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 .
1. This communication is responsive to the Amendment filed 10/28/2025.
2. Claims 254, 256, 258, 262-264, 267, 270-272, 278-286, 288-289, 293-294, 296, 298-299, 301-302, 304-305, 311, 317-318, 321 and 326-327 are pending in this application. Claim 254 is independent. In the instant Amendment, claim 254 was amended and claims 326-327 were added. This is a Non-Final action on the RCE filed 1/7/2026.
Claim Rejections - 35 USC § 103
3. 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.
4. 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.
5. Claim(s) 254,256,258,262-264,293,296,298,311,317,321 and 326-327 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman et al (“Freeman”, US 2014/0296675) in view of Pirtini Cetingul (“Pirtini”, US 2018/0368762) and further in view of Giordano et al (“Giordano” 2017/0300627) and further in view of Homuth et al (“Homuth” US 2019/0030269).
As per claim 254, Freeman teaches a respiratory distress (RD) context sensitive guidance (CSG) system for providing RD CSG during an emergency medical encounter, the RD CSG system comprising:
at least one medical device configured to couple to a patient via one or more patient interface devices ([0087] In another embodiment, the defibrillator contains a docking feature for propping up a computer tablet such as an Apple.RTM. iPad.RTM. on top of the defibrillator in a stable position via mounting features integrated onto the defibrillator, as illustrated in FIG. 11. Other mobile computing devices, including tablet computers.), and
a mobile computing device configured to communicatively couple to the at least one medical device ([0087] In another embodiment, the defibrillator contains a docking feature for propping up a computer tablet such as an Apple.RTM. iPad.RTM. on top of the defibrillator in a stable position via mounting features integrated onto the defibrillator, as illustrated in FIG. 11. Other mobile computing devices, including tablet computers. See also [0088] According to some embodiments of the present invention, the tablet computer, or other mobile computing device, may be communicably coupled with the defibrillator or other physiological assessment device, for example through a wireless connection.) and comprising:
a mobile device display screen ([0087] In another embodiment, the defibrillator contains a docking feature for propping up a computer tablet such as an Apple.RTM. iPad.RTM. on top of the defibrillator in a stable position via mounting features integrated onto the defibrillator, as illustrated in FIG. 11. Other mobile computing devices, including tablet computers, an iPhone.RTM., an iTouch.RTM., and other touchscreen monitors may be used.),
a RD CSG engine comprising hardware logic and/or software logic ([0083] decision support system) and configured to, during the emergency medical encounter (see paragraph [0087]; e.g., use in an emergency setting):
receive a plurality of physiologic parameters from the at least one medical device ([0083] According to embodiments of the present invention, the processor communicably coupled with the touchscreen portion of a decision support system may be configured to recognize the wave shape of a wave signal being displayed, and/or recognize the edge of an image being displayed, in order to improve the accuracy of a caliper touch gesture.),
provide a user interface (UI) comprising a CSG UI window at the mobile device display screen ([0089] According to embodiments of the present invention, a user interface device is communicably coupled to a processor, and the processor is configured to receive data entered via the user interface device, as well as data received from one or more sensors, in order to perform clinical decision support based on both data sources. The user interface device may include one or more devices such as a touch screen computer, a tablet computer, a mobile computing device. [0110] FIG. 28 illustrates one example of a decision support tree that may be shown to a user on an auxiliary screen (operated by module 156) during a medical event, to guide the user through a treatment protocol or pre-diagnosis of the patient. The decision support module 153 may be navigated through the various decision points (e.g. "nodes") either by manual selection of the next available option or branch, or by complete or partial automatic selection of the next available option or branch based upon patient data collected during the medical event, for example physiological data collected by the patient monitor/defibrillator 154 that is connected to the patient, or by a combination of these two processes. A process that is wholly or partially automatic may also be configured to prompt a user for confirmation before moving to a subsequent or previous node, according to embodiments of the present invention. See also [0111]-[0112]).)
control a display in real-time of the plurality of physiologic parameters at the UI ([0094] For example, the decision support system may display and/or analyze the patient's end-tidal waveform. [0094] At step 808, the decision support system may help the caregiver decide whether the patient is extremely bronchoconstricted, for example by showing data or measurements related to blood oxygen content, respiration rate, or respiration volume. See also [0084] automatically display on the computer tablet. See also [0088]),
detect a degradation in a medical state of the patient based on a change in at least one physiologic parameter of the plurality of physiologic parameters ([0092] In addition to, or alternatively to, the informational diagnosis support reflected in FIG. 6, the decision support system may gather findings using physiological data to help the caregiver determine the appropriate treatment path).,
select at least one clinical intervention based on the detected degradation , ([0094] Upon a confirmation by the caregiver that the patient is extremely bronchoconstricted at step 808, the decision support system may then suggest to the caregiver that a 125 milligram dose of Solumedrol be administered over a slow (e.g. 2 minute) intravenous push. For example, the decision support system may display and/or analyze the patient's end-tidal waveform, and suggest that the patient does not appear to be responding to the treatment, and ask for the caregiver's confirmation. If the caregiver confirms the decision, then the decision support system may continue to guide the caregiver through additional treatment options, for example those indicated in FIG. 8. In this way, the decision support system guides the caregiver through complex decision making processes, during the clinical encounter, using both physiological data and informational data gathered from the patient or input by the caregiver, in a way which would be too inconvenient or time-consuming for the caregiver to perform absent the decision support system. )
provide instructions for the at least one clinical intervention at the CSG UI window ([0094] Upon a confirmation by the caregiver that the patient is extremely bronchoconstricted at step 808, the decision support system may then suggest to the caregiver that a 125 milligram dose of Solumedrol be administered over a slow (e.g. 2 minute) intravenous push. If the caregiver confirms the decision, then the decision support system may continue to guide the caregiver through additional treatment options, for example those indicated in FIG. 8. In this way, the decision support system guides the caregiver through complex decision making processes, during the clinical encounter, using both physiological data and informational data gathered from the patient or input by the caregiver, in a way which would be too inconvenient or time-consuming for the caregiver to perform absent the decision support system.),
identify a subset of the plurality of physiologic parameters as critical physiologic parameters based on the degradation and the at least one clinical intervention, and
modify the display of the plurality of physiologic parameters at the UI to emphasize the critical physiologic parameters ([0094] If the caregiver confirms the decision, then the decision support system may continue to guide the caregiver through additional treatment options, for example those indicated in FIG. 8. In this way, the decision support system guides the caregiver through complex decision making processes, during the clinical encounter, using both physiological data and informational data gathered from the patient or input by the caregiver, in a way which would be too inconvenient or time-consuming for the caregiver to perform absent the decision support system. Figure 8A).
Freeman fails to teach providing instructions for one of the bilevel positive airway pressure therapy or the continuous positive airway pressure therapy; generate an event marker for the bilevel positive airway pressure therapy or the continuous positive airway pressure therapy, transmit, to the at least one medical device, the event marker for recordation in a patient encounter data file stored on the at least one medical device; monitor the critical physiological parameters during a period of delay, evaluate the monitored critical physiological parameters after the period of delay, and update the at least one clinical intervention based on the evaluation.
However, Pirtini teaches the at least one clinical intervention comprising one of bilevel positive airway pressure therapy or continuous positive airway pressure therapy, the caregiver instructions comprising caregiver instructions for providing the selected one of the bilevel positive airway pressure therapy or the continuous positive airway pressure therapy ([0023] The warming system 10 may further include devices and systems for providing ventilation support for the infant. In the schematic example of FIG. 1, a breathing circuit 35 for providing gas to the infant 2 includes a ventilator device 40, such as a continuous positive airway pressure (CPAP) device, a positive pressure ventilation (PPV) device, or a positive end expiratory pressure (PEEP) device (or a ventilator device providing all three respiratory therapies).)
Therefore it would have been obvious before the effective filing date of the invention to combine the teaching of Pirtini with the system of Freeman. Motivation to do so would have been obvious to try. Providing instructions for CPAP is one of a finite number of possibilities, and when combined with Freeman, which already provides instructions to the user, would yield predictable results.
Moreover, Giordano discloses generate an event marker for the selected one of the bilevel positive airway pressure therapy or the continuous positive airway pressure therapy (see paragraphs [0071] and [0085]; e.g., CPAP generate patient reports), transmit, to the at least one medical device, the event marker for recordation in a patient encounter data file stored on the at least one medical device (see paragraphs [0071] and [0085]; e.g., transmit and add record of report to patient’s medical record). Therefore it would have been obvious before the effective filing date of the invention to combine the teaching of Giordano with the system of Freeman. Motivation to do so would have been obvious to try. Transmitting and storing data for CPAP is one of a finite number of possibilities, and when combined with Freeman, which already provides instructions to the user, would yield predictable results.
Even further, Homuth discloses monitor the critical physiological parameters during a period of delay (see paragraphs [0029], [0104] and [0132]-[0133]; e.g., monitoring airway sensors, etc; physiologic monitors), evaluate the monitored critical physiological parameters after the period of delay (see paragraphs [0029], [0104] and [0132]-[0133]; e.g., monitoring and feedback information throughout treatment), and update the at least one clinical intervention based on the evaluation (see paragraphs [0021], [0104], [0132]-[0133] and [0158]; e.g., feedback loops and physiological measures).
Therefore it would have been obvious before the effective filing date of the invention to combine the teaching of Homuth with the system of Freeman. Motivation to do so would have been obvious to try. Providing real-time feedback, and when combined with Freeman, which already provides instructions to the user, would yield predictable results.
As per claim 256, Freeman teaches the RD CSG system of claim 254, wherein the at least one medical device comprises two or more medical devices comprise comprising a patient monitor-defibrillator ( [0078] FIG. 1 shows a block diagram of the system, according to embodiments of the present invention. In one embodiment, a combined defibrillator/monitor device such as the E-Series manufactured by ZOLL Medical of Chelmsford Mass. has keys whose labeling is provided by on-screen text.) and a ventilation system ([0143] The system's 3500 determination of ventilation needs is not only relevant for deciding whether to actively ventilate a patient when commencing treatment, but also for determining when to commence active ventilation when a patient was not initially ventilated during treatment.), and wherein the one or more patient interface devices comprise a pulse oximeter, a nasal cannula or mask coupled to a capnography sensor, a non-invasive blood pressure (NIBP) sensor, a temperature probe, and electrodes ([0080] A flowchart for evaluating heart sounds is shown in FIGS. 8A and 8B. Pulse oximetry and capnography are also very helpful measures and may be automatically incorporated into the algorithm for more accurate diagnosis.)
As per claim 258, Freeman teaches the RD CSG system of claim 256, wherein the plurality of physiologic parameters comprises ECG, EtCO2, SpO2, heart rate, body temperature, and non-invasive blood pressure ([0096] Tissue CO2 and pH are particularly helpful in monitoring in the trauma DTP. Physiological parameters on display for the trauma DTP may be one or more of: invasive and non-invasive blood pressure, tissue CO2 and pH, ECG, SpO2 trending, and heart rate variability risk index. The ECG may be analyzed to determine the interval between adjacent R-waves of the QRS complexes and using this interval to calculate heart rate variability as a running difference between adjacent R-R intervals.), the degradation in the medical state comprises respiratory distress, and the critical physiologic parameters comprise EtCO2 and SpO2 ([0139] FIG. 35 illustrates a clinical decision support system 3500 similar to that of FIG. 26, with a muscle oxygen saturation detector 502, a pH detector 504, a hematocrit detector 506, and an end tidal carbon dioxide detector 508 in communication with the patient monitoring device 154. Alternatively, detectors 502, 504, 506, 508 may be part of or integral with device 154, according to embodiments of the present invention. In addition to that which is described below, system 3500 operates, or is capable of operating, in the same manner as system 2600, according to embodiments of the present invention. Detectors 502, 504, 506, 508 may be coupled with a patient or otherwise in communication with a patient. Detectors 502, 504, 506, 508 may each be part of a common detector unit which observes infrared spectroscopy characteristics of the patient's blood and applies different algorithms to the same spectroscopy information to calculate and output (to the device 154 and/or processor 150) the muscle oxygen saturation, pH, and/or hematocrit values of the patient. The muscle oxygen saturation detector 502 may be a sensor placed on the patient's muscle, for example on the patient's deltoid, calf, or on the thigh. According to some embodiments of the present invention, the detectors 502, 504, 506, 508 use near infrared spectroscopy to non-invasively determine the respective values of muscle oxygen saturation, pH, and hematocrit. The detectors 502, 504, and/or 506 may each be, or may collectively be, for example a CareGuide.TM. monitor available from Reflectance Medical, Inc., according to embodiments of the present invention.)
As per claim 262, Freeman the RD CSG system of claim 254, wherein the RD CSG engine is configured to during the emergency medical encounter replace a display of the plurality of physiologic parameters at a first data view window at the UI with a display of a CSG UI window inclusive of only the critical physiologic parameters to modify the display ([0094] For example, the decision support system may display and/or analyze the patient's end-tidal waveform. [0094] At step 808, the decision support system may help the caregiver decide whether the patient is extremely bronchoconstricted, for example by showing data or measurements related to blood oxygen content, respiration rate, or respiration volume. See also [0084] automatically display on the computer tablet. See also [0088]).
As per claim 263, Freeman teaches the RD CSG system of claim 262, wherein the first data view window at the UI comprises one of a device view window, a trends view window, or a working view window (Figure 34 [0136] Although FIG. 34 depicts a user interface replicator 455, other replicators may be used to display or play back other observed parameters that occurred over the course of a medical event; for example, graphs, trends, and/or charts representing patient information or physiological status. Such an ability to quickly and efficiently review patient data for a medical event or portions thereof may be helpful not only for a subsequent reviewer, but may also be helpful for the user during the medical event, and/or for a subsequent user during the medical event, for example when a patient is transferred from a Basic Life Support crew to an Advanced Life Support crew. The interface of FIG. 34, or a similar interface, may permit review of the patient's care report, ECG or 12-lead waveforms, cardiopulmonary resuscitation quality, and other patient care information or data. Event markers may be used as described above.)
As per claim 264, Freeman teaches the RD CSG system of claim 254, wherein the RD CSG engine is configured to during the emergency medical encounter provide a user notification at the UI to modify the display, the user notification comprising a notification of acute respiratory failure and values and/or trends of the critical physiologic parameters ([0147] According to some embodiments of the present invention, the patient muscle oxygen saturation and/or pH levels are used to create alarm limits based on thresholds, for example to notify the user (e.g. via display module 156 and/or 155) when the observed values fall outside of the thresholds.)
As per claim 293, Freeman teaches the RD CSG system of claim 292, wherein the caregiver instructions comprise a list of instructions, and wherein the CSG UI window is configured to a visually distinguish between a current step in the list of instructions and one or more of subsequent and previous steps in the list of instructions ([0110] FIG. 28 illustrates one example of a decision support tree that may be shown to a user on an auxiliary screen (operated by module 156) during a medical event, to guide the user through a treatment protocol or pre-diagnosis of the patient. The decision support module 153 may be navigated through the various decision points (e.g. "nodes") either by manual selection of the next available option or branch, or by complete or partial automatic selection of the next available option or branch based upon patient data collected during the medical event, for example physiological data collected by the patient monitor/defibrillator 154 that is connected to the patient, or by a combination of these two processes. A process that is wholly or partially automatic may also be configured to prompt a user for confirmation before moving to a subsequent or previous node, according to embodiments of the present invention. See also [0111]-[0112]).
As per claim 296, Freeman teaches the RD CSG system of claim 254, wherein the caregiver instructions comprise one or more of a hospital transport instruction and drug delivery instructions ([0094] At step 808, the decision support system may help the caregiver decide whether the patient is extremely bronchoconstricted, for example by showing data or measurements related to blood oxygen content, respiration rate, or respiration volume. Upon a confirmation by the caregiver that the patient is extremely bronchoconstricted at step 808, the decision support system may then suggest to the caregiver that a 125 milligram dose of Solumedrol be administered over a slow (e.g. 2 minute) intravenous push).
As per claim 298, Freeman teaches the RD CSG system of claim 254, wherein the drug delivery instructions include a drug delivery confirmation control and a dose interval timer ([0094] At step 808, the decision support system may help the caregiver decide whether the patient is extremely bronchoconstricted, for example by showing data or measurements related to blood oxygen content, respiration rate, or respiration volume. Upon a confirmation by the caregiver that the patient is extremely bronchoconstricted at step 808, the decision support system may then suggest to the caregiver that a 125 milligram dose of Solumedrol be administered over a slow (e.g. 2 minute) intravenous push.)
As per claim 311, Freeman teaches the RD CSG system of claim 254, wherein to modify the display based on the detected degradation comprises to provide a user notification of the detected degradation at a working view window of the CSG UI window, wherein the user notification includes an identification of the detected degradation and the critical physiologic parameters, and wherein the working view window comprises at least one CSG control configured to transition the mobile device display screen from the working view window to the CSG UI window in response to caregiver activation of the at least one CSG control ([0121] As an alternative, or in combination with the color, font, font size, shape, and similar visual distinguishing features, based on this physiological data, the display module 155 resizes the Cardiac Distress softkey 70 by making it larger, or by making the other softkeys smaller, as shown in FIG. 33. Although FIGS. 32 and 33 illustrate only one softkey 70 being emphasized and/or resized based on available patient data, the display module 155 may further be configured to dynamically emphasize and/or resize more than one softkey, in more than one way, according to embodiments of the present invention.)
As per claim 317 Freeman teaches the RD CSG system of claim 254, wherein the CSG UI window is configured to provide the caregiver instructions for the at least one clinical intervention and the critical physiologic parameters ([0094] For example, the decision support system may display and/or analyze the patient's end-tidal waveform. [0094] At step 808, the decision support system may help the caregiver decide whether the patient is extremely bronchoconstricted, for example by showing data or measurements related to blood oxygen content, respiration rate, or respiration volume. See also [0084] automatically display on the computer tablet. See also [0088]),
As per claim 321, Freeman teaches the RD CSG system of claim 317, wherein the CSG UI window excludes one or more physiologic parameters other than the critical physiologic parameters to emphasize the critical physiologic parameters (Figure 34).
As per claim 326, Homuth discloses wherein the period of delay is a period for the medical state of the patient to reach a steady state and is determined based on the at least one clinical intervention (see paragraphs [0110], [0117], [0132] and [0151]; e.g., continually adjusting air flow pressure until a steady state is reached).
As per claim 327, Homuth discloses wherein updating the at least one clinical intervention includes at least one of maintaining the at least one clinical intervention, modifying the at least one clinical intervention, supplementing the at least one clinical intervention with one or more other clinical interventions, or replacing the at least one clinical intervention with one or more other clinical interventions (see paragraphs [0021], [0104], [0132]-[0133] and [0158]; e.g., feedback loops and physiological measures to alter gas flow).
5. Claim(s) 267,270-272,278,280-284,288-289 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman and Pirtini Cetingul and Giordano and Homuth in view of Lee et al (“Lee”, US 2014/0240123)
As per claim 267, Freeman teaches establishing a connection as taught above, but fails to teach the mobile computing device comprises a communications interface configured to: establish a first communicative coupling with the at least one medical device, and identify the at least one medical device based on the first communicative coupling, and wherein the RD CSG engine is configured to during the emergency medical encounter: provide a connected devices window at the UI that indicates the identification of the at least one medical device. However, Lee teaches the RD CSG system of claim 254, wherein the mobile computing device comprises a communications interface configured to: establish a first communicative coupling with the at least one medical device, and identify the at least one medical device based on the first communicative coupling, and wherein the RD CSG engine is configured to: provide a connected devices window at the UI that indicates the identification of the at least one medical device ([0088] The mobile device may establish connections with a plurality of medical devices. In the present exemplary embodiment, the mobile device currently establishes connections with two medical devices (medical device A and medical device B). The medical devices A and B may be distinguished by their corresponding icons and a reference numeral 601.)
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the teaching of Lee with the system of Freeman- Pirtini. Motivation to do so would have been to provide a way to communicate with more than one medical device at a time thereby allowing a user to receive alerts from more than one device so as to not miss an emergency event.
As per claim 270, Lee teaches the RD CSG system of claim 267, wherein the at least one medical device is an initial medical device, the communications interface is configured to:
establish a second communicative coupling with at least one additional medical device subsequent to the initial medical device, and identify the at least one additional medical device based on the second communicative coupling ([0088] The mobile device may establish connections with a plurality of medical devices. In the present exemplary embodiment, the mobile device currently establishes connections with two medical devices (medical device A and medical device B). The medical devices A and B may be distinguished by their corresponding icons and a reference numeral 601.), and the RD CSG engine is configured to during the emergency medical encounter: update the connected devices window to include the identification of the at least one additional medical device ([0089] FIG. 7 is a schematic diagram of a screen of a mobile device that displays a medical device list or appears when the button 605 shown in FIG. 6 for registering an unregistered medical device is selected, according to an exemplary embodiment. Medical devices A and B connected to the mobile device are distinguished by their corresponding ions and reference numeral 701 and displayed on the medical device list together with IP addresses 703 thereof.)
As per claim 271, Freeman-Lee teaches the RD CSG system of claim 270, wherein the RD CSG engine is configured to during the emergency medical encounter: receive the plurality of physiologic parameters from the initial medical device, receive one or more additional physiologic parameters from the at least one additional medical device, and modify the UI in real-time to include at least one of the one or more additional physiologic parameters (Freeman, [0094] If the caregiver confirms the decision, then the decision support system may continue to guide the caregiver through additional treatment options, for example those indicated in FIG. 8. In this way, the decision support system guides the caregiver through complex decision making processes, during the clinical encounter, using both physiological data and informational data gathered from the patient or input by the caregiver, in a way which would be too inconvenient or time-consuming for the caregiver to perform absent the decision support system. Figure 8A).
As per claim 272, Freeman teaches the RD CSG system of claim 271, wherein the initial medical device comprises a patient monitor-defibrillator and the plurality of physiologic parameters comprises ECG, EtCO2, SpO2, heart rate, body temperature, and non-invasive blood pressure ([0096] Tissue CO2 and pH are particularly helpful in monitoring in the trauma DTP. Physiological parameters on display for the trauma DTP may be one or more of: invasive and non-invasive blood pressure, tissue CO2 and pH, ECG, SpO2 trending, and heart rate variability risk index. The ECG may be analyzed to determine the interval between adjacent R-waves of the QRS complexes and using this interval to calculate heart rate variability as a running difference between adjacent R-R intervals.),
and wherein the at least one additional medical device comprises a ventilation system, and wherein the one or more additional physiologic parameters comprise one or more of airway pressure (Paw), plateau pressure (Pplat), peak inspiratory pressure (PIP), patient oxygen saturation (SpO2), fraction of inspired oxygen (FiO2), positive end-expiratory pressure (PEEP), forced vital capacity (FVC), forced expiratory volume (FEV), peak expiratory flow rate (PEF or PEFR), respiratory resistance (Rrs), respiratory compliance (Crs), inspired and expired tidal volume, minute volume (Ve), end-tidal CO2 (EtCO2), and volume of exhaled carbon dioxide (VCO2) ([0143] If the values of pH and/or SmO2 are low or lowering, or if the value of ETCO2 is high or increasing, the decision support module 153 displays on the display module 155 and/or 156 instructions to increase the frequency or effectiveness of active ventilation, according to embodiments of the present invention.)
As per claim 278, Lee teaches the RD CSG system of claim 267, wherein the communications interface is configured to communicatively couple the mobile computing device to one or more remote computing devices outside of a local patient care environment via a long-range wireless network ([0058] The mobile device establishes a connection (Operation 203) with the medical device to have access therewith. The mobile device is connected to the medical device via wired or wireless communication networks such as in-house networks (Local Area Network (LAN) and Wireless Fidelity (WiFi)) or public networks (3G and 4G).)
As per claim 280, Freeman teaches the RD CSG system of claim 267, wherein the RD CSG engine is configured to during the emergency medical encounter: select the at least one clinical intervention based at least in part on the identified at least one medical device; and provide the caregiver instructions for the at least one clinical intervention based on the identified at least one medical device ([0094] For example, the decision support system may display and/or analyze the patient's end-tidal waveform. [0094] At step 808, the decision support system may help the caregiver decide whether the patient is extremely bronchoconstricted, for example by showing data or measurements related to blood oxygen content, respiration rate, or respiration volume. See also [0084] automatically display on the computer tablet. See also [0088] and [0093]).
As per claim 281, Freeman teaches the RD CSG system of claim 280, wherein the RD CSG engine is configured to during the emergency medical encounter: provide the caregiver instructions for the at least one clinical intervention to the at least one medical device ([0094] For example, the decision support system may display and/or analyze the patient's end-tidal waveform. [0094] At step 808, the decision support system may help the caregiver decide whether the patient is extremely bronchoconstricted, for example by showing data or measurements related to blood oxygen content, respiration rate, or respiration volume. See also [0084] automatically display on the computer tablet. See also [0088] and [0093])..
As per claim 282, Freeman teaches the RD CSG system of claim 281, wherein the caregiver instructions comprise one or more of operational mode instructions, operational setting instructions, physiologic closed- loop control instructions for the at least one medical device ([0094] For example, the decision support system may display and/or analyze the patient's end-tidal waveform. [0094] At step 808, the decision support system may help the caregiver decide whether the patient is extremely bronchoconstricted, for example by showing data or measurements related to blood oxygen content, respiration rate, or respiration volume. See also [0084] automatically display on the computer tablet. See also [0088] and [0093] According to embodiments of the present invention, the decision support system may suggest or propose a diagnosis or treatment path, for example by indicating statistical probabilities (based on charts and data such as those of FIGS. 6 and 7) or relative likelihoods, and ask for confirmation or final selection by the caregiver.)
As per claim 283, Freeman teaches the RD CSG system of claim 282, wherein the at least one medical device comprises a ventilator, and wherein the RD CSG engine is configured to during the emergency medical encounter generate the physiologic closed-loop control instructions based on oxygen concentration of a patient's blood, wherein the physiologic closed- loop control instructions adjust oxygen delivery during a delivery of a mechanical ventilation to the patient to maintain the oxygen concentration of the patient's blood at a desired level or range ([0143] The system's 3500 determination of ventilation needs is not only relevant for deciding whether to actively ventilate a patient when commencing treatment, but also for determining when to commence active ventilation when a patient was not initially ventilated during treatment. Some existing EMS systems do not actively ventilate a patient until six to eight minutes into treatment. Embodiments of the present invention permit the time at which ventilation is initiated to be patient-specific. A patient with a short "down time" and a cardiac etiology often has different ventilation requirements compared to someone with a long "down time" and an arrest of respiratory etiology. Embodiments of the present invention further assist the caregiver in determining not only whether or not to actively ventilate, but also how much to ventilate. If the values of pH and/or SmO2 are low or lowering, or if the value of ETCO2 is high or increasing, the decision support module 153 displays on the display module 155 and/or 156 instructions to increase the frequency or effectiveness of active ventilation, according to embodiments of the present invention.)
As per claim 284, Freeman teaches the RD CSG system of claim 280, wherein the caregiver instructions for the at least one clinical intervention include instructions provided at a CSG UI window for caregiver use of the identified at least one medical device ([0093] According to embodiments of the present invention, the decision support system may suggest or propose a diagnosis or treatment path, for example by indicating statistical probabilities (based on charts and data such as those of FIGS. 6 and 7) or relative likelihoods, and ask for confirmation or final selection by the caregiver.)
As per claim 288, Freeman teaches the RD CSG system of claim 284, wherein the caregiver instructions for the at least one clinical intervention comprise one or more of bronchodilator administration instructions and mask positioning instructions ([0094] For example, the decision support system may display and/or analyze the patient's end-tidal waveform. [0094] At step 808, the decision support system may help the caregiver decide whether the patient is extremely bronchoconstricted, for example by showing data or measurements related to blood oxygen content, respiration rate, or respiration volume.)
As per claim 289, Freeman teaches RD CSG system of claim 284, wherein the caregiver instructions for the at least one clinical intervention comprise patient monitoring instructions, wherein the patient monitoring instructions include an indication of therapy targets for the critical physiologic parameters and a status indication of physiologic closed-loop control of a ventilator ([0143] The system's 3500 determination of ventilation needs is not only relevant for deciding whether to actively ventilate a patient when commencing treatment, but also for determining when to commence active ventilation when a patient was not initially ventilated during treatment. Some existing EMS systems do not actively ventilate a patient until six to eight minutes into treatment. Embodiments of the present invention permit the time at which ventilation is initiated to be patient-specific. A patient with a short "down time" and a cardiac etiology often has different ventilation requirements compared to someone with a long "down time" and an arrest of respiratory etiology. Embodiments of the present invention further assist the caregiver in determining not only whether or not to actively ventilate, but also how much to ventilate. If the values of pH and/or SmO2 are low or lowering, or if the value of ETCO2 is high or increasing, the decision support module 153 displays on the display module 155 and/or 156 instructions to increase the frequency or effectiveness of active ventilation, according to embodiments of the present invention.).
6. Claim(s) 279 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman and Pirtini Cetingul and Giordano and Homuth and Lee in view of Montague et al (“Montague” US 2021/0093876)
As per claim 279, Freeman-Pirtini-Lee fails to distinctly point out a remote computing device being a cloud server or a medicine provider. However, Montague teaches the RD CSG system of claim 278, wherein the one or more remote computing devices comprise one or more of an electronic patient care record service, a health information exchange, an electronic medical record service, a cloud server, and a computing device associated with a telemedicine provider ([0166] Continuing to refer to the embodiment illustrated in FIG. 26, communications module 2570 is also configured to communicate with a mobile device 2620 using, for example, cellular modem 2572, Bluetooth modem 2574, Wi-Fi modem 2576, of satellite modem 2580, as shown in FIG. 25. As an example, a native or web app is installed on mobile device 2620 enables a user to perform AED-related tasks such as registration of the AED with the AED provider, and access to AED information and tutorials related to AED use. Optionally, mobile device 2620 is connected to cloud 2610 so as to be able to connect with server 2612 therethrough, thus enabling the user to access data available at server 2612.)
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the teaching of Montague with the system of Freeman-Pirtini-Lee. Motivation to do so would have been to be able to connect with server 2612 therethrough, thus enabling the user to dynamically access data available at server.
7. Claim(s) 285,286,294 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman and Pirtini Cetingul and Giordano and Homuth and Lee in view of Al-Ali (“Al-Ali”, US 2015/0238722).
As per claim 285, Freeman-Pirtini-Lee fails to distinctly point out that the instructions include operation and assembly instructions. However, Al-Ali teaches the RD CSG system of claim 284, wherein the identified at least one medical device is a ventilation system and wherein the cafregiver instructions comprise at least one of ventilation system operation instructions and ventilation system assembly instructions. ([0053] The smartphone 400 may include software such as an application configured to enable interaction with the instructions 405 as well as to manage output measurement data from the measurement head processing module. The instruction application functionality can include provision of assembly or operation instructions prior to and during ventilation assistance, allowing clinician input of patient and/or equipment characteristics, and provision of feedback during ventilation assistance based on physiological parameters. Figure 4A).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the teaching of Al-Ali with the system of Freeman-Pirtini-Lee. Motivation to do so would have been to provide a guide to assists users that may not be familiar with the system in an emergency situation
As per claim 286, Al-Ali teaches the RD CSG system of claim 285, wherein the ventilation system operation instructions comprise one or more of power-on instructions, mode selection instructions, hose connection instructions, oxygen tank connection instructions, and mask connection instructions ([0053] The smartphone 400 may include software such as an application configured to enable interaction with the instructions 405 as well as to manage output measurement data from the measurement head processing module. The instruction application functionality can include provision of assembly or operation instructions prior to and during ventilation assistance, allowing clinician input of patient and/or equipment characteristics, and provision of feedback during ventilation assistance based on physiological parameters. Figure 4A).
As per claim 294, Al-Ali teaches the RD CSG system of claim 292, wherein the CSG UI window is configured to provide the caregiver instructions as alphanumeric instructions, graphic instructions, and a combination thereof, wherein the graphic instructions comprise drawings of the at least one medical device, where the drawings are configured to guide a caregiver through use of the at least one medical device ([0053] The smartphone 400 may include software such as an application configured to enable interaction with the instructions 405 as well as to manage output measurement data from the measurement head processing module. The instruction application functionality can include provision of assembly or operation instructions prior to and during ventilation assistance, allowing clinician input of patient and/or equipment characteristics, and provision of feedback during ventilation assistance based on physiological parameters. Figure 4A).
8. Claim(s) 299,301,302,304-305,318 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freeman and Pirtini Cetingul and Giordano and Homuth in view of Bastide et al (“Bastide”, 2020/0390401)
As per claim 299, Freeman-Pirtini fails to teach guidance selection controls to select a level of detail. However, Bastide teaches the RD CSG system of claim 254, wherein the RD CSG engine is configured to during the emergency medical encounter provide guidance selection controls at the CSG UI window in conjunction with the caregiver instructions for the at least one clinical intervention, wherein the guidance selection controls enable a caregiver to select a level of detail of the provided instructions ([0024] Consider, in another example, a monitoring device 140 providing the second tutorial 202 and monitoring the mental state of the administering individual 110 that determines that the administering individual 110 is neither confused nor disoriented, but has a clear and focused attentiveness level (and may be impatient to progress through the instructions). Based on the determined clarity/focus, the monitoring device 140 adjusts the second tutorial 202 to the first tutorial 201, which provides the administering individual 110 an overview of how to use the medical device 130 rather than individual steps. In this way, the monitoring device 140 may provide more detailed or more controlled provision of the instructions to portions of the tutorial posing particular problems to the user, and provide less detailed or less controlled provision of the instructions to those portions of the tutorial not posing difficulty to the user; thus speeding up treatment of the medical event by providing an appropriately matched level of detail and control for providing the tutorial based on the user's attentiveness level in the observed mental state.)
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the teaching of Bastide with the system of Freeman-Pirtini. Motivation to do so would have been to provide less detailed or less controlled provision of the instructions to those portions of the tutorial not posing difficulty to the user; thus speeding up treatment of the medical event by providing an appropriately matched level of detail and control for providing the tutorial based on the user's attentiveness level in the observed mental state.)
As per claim 301, Bastide teaches the RD CSG system of claim 299, wherein the guidance selection controls comprise at least one of a continue instructions control, an exit instructions control, a proceed to a next step control, an increase a detail level for guidance control, and a return to a previous instruction control, and a mute or unmute audible UI output control ([0018] In the second tutorial 202, each step is presented in a controlled manner to guide the administering individual 110 through the treatment process. For example, the monitoring device 140 may display the first GUI 210a and play an associated first sound clip 220a to provide the administering individual 110 with instructions to “remove the cap and shake the inhaler”. Once the monitoring device 140 detects a triggering event, the monitoring device 140 advances to the next step to display the second GUI 210b and play a second sound clip 220b. The monitoring device 140 may thus confirm each step is being performed before advancing to a subsequent step to guide the administering individual 110 through the treatment process. [0019] Depending on the triggering event, the monitoring device 140 may repeat the current step (e.g., replaying the associated sound clip 220), advance to a next step in a sequence, return to an earlier step in the sequence, or adjust which tutorial 201/202 is provided to the individuals. Triggering events may be generally classified into three categories: instructional, physical, and mental.)
As per claim 302, Bastide teaches the RD CSG system of claim 292, wherein the RD CSG engine is configured to during the emergency medical encounter receive a caregiver confirmation at the mobile computing device in response to the caregiver instructions for the at least one clinical intervention, wherein the caregiver confirmation comprises one or more of a medication administration confirmation, a clinical intervention step confirmation, and a medical device connection confirmation( [0018] In the second tutorial 202, each step is presented in a controlled manner to guide the administering individual 110 through the treatment process. For example, the monitoring device 140 may display the first GUI 210a and play an associated first sound clip 220a to provide the administering individual 110 with instructions to “remove the cap and shake the inhaler”. Once the monitoring device 140 detects a triggering event, the monitoring device 140 advances to the next step to display the second GUI 210b and play a second sound clip 220b. The monitoring device 140 may thus confirm each step is being performed before advancing to a subsequent step to guide the administering individual 110 through the treatment process.)
As per claim 304, Bastide teaches the RD CSG system of claim 302, wherein the RD CSG engine generates and transmits the event marker to the at least one medical device during the emergency medical encounter in response to receiving the caregiver confirmation ([0019] Depending on the triggering event, the monitoring device 140 may repeat the current step (e.g., replaying the associated sound clip 220), advance to a next step in a sequence, return to an earlier step in the sequence, or adjust which tutorial 201/202 is provided to the individuals. Triggering events may be generally classified into three categories: instructional, physical, and mental.)
As per claim 305, Bastide teaches the RD CSG system of claim 254, wherein the RD CSG engine is configured to during the emergency medical encounter receive caregiver input via one or more of a touch screen entry or a voice command and provide audible output ([0020] Examples of instructional triggering events include: a manual commands (e.g., a button push of either a software button in the associated GUI 210 or a physical button on the monitoring device 140), voice commands (e.g., “acknowledged,” “next step please,” “repeat that,” “I do not understand”), and the like. Examples of physical triggering events include: movement of the medical device 130 (e.g., based on camera images, an accelerometer/gyroscope), sounds from the environment (e.g., a discharging sound from the medical device 130), and the like. Examples of mental triggering events include determinations of the current mental state of the administering individual 110 has changed by one or more biological features that are indicative of focus, understanding, or clarity of thought in the administering individual 110.)
As per claim 318, Bastide teaches the RD CSG system of claim 317, wherein the CSG UI window is configured to provide one or more of a medication dosage timer, reminders for intervention steps, instructions for caregiver use of the at least one medical device, and status updates for the at least one medical device (Figure 2A).
Response to Arguments
9. Applicant’s arguments with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al (US 2022/0020463).
11. Any inquiry concerning this communication or earlier communications from the examiner should be directed to RASHAWN N TILLERY whose telephone number is (571)272-6480. The examiner can normally be reached M-F 9:00a - 5:30p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, William L Bashore can be reached on (571) 272-4088. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RASHAWN N TILLERY/Primary Examiner, Art Unit 2174