DETAILED ACTION
This action is pursuant to claims filed on 03/07/2024. Claims 36-53 are pending. A first action on the merits of claims 36-53 is as follows.
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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “703” has been used to designate both the step of producing detector signals within the operating range in Figure 7 and paragraph 0088 in the specification and a step in which the tissue oxygen saturation and pulse oximetry values are calculated by the processor in paragraph 0088 in the specification.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "703" and "706" have both been used to designate a step in which the tissue oxygen saturation and pulse oximetry values are calculated by the processor in paragraph 0088 of the specification.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Reference character “704” in Figure 7 does not appear in the specification.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 36, 41, and 50-52 are objected to because of the following informalities:
In claim 36, lines 6-7, “the portion” should read “a portion”, as there is a lack of antecedent basis in the claim
In claim 36, lines 43-44, “tissue oxygen saturation data” should read “the tissue oxygen saturation data”
In claim 36, lines 47-48, “tissue oxygen saturation data” should read “the tissue oxygen saturation data”
In claim 36, line 53, “tissue oxygen saturation data” should read “the tissue oxygen saturation data”
In claim 41, line 2, “tissue oxygen saturation data” should read “the tissue oxygen saturation data”
In claim 50, line 2, “a corresponding external device” should read “the corresponding external device”
In claim 51, line 2, “a corresponding external device” should read “the corresponding external device”
In claim 52, line 2, “a corresponding external device” should read “the corresponding external device”
Appropriate correction is required.
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 36-53 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.
Regarding claim 36, the claim recites the limitation “the subject’s skin” in lines 7, 9, and 12. It is unclear if this limitation is referring to the patients from line 2 of the claim, or a different subject. If it is referring to the patient, it needs to refer back to it. If it is referring to a different person, it is unclear how the method uses data from a different subject to monitor a different patient. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to the patients from line 2 of the claim. Claims 37-53 are also rejected due to their dependence on claim 36.
Further regarding claim 36, the claim recites the limitation “the output of the photodetector” in lines 34 and 37. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, it is being interpreted as referring to the receiving step from lines 11-13. Claims 37-53 are also rejected due to their dependence on claim 36.
Further regarding claim 36, the claim recites the limitation “the tissue” in lines 35 and 38. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this is meant to refer to the portion of the subject’s skin introduced in lines 6-7, or a different tissue. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as referring to the portion of the subject’s skin introduced in lines 6-7. Claims 37-53 are also rejected due to their dependence on claim 36.
Further regarding claim 36, the claim recites the limitation “photodetector measurements” in lines 39-40 and 41-42. It is unclear if this is meant to refer to the measure of the output of the photodetector from lines 34 and 37, or different photodetector measurements. If it is referring to the measure of the output of the photodetector from lines 34 and 37, it needs to refer back to it. If it is referring to different photodetector measurements, it needs to be distinguished from the measure of the output of the photodetector. For purposes of examination, it is being interpreted as referring to the measure of the output of the photodetector from lines 34 and 37. Claims 37-53 are also rejected due to their dependence on claim 36.
Further regarding claim 36, the claim recites the limitation “a hospital patient-monitoring data system” in line 52. It is unclear if this is meant to refer to the remote hospital patient-monitoring data system from line 27, or a different hospital patient-monitoring data system. If it is referring to the data system from line 27, it needs to refer back to it. If it is referring to a different data system, it needs to be distinguished from the data system from line 27. For purposes of examination, it is being interpreted as referring to the remote hospital patient-monitoring data system from line 27. Claims 37-53 are also rejected due to their dependence on claim 36.
Regarding claim 42, the claim recites the limitation “pulse oximetry values” in line 2. It is unclear if this limitation is meant to refer to pulse oximetry values from claim 1 line 39, or different pulse oximetry values. If it is referring to the pulse oximetry values from claim 1, it needs to refer back to it. If it is referring to different pulse oximetry values, it needs to be distinguished from the pulse oximetry values from claim 1. For purposes of examination, it is being interpreted as referring to the pulse oximetry values from claim 1. Claims 43-47 are also rejected due to their dependence on claim 42.
Further regarding claim 42, the claim recites the limitation “tissue oxygen saturation values” in line 2. It is unclear if this limitation is meant to refer to the tissue oxygen saturation values from claim 1, line 41, or different tissue oxygen saturation values. If it is referring to the tissue oxygen saturation values from claim 1, it needs to refer back to it. If it is referring to different tissue oxygen saturation values, it needs to be distinguished from the tissue oxygen saturation values from claim 1. For purposes of examination, it is being interpreted as referring to the tissue oxygen saturation values from claim 1. Claims 43-47 are also rejected due to their dependence on claim 42.
Regarding claim 43, the claim recites the limitation “values” in line 2. It is unclear if this is meant to refer to the pulse oximetry values from claim 42, the tissue oxygen saturation values from claim 42, the pulse oximetry values from claim 36, the tissue oxygen saturation values from claim 36, some of these values, all of these values, or completely different values. If it is referring to any of the previously introduced values, it needs to refer back to them. If it is referring to different values, it needs to be distinguished from all of the previously presented values. For purposes of examination, it is being interpreted as referring to any of the previously presented values.
Regarding claim 44, the claim recites the limitation “values” in line 2. It is unclear if this is meant to refer to the pulse oximetry values from claim 42, the tissue oxygen saturation values from claim 42, the pulse oximetry values from claim 36, the tissue oxygen saturation values from claim 36, some of these values, all of these values, or completely different values. If it is referring to any of the previously introduced values, it needs to refer back to them. If it is referring to different values, it needs to be distinguished from all of the previously presented values. For purposes of examination, it is being interpreted as referring to any of the previously presented values.
Regarding claim 45, the claim recites the limitation “values” in line 2. It is unclear if this is meant to refer to the pulse oximetry values from claim 42, the tissue oxygen saturation values from claim 42, the pulse oximetry values from claim 36, the tissue oxygen saturation values from claim 36, some of these values, all of these values, or completely different values. If it is referring to any of the previously introduced values, it needs to refer back to them. If it is referring to different values, it needs to be distinguished from all of the previously presented values. For purposes of examination, it is being interpreted as referring to any of the previously presented values.
Regarding claim 46, the claim recites the limitation “a tracked value” in line 2. It is unclear if this limitation is meant to refer to the pulse oximetry values from claim 42, the tissue oxygen saturation values from claim 42, the pulse oximetry values from claim 36, the tissue oxygen saturation values from claim 36, some of these values, all of these values, or completely different values. If it is referring to any of the previously introduced values, it needs to refer back to them. If it is referring to different values, it needs to be distinguished from all of the previously presented values. For purposes of examination, it is being interpreted as referring to any of the previously presented values.
Regarding claim 47, the claim recites the limitation “a tracked value” in line 2. It is unclear if this limitation is meant to refer to the pulse oximetry values from claim 42, the tissue oxygen saturation values from claim 42, the pulse oximetry values from claim 36, the tissue oxygen saturation values from claim 36, some of these values, all of these values, or completely different values. If it is referring to any of the previously introduced values, it needs to refer back to them. If it is referring to different values, it needs to be distinguished from all of the previously presented values. For purposes of examination, it is being interpreted as referring to any of the previously presented values.
Regarding claim 48, the claim recites the limitation “trend awareness/alarms” in line 2. It is unclear if this limitation requires just simply trend awareness, or if an alarm is also required structure of the claim. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as only requiring trend awareness, only an alarm, or both. Claim 49 is also rejected due to its dependence on claim 48.
Regarding claim 49, the claim recites the limitation “the integrated health system EHR” in line 2. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this limitation is meant to read “an integrated health system EHR”, or be dependent on another dependent claim that has introduced the integrated health system EHR. The broad and indefinite scope of the limitation fails to inform a person of ordinary skill in the art with reasonable certainty of the metes and bounds of the claimed invention, therefore the claim is rendered indefinite. For purposes of examination, it is being interpreted as being meant to read as “an integrated health system EHR”.
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.
Claims 36-50 and 52-53 are rejected under 35 U.S.C. 103 as being unpatentable over Lash (US 20130096401) in view of Seemakurty (US 11195616), Lynn (US 20130338459), and Shaya (US 20180110475).
Regarding independent claim 36, Lash teaches a method of managing extra-hospital patient care from a remote location by monitoring patients via wearable wireless tissue and pulse oximetry devices ([0003]: “The present invention relates generally to optical systems that monitor oxygen levels in tissue.”), comprising steps of:
(a) providing one or more wearable sensor units ([0042]: “FIG. 1 is a block diagram representation of a wireless disposable shock trauma monitoring system 100 in accordance with an embodiment of the present invention consisting of sensor 101”; [0048]: “FIG. 3 is a perspective view of a wireless disposable shock trauma monitoring device placed on and secured to a hand”), each having:
(i) a contact surface ([0042]: “Skin contact detector 105 is electrically insulated from the skin by means of adhesive fixation unit 160”),
(ii) a skin contact detector comprising at least one electrode configured to provide a detection signal when the contact surface is in contact with the portion of the subject's skin to be analyzed ([0042]: “skin contact detector 105 may consist of a planar conductive element”),
(iii) at least one light source ([0042]: “a wireless disposable shock trauma monitoring system 100 in accordance with an embodiment of the present invention consisting of sensor 101 which contains a first light source 102”), the at least one light source arranged to provide a first beam of light towards the portion of the subject's skin to be analyzed at a first wavelength ([0042]: “The first light source 102 emits a first beam of light in the near infrared region into the tissue”) and a second beam of light at a second wavelength ([0042]: “the second light source 103 emits a second beam of light in the visible red region into the tissue”),
(iv) a photodetector arranged to receive the first beam of light and the second beam of light that are reflected from the portion of the subject's skin to be analyzed ([0042]: “sensor 101 which contains … photodetector 104 … The first beam of light and the second beam of light enter the tissue, and a portion of each beam is reflected by the tissue and received by photodetector 104”),
(v) a sensor unit wireless transceiver, and (vi) a sensor unit microprocessor and a sensor unit computer-readable storage medium storing instructions for execution by the sensor unit microprocessor ([0018]: “the system on a chip contains a processor, read only memory, read-write memory, and a serial interface to communicate with the wireless transceiver”);
(b) for each extra-hospital patient to be monitored, attaching at least one of the wearable sensor units to the respective patient ([0048]: “FIG. 3 is a perspective view of a wireless disposable shock trauma monitoring device placed on and secured to a hand”);
and an external device, the external device having:
(i) an external device wireless transceiver,
(ii) an external device microprocessor and an external device computer- readable storage medium storing instructions for execution by the external device microprocessor, and
(iii) a user interface (Abstract: “The oxygen saturation measurements are wirelessly transmitted to a remote display device, such as a smartphone running a smartphone software application which receives the measurements and displays them in numeric, graphical, and audible form. In addition, the smartphone software application may relay the data to the Internet for remote viewing on a web site or remote transfer to a hospital patient data system.”).
However, Lash does not specifically teach equipping each respective patient with a corresponding external device.
Seemakurty discloses systems and methods to process and analyze real-time data. Specifically, Seemakurty teaches equipping each respective patient with a corresponding external device (Column 8, lines 48-53: “the system comprises a communication module configured to send the predicted health status of the one or more patients and the one or more predictive alerts to one or more handheld computing devices or one or more handheld electronic devices associated with at least one of the one or more patients”). Lash and Seemakurty are analogous arts as they are both related to systems that monitor oxygen saturation and pulse oximetry for health analysis.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include equipping the patients with the external devices from Seemakurty into the method from Lash as it allows the method to provide the patient with their own health information, which can keep them informed of their health status.
The Lash/Seemakurty combination teaches (d) providing a remote hospital patient-monitoring data system (Lash, Abstract: “the smartphone software application may relay the data to the Internet for remote viewing on a web site or remote transfer to a hospital patient data system”);
(e) remotely monitoring each extra-hospital patient for shock using the patient's respective wearable sensor unit, the corresponding external device, and the remote hospital patient-monitoring data system (Lash, [0042]: “FIG. 1 is a block diagram representation of a wireless disposable shock trauma monitoring system”).
However, the Lash/Seemakurty combination does not teach monitoring for sepsis.
Lynn discloses a system and method for monitoring pulse oximetry. Specifically, Lynn teaches monitoring for sepsis using oxygen saturation and pulse oximetry ([0080]: “The parameters, which may represent time series data, may be defined to correspond with data that is variable in response to certain conditions such as sleep apnea or sepsis”). Lash. Seemakurty, and Lynn are analogous arts as they are all related to systems that monitor oxygen saturation and pulse oximetry for health analysis.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the monitoring for sepsis from Lynn into the Lash/Seemakurty combination as it allows the device to determine if the patients could have sepsis, which can allow for them to know if they have a life-threatening condition, and can allow for a more comprehensive health analysis.
The Lash/Seemakurty/Lynn combination teaches (i) so long as a detection signal is received at the respective sensor unit microprocessor, repeatedly causing the sensor unit to:
(A) emit the first beam of light from the at least one light source,
(B) measure the output of the photodetector receiving the reflection of the first light beam from the tissue,
(C) emit the second beam of light from the at least one light source,
(D) measure the output of the photodetector receiving the reflection of the second light beam from the tissue,
(F) compute tissue oxygen saturation values based on photodetector measurements, and
(G) communicate the computed pulse oximetry and tissue oxygen saturation data to the corresponding external device via the sensor unit wireless transmitter (Lash, Fig. 5 discloses ensuring skin contact is detected, and then emitting the beams of light, measure the output, and compute tissue oxygenation results, and transmitting them to a wireless transceiver).
However, the Lash/Seemakurty/Lynn combination does not teach computing pulse oximetry values based on photodetector measurements.
Lynn teaches computing pulse oximetry values based on photodetector measurements ([0087]: “the system comprises a monitor having a plurality of sensors for positioning adjacent a patient and a processor programmed to produce a first timed waveform based on a first physiologic parameter of the patient, produce a second timed waveform based on a second physiologic parameter which is generally subordinate to the first physiologic parameter, so that the second parameter normally changes in response to changes in the first parameter, identify pathophysiologic divergence of at least one of the first and second physiologic parameters in relationship to the other physiologic parameter … The second parameter can, for example, comprise a measure of oxygen saturation and can be pulse oximetry value”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the pulse oximetry values calculation from Lynn into the Lash/Seemakurty/Lynn combination as pulse oximetry is a parameter that can be calculated based on photodetector measurements and can be used for valuable calculations in health monitoring processes, so it would be a valuable parameter to include in the monitoring method.
The Lash/Seemakurty/Lynn combination teaches (ii) at the corresponding external device:
(A) receiving the repeatedly-computed pulse oximetry and tissue oxygen saturation data that is communicated from the wearable sensor unit,
(B) providing the received data to the patient via the user interface (Lash, Abstract: “The oxygen saturation measurements are wirelessly transmitted to a remote display device, such as a smartphone running a smartphone software application which receives the measurements and displays them in numeric, graphical, and audible form”), and
(C) relaying the received data from the corresponding external device to a hospital patient-monitoring data system (Lash, Abstract: “the smartphone software application may relay the data to the Internet for remote viewing on a web site or remote transfer to a hospital patient data system”).
However, the Lash/Seemakurty/Lynn combination does not teach based on the pulse oximetry and tissue oxygen saturation data relayed to the hospital patient-monitoring data system, enacting clinical intervention for the patient by a virtual care team.
Lynn teaches based on the pulse oximetry and tissue oxygen saturation data relayed to the hospital patient-monitoring data system, enacting clinical intervention for the patient by a team ([0086]: “data obtained from embodiments of the present invention may be employed to initiate or control a wide range of actions, depending on the condition being identified and other design considerations … Examples of therapeutic activities that may be controlled or initiated responsive to data analysis performed in accordance with embodiments of the present invention include providing an audiovisual alarm, waking a patient, providing a remote notification, sending human intervention, altering setting of life support event (ventilator), writing a severity index to a display device such as a Digicalc, switching display modes of a display device, showing a list of options, printing a warning, …”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the intervention from Lynn into the Lash/Seemakurty/Lynn combination as it allows the calculated information to be able to be used to provide intervention to the user, which can help improve the user’s health condition.
However, the Lash/Seemakurty/Lynn combination is silent on who provides the intervention.
Shaya discloses a system and method for performing real-time virtual medical examinations. Specifically, Shaya teaches providing intervention by a virtual care team ([0130]: “the system is capable of providing virtual care throughout the world. Select providers can then deliver second opinions to patients virtually”). Lash and Shaya are analogous arts as they are both related to methods that use a remote monitoring system.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the virtual care team from Shaya into the Lash/Seemakurty/Lynn combination as the combination is silent on who provides the intervention, and Shaya discloses a suitable intervention provider in an analogous art.
Regarding claim 37, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 36, wherein the step of attaching at least one of the wearable sensor units includes attaching at least one of the wearable sensor units to the respective patient in a long term care or at-home monitoring scenario, and wherein the step of remotely monitoring the respective patient, including the steps of relaying the received data to the hospital patient- monitoring data system and enacting clinical intervention for the patient by the virtual care team, is carried out while the patient is in the long term care or at-home monitoring scenario (Lash, [0013]: “what is needed is a miniaturized wireless tissue oximeter that is inexpensive to manufacture, and can be worn in mobile settings to wirelessly transmit immediate and continuous tissue oxygen saturation readings for both local and remote use”. Remote use can include long term care and at home monitoring.).
Regarding claim 38, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 36, wherein the step of attaching at least one of the wearable sensor units includes attaching at least one of the wearable sensor units to the respective patient in pre-hospital/EMS transport, and wherein the step of remotely monitoring the respective patient, including the steps of relaying the received data to the hospital patient-monitoring data system and enacting clinical intervention for the patient by the virtual care team, is carried out while the patient is in pre-hospital/EMS transport (Lash, [0013]: “what is needed is a miniaturized wireless tissue oximeter that is inexpensive to manufacture, and can be worn in mobile settings to wirelessly transmit immediate and continuous tissue oxygen saturation readings for both local and remote use”. Local and remote use can include pre-hospital/EMS transport.).
Regarding claim 39, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 36, wherein the step of attaching at least one of the wearable sensor units includes attaching at least one of the wearable sensor units to the respective patient for post-acute care stabilization, and wherein the step of remotely monitoring the respective patient, including the steps of relaying the received data to the hospital patient-monitoring data system and enacting clinical intervention for the patient by the virtual care team, is carried out while the patient is in outpatient care (Lash, [0013]: “what is needed is a miniaturized wireless tissue oximeter that is inexpensive to manufacture, and can be worn in mobile settings to wirelessly transmit immediate and continuous tissue oxygen saturation readings for both local and remote use”. Remote and local use can include post-acute care stabilization and outpatient care.).
Regarding claim 40, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 36.
However, the Lash/Seemakurty/Lynn/Shaya combination does not teach wherein the hospital patient-monitoring data system is integrated into a health system electronic health record (EHR).
Lynn teaches wherein the hospital patient-monitoring data system is integrated into a health system electronic health record (EHR) ([0335]: “An application program may be adapted to analyze and view physiologic datasets as accessible from a primary program used to view the patient's electronic medical records”; [0406]: “the processor can include an input for manual designation of oxygen therapy on the display or can be programmed to receive the information relevant to the presence of oxygen from the patient's electronic chart”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the electronic health record from Lynn into the Lash/Seemakurty/Lynn/Shaya combination as it allows the user’s records to be stored in an easily accessible and retained location.
Regarding claim 41, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 40, further comprising a step of generating alerts based on the pulse oximetry and tissue oxygen saturation data and provided to the virtual care team via the integrated health system HER (Lash, Abstract: “The oxygen saturation measurements are wirelessly transmitted to a remote display device, such as a smartphone running a smartphone software application which receives the measurements and displays them in numeric, graphical, and audible form … the smartphone software application may relay the data to the Internet for remote viewing on a web site or remote transfer to a hospital patient data system”).
Regarding claim 42, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 36.
However, the Lash/Seemakurty/Lynn/Shaya combination does not teach wherein the remotely monitoring step includes tracking trends in pulse oximetry values and tissue oxygen saturation values for each respective patient, and wherein the step of enacting clinical intervention is carried out based on the tracked trends.
Lynn teaches wherein the remotely monitoring step includes tracking trends in pulse oximetry values and tissue oxygen saturation values for each respective patient ([0082]: “The slope or trend of the index of "airflow" and oxygen saturation will rise significantly as septic shock evolves and this can be correlated with the slope of the variability of that index”), and wherein the step of enacting clinical intervention is carried out based on the tracked trends ([0086]: “data obtained from embodiments of the present invention may be employed to initiate or control a wide range of actions, depending on the condition being identified and other design considerations … Examples of therapeutic activities that may be controlled or initiated responsive to data analysis performed in accordance with embodiments of the present invention include providing an audiovisual alarm, waking a patient, providing a remote notification, sending human intervention, altering setting of life support event (ventilator), writing a severity index to a display device such as a Digicalc, switching display modes of a display device, showing a list of options, printing a warning, performing genioglossal stimulation, performing phrenic nerve stimulation, performing diaphragm stimulation (implantable pacemaker), titrating a CPAP or bi-level pressure device, triggering another process, administering respiratory stimulant drugs, administering theophylline (caffeine or the like), reducing or ceasing administration of narcotics, reducing administration of O.sub.2 or closing a control loop to processes such as FiO.sub.2, CPAP, PCA or PEEP.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the monitoring of trends from Lynn into the Lash/Seemakurty/Lynn/Shaya combination as it allows the combination to determine trends, which can provide information about the user’s condition and how it evolves over time, allowing for a more comprehensive analysis.
Regarding claim 43, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 42, wherein the step of tracking trends includes tracking changes in values relative to a baseline (Lynn, [0120]: “Once a baseline is established for a patient, either for example as the patient's baseline settings for a selected or steady state time period (of for example 10-15 minutes) or by a selected or calculated set of normal ranges, the cube may be illustrated as a square”).
Regarding claim 44, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 42, wherein the step of tracking trends includes tracking changes in values as they change over time (Lynn, [0057]: “The configurations of the animation changes with the analysis output, as this output changes over time in relation to changes in the patient's physiologic state”).
Regarding claim 45, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 42, wherein the step of tracking trends includes tracking rates of change in values over time (Lynn, [0111]: “similar index characteristics of the complex objects can be derived from these characteristics for example; a "shape characteristic" derived from the mean rate of change along the dataset of the mean slopes of composite objects”).
Regarding claim 46, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 42.
However, the Lash/Seemakurty/Lynn/Shaya combination does not teach wherein the remotely monitoring step includes triggering an alert when a tracked value continues to increase, or continues to decrease, for a predetermined period of time.
Lynn teaches wherein the remotely monitoring step includes triggering an alert when a tracked value continues to increase, or continues to decrease, for a predetermined period of time ([0120]: “The computer can flag with a red indicator a cube that is showing pathophysiologic divergence when compared with the baseline values even though none of the values are at a typical alarm threshold.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the alert from Lynn into the Lash/Seemakurty/Lynn/Shaya combination as it allows the method to alert the user if there is a change in a tracked value, which can keep them informed of their health status.
Regarding claim 47, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 42.
However, the Lash/Seemakurty/Lynn/Shaya combination does not teach wherein the remotely monitoring step includes triggering an alert when a tracked value rises above a first predetermined threshold or drops below a second predetermined threshold.
Lynn teaches wherein the remotely monitoring step includes triggering an alert when a tracked value rises above a first predetermined threshold or drops below a second predetermined threshold ([0349]: “the processor can be programmed to detect a threshold value indicative of the peak value and/or a magnitude of rise event and to provide an indication, for example to highlight the region of recovery failure and to output a text warning indicative of "Severe Recovery Failure" along with the instability index value which is calculated for the recovery failure and the surrounding associated patterns”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the alert from Lynn into the Lash/Seemakurty/Lynn/Shaya combination as it allows the method to alert the user if there is a change in a tracked value, which can keep them informed of their health status.
Regarding claim 48, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 36.
However, the Lash/Seemakurty/Lynn/Shaya combination does not teach further comprising a step of using predictive software modeling in step will trigger trend awareness/alarms based on clinical guardrails.
Seemakurty teaches further comprising a step of using predictive software modeling in step will trigger trend awareness/alarms based on clinical guardrails (Column 8, lines 36-48: “the alert generation module is configured to: transmit the one or more predictive alerts to one or more corresponding stakeholders for creating awareness associated with the health status of the one or more patients based on a predictive value corresponding to the health status predicted using the ensemble modelling technique; and prioritize a list of the one or more patients with a predictive value higher than a predetermined predictive value based on transmission of the one or more predictive alerts. In some embodiments, the alert generation module is configured to receive a feedback response corresponding to the one or more predictive alerts from the one or more stakeholders”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the predictive software from Seemakurty into the Lash/Seemakurty/Lynn/Shaya combination as it allows the method to predict the user’s future conditions and alert the user if there are predicted issues.
Regarding claim 49, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 48, further comprising a step of providing the trend awareness/alarms to the virtual care team (Lash, Abstract: “The oxygen saturation measurements are wirelessly transmitted to a remote display device, such as a smartphone running a smartphone software application which receives the measurements and displays them in numeric, graphical, and audible form … the smartphone software application may relay the data to the Internet for remote viewing on a web site or remote transfer to a hospital patient data system”).
However, the Lash/Seemakurty/Lynn/Shaya combination does not teach a health system electronic health record (EHR).
Lynn teaches a health system electronic health record (EHR) ([0335]: “An application program may be adapted to analyze and view physiologic datasets as accessible from a primary program used to view the patient's electronic medical records”; [0406]: “the processor can include an input for manual designation of oxygen therapy on the display or can be programmed to receive the information relevant to the presence of oxygen from the patient's electronic chart”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the electronic health record from Lynn into the Lash/Seemakurty/Lynn/Shaya combination as it allows the user’s records to be stored in an easily accessible and retained location.
Regarding claim 50, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 36, wherein the step of equipping each respective patient with a corresponding external device includes equipping at least one patient with a smartphone (Lash, Abstract: “The oxygen saturation measurements are wirelessly transmitted to a remote display device, such as a smartphone”).
Regarding claim 52, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 36, wherein the step of equipping each respective patient with a corresponding external device includes equipping at least one patient with a smartphone (Lash, Abstract: “The oxygen saturation measurements are wirelessly transmitted to a remote display device, such as a smartphone”).
Regarding claim 53, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 36.
However, the Lash/Seemakurty/Lynn/Shaya combination does not teach wherein the remotely monitoring step is carried out in conjunction with continuously monitoring heartrate, temperature, and blood pressure.
Lynn teaches wherein the remotely monitoring step is carried out in conjunction with continuously monitoring heartrate, temperature, and blood pressure ([0072]: “Additional parameters that may be analyzed include … blood pressure, heart rate”; [0253]: “Examples of parameters that can be included within the representation include the parameters previously discussed as well as body dimension characteristics (for example, weight), temperature”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include monitoring heartrate, temperature, and blood pressure from Lynn into the Lash/Seemakurty/Lynn/Shaya combination as it allows the device to monitor more parameters related to the user’s health, which can provide a more comprehensive analysis.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over the Lash/Seemakurty/Lynn/Shaya combination as applied to claim 36 above, and further in view of Freeman (US 20190255340).
Regarding claim 51, the Lash/Seemakurty/Lynn/Shaya combination teaches the method of Claim 36.
However, the Lash/Seemakurty/Lynn/Shaya combination does not teach wherein the step of equipping each respective patient with a corresponding external device includes equipping at least one patient with a smartwatch.
Freeman discloses a treatment system for a user. Specifically, Freeman teaches wherein the step of equipping each respective patient with a corresponding external device includes equipping at least one patient with a smartwatch ([0056]: “communication with external devices such as laptops, wireless networks, wearable electronic devices, smartwatches, servers, tablets, phones, etc., may be accomplished with wireless and wired communication”). Lash, Seemakurty, Lynn, Shaya, and Freeman are analogous arts as they are all related to systems that measure pulse oximetry.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to use a smart watch instead of a smart phone, as they are both known forms of external devices, therefore it would be a simple substitution.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791