DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Amendment Entered
This Office action is responsive to the Amendment filed on November 3rd, 2025. The examiner acknowledges the amendments to claims 1, 7, 9, 16, and 19, as well as the cancellation of claims 11-13. Claims 1-10 and 14-20 remain pending in the application.
Response to Arguments
Applicant’s arguments and amendments, filed November 3rd, 2025, with respect to the claim interpretations have been considered. The claim interpretations are withdrawn.
Applicant’s arguments, filed November 3rd, 2025, with respect to the rejections of claims 7-20 under 35 U.S.C. 101 have been considered but are not persuasive. The rejections of claims 7-20 under 35 U.S.C. 101 are maintained.
At pages 8-9, Applicant argues that claim 7 recites a judicial exception because it recites a particular transformation (administration of fluids) in response to a specific combination of patient parameters. Examiner respectfully disagrees. “The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s) … must have more than a nominal or insignificant relationship to the exception(s).” See MPEP 2106.04(d)(2). The claims do not explicitly recite what treatment is being administered, rather the claim recites “administering the treatment recommendation”. The treatment recommendation being administered could be any kind of medication that could be delivered by the actuator, see para. [0026] of the specification. Furthermore, it seems as if the treatment or prophylaxis limitation has a nominal or insignificant relationship to the exceptions as it is unclear what type of fluids are being administered as treatment and what condition the administration of fluids is working to prevent, reduce, or treat. Examiner suggests the claim to explicitly recite what treatment recommendation is being administered or further specifying the type of fluids being administered by the actuator such that the treatment or prophylaxis limitation has more than a nominal or insignificant relationship to the exception.
At pages 8-9, Applicant argues that determining rates at which the plurality of patient parameters is obtained from each of the monitoring devices is not an action that can be performed in the human mind. Examiner respectfully disagrees. “It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility.” MPEP 2106 II. In light of Applicant’s specification, the claim encompasses physiological signals for 4 patient parameters updated during a time period of 1 minute. See, for example, [0028-0029]. “The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea.” MPEP 2106.04(a)(2) III. The claimed steps can be performed using four data points, one for each parameter updated during a time period of one minute, in the human mind or by using a pen and paper. It is certainly possible for a human mind to determine if parameters are received at non-equivalent data rates based on analyzing if there are more or less than four data points of the physiological signals without the help of a computer during a one minute time period. There is no level of complexity claimed that would preclude a person from practically completing this process in the mind.
At page 9, Applicant argues that the claims provide an improvement in the technical field of patient monitoring. Examiner respectfully disagrees. The improvement cannot be found in the abstract idea itself. “[I]t is important to keep in mind that an improvement in the abstract idea itself ... is not an improvement in technology.” MPEP 2106.05(a) Il. The claims recite steps for processing data. The claims do not integrate the processing into a practical application. Rather, the alleged improvement lies solely within the processing steps performed by the computing unit. “Merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology." Id.
Applicant’s arguments, filed November 3rd, 2025, with respect to the rejections of claims 1-6 under 35 U.S.C. 102/103 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.
At page 13, Applicant argues, with respect to claim 3, that Koehler does not disclose automatically launching the one or more multidimensional plots because triggering an interface for inputting meal related information is not equivalent to launching an abbreviated representation. Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Koehler was not relied upon to disclose the one or more multidimensional plots. Rather Olsen 462 was relied upon to disclose the one or more multidimensional plots as recited in claim 1 (see claim 1). Koehler does disclose in the interface for entering meal-related event information, displaying the patient's current or most recent glucose level reading 1616 and a trend graph 1620 (multidimensional plot). Further, para. [0230] is related to a specific implementation having an insulin pump and was not relied upon with respect to claim 3. Rather, para. [0139, 0142] were relied upon to disclose launching an interface (“automatically triggered”; “alarm”) based on a change in a physiological parameter (“a change in glucose levels/rising glucose level”; “glucose level drops below or rises above a predetermined threshold value”, para. [0139, 0142]). Para. [0139] was relied upon to disclose the detection of the change or rising glucose level with respect to a predetermined threshold value and further para. [0222-0223] discloses an interface 1510 that displays a rise rate alert 1512/1514 which may include a graphical representation of the alert. Koehler clearly discloses automatically launching the one or more multidimensional plots in response to at least one of the real time values of the plurality of patient parameters being outside of the lower and upper threshold values of a respective patient parameter of the plurality of patient parameters ("generate an alarm if a patient's glucose level drops below or rises above a predetermined threshold value"; "interface automatically triggered when application 255 receives input glucose levels indicative of eating a meal (e.g., a rising glucose level) … also displays trend graph 1620", para. [0139, 0142]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 462 such that the one or more multidimensional plots are automatically launched in response to at least one of the real time values of the plurality of patient parameters being outside of the lower and upper threshold values of a respective patient parameter of the plurality of patient parameters, in view of the teachings of Koehler, in order to automatically trigger the user interface in response to input indicating a change in patient parameters and providing the user with a graphical view of fluctuations in the patient parameters over time.
Applicant’s arguments, filed November 3rd, 2025, with respect to the rejections of claims 7-15 under 35 U.S.C. 102/103 regarding the administration of fluids 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.
Applicant’s arguments, filed November 3rd, 2025, with respect to the rejections of claims 7-20 under 35 U.S.C. 102/103 regarding the multidimensional plot including all three of real time values, historical values, and upper or lower thresholds and rates of obtaining have been fully considered but are not persuasive.
At pages 12 and 16-17, Applicant argues that Olsen 488 does not disclose the multidimensional plot including all three of real time values, historical values, and upper or lower thresholds and further that the multidimensional plot does not include at least one trace corresponding to real time values because Olsen only discloses the display of real-time values with respect to the user interface 400, which does not include radial axes. Examiner respectfully disagrees. Olsen discloses that the user interface 400 can include any one, or any combination, of the features of the user interfaces 200, 300 and that the user interface 400 can be substantially similar to the user interfaces 200, 300 and that the user interface 400 can update and display the one or more metrics in real-time (para. [0113, 0117]). Olsen further discloses, in para. [0056, 0079], that user data 202 can include one or more data points corresponding to one or more physiological parameters 203 and that the user would be able to view the display information within seconds, the system 100 can dynamically update the trend graph 230 according to the user's selections in real time, the selections including the plurality of physiological parameters. Therefore, Olsen does disclose the multidimensional plot (one or more graphs 204/404; multi quadrant seasonal variation spider graph; plurality of graphs 430, para. [0057, 0112, 0121, figs. 2A-B & 12A-C) which includes an overlay of real time values of the plurality of patient parameters (para. [0108, 0113-0114, 0117]), the historical values of the plurality of patient parameters (para. [0049, 0054, 0062]), and upper or lower thresholds of the plurality of patient parameters (para. [0062-0064]). Furthermore, with respect to the consecutive data points 246, Olsen discloses assigning a time, date, and season to each recorded physiological parameter and displaying at least two/consecutive data points 246, the historical or trending data related to one or more of the measured values, and updating and displaying the one or more metrics in real-time (para. [0049, 0056, 0113, 0117). Displaying the at least two/consecutive data points would display the real-time data/metric (most recent data point of the at least two data points) and the historical data/metric (the other data point of the at least two data points).
At pages 15-16, Applicant argues that Das does not teach generating an alert if the rates at which patient parameters are obtained from each of the monitoring devices is not equal because Das teaches to increase the sample rate of a sensor in response to a determined condition of the patient and only mentions a “warning” with respect to a condition. Examiner respectfully disagrees. Das discloses, in para. [0049-0050], that patient sensors 110a-n may be configured to sample data at a particular rate, edge device may be configured with four sampling rates, and a “normal” sampling rate may be a rate of once per thirty seconds. In para. [0057, 0061], Das discloses that some blocks of the method 400 may result increased sensor sample rates or decreased sensor sample rates and that the edge device 120 increases a sampling rate of one or more patient sensors 110a-n (Examiner note: sampling rates would be increased from the normal sampling rate and would be non-equivalent to the normal sampling rate). Furthermore, Das discloses in para. [0061-0062], that the edge device 120 may transmit a message to the patient device to indicate a new sample rate for one or more sensors and the message may identify individual sensors and provide sample rates for each identified sensor, or may provide a sample rate for all available sensors and that the sample rate increase is trigged by a “warning”-type patient condition (Examiner note: the message that is transmitted to the patient device is the alert that is generated when a new sample rate is indicated). Therefore, Das clearly discloses “determining rates at which the plurality of patient parameters is obtained from each of the monitoring devices and generating an alert if the rates are not equivalent” (para. [0049-0050, 0057, 0061-0062]).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 7-10 and 14-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1
Claims 7-10 and 14-20 are all within at least one of the four categories.
Independent claim 7 recites:
obtaining, in real time, a plurality of patient parameters from monitoring devices coupled to the patient and storing the plurality of patient parameters on non-volatile memory of a computing unit;
automatically calculating, with the computing unit, historical values of the plurality of patient parameters, and wherein the historical values of the plurality of patient parameters correspond to an average of stored values of the plurality of patient parameters obtained for a duration immediately preceding obtaining a real time value of the plurality of patient parameters;
displaying, at a display device, a multidimensional plot including an overlay of real time values of the plurality of patient parameters, the historical values of the plurality of patient parameters, and upper or lower thresholds of the plurality of patient parameters;
indicating that at least one of the plurality of patient parameters is outside of the upper or lower threshold by generating a notification and displaying the notification at the display device, wherein the plurality of patient parameters includes a fluid management parameter and blood pressure, and in response to real time values of the blood pressure below a first threshold and the fluid management parameter outside a target range, the notification includes a treatment recommendation to administer more fluids; and
automatically administering the treatment recommendation by an actuator coupled to the patient.
Independent claim 16 recites:
collect physiological signals in real time from the monitoring devices and convert the physiological signals to a plurality of patient parameters;
determine rates at which the physiological signals from the monitoring devices are obtained and generate an alert if the rates are not equivalent;
store the plurality of patient parameters on the non-volatile memory;
output, to the display, a shaped multidimensional plot including radial axes for each of the plurality of patient parameters and circumferential axes intersecting the radial axes according to numerical scales of each of the plurality of patient parameters, the radial and circumferential axes defining sections of the shaped multidimensional plot and the sections or portions of the sections being shaded according to a target range of the plurality of patient parameters,
wherein the shaped multidimensional plot further includes at least one of a trace corresponding to real time values of the plurality of patient parameters and a trace corresponding to historical values of the plurality of patient parameters; and
in response to the real time value of the plurality of patient parameters being outside of the target range, generate a notification and output the notification to the display.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception.
The above claim limitations (determining, calculating, convert[ing]) constitute an abstract idea that is part of the Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019
The claimed steps of determining, calculating, convert[ing] can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for monitoring a patient that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
This judicial exception (abstract idea) in Claims 7-10 and 14-20 is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for determining, calculating, convert[ing] merely invoke a computer as a tool.
The data-gathering step (obtaining, collect[ing], stor[ing]) and the data-output step (output/displaying, generate, indicating) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for determining, calculating, convert[ing].
The claims do not apply the abstract idea to affect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to monitor a patient. The step of “administering the treatment recommendation” has a nominal or insignificant relationship to the exceptions as the treatment recommendation being administered could be any kind of medication that could be delivered by the actuator and it is unclear what type of fluids are being administered as treatment and what condition the administration of fluids is working to prevent, reduce, or treat.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for determining, calculating, convert[ing]. The claims do not apply the obtained calculation to a particular machine. Rather, the data is merely output in a post-solution step.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Claims 8-10, 14, 15, and 17-20 are directed to more abstract ideas.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception.
The additional elements are identified as follows: monitoring devices, computing/computer unit, display device/display, non-volatile memory; actuator.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
Applicant’s specification (e.g., para. [0020-0021]) which discloses that the processor(s)/computer unit and non-volatile memory comprise generic computer components that are configured to perform the generic computer functions (e.g., calculating, convert[ing]) that are well-understood, routine, and conventional activities previously known to the pertinent industry.
The Non-Patent Literature of record:
Thomas et al. "Echo: A large display interactive visualization of ICU data for effective care handoffs," 2017 IEEE Workshop on Visual Analytics in Healthcare (VAHC), Phoenix, AZ, USA, 2017, pp. 47-54, doi: 10.1109/VAHC.2017.8387500.
Hande A, Polk T, Walker W, Bhatia D. Self-Powered Wireless Sensor Networks for Remote Patient Monitoring in Hospitals. Sensors. 2006; 6(9):1102-1117. https://doi.org/10.3390/s6091102
Charabati et al., Comparison of four different display designs of a novel anaesthetic monitoring system, the ‘integrated monitor of anaesthesia (IMA™)’, BJA: British Journal of Anaesthesia, Volume 103, Issue 5, November 2009, Pages 670–677, https://doi.org/10.1093/bja/aep258
Malasinghe, L.P., Ramzan, N. & Dahal, K. Remote patient monitoring: a comprehensive study. J Ambient Intell Human Comput 10, 57–76 (2019). https://doi.org/10.1007/s12652-017-0598-x
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e., the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen 462 (US 20150051462 A1) in view of Olsen 488 (US 20160324488 A1).
Regarding claim 1, Olsen 462 discloses a patient monitoring system (Abstract, figs. 1-2), comprising: a computer unit (“physiological status monitor”, para. [0008]); a display device (“display”, para. [0008]) having a screen (“screen”, para. [0008]) and operably coupled to the computer unit (“incorporated”, para. [0008]) and configured to display a patient status view (physiological status monitor 100/200, figs. 1-2) including one or more multidimensional plots (pie chart 130 & graph 150, fig. 1) overlaying more than one of real time values of a plurality of patient parameters, historical values of the plurality of patient parameters, and lower and upper threshold values of the plurality of patient parameters (“historical”; “parameter values versus time over a period”; upper alarm limit 153, lower alarm limit 155; “color … zone … condition”, fig. 1, para. [0008, 0019, 0024-0025, 0028]), and additionally being configured to display in the patient status view (physiological status monitor 100/200, figs. 1-2) an abbreviated representation of at least one of the one or more multidimensional plots that can be reached directly from the patient status view (colored pie charts 110/210, as seen in figs. 1-2, para. [0023]), wherein the abbreviated representation displays a limited version of the respective multidimensional plot (as seen in figs. 1-2, para. [0023], (Examiner note: para. [0023] discloses that the display 120 provides more details regarding a selected patient/parameter than are available from the display 110/210, therefore the charts 110/210 would show an abbreviated representation as they show less details, as seen in figs. 1-2), the abbreviated representation being selectable to launch and enable the respective multidimensional plot to be seen (para. [0023], “selected patient display … provide more details … selected parameter”, as seen in figs. 1-2), and wherein the abbreviated representation is displayed while in an unlaunched state (110/210, as seen in figs. 1-2).
Olsen 462 does not disclose the display device configured to display, based on instructions stored in a non-transitory memory of the computer unit.
However, Olsen 488 discloses a computer unit (“processor”, para. [0049, 0130]); a display device (patient monitor 102 including the host instrument 108 including display devices 124 capable of displaying indicia; “processor”, para. [0049, 0130], fig. 2A) having a screen (as seen in fig. 2A, “screen”, para. [0080]) and operably coupled to the computer unit (as seen in fig. 1A) and configured to display, based on instructions stored in a non-transitory memory of the computer unit (“display devices capable of displaying indicia”; “steps of a method … non-transitory computer-readable storage medium … integral to the processor”, para. [0049, 0130]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 462 such that the display device is configured to display, based on instructions stored in a non-transitory memory of the computer unit, in view of the teachings of Olsen 488, as such a modification would have been merely a substitution of the physiological status monitor of Olsen 462 for the patient monitor of Olsen 488 in order to display the physiological status.
Regarding claim 2, Olsen 462, as modified by Olsen 488 hereinabove, discloses the patient monitoring system of claim 1. Olsen 462, as modified by Olsen 488 hereinabove, does not disclose wherein the one or more multidimensional plots further include text boxes with numbers corresponding to the real time values of the plurality of patient parameters, and wherein the abbreviated representation does not include the text boxes.
However, Olsen 488 discloses wherein the one or more multidimensional plots further include text boxes with numbers corresponding to the real time values of the plurality of patient parameters (“update … metrics in real-time”; “display values and/or units”; “text boxes”, para. [0117, 0125, 0127], as seen in fig. 12B), and wherein the abbreviated representation does not include the text boxes (Yin Yang widget, as seen in figs. 12A & 12C, “unbalanced metrics … not equal in size and shape”, para. [0121]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 462, as modified by Olsen 488 hereinabove, such that the one or more multidimensional plots further include text boxes with numbers corresponding to the real time values of the plurality of patient parameters, and wherein the abbreviated representation does not include the text boxes, in view of the teachings of Olsen 488, as such a modification would have yielded predictable results, namely providing more details in the selected patient display with respect to the selected parameter and providing less details in the multiple patient/ multiple parameter display.
Regarding claim 4, Olsen 462, as modified by Olsen 488 hereinabove, discloses the patient monitoring system of claim 1, wherein each of the one or more multidimensional plots corresponds to a different plurality of patient parameters (“represent multiple parameters over time”; “SpO2, pulse rate, blood pressure, perfusion index, respiration rate, temperature”, para. [0012, 0025-0027], as seen in figs. 1-2).
Regarding claim 5, Olsen 462, as modified by Olsen 488 hereinabove, discloses the patient monitoring system of claim 1, wherein the abbreviated representation includes upper (green … predetermined value ranges, para. [0009, 0020, 0023, 0025]) and lower (red … predetermined value ranges, para. [0009, 0020, 0023, 0025]) threshold values of a respective patient parameter of the plurality of patient parameters (“colored … zones … visual distinction … green … normal … red … serious”; “range categories 138 have predetermined value ranges … color corresponding”, para. [0009, 0020, 0023, 0025]).
Olsen 462, as modified by Olsen 488 hereinabove, does not disclose the abbreviated representation including a real time value of the respective patient parameter.
However, Olsen 488 discloses an abbreviated representation including a real time value of the respective patient parameter (“summary dashboard … real time … optimal physiological parameters”; “update and display the one or more metrics in real-time”, para. [0106-0111, 0117]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 462, as modified by Olsen 488 hereinabove, such that the abbreviated representation includes a real time value of the respective patient parameter, in view of the teachings of Olsen 488, as such a modification would have yielded predictable results, namely updating and displaying the metrics in real-time.
Regarding claim 6, Olsen 462, as modified by Olsen 488 hereinabove, discloses the patient monitoring system of claim 1. Olsen 462, as modified by Olsen 488 hereinabove, does not disclose wherein the one or more multidimensional plots overlay real time values of a plurality of patient parameters, historical values of the plurality of patient parameters, and lower and upper threshold values of the plurality of patient parameters.
However, Olsen 488 discloses wherein the one or more multidimensional plots (one or more graphs 204/404; multi quadrant seasonal variation spider graph; plurality of graphs 430, para. [0057, 0112, 0121], figs. 2A-B & 12A-C) overlay (as seen in figs. 2A-B, 3A, & 12A-C) real time values of a plurality of patient parameters (“display the one or more metrics in real-time”, para. [0079, 0108, 0113-0114, 0117]), historical values of the plurality of patient parameters (“displaying … pulse rate, plethysmograph data, perfusion quality … historical or trending data related to one or more of the measured values”, para. [0049, 0054], 0062), and lower and upper threshold values of the plurality of patient parameters (“display … plurality of indicator rings 242 can present an optimal range of physiological parameters 203 … lower … upper value and/or range”, para. [0062-0064]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 462, as modified by Olsen 488 hereinabove, such that the one or more multidimensional plots overlay real time values of a plurality of patient parameters, historical values of the plurality of patient parameters, and lower and upper threshold values of the plurality of patient parameters, in view of the teachings of Olsen 488, as such a modification would have been merely a substitution of the selected-patient display of Olsen 462 for the spider graph of Olsen 488 in order to present an aesthetically pleasing display of physiological parameters.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over OIsen 462 in view of Olsen 488, as applied to claim 1 above, and further in view of Koehler (US 20160119210 A1).
Regarding claim 3, Olsen 462, as modified by Olsen 488 hereinabove, discloses the patient monitoring system of claim 1. Olsen 462, as modified by Olsen 488 hereinabove, does not disclose wherein the one or more multidimensional plots are automatically launched in response to at least one of the real time values of the plurality of patient parameters being outside of the lower and upper threshold values of a respective patient parameter of the plurality of patient parameters.
However, Koehler directed to methods for presenting glucose level data discloses wherein the one or more multidimensional plots are automatically launched in response to at least one of the real time values of the plurality of patient parameters being outside of the lower and upper threshold values of a respective patient parameter of the plurality of patient parameters (“generate an alarm if a patient's glucose level drops below or rises above a predetermined threshold value”; “interface … automatically triggered when application 255 receives input … glucose levels indicative of eating a meal (e.g., a rising glucose level) … trend graph 1620”, para. [0139, 0142]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 462, as modified by Olsen 488 hereinabove, such that the one or more multidimensional plots are automatically launched in response to at least one of the real time values of the plurality of patient parameters being outside of the lower and upper threshold values of a respective patient parameter of the plurality of patient parameters, in view of the teachings of Koehler, in order to automatically trigger the user interface in response to input indicating a change in patient parameters and providing the user with a graphical view of fluctuations in the patient parameters over time.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over OIsen 488 in view of Nguyen (US 20140276552 A1), and further in view of Kiani (US 20200138368 A1).
Regarding claim 7, Olsen 488 discloses a method for monitoring a patient (Abstract, para. [0010]), comprising: obtaining, in real time, a plurality of patient parameters (“user data collected in real time”, para. [0108, 0114, 0117]) from monitoring devices coupled to the patient (sensor 106, fig. 1, “adhesive … finger … sensor”, para. [0047-0048]) and storing the plurality of patient parameters on non-volatile memory (memory 122 stores data, fig. 1, para. [0047-0048]) of a computing unit (digital signal processor 112, fig. 1, “system”, para. [0111]); automatically calculating (“automatically determine”, para. [0111]), with the computing unit (“system”, para. [0111]), historical values of the plurality of patient parameters (“historical or trending data”; “ automatically determine and display the physiological parameters”, para. [0049, 0094-0096, 0111]), and wherein the historical values of the plurality of patient parameters correspond to an average of stored values of the plurality of patient parameters obtained for a duration immediately preceding obtaining a real time value of the plurality of patient parameters (“average … measurements … period of time”; “ consecutive data points 246”; “automatically update … real-time … predefined intervals”, para. [0053-0055, 0074, 0107-0108, 0117]); displaying, at a display device (display a user interface 200, para. [0057], fig. 2A), a multidimensional plot (one or more graphs 204/404; multi quadrant seasonal variation spider graph; plurality of graphs 430, para. [0057, 0112, 0121], figs. 2A-B & 12A-C) including an overlay (as seen in figs. 2A-B, 3A, & 12A-C) of real time values of the plurality of patient parameters (“updates the trend graph 230 according to the user's selections in real time”; “display the one or more metrics in real-time”, para. [0079, 0108, 0114, 0117]), the historical values of the plurality of patient parameters (“displaying … pulse rate, plethysmograph data, perfusion quality … historical or trending data related to one or more of the measured values”, para. [0049, 0054, 0062]), and upper or lower thresholds of the plurality of patient parameters (“display … plurality of indicator rings 242 can present an optimal range of physiological parameters 203 … lower … upper value and/or range”, para. [0062-0064]); indicating that at least one of the plurality of patient parameters is outside of the upper or lower threshold by generating a notification and displaying the notification at the display device (“determine … display and/or notify … the user … higher … lower than an optimal physiological parameter”, para. [0110]), wherein the plurality of patient parameters includes a fluid management parameter (“pulse variability index (PVI)”; “perfusion index”, para. [0004, 0036, 0049]) and blood pressure (“blood pressure”, para. [0051]), and real time values of the blood pressure below a first threshold and the fluid management parameter outside a target range (“system can determine and the summary dashboard can display and/or notify the user when a physiological parameter is not generally optimal … lower than an optimal physiological parameter”; “push notifications real time”; “real-time”, para. [0036, 0049, 0051, 0108-0110, 0114, 0117]).
Olsen 488 does not disclose, and in response to real time values of the blood pressure below a first threshold and the fluid management parameter outside a target range, the notification includes a treatment recommendation to administer more fluids; and automatically administering the treatment recommendation by an actuator coupled to the patient.
However, Nguyen directed to a system for diagnosing and/or treating a patient comprising a patient information database including real-time patient health data/sensor data (Abstract, para. [0040]) discloses in response to real-time patient health data/sensor data below a threshold and outside a target range (“sensor readings correspond to a minimum threshold”; “provide immediate, real-time reading and recording of patient health statistics … database 115”; step 730 in fig. 7, para. [0040, 0046-0048, 0054-0055]), the notification includes a treatment recommendation (“provide immediate, real-time reading and recording of patient health statistics … database 115”; step 730 in fig. 7; “interrogates the patient information … database to generate a report … recommended course of treatment … warning is transmitted”, para. [0046-0048, 0054-0055], figs. 7& 9); and automatically administering the treatment recommendation (“instructs the micro-actuators to dispense”; “IV or SC delivery systems … smart delivery device … dispense an emergency dosage of medication”, para. [0040, 0049], step 794 in fig. 7) by an actuator coupled to the patient (“TD patch 600 … micro-actuators”, para. [0037, 0039-0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 488 such that in response to real time values of the blood pressure below a first threshold and the fluid management parameter outside a target range, the notification includes a treatment recommendation; and automatically administering the treatment recommendation by an actuator coupled to the patient, in view of the teachings of Nguyen, in order to prevent or minimize the damages caused by an immediate medical crisis by delivering an immediate treatment.
Nguyen further discloses that algorithm 900 reports and recommends a diuretic dosing adjustment to determine the proper dosing frequency or dose amount to maintain proper fluid levels (para. [0056]).
Olsen 488, as modified by Nguyen hereinabove, does not disclose a treatment recommendation to administer more fluids.
However, Kiani directed to management of patient hydration and assessment of fluids responsiveness discloses a treatment recommendation to administer more fluids (“display an indication of a recommendation for fluid administration”, para. [0011, 0021], fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 488, as modified by Nguyen hereinabove, such that the notification includes a treatment recommendation to administer more fluids, in view of the teachings of Kiani, in order to maintain proper fluid levels.
Regarding claim 8, Olsen 488, as modified by Nguyen and Kiani hereinabove, discloses the method of claim 7, wherein the method further comprises calculating, with the computing unit (system comprising digital signal processor, fig. 1, para. [0042, 0108]), a change in at least one of the plurality of patient parameters (“determine … changes … physiological parameters”, para. [0108]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over OIsen 488 in view of Nguyen and Kiani, as applied to claim 7 above, and further in view of Huiki (US 20060217628 A1) .
Regarding claim 9, Olsen 488, as modified by Nguyen and Kiani hereinabove, discloses the method of claim 7.
Olsen 488, as modified by Nguyen and Kiani hereinabove, does not disclose wherein the plurality of patient parameters further includes an analgetic state parameter and a sedative state parameter.
However, Huiki directed to the determination of the anesthetic state of a patient discloses wherein the plurality of patient parameters further includes an analgetic state parameter (“index of nociception”, para. [0022]), a sedative state parameter (“state entropy”; “bispectral index”, para. [0017, 0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 488, as modified by Nguyen and Kiani hereinabove, such that the plurality of patient parameters further includes an analgetic state parameter and a sedative state parameter, in view of the teachings of Huiki, in order to determine and monitor the anesthetic state of a patient.
Regarding claim 10, Olsen 488, as modified by Nguyen, Kiani, and Huiki hereinabove, discloses the method of claim 9, wherein. the plurality of patient parameters further includes a peripheral perfusion parameter (“perfusion index”; “perfusion quality index”, para. [0036, 0048-0049]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over OIsen 488 in view of Nguyen and Kiani, as applied to claim 7 above, and further in view of Bao (US 20060293571 A1) .
Regarding claim 14, Olsen 488, as modified by Nguyen and Kiani hereinabove, discloses the method of claim 8. Olsen 488, as modified by Nguyen and Kiani hereinabove, does not expressly disclose wherein the change in at least one of the plurality of patient parameters is calculated by a difference between the real time value of one of the plurality of patient parameters and a corresponding historical value of one of the plurality of patient parameters.
However, Bao directed to system and method for remote patient monitoring discloses wherein the change in at least one of the plurality of patient parameters is calculated by a difference between the real time value of one of the plurality of patient parameters and a corresponding historical value of one of the plurality of patient parameters (“comparing the real-time physiological parameters and the historical medical data of the patient and deriving trends for each real-time physiological parameter, of each patient”, para. [0032, 0104]). Bao further discloses that comparing real-time physiological parameters of the patients with their medical histories allows the medical staff to get a complete perspective of the patients' medical condition, thereby, enabling them to provide efficient medical care and assistance to their patients (para. [0032]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 488, as modified by Nguyen and Kiani hereinabove, such that the change in at least one of the plurality of patient parameters is calculated by a difference between the real time value of one of the plurality of patient parameters and a corresponding historical value of one of the plurality of patient parameters, in view order to help judge the condition of the patient based on a complete perspective of the patient’s medical condition and provide efficient medical care.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over OIsen 488 in view of Nguyen and Kiani, as applied to claim 7 above, and further in view of Das (US 20190080056 A1).
Regarding claim 15, Olsen 488, as modified by Nguyen and Kiani hereinabove, disclose the method of claim 7. Olsen 488, as modified by Nguyen and Kiani hereinabove, does not disclose the method further comprising determining rates at which the plurality of patient parameters is obtained from each of the monitoring devices and generating an alert if the rates are not equivalent.
However, Das directed to systems and methods for remote patient monitoring and event detection having an edge device 120 and a plurality of patient sensors 110a-n discloses determining rates at which the plurality of patient parameters is obtained from each of the monitoring devices (“sensors 110a-n … configured sample rate … selected based on patient condition”; “identify individual sensors and provide sample rates for each identified sensor”, para. [0049-0051, 0061]) and generating an alert if the rates are not equivalent (“edge device 120 may transmit a message to the patient device to indicate a new sample rate for one or more sensors … message may identify individual sensors and provide sample rates for each identified sensor, or may provide a sample rate for all available sensors … warning-type patient condition … increased sampling rates”, para. [0061-0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 488, as modified by Nguyen and Kiani hereinabove, such that the method further comprises determining rates at which the plurality of patient parameters is obtained from each of the monitoring devices and generating an alert if the rates are not equivalent, in view of the teachings of Das, in order to identify individual sensors and sample rates for each sensor and configure sampling rates based on patient conditions.
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over OIsen 488 in view of Das, and further in view of Olsen 462.
Regarding claim 16, Olsen 488 discloses a system (user monitoring system 100, fig. 1) comprising: a display (display a user interface 200, para. [0057], fig. 2A), monitoring devices (sensor 106 having emitters 116 & detectors 120, fig. 1, “adhesive … finger … sensor”, para. [0047-0048]); and a computer unit (digital signal processor 112, fig. 1) including non-volatile memory operably coupled to the display and storing instructions executable (memory 122, fig. 1, “executable instructions” para. [0129-0130]) to: collect physiological signals in real time (“sensor components … determining real-time … emitters 116”; “user data collected in real-time”, para. [0047, 0108, 0114]) from the monitoring devices (sensors 106, para. [0047, 0114, 0108]) and convert the physiological signals to a plurality of patient parameters (“intensity signals … parameters … calculated”, para. [0042]); store the plurality of patient parameters on the non-volatile memory (memory 122 stores data … parameters, para. [0048]); output, to the display (display devices 124 as seen in fig. 1), a shaped multidimensional plot (one or more graphs 204/404; trend graph 230; multi quadrant seasonal variation spider graph; plurality of graphs 430, para. [0057, 0112, 0121], figs. 2A-B & 12A-C) including radial axes for each of the plurality of patient parameters (“quadrants”, lines 248, horizontal axis, vertical axis, para. [0060-0061, 0074]) and circumferential axes intersecting the radial axes according to numerical scales of each of the plurality of patient parameters (indicator rings 242, 242A-C illustrating optimal ranges, fig. 2A-3A, para. [0063]), the radial and circumferential axes defining sections of the shaped multidimensional plot (“quadrants”, para. [0060-0061]) and the sections or portions of the sections being shaded (“color and glowing effects can be used to indicate points at which the user's data reflects a significant change”; “each quadrant of the plurality of quadrants 234 can be displayed using different colors”; “area beneath … lines 248 … shaded”, para. [0037, 0061-0063, 0074], as seen in fig. 3A & 6C), wherein the shaped multidimensional plot further includes at least one of a trace corresponding to real time values of the plurality of patient parameters (“consecutive data points 246”, “display the one or more metrics in real-time”, para. [0049, 0055, 0074-0075, 0117]) and a trace corresponding to historical values of the plurality of patient parameters (“displaying historical or trending data related to one or more of the measured values”; “consecutive data points 246”, para. [0049, 00555, 0074-0075, 0117]); and in response to the real time values of the plurality of patient parameters being outside of the target range, generate a notification and output the notification to the display (“system can … notify the user of any particular elevations that affect one or more of the user's physiological parameters based on user data collected in real time … when any one of the user's physiological parameters is higher than an optimal physiological parameter … lower than an optimal physiological parameter”; “user interface 400 can update and display the one or more metrics in real-time”, para. [0108-0111, 0117]).
Olsen 488 does not expressly disclose the computer unit to determine rates at which the physiological signals from the monitoring devices are obtained and generating an alert if the rates are not equivalent.
However, Das discloses an edge device 120 configured to determine rates at which the physiological signals from the monitoring devices are obtained (“normal” sampling rate … once per thirty seconds”; “identify individual sensors and provide sample rates for each identified sensor”, para. [0049-0050, 0057, 0061]) and generate an alert if the rates are not equivalent (“increased … or decreased sensor sampling rate” (Examiner note: increased or decreased sampling rates would be increased or decreased from the normal sampling rate and would be non-equivalent to the normal sampling rate); "edge device 120 may transmit a message to the patient device to indicate a new sample rate for one or more sensors … message may identify individual sensors and provide sample rates for each identified sensor, or may provide a sample rate for all available sensors … warning-type patient condition …increased sampling rates", para. [0057, 0061-0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 488 such that the computer unit determines rates at which the physiological signals from the monitoring devices are obtained and generating an alert if the rates are not equivalent, in view of the teachings of Das, in order to identify individual sensors and sample rates for each sensor and configure sampling rates based on patient conditions.
Olsen 488, as modified by Das hereinabove, does not expressly disclose the sections or portions of the sections being shaded according to a target range of the plurality of patient parameters.
However, Olsen 462 directed to a physiological status monitor discloses the sections or portions of the sections being shaded according to a target range of the plurality of patient parameters (“zones … medical conditions … zones are assigned colors to make visual distinctions” “first zone 112 … green … normal condition”; “pie chart colors correspond to assigned ranges for the parameter”, para. [0009, 0013, 0020, 0023-0025, 0034]). Olsen 462 further discloses each zone 712, 714, 716 is assigned to a different color so as to be easily viewed by a user to determine, at a glance, an overview of a patient's condition over a time interval (para. [0034]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Olsen 488, as modified by Das hereinabove, such that the sections or portions of the sections being shaded according to a target range of the plurality of patient parameters, in view of the teachings of Olsen 462, in order to make visual distinctions such that a user can easily view and determine, at a glance, an overview of a patient's condition over a time interval.
Regarding claim 17, Olsen 488, as modified by Das and Olsen 462 hereinabove, discloses the system of claim 16, wherein the shaped multidimensional plot further includes text boxes including numbers corresponding to real time values of the plurality of patient parameters and/or the historical values of the plurality of patient parameters (“trend graph 230 can display text”; “update … metrics in real-time”; “display values and/or units”; “text boxes”, para. [0071, 0117, 0125, 0127], as seen in figs. 2A-3A & 12B).
Regarding claim 18, Olsen 488, as modified by Das and Olsen 462 hereinabove, discloses the system of claim 17, where the notification includes a modification of a color or shading of a number and/or one or more sections of the shaped multidimensional plot corresponding to the one or more of the plurality of patient parameters outside of the target range (“color and glowing effects can be used to indicate points at which the user's data reflects a significant change”; “each quadrant of the plurality of quadrants 234 can be displayed using different colors”; “area beneath … lines 248 … shaded”, para. [0037, 0061-0063, 0074], as seen in fig. 3A & 6C).
Regarding claim 19, Olsen 488, as modified by Das and Olsen 462 hereinabove, discloses the system of claim 16, wherein the each of the historical values of the plurality of patient parameters (“historical or trending data”, para. [0049]) are an average each of the plurality of patient parameters stored for a duration immediately prior to storing the real time value (“average … measurements … period of time”; “ consecutive data points 246”; “automatically update … real-time … predefined intervals”, para. [0053-0055, 0074, 0107-0108, 0117])
Regarding claim 20, Olsen 488, as modified by Das and Olsen 462 hereinabove, discloses the system of claim 16, wherein a shape of the shaped multidimensional plot is a circle or a polygon. (“spider graph”; “circle”, para. [0053, 0121], unlabeled but as seen in figs. 2A-B)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Lee (US 20070177565 A1) directed to a method for controlling a data rate for a forward data service in a CDMA 2000-1x system discloses comparing the determined data rate with an original data rate (S104) and if the above two data rates are not equal, including information on the determined data rate in a Power Measurement Report Message (PMRM) (S105) (para. [0012]).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791