DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 4th, 2026 has been entered.
Claims 1-10 and 14-20 remain pending in the application.
Response to Arguments
Applicant's arguments filed May 5th, 2026 with respect to the rejections of claims 7-15 under 35 U.S.C. 101 have been fully considered but are not persuasive.
At page 8, Applicant argues that the claims are directed to a practical application of administering fluid by an actuator in response to the blood pressure being below the first threshold and the fluid management parameter being outside a target range and that one skilled in the art understands fluid administration to be a specific type of treatment. 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 type or amount/dosage of fluid is being administered, rather the claim recites "administering the fluid". The fluid being administered could be any kind of fluid 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 and amount/dosage of fluids are being administered as treatment and what condition the administration of fluid is working to prevent, reduce, or treat. Examiner suggests the claim to further specify the type and amount/dosage of fluids being administered by the actuator and the condition that is prevented, reduced, or treated such that the treatment or prophylaxis limitation has more than a nominal or insignificant relationship to the exception.
At page 8-9, Applicant argues that the claims are similar to claim 2 of PEG Example 45 because the claims include meaningful limitations which link the real-time monitoring of the plurality of patient parameters to the automatically administering the fluid. Examiner respectfully disagrees. In Example 45 the steps of the controller opening the mold and ejecting the molded polyurethane at the time when the target percentage of cure is reached, the claimed controller avoids the technical problems associated with undercure and overcure, which would otherwise negatively affect the cured polyurethane’s strength and wear performance and controls the injection molding apparatus in a particular way. The claim as a whole improves upon previous controllers used in this technical field of injection molding. Unlike Example 45, the actuator is not controlled in a particular way, the claim omits how the actuator is controlled to administer fluid in response to the parameters, and the disclosure as originally filed at the time of effective filing date of the claimed invention discloses, in para. [0025-0026, 0035], that fluid therapy may be administered and that the output treatment recommendations may be carried out by the clinician. The administration of the fluid is merely referring to the relevant pre-existing audience of doctors who used fluid therapy to treat patients suffering from hypotension. The step of administering fluids was known to doctors, and was well-known, routinely, and conventionally used to treat hypotension – as evidenced by the non-patent literature of record (Valverde A (2021) Fluid Resuscitation for Refractory Hypotension. Front. Vet. Sci. 8:621696. doi: 10.3389/fvets.2021.621696; Douglas et al., Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial, Chest, Volume 158, Issue 4, 2020, Pages 1431-1445, ISSN 0012-3692, https://doi.org/10.1016/j.chest.2020.04.025). A clinician knowledgeable in treating hypotension would have known and be capable to perform/prescribe the well-known, routine, and conventionally used treatments/therapies of hypotension using the fluids. Furthermore, when considered as a whole, the claims are not improving upon computing units and actuators used in the technical field of monitoring patients and do not provide an improvement to the technological field of patient monitoring. The computing unit and actuators perform the same with or without the claimed abstract idea. Therefore, it is unclear how the abstract idea can improve the standard functions of the additional elements. Therefore, the step of “automatically administering fluid by an actuator coupled to the patient in response to the blood pressure below the first threshold and the fluid management parameter outside a target range” is merely an instruction to “apply” the fluid using well-understood, routine, or conventional techniques in the field.
Applicant's arguments filed May 5th, 2026 with respect to the rejections of claims 16-20 under 35 U.S.C. 101 have been fully considered but are not persuasive.
At page 10, Applicant argues that claim 16 recites digital physiological signals that are not directly observable and the claim requires a comparison of computer data structures which cannot 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 digital physiological signals for patient parameters with as few as four parameters updated during a time period. 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 in the human mind or by using a pen and paper. Furthermore, the digital signals are part of insignificant pre-solution activity, in the form of data-gathering. It is certainly possible for a human mind to look out a print out and determine if a rate of the rates is not equivalent to the remaining rates based on analyzing the number of signals/parameters appearing for each parameter within a time period. There is no level of complexity claimed that would preclude a person from practically completing this process in the mind. Furthermore, the step of generating the alert merely adds insignificant extra-solution activity, e.g., mere data-outputting steps to the judicial exception (MPEP 2106.05(g)).
Applicant's arguments filed May 5th, 2026 with respect to the rejections of claims 1-6 under 35 U.S.C. 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.
Applicant's arguments filed May 5th, 2026 with respect to the rejections of claims 7-15 under 35 U.S.C. 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.
Applicant's arguments filed May 5th, 2026 with respect to the rejections of claims 16-20 under 35 U.S.C. 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.
Claim Objections
Claim 7 is objected to because of the following informalities:
In claim 7 line 10 the limitation “on a same multidimensional plot” should be moved to the end of line 12 because the “multidimensional plot” is not introduced/recited until line 10 of claim 7. For examination purposes, the limitation “on a same multidimensional plot” will be treated as being recited at the end of line 12.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 16-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 16 (claims 17-20 by virtue of dependency) recites “generate an alert if a rate of the rates is not equivalent to the remaining rates”. The specification as originally filed at the time of the effective filing date does not disclose generating an alert if a rate of the rates is not equivalent to the remaining rates. Rather the specification, as originally filed at the time of the effective filing date, discloses in para. [0028-0031, 0062] determining if the rates received for each of the N parameters are equivalent, that determining rates may include determining if one or more of the N patient parameters received at 202 has been updated within a time period, and the clinician may be automatically alerted when the plurality of patient parameters is not being updated at the same rate. Therefore, the specification, as originally filed at the time of the effective filing date, does not adequately disclose generating an alert if a rate of the rates is not equivalent to the remaining rates, but rather determining if rates of data received for each of the N patient parameters are equivalent/determining if the rates of the N parameters are being updated at the same rate.
Examiner suggests amending the limitation in claim 16 to correspond with language used in para. [0028-0031, 0062] of the specification.
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 7-10 and 14-20 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.
Claim 7 (claim 7-10 and 14-15) by virtue of dependency) recites the “a target range” in line 21. It is unclear if this is the same target range or a different target range than recited in line 17. The limitation is suggested to recite “the target range”.
Claim 16 (claims 17-20 by virtue of dependency) recites the limitation "the remaining rates" in line 9. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the limitation in claim 16 to correspond with language used in para. [0028-0031, 0062] of the specification.
Claim Rejections - 35 USC § 101
Claims 7-10 and 14-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claims 7 and 16 follows.
STEP 1
Regarding claims 7 and 16, the claims recite a series of steps or acts and/or a series of structural elements, including a system. Thus, the claims are directed to a process and/or a machine, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
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;
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
convert the physiological signals to a plurality of patient parameters
determine rates at which the digital physiological signals from the monitoring devices are obtained and generate an alert if a rate of the rates is not equivalent to the remaining rates;
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
set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claims as a whole are 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.
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, displaying, at a display device, and 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, which is merely adding insignificant pre-solution and insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The obtaining, storing, displaying, indicating does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the obtaining, displaying, indicating, nor does the method use a particular machine to perform the Abstract Idea. The step of “administering fluid” has a nominal or insignificant relationship to the exceptions as the fluid being administered could be any kind of fluid that could be delivered by an actuator, the type of fluid and amount/dosage is not specified, and the claim omits any recitation as to what condition the administration of fluid is working to prevent, reduce, or treat. The administration of the fluid is merely referring to the relevant pre-existing audience of doctors who used fluid therapy to treat patients suffering from hypotension. The step of administering fluids was known to doctors, and was well-known, routinely, and conventionally used to treat hypotension – as evidenced by the non-patent literature of record (Valverde A (2021) Fluid Resuscitation for Refractory Hypotension. Front. Vet. Sci. 8:621696. doi: 10.3389/fvets.2021.621696; Douglas et al., Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial, Chest, Volume 158, Issue 4, 2020, Pages 1431-1445, ISSN 0012-3692, https://doi.org/10.1016/j.chest.2020.04.025). A clinician knowledgeable in treating hypotension would have known and be capable to perform/prescribe the well-known, routine, and conventionally used treatments/therapies of hypotension using the fluids.
Claim 16 recites a computer unit including non-volatile memory operably coupled to the display and storing instructions executable to: collect digital physiological signals in real time from the monitoring devices, store the plurality of patient parameters on the non-volatile memory; generate an alert; output, to the display; 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, which is merely adding insignificant pre-solution and insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The collecting, storing, outputting, and generating does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the collecting, storing, outputting, and generating, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claims as a whole are analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
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;
displaying, at a display device;
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;
automatically administering fluid by an actuator coupled to the patient in response to the blood pressure below the first threshold and the fluid management parameter outside a target range;
display
monitoring devices
a computer unit including non-volatile memory operably coupled to the display and storing instructions;
collect digital physiological signals in real time from the monitoring devices;
generate an alert;
output, to the display;
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.
The monitoring devices, display, obtaining, collecting, displaying, indicating, generating, outputting, and generating steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the monitoring devices, display, obtaining, collecting, displaying, indicating, generating, outputting, and generating steps are each recited at a high level of generality such that it amounts to insignificant pre-solution activity and insignificant extra-solution activity, e.g., mere data gathering and data-outputting steps necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claims 7 and 16, the system recited in the claim is a generic system comprising generic components configured to perform the abstract idea. The recited monitoring devices are generic sensors configured to perform pre-solutional data gathering activity, the display is configured to perform insignificant extra-solution activity, and the computer unit is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The step of “administering fluid” has a nominal or insignificant relationship to the exceptions as the fluid being administered could be any kind of fluid that could be delivered by an actuator, the type of fluid and amount/dosage is not specified, and the claim omits any recitation as to what condition the administration of fluid is working to prevent, reduce, or treat. The administration of the fluid is merely referring to the relevant pre-existing audience of doctors who used fluid therapy to treat patients suffering from hypotension. The step of administering fluids was known to doctors, and was well-known, routinely, and conventionally used to treat hypotension – as evidenced by the non-patent literature of record (Valverde A (2021) Fluid Resuscitation for Refractory Hypotension. Front. Vet. Sci. 8:621696. doi: 10.3389/fvets.2021.621696; Douglas et al., Fluid Response Evaluation in Sepsis Hypotension and Shock: A Randomized Clinical Trial, Chest, Volume 158, Issue 4, 2020, Pages 1431-1445, ISSN 0012-3692, https://doi.org/10.1016/j.chest.2020.04.025). A clinician knowledgeable in treating hypotension would have known and be capable to perform/prescribe the well-known, routine, and conventionally used treatments/therapies of hypotension using the fluids.
The dependent claims also fail to add something more to the abstract independent claims. Claims 8-10, 14-15, 17-20 are directed to more abstract ideas (mental processes), which does not add anything significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
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 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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen 462 (US 20150051462 A1 -previously cited) in view of Ozu (JP 2022121980 A English Translation).
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 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 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 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 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 and one or more multidimensional plots 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 on a same multidimensional plot.
However, Ozu directed to displaying a trend graph screen for monitoring targets discloses a computer unit (CPU 12A, para. [0021-0022]); a display device (display device 12K, para. [0021]) configured to display, based on instructions stored in a non-transitory memory of the computer unit (“memory 12B which consists of ROM ... executes programs loaded into memory 12B”; “display graphs”, para. [0020-0024]) and one or more multidimensional plots (“radar chart”, para. [0033-0034], as seen in figs. 9-11, “four items (monitoring targets) ... 7 items ... seven axes”, para. [0094, 0100]) overlaying more than one of real time values of a plurality of parameters (“real-time graph based on the latest data”; “monitoring targets ... 7 items”, para. [0049, 0094]), historical values of the plurality of parameters (“historical graph based on past data”; “monitoring targets ... 7 items”, para. [0049, 0094, 0100]), and lower and upper threshold values of the plurality of parameters (“upper and lower limits for numerical values in the graph display”; “monitoring targets ... 7 items”, para. [0055, 0080, 0094, 0100]) on a same multidimensional plot (“each of the multiple items will be displayed simultaneously on a single graph screen”; “overlaying radar charts for multiple time periods on the graph display area ... overlay real-time and historical radar charts, or overlay historical radar charts on each other”, para. [0034, 0090]).
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, the one or more multidimensional plots 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 on a same multidimensional plot, in view of the teachings of Ozu, as this would aid in executing stored programs for displaying trend graphs and would aid in easily monitoring changes in the physiological status of patients on a single graph screen by incorporating radar charts for displaying multiple monitoring targets (Ozu, para. [0020-0024, 0103, 0106-0107]).
Regarding claim 4, Olsen 462, as modified by Ozu 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] & Ozu, figs. 9-11).
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Olsen 462 in view of Ozu, as applied to claim 1 above, and further in view of Olsen 488 (US 20160324488 A1 – previously cited).
Regarding claim 2, Olsen 462, as modified by Ozu hereinabove, discloses the patient monitoring system of claim 1. Olsen 462, as modified by Ozu 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 Ozu 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 this would aid in 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 5, Olsen 462, as modified by Ozu 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 Ozu 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 Ozu 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 this would aid in updating and displaying the metrics in real-time.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over OIsen 462 in view of Ozu, as applied to claim 1 above, and further in view of Kincaid (US 20060028471 A1).
Regarding claim 3, Olsen 462, as modified by Ozu hereinabove, discloses the patient monitoring system of claim 1, Olsen 462, as modified by Ozu 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, Kincaid directed to systems and computer readable media for visualizing a collection of graphs 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 (“compressed visualizations .... exceeds predetermined threshold ... zoomed to display an open visualization of that graph”; “comparing EKGS in real time ... threshold ... automatically open ... graph exhibiting a change that exceeds the threshold”, para. [0009, 0143-0145]).
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 Ozu 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 Kincaid, as this would aid in alerting medical staff that there may be an abnormality occurring with the patient associated with the graph/multidimensional plot that is automatically opened.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over OIsen 462 in view of Ozu, as applied to claim 1 above, and further in view of Yamamoto (US 20130131465 A1).
Regarding claim 6, Olsen 462, as modified by Ozu hereinabove, discloses the patient monitoring system of claim 1, wherein the one or more multidimensional plots overlay real time values of a plurality of patient parameters and historical values of the plurality of patient parameters (Ozu, figs. 9-11, para. [0034, 0090], see claim 1 above). Olsen 462, as modified by Ozu 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, Yamamoto discloses directed to an analysis device for measuring a state of a living body discloses one or more multidimensional plots (as seen in fig. 12) overlaying values of a plurality of patient parameters (“measurement result (solid line) of this time”, para. [0228], as seen in fig. 12), historical values of the plurality of patient parameters (“previous measurement value of the same subject ... broken line D”, para. [0228], as seen in fig. 12), and lower and upper threshold values of the plurality of patient parameters (“threshold ... "ABNORMAL"”; “region A, which is the closest to the center, and the outer region C each indicate "ABNORMAL"”, para. [0194, 0226], as seen in fig. 12).
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 Ozu 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 Yamamoto, as this would aid in easily understanding and presenting a measurement result to a user indicating a normal or abnormal state (Yamamoto, para. [0140, 0148, 0223-0224]).
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kiani (US 20200138368 A1 – previously cited) in view of Olsen 488, further in view of Yamamoto, and further in view of Ozu.
Regarding claim 7, Kiani discloses a method for monitoring a patient (“method of determining fluid responsiveness of a patient”, para. [0007]), comprising: obtaining, in real time, a plurality of patient parameters from monitoring devices coupled to the patient (“perfusion index (Pi), pulse rate (PR) of blood pressure ... pleth variability index (PVI)”; “parameters can be measured in real-time by one or more sensors”, para. [0023, 0043, 0059, 0075, 0084]) and storing (para. [0024, 0027, 0029, 0032], fig. 1) the plurality of patient parameters on non-volatile memory (memory 118/128, fig. 1) of a computing unit (patient monitoring device 100 & processor 104, fig. 1); automatically calculating, historical values of the plurality of patient parameters (“the fluid responsiveness parameter can be determined prior to performance of the PLR test ... first fluid responsiveness parameter is measured prior”, para. [0084-0085]), displaying, at a display device (display 224, fig. 2A, para. [0043]) a plot including an overlay of the plurality of patient parameters (as seen in fig. 2A); 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 (“generate alarms ... parameters exceeding ... thresholds”, “hydration threshold ... display ... indication of the patient's hydration status (for example, dehydrated, hydrated, no dehydrated, mildly dehydration, moderately dehydration, or severely dehydration mild dehydration, etc.) based at least in part on PVI”, para. [0029-0030, 0065]), wherein the plurality of patient parameters includes a fluid management parameter and blood pressure (“PVI”, “blood pressure, heart rate, or cardiac output can be used to guide the assessments on the patient's fluid responsiveness”, para. [0043, 0065, 0075, 0084]), and in response to real time values of the blood pressure below a first threshold and the fluid management parameter outside a threshold (“real-time effects of the PLR test on hemodynamic parameters such as blood pressure, heart rate, or cardiac output ... does not satisfy threshold ”, para. [0065, 0075, 0084-0085], fig. 5), the notification includes a treatment recommendation to administer more fluids (“outputting an indication to administer fluids”, para. [0009, 0085, 0089], figs. 5 & 7); and automatically administering the fluid by an actuator coupled to the patient in response to the blood pressure below the first threshold and the fluid management parameter outside a threshold (“threshold amount”; “based on a prediction of fluid responsiveness, the processor can cause fluid to be administered to the patient, either by operating or controlling ... infusion pump, to administer fluids to the patient”, para. [0029, 0066, 0085, 0089]).
Kiani does not expressly disclose 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 on a same multidimensional plot; and a target range.
However, Olsen 488 directed to a sensor system for obtaining and displaying information relating to physiological parameters discloses that 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, 0095, 0105-0108, 0117]) and a target range (“optimal range ... lower value and/or range ... upper value and/or range”, para. [0064-0065, 0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kiani such that 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 and a target range, in view of the teachings of Olsen 488, as this would aid in monitoring an average of data points over a particular time period and would aid in displaying and/or notifying the user when a physiological parameter is not generally optimal.
Kiani, as modified by Olsen 488 hereinabove, does not disclose 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 on a same multidimensional plot.
However, Yamamoto directed to a biometric device for measuring a state of a living body discloses displaying, at a display device (display section, fig. 1 & display of a measurement result in fig. 12) a multidimensional plot (as seen in figs. 12-18, “radar chart”, para. [0222-0224]) including an overlay of values of the plurality of patient parameters (“measurement result (solid line) of this time”, para. [00228], as seen in figs. 12-18), the historical values of the plurality of patient parameters (“previous measurement value of the same subject ... broken line D”, para. [0228], as seen in figs. 12-18), and upper or lower thresholds of the plurality of patient parameters (“regions of "NORMAL", "CAUTION", and "ABNORMAL" may be plotted in the radar chart”, para. [0224], as seen in figs. 12-18) on a same multidimensional plot (as seen in figs. 12-18, para. [0222-0228]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kiani, as modified by Olsen 488 hereinabove, such that the method comprises displaying, at a display device a multidimensional plot including an overlay of 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 on a same multidimensional plot, in view of the teachings of Yamamoto, as this would aid in displaying the state assessment result in a form that is easily understood by the user and enabling a user to easily understand evaluation of each value in the three levels (Yamamoto, para. [0223-0224]).
Kiani, as modified by Olsen 488 and Yamamoto hereinabove, does not disclose the multidimensional plot including an overlay of real time values of the plurality of patient parameters.
However, Ozu directed to displaying a trend graph screen for monitoring targets discloses displaying, at a display device (display device 12K, para. [0021]) a multidimensional plot (“radar chart”, para. [0033-0034], as seen in figs. 9-11, “four items (monitoring targets) ... 7 items ... seven axes”, para. [0094, 0100]) including an overlay of real time values of a plurality of parameters (“real-time graph based on the latest data”; “monitoring targets ... 7 items”, para. [0049, 0094]), historical values of the plurality of parameters (“historical graph based on past data”; “monitoring targets ... 7 items”, para. [0049, 0094, 0100]). Ozu further discloses that when displaying comparison lines, it is possible to overlay real-time and historical radar charts, or overlay historical radar charts on each other and that by displaying multiple historical graphs overlaid in this way, it is easy to compare the balance of the states of multiple monitored targets during a given time period and easy to understand the current state of the balance of the states of multiple monitored targets (para. [0049, 0090, 0103])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Kiani, as modified by Olsen 488 and Yamamoto hereinabove, such that the multidimensional plot further includes an overlay of real time values of the plurality of patient parameters, in view of the teachings of Ozu, as this would aid in easily understanding the current state of the balance of the states of multiple monitored targets and easily grasping the changes in the balance of the physiological parameters over time on a single graph screen (Ozu, para. [0020-0024, 0103, 0106-0107]).
Regarding claim 8, Kiani, as modified by Olsen 488, Yamamoto, and Ozu hereinabove, discloses the method of claim 7, wherein the method further comprises calculating, with the computing unit (fig. 1, “processor”, para. [0062-0064, 0078]), a change in at least one of the plurality of patient parameters (“changes in a pleth variability parameter ... calculation for PVI can be accomplished by measuring changes in PI over a time interval”; “quantifies changes”, para. [0062-0064, 0074, 0085]).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kiani in view of OIsen 488, Yamamoto, and Ozu, as applied to claim 7 above, and further in view of Huiki (US 20060217628 A1 – previously cited).
Regarding claim 9, Kiani, as modified by Olsen 488, Yamamoto, and Ozu hereinabove, discloses the method of claim 7.
Kiani, as modified by Olsen 488, Yamamoto, and Ozu 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]), and 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 Kiani, as modified by Olsen 488, Yamamoto, and Ozu 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, as this would aid in determining and monitoring the anesthetic state of a patient.
Regarding claim 10, Kiani, as modified by Olsen 488, Yamamoto, Ozu, Huiki hereinabove, discloses the method of claim 9, wherein the plurality of patient parameters further includes a peripheral perfusion parameter (“perfusion index”, para. [0026, 0030, 0043, 0077-0079]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kiani in view of OIsen 488, Yamamoto and Ozu, as applied to claim 8 above, and further in view of Bao (US 20060293571 A1 – previously cited).
Regarding claim 14, Kiani, as modified by Olsen 488, Yamamoto, and Ozu hereinabove, discloses the method of claim 8. Kiani, as modified by Olsen 488, Yamamoto, and Ozu hereinabove, does not 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 Kiani, as modified by Olsen 488, Yamamoto, and Ozu 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 of the teachings of Bao, as this would aid judging the condition of the patient based on a complete perspective of the patient’s medical condition and providing efficient medical care.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kiani in view of OIsen 488, Yamamoto, and Ozu, as applied to claim 7 above, and further in view of Das (US 20190080056 A1 – previously cited).
Regarding claim 15, Kiani, as modified by Olsen 488 Yamamoto, and Ozu hereinabove, discloses the method of claim 7. Kiani, as modified by Olsen 488 Yamamoto, and Ozu 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 Kiani, as modified by Olsen 488 Yamamoto, and Ozu 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, as this would aid in identifying 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 Suzuki (US 20150103095 A1) in view of Kellner (US 20160253077 A1), further in view of Ozu, and further in view of Olsen 488.
Regarding claim 16, Suzuki discloses a system (fig 1) comprising: a display (display 100, fig. 1, para. [0042]), monitoring devices (fig. 1, “sensors”, para. [0034, 0060]); and a computer unit (“computer”, para. [0044]) including non-volatile memory (memory 70/110, fig. 1, para. [0039, 0044-0045]) operably coupled to the display (as seen in fig. 1) and storing instructions executable (“program ... stored in a non-transitory computer-readable recording medium”, para. [0044-0045]) to: collect digital physiological signals in real time from the monitoring devices and convert the physiological signals to a plurality of patient parameters (“sensors for obtaining measurement values of parameters”; “processor 80 obtains by means of calculations parameters”; “biological information ... sensors ... real time”, para. [0034, 0040, 0060], fig. 1); store the plurality of patient parameters on the non-volatile memory (“data ... stored”, para. [0039]); output, to the display, a shaped multidimensional plot (“a radar chart having a regular n-polygonal shape based on the number n (integer) of parameters”; “parameters are displayed ... radar chart”, para. [0017, 0049], figs. 4-9) including radial axes for each of the plurality of patient parameters (“line segments which radially extend from the center”, para. [0015, 0042, 0047], as seen in figs. 4-9) and circumferential axes intersecting the radial axes according to numerical scales of each of the plurality of patient parameters (as seen in figs. 4-9, “range is divided into ... normal and abnormal ranges”; “normal ranges of parameters are located at equal distances”, para. [0047-0048, 0053]), the radial and circumferential axes defining sections of the shaped multidimensional plot (unlabeled, but as seen in figs. 4-9) and the sections or portions of the sections being shaded according to a target range of the plurality of patient parameters (as seen in figs. 4-9, “normal and abnormal ranges ... the ranges are displayed in different colors and/or textures”, para. [0048, 0053], S13, fig. 2),
Suzuki does not disclose determining rates at which the digital physiological signals from the monitoring devices are obtained and generate an alert if a rate of the rates is not equivalent to the remaining rates.
However, Kellner directed to a synchronizing system and method discloses determining rates at which the digital physiological signals from the monitoring devices are obtained (“monitoring systems ... record the sampling rates ... controller 302 can determine the sampling rates for different logs”, para. [0056-0058]) and generate an alert if a rate of the rates is not equivalent to the remaining rates (“controller 302 can determine the sampling rates for different logs and determine whether the sampling rates differ ... modify a representation of event log data ... generate display signals that dictate how different event logs are to be displayed on the output device 308”; “event log data from two or more monitoring systems that is correlated ... initiate ... notify ... operator”, para. [0021, 0056-0058, 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 Suzuki such that the computer unit determines rates at which the digital physiological signals from the monitoring devices are obtained and generate an alert if a rate of the rates is not equivalent to the remaining rates, in view of the teachings of Kellner, as this would aid in modifying a representation of the event log data/parameters and initiating an action of notifying the user/operator of a problem or fault with the system.
Suzuki, as modified by Kellner hereinabove, does not disclose 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.
However, Ozu directed to displaying a trend graph screen for monitoring targets discloses a shaped multidimensional plot (as seen in figs. 9-11, “radar chart ... monitoring targets ... four axes”; “radar chart ... 7 items ... seven axes”, para. [0094, 0100]) 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 (“real-time graph ... historical graph”; “overlay real-time and historical radar charts, or overlay historical radar charts on each other”, para. [0049, 0090, 0100, 104-0106], as seen in fig. 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Suzuki, as modified by Kellner hereinabove, such that 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, in view of the teachings of Ozu, as this would aid in easily monitoring changes in the physiological status of patients on a single graph screen (Ozu, para. [0020-0024, 0103, 0106-0107]).
Suzuki, as modified by Kellner and Ozu hereinabove, does not disclose 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.
However, Olsen 488 directed to discloses 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 (“user data collected in real time ... system can determine and the summary dashboard can display and/or notify the user when a physiological parameter is not generally optimal ... higher ... lower”, para. [0108, 0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Suzuki, as modified by Kellner and Ozu hereinabove, such that 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, in view of the teachings of Olsen 488, as this would aid in notifying the user of abnormal/not optimal physiological parameters.
Regarding claim 17, Suzuki, as modified by Kellner, Ozu, and Olsen 488 hereinabove, disclose the system of claim 16. Regarding claim 17, Suzuki, as modified by Kellner, Ozu, and Olsen 488 hereinabove, does not disclose 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.
However, Olsen 488 discloses 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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Suzuki, as modified by Kellner, Ozu, and Olsen 488 hereinabove, such that 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, in view of the teachings of Olsen 488, as this would aid in displaying values and/or units of each of the metrics.
Regarding claim 18, Suzuki, as modified by Kellner, Ozu, and Olsen 488 hereinabove, discloses system of claim 17. Suzuki, as modified by Kellner, Ozu, and Olsen 488 hereinabove 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.
However, Olsen 488 discloses 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).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Suzuki, as modified by Kellner, Ozu, and Olsen 488 hereinabove, such that 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, in view of the teachings of Olsen 488, as this would aid in indicating points at which the user’s data reflects a significant change.
Regarding claim 19, Suzuki, as modified by Kellner, Ozu, and Olsen 488 hereinabove, discloses the system of claim 16. Suzuki, as modified by Kellner, Ozu, and Olsen 488 hereinabove, does not disclose wherein the each of the historical values of the plurality of patient parameters are an average each of the plurality of patient parameters stored for a duration immediately prior to storing the real time values.
However, Olsen 488 discloses wherein the each of the historical values of the plurality of patient parameters are an average each of the plurality of patient parameters stored for a duration immediately prior to storing the real time values (“average … measurements … period of time”; “ consecutive data points 246”; “automatically update … real-time … predefined intervals”, para. [0053-0055, 0074, 0095, 0105-0108, 0117]) and a target range (“optimal range ... lower value and/or range ... upper value and/or range”, para. [0064-0065, 0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Suzuki, as modified by Kellner, Ozu, and Olsen 488 hereinabove, such that the each of the historical values of the plurality of patient parameters are an average each of the plurality of patient parameters stored for a duration immediately prior to storing the real time values, in view of the teachings of Olsen 488, as this would aid in monitoring an average of data points over a particular time period and would aid in displaying and/or notifying the user when a physiological parameter is not generally optimal.
Regarding claim 20, Suzuki, as modified by Kellner, Ozu, and Olsen 488 hereinabove, discloses the system of claim 16, wherein a shape of the shaped multidimensional plot is a circle or a polygon (as seen in figs. 4-9, “polygon”, para. [0047]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Thompson (US 11877087 B2) directed to a method for remote monitoring of electrical equipment, see col. 7 lines 30-41;
Su (US 20140073889 A1) directed to processing signals to determine the fluid responsiveness of a patient;
Muramatsu (US 20230355218 A1) directed to an ultrasound diagnostic apparatus wirelessly connected to a displayer and acquiring refresh rate information of the ultrasound image data and causing a notifier to notify of notification information, see Abstract;
Komatsuzaki (JP 2021094307 A) directed to an information processing device comprising a data acquisition rate determination unit 602.
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/A.E.H./Examiner, Art Unit 3791
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
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