This action is in reference to the communication filed on 30 DEC 2025.
Amendments to claims 1, 11, 21 have been entered and considered. No claims canceled or added.
Claims 1-30 are present and have been examined.
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 1-30 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1-30 the independent claim(s) 1, 11, 21 recite(s) a method, a product, and system, each of which is a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1-30, the independent claim(s) (claims 1, 11, 21) is/are directed, in part, as shown in exemplary claim 1:
monitoring a plurality of
acoustically monitoring the medical environment via one or more of an
generating an acoustic signal indicative of audio within the medical environment; and
identifying one or more audible alarms within the medical environment, wherein the one or more audible alarms within the medical environment are generated by one or more bedside
processing the plurality of
if such an urgent care event is occurring, notifying an on-call care member so that the urgent care event can be addressed.
These claim elements are considered to be abstract ideas because they are directed to a method of organizing human activity which include managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions. Notifying an on call care member in the event of a detected or determined urgent care event of a patient is a management of a personal behavior between people, as is monitoring for an alarm or acoustical alert.
In the interest of compact prosecution Examiner also notes the claims are directed to a mental process - i.e. concepts performed in the human mind including observation, evaluation, judgement, opinion. Monitoring signals associated with patients, listening for and identifying an alarm, processing the signals to determine if a patient is experiencing an urgent care, and potentially even addressing the urgent care event are examples of observation and/or judgement.
If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior/interactions, and/or concepts performed in the human mind then it falls within the “method of organizing human activity” and/or the “mental processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional elements to perform the claim steps: Claim 1 recites a “computer implemented method…on a computing device”, claim 11 recites a computer program product on a non-transitory computer readable medium, as well as a processor, and claim 21 recites a processor and a memory. Each of claims 1, 11, 21 have been amended to also include a handheld or dedicated network device with an application installed, and one or more bedside monitoring devices. The computing device, computer readable medium, the processor/memory, as well as the handheld/dedicated network device in the independent claims recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception, or mere instructions to implement the abstract idea on a computer, or merely uses the computer as a tool to perform the abstract idea (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use/computing environment (see MPEP 2106.05h). Examiner notes that the claims further recite or imply the sending/receiving of data using the computing elements identified above, as well as storing information in a memory – sending and receiving data, and storing data in memory, is generally analogous to adding insignificant extra solution activity to the judicial exception(s) identified (see MPEP 2106.05g). Examiner finds no improvement to the functioning of the computer or any other technology or technical field in the computing device/readable medium and/or processor/memory as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general like between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e). Examiner also finds the one or more bedside monitoring devices are analogous to adding “apply it” as discussed above – the device itself is not improved in any meaningful way nor does the device itself actually generate transit information beyond the actual alarm, similar to an alarm clock.
Accordingly, this/these additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements such as: Claim 1 recites a “computer implemented method…on a computing device”, claim 11 recites a computer program product on a non-transitory computer readable medium, as well as a processor, and claim 21 recites a processor and a memory. Each of claims 1, 11, 21 have been amended to also include a handheld or dedicated network device with an application installed, and one or more bedside monitoring devices. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification in:
[0059] The instruction sets and subroutines of information process 10s, which may be stored on storage
device 16 coupled to computing device 12, may be executed by one or more processors (not shown) and
one or more memory architectures (not shown) included within computing device 12. Examples of
storage device 16 may include but are not limited to: a hard disk drive; a RAID device; a random-access
memory (RAM); a read-only memory (ROM); and all forms of flash memory storage devices.
[0108] Examples of computing devices may include but are not limited to: [0109] Personal Computers (PCs): Personal computers are general-purpose computing devices designed for individual use. They consist of a central processing unit (CPU), memory, storage devices, input/output peripherals (keyboard, mouse, display), and an operating system. PCs are versatile devices used for tasks such as browsing the web, word processing, gaming, multimedia, and more. [0110] Laptops: Laptops are portable computing devices that provide the same functionality as personal computers. They incorporate a keyboard, display, and a built-in battery, allowing users to work or perform tasks on the go. [0111] Tablets: Tablets are lightweight, portable devices with touchscreens and simplified user interfaces. They offer functionality similar to laptops but with a more compact and intuitive design. Tablets are commonly used for web browsing, media consumption, e-books, and mobile applications. [0112] Smartphones: Smartphones are mobile computing devices that combine telephony capabilities with computing features. They offer advanced functionality, including internet access, email, multimedia, applications, and various sensors. Smartphones have become an essential part of modern life, providing communication, entertainment, and productivity features. [0113] Servers: Servers are powerful computing devices designed to manage and process vast amounts of data and provide services to other devices or users. They are typically used in network environments to store and deliver data, host websites and applications, handle database management, and perform complex computations….[0119] These are just a few examples of computing devices, each serving different purposes and catering to various computing needs. The computing landscape is continually evolving, with new devices and technologies being developed to meet changing user requirements.
[0325] “ Additionally/alternatively, information process 10 may enable 502 adjustment of one or more of the monitoring criteria (e.g., namely defined signal norms of 60-100 beats per minute for a heart rate and 12-20 breaths per minute for a respiratory rate) by the user (e.g., user 236) by providing the user (e.g., user 236) with instructions (e.g., graphical and/or text-based) concerning how to manually adjust the one or more of the monitoring criteria (e.g., namely defined signal norms of 60-100 beats per minute for a heart rate and 12-20 breaths per minute for a respiratory rate) via e.g., a user interface (not shown) included within the plurality of bedside monitoring devices (e.g., one or more of first vendor devices 202 and/or one or more of second vendor devices 206).”
[0377] “…information process 10 may acoustically monitor 702 a medical environment (e.g., hospital 246 . . . or a portion thereof) via an application (e.g., application 250) installed on a handheld electronic device (e.g., handheld electronic device 252), examples of which may include but are not limited to a smart phone, a tablet computer, a wireless dedicated device, etc.).”
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The bedside devices do not appear to have any significant distinction or function in the specification. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 2-10, 12-20, 22-30:
Dependent claims 2, 3, 5, 6, are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as the types of alerts/groupings of alerts, and the on call care team member. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Dependent claims 4, 7, 8-10 are not directed to any additional abstract ideas than those identified above, however, claims 4, 8-10 nominally recite the use of a medical device as sending/receiving the signals to generate the alert, and claim 7 recites a “massive data set processed by ML” The medical device itself is recited at a high level of generality, and merely sends/receives the data as currently claimed. This is insignificant extra solution activity and is no more than a general link between a generic “medical device” and the claimed limitations. No improvement is present in the functioning or use of the medical device. Similarly, Examiner finds no improvement to the use of the massive data set nor the ML as used, and instead just finds an application therein. As such there is nothing to support a finding that a practical application nor significantly more than the abstract idea is present in the elements.
Claims 12-20, 22-30 recite similar elements as those identified above and are rejected for the same reasons.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Katra et al (US 20200357513 A1, hereinafter Katra), in view of Welch et al (US 20070180140 A1, hereinafter Welch), further in view of Falck et al (US 20160283681 A1, hereinafter Falck).
In reference to claim 1, 11, 21:
Katra teaches: A computer-implemented method, executed on a computing device, a computer program product residing on a computer readable medium having a plurality of instructions stored thereon which, when executed by a processor, cause the processor to perform the operations, and a computing system including a processor and memory configured to perform operations (at least [fig 3 and related text], all comprising:
monitoring a plurality of data signals associated with a plurality of patients within a medical environment (at least [048, 081] “ The computing device executing the app (e.g., a virtual check-in process) may perform various functionalities described below, whether via local computing resources provided by the computing device, via cloud-based backend systems, or both. In such examples, the computing device may implement one or more interrogations of one or more medical devices (e.g., IMDs, CIEDs, etc.). In addition, the computing device may analyze medical device settings, parameters, and performance metrics.” See also fig 20 and related text for discussion of abnormality) ;
processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event (at least [081] “In an example, medical device(s) 6 may include a device that predicts heart failure events or that detects worsening heart failure of patient 4. In a non-limiting and illustrative example, system 100 may be configured to measure impedance fluctuations of patient 4 and process impedance data to accumulate evidence of worsening heart failure. In any case, medical device(s) 6 may be configured to determine a health status relating to patient 4. Medical device(s) 6 may transmit the diagnostic data or health status to computing device(s) 2 as interrogation data, such that computing device(s) 2 may correlate the interrogation data with image data to determine whether an abnormality present with a particular one of medical device(s) 6 (e.g., an IMD) or patient 4 (e.g., infection at an implantation site). At [0299] “In some examples, edge device(s) 12, medical device(s) 17 (e.g., IMD 6), server(s) 94, and/or computing device(s) 2 may use the gathered data to predict adverse health events (e.g., worsening infections) using integrated diagnostic methods. “); and
if such an urgent care event is occurring, notifying care member so that the urgent care event can be addressed (at least [fig 19 and related text including 0259] “ In any case, such an evaluation may inform patient 4 and/or an HCP about how an implantation site (e.g., an explant site) is altering (e.g., progressing) over time towards healing or an abnormality situation (e.g., a rapidly worsening infection or a slowly developing infection)”). Katra as cited teaches wherein a notification is sent to a healthcare provider such as a caretaker about the urgent event (see 0259 as cited above, and 0299 referencing a caretaker), and while one of ordinary skill in the art could infer that a healthcare professional would be working at the time of the notification, in the interest of compact prosecution Examiner notes that Welch teaches: if an urgent care event is occurring, notifying an on call care member so that the urgent care event can be addressed (at least [fig 4 and related text] “At 405, the process 400 determines whether an alarm condition or alert has occurred. If an alarm condition or alert has occurred, the process 400 proceeds to 406. In one embodiment, establishing a network connection at 410 includes connecting a network interface module to an end user device, such as a notifier device assigned to a nurse during his or her work shift. The process 400 then determines at 412 whether the user of the device (e.g., the nurse) has been authenticated. If the user has not been authenticated, the process 400 proceeds to 420. On the other hand, if the user has been authenticated, the process 400 proceeds to 414.” At [081] “The escalation rules module 518 has a rules engine that actuates an escalation policy defined by the hospital. The escalation rules module 518 provides alternative routing of alarms to alternative and additional clinical users in the event an alarm is not responded to or persists for a predefined (e.g., by a policy) period of time. The escalation rules module 518 in certain embodiments routes alarms to an emergency response team.”) Katra and Welch are analogous references as both disclose with ongoing patient monitoring. One of ordinary skill in the art at the time would have found the “on call” medical professional as taught by Welch to be an obvious variant of the “health care professional” or “caretaker” as referenced in Katra, as a nurse or other physician is obviously a health care provider. Particularly given the seriousness of the types of urgent events monitored by both Katra and Welch, one would have found the inclusion of an on call professional to deal with the alert to be obvious.
The combination of Katra and Welch teaches all the limitations above, as well as acoustically monitoring an area (i.e. in the form of the on call professional), but does not specifically teach acoustic monitoring and signals as claimed. Falck however does teach:
Acoustically monitoring the medical environment via one or more of an application installed on a handheld electronic device and a dedicated network device (at least [figs 3, 1, and related text] alarm validation device 1 monitors for audio signals 18 from medical device 10) ;
Generating an acoustic signal indicative of audio within the medical environment (at lest [fig 1, 3 and related text] “In a second step 33 of the validation method the validation device 1 detects audio (with the microphone 12) and analyzes the detected audio (with the processing unit 14). In some embodiments the microphone 12 is activated when the medical device 10 generates an acoustic alarm. For example, in embodiments where the signal 19 is sent before or concurrently with the signal to the loudspeaker, the processing unit 14 can activate the microphone in response to receiving the signal 19.; and
Identifying one or more audible alarms within the medical environment, wherein the one or more audible alarms within the medical environment are generated by one or more bedside monitoring devices associated with at least a portion of the plurality of patients (at least [figs 1, 3, and related text] “ Generation 30 of the acoustic alarm also involves the medical device 10 sending a signal 19 to the processing unit 14 of the validation device 1 indicating that an acoustic alarm has been generated. In some embodiments the signal 19 is the same as the signal sent to the loudspeaker. In these embodiments the processing unit 14 is configured to interpret the signal 19 as a notification that an acoustic alarm has been generated. The signal 19 may be sent concurrently with the signal from the medical device 10 to the loudspeaker. Alternatively, the signal 19 to the processing unit 14 may be sent before or after the signal to the loudspeaker. Preferably the signal 19 indicates the time at which the acoustic alarm was generated (i.e. the time at which the processing unit of the medical device signaled or expects to signal the loudspeaker to emit the acoustic alarm). Preferably the signal 19 also indicates the type of acoustic alarm generated. The processing unit 14 is further arranged to analyze the first signal 16 to determine whether the audio 18 detected by the microphone 12 includes the acoustic alarm generated by the medical device 10,” “In a second step 33 of the validation method the validation device 1 detects audio (with the microphone 12) and analyzes the detected audio (with the processing unit 14). In some embodiments the microphone 12 is activated when the medical device 10 generates an acoustic alarm. For example, in embodiments where the signal 19 is sent before or concurrently with the signal to the loudspeaker, the processing unit 14 can activate the microphone in response to receiving the signal 19.” See also [fig 5 and related text] “Each patient 52 has one or more medical devices 56 associated with them…” medical devices 56 each have local loudspeakers and are connected to remote alarm unit 57 and verification device 59). Falck is analogous to both Katra and Welch as each reference discloses a means of monitoring individual patients in a medical environment. One of ordinary skill in the art would have found the inclusion of acoustical monitoring, as taught by Falck to be an obvious inclusion in the alarm monitoring as taught by Katra/Welch, as Falck teaches this allows for an improved patient experience in that the acoustic alarms may be located further from the patient(s), thereby reducing the background noise to patients and the chances that such an alarm will get drowned out or ignored by staff (see 0037). Falck also teaches that this allows for the medical device to be located near other medical devices without impacting the efficacy of the sound emitting device itself (see 0037). As such one would have been motivated to include acoustical monitoring in order to improve both staff efficiency and eliminate stress on the part of the subject patient(s).
In reference to claim 2, 12, 22:
Katra further teaches: wherein processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event includes: detecting one or more incidents defined within the plurality of data signals (at least [0194-0195] “transmit the abnormality results to edge device(s) 12 for reporting purposes, e.g., for providing an alert to patient 4 or another user.” At [0284] “In an illustrative example, where processing circuitry 20 labels a result for an image as comprising a ‘potential infection,’ processing circuitry 20 may generate an alert and provide an alert indication to one or more HCPs (e.g., via UI 22). The alert indication may include a summary of the result, a post-implant report, one or more images, and in some instances, highlighting of the images to indicate characteristics of the potential abnormality.” – i.e. a report may be generated from the collection of abnormalities/alerts).
In reference to claim 3, 13, 23:
Katra further teaches: wherein an incident includes the occurrence of one or more alarms (at least [0298] “ In some examples, processing circuitry 20 may provide an alert, such as a text- or graphics-based notification, a visual notification, etc. In some examples, processing circuitry 20 may cause an audible alarm to sound or cause a tactile alarm, alerting patient 4 of a determined abnormality. In other examples, computing device(s) 2 may provide a visual light indication, such as emitting a red light for high severity or a yellow light for medium severity. The alert may indicate a potential, possible or predicted abnormality event (e.g., a potential infection).” At [0100] “In some instances, processing circuitry of system 100, e.g., of computing device(s) 2, provides an alert to patient 4 and/or other users when a combination of patient health data (e.g., implantation site images, ECG parameters, etc.), medical device diagnostic data, and indicates the onset of an abnormality. The process for determining when to alert patient 4 involves measuring an abnormality (e.g., severity or probability levels) against one or more threshold values and is described in greater detail below. The alert may be an audible alert generated by medical device(s) 6 and/or computing device(s) 2, a visual alert generated by computing device(s) 2, such as a text prompt or flashing buttons or screen, or a tactile alert generated by medical device(s) 6 and/or computing device(s) 2 such as a vibration or vibrational pattern. Furthermore, the alert may be provided to other devices, e.g., via network 10. Several different levels of alerts may be used based on a severity of a potential abnormality detected through the techniques disclosed herein. “ at [0133] “In further examples, computing device 2 may generate an alert to patient 4 (or relay an alert determined by medical device(s) 17, edge device(s) 12, or server(s) 94) based on an abnormality determined from a combination of data items, which may enable patient 4 proactively to seek medical attention prior to receiving instructions for a medical intervention. “).
In reference to claim 4, 14, 24:
wherein detecting one or more incidents defined within the plurality of data signals includes: monitoring one or more data signals associated with a medical device utilized on a patient within the medical environment to detect the occurrence of the one or more alarms (at least [0100, 0133, 0298] as cited above with respect to claim 3 – alarms of varying severity or increased levels may indicate the severity of the potential abnormality).
In reference to claim 5, 15, 25:
Welch teaches: wherein the on-call care member includes one or more of: an on-call nurse; an on-call manager; and an on-call physician (at least [fig 4 and related text] “At 405, the process 400 determines whether an alarm condition or alert has occurred. If an alarm condition or alert has occurred, the process 400 proceeds to 406. In one embodiment, establishing a network connection at 410 includes connecting a network interface module to an end user device, such as a notifier device assigned to a nurse during his or her work shift. The process 400 then determines at 412 whether the user of the device (e.g., the nurse) has been authenticated. If the user has not been authenticated, the process 400 proceeds to 420. On the other hand, if the user has been authenticated, the process 400 proceeds to 414.” At [081] “The escalation rules module 518 has a rules engine that actuates an escalation policy defined by the hospital. The escalation rules module 518 provides alternative routing of alarms to alternative and additional clinical users in the event an alarm is not responded to or persists for a predefined (e.g., by a policy) period of time. The escalation rules module 518 in certain embodiments routes alarms to an emergency response team.”) The motivation to combine Katra and Welch is the same as the above independent claim(s) and is therefore incorporated by reference herein.
In reference to claim 6, 16, 26:
Welch teaches: wherein the plurality of patients includes one or more of: a plurality of patients assigned to the on-call nurse; a plurality of patients assigned to the on-call manager; and a plurality of patients assigned to the on-call physician (at least [078] “A nursing supervisor assigns individual nurses to specific patients at the start of each shift and upon admission of new patients. Shift assignments take place at change of shift during a "report" transition exercise where individual nurses and nursing supervisor from previous shift "hand off" patients to the next shift. ). The motivation to combine Katra and Welch is the same as the above independent claim(s) and is therefore incorporated by reference herein.
In reference to claim 7, 17, 27:
Katra teaches: wherein processing the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event includes: utilizing massive data sets processed by ML to process the plurality of data signals to determine if one or more of the plurality of patients is experiencing an urgent care event (at least [099-0101] alerts generated from input, and at [0103] “A trained ML model 30 and/or AI engine 28 may be configured to process and analyze the user input (e.g., images of the implantation site, patient status data, etc.), device parameters (e.g., accelerometer data), historical data of medical device (e.g., medical device 6), and/or physiological parameters, in accordance with certain examples of this disclosure where ML models are considered advantageous (e.g., predictive modeling, inference detection, contextual matching, natural language processing, etc.). Examples of ML models and/or AI engines that may be so configured to perform aspects of this disclosure include classifiers and non-classification ML models, artificial neural networks (“NNs”), linear regression models, logistic regression models, decision trees, support vector machines (“SVM”), Naïve or a non-Naïve Bayes network, k-nearest neighbors (“KNN”) models, deep learning (DL) models, k-means models, clustering models, random forest models, or any combination thereof.”).
Examiner’s Note: For purposes of 2173.05(b) Relative Terminology, Examiner makes reference to 0595-0604 in Applicant’s specification, providing a range of a size for the dataset.
In reference to claim 8, 18, 28:
Katra teaches: wherein the plurality of data signals include one or more of:
one or more data signals associated with a medical device utilized on a patient within the medical environment (at least [080-081] “In some examples, medical device(s) 6 may include one or more CIEDs. In some examples, patient 4 may interface with multiple medical device(s) 6, concurrently. In an illustrative example, patient 4 may have multiple IMDs implanted within the body of patient 4. In some examples, medical device(s) 6 may include diagnostic medical devices. In an example, medical device(s) 6 may include a device that predicts heart failure events or that detects worsening heart failure of patient 4. In a non-limiting and illustrative example, system 100 may be configured to measure impedance fluctuations of patient 4 and process impedance data to accumulate evidence of worsening heart failure. In any case, medical device(s) 6 may be configured to determine a health status relating to patient 4. Medical device(s) 6 may transmit the diagnostic data or health status to computing device(s) 2 as interrogation data, such that computing device(s) 2 may correlate the interrogation data with image data to determine whether an abnormality present with a particular one of medical device(s) 6 (e.g., an IMD) or patient 4 (e.g., infection at an implantation site).”);
one or more data signals associated with drugs administered to the patient within the medical environment (at least [082] “For example, medical device(s) may deliver electrical signals to the heart of patient 4, such as an implantable pacemaker, a cardioverter, and/or defibrillator, a drug delivery device that delivers therapeutic substances to patient 4 via one or more catheters, or as a combination therapy device that delivers both electrical signals and therapeutic substances.”);
one or more data signals associated with lab work performed on the patient within the medical environment;
one or more data signals associated with clinical assessments performed on the patient within the medical environment;
one or more data signals associated with clinical procedures performed on the patient within the medical environment;
one or more data signals associated with electronic health records and/or electronic medical records of the patient within the medical environment; and one or more data signals associated with a medical history of the patient within the medical environment.
In reference to claim 9, 19, 29:
Katra further teaches: wherein the one or more data signals associated with a medical device utilized on a patient within the medical environment concern one or more details of the medical device and/or uses of the medical device (at least [048, 081-083] a plurality of types of device(s) may be used to receive ongoing information about the patient, and/or dosing of a medication or treatment administered to the patient, as well as how/when the treatment is administered; at [fig 14 and related text] device parameters/health of the device itself is considered, and at [0299] “…that one of medical device(s) 17 (e.g., IMD 6) is likely to experience a functional abnormality (e.g., a malfunction), etc.”.).
In reference to claim 10, 20, 30:
Katra further teaches: wherein the medical device includes one or more sub-medical devices (at least [086, 0141] subcutaneous devices: ”In some examples, electrodes 16 may be configured for implantation outside of a thorax of patient 4. In some examples, the housing of medical device(s) 17 may be used as an electrode in combination with electrodes located on leads. In some examples, medical device(s) 17 may be configured to measure impedance changes within the interstitial fluid of patient 4, ECG morphology changes, etc. For example, medical device(s) 17 may be configured to receive one or more signals indicative of a subcutaneous tissue impedance. “ at [075] “ In another example, the image data may include a frame of a still-image of areas of the body of patient 4 adjacent the implantation site, such as where leads may be routed beneath the skin of patient 4.” at [0098] “Processing circuitry of system 100, e.g., of medical device(s) 6, computing device(s) 2, edge device(s) 12, and/or of one or more other computing devices (e.g., remote servers), may be configured to perform the example techniques of this disclosure for determining an abnormality status of patient 4 and/or of components of IMD 6.”)
Response to Arguments
Applicant’s remarks as filed on 30 DEC 2025 have been fully considered.
Applicant’s remarks regarding the 101 rejection begin on page 10, and alleges that the amended limitations recite a practical application. In view of the discussion/updated rejection above, Examiner respectfully disagrees. Applicant’s amendments to claim 11 have cured the additional 101 rejection.
Applicant’s remarks regarding the prior art begin on page 11, with a restatement of exemplary claim 1. Applicant’s references to the specification are appreciated. Examiner notes that the newly amended limitations are cited to the newly added reference as shown above.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20220310241, to Atallah discloses prioritizing and grouping types of alerts of urgent situations in a medical facility.
US20220241502, to Campbell teaches a means of detecting audible medical alerts using a mobile device.
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 KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
Prosecution Insights