DETAILED ACTION
This action is pursuant to claims filed on 11/06/2025. Claims 1-8, 10-11, 14-18, and 20-24 are pending. A first action on the merits of claims 1-8, 10-11, 14-18, and 20-24 is as follows.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/06/2025 has been entered.
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 1-8, 10-11, 14-18, and 20-24 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.
Regarding claim 1, Applicant has added the limitation “calculate a current oxygenation value based on a combination of the FTOE data, the first rSO2 data, the second rSO2 data, and the SpO2 data”, which is not described in the originally filed claims, specification, or drawings to support this newly added limitation, thus the newly added limitation is deemed new matter. The specification describes displaying the calculated FTOE values on the same plot as the rSO2 and SpO2 values, however it does not describe calculating a current oxygenation value using the FTOE values, therefore the claim fails the new matter requirement and is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
Regarding claim 11, Applicant has added the limitation “calculate a current oxygenation value based on a combination of the FTOE data, the first rSO2 data, the second rSO2 data, and the SpO2 data”, which is not described in the originally filed claims, specification, or drawings to support this newly added limitation, thus the newly added limitation is deemed new matter. The specification describes displaying the calculated FTOE values on the same plot as the rSO2 and SpO2 values, however it does not describe calculating a current oxygenation value using the FTOE values, therefore the claim fails the new matter requirement and is rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 6-8, 10-11, 16-18, and 20-24 are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali (US 20150099955) in further view of Addison (US 20170095161), Bruckner (“Cerebral and peripheral tissue oxygenation in stable neonates: Absent influence of cardiac function”), and Saidara (US 20080255438).
Regarding independent claim 1, Al-Ali teaches the system for displaying patient oxygenation (Abstract: “A regional oximetry system has a display and at least one processor causing a plurality of views to be displayed on the display, each configured to occupy at least a portion of the display.”), comprising:
a first regional oximetry (rSO2) sensor configured to be positioned on a patient at a first location, the first rSO2 sensor configured to determine first rSO2 data of the patient ([0087]: “In an embodiment the regional oximetry platform uses near-infrared spectroscopy (NIRS) to continuously and simultaneously measure regional oxygen saturation (rSO.sub.2) and arterial oxygen saturation (SpO.sub.2), enabling the regional oximetry platform to automatically derive the differential analysis of a patient's regional-to-central oxygen saturation.”; [0086]: “the regional oximetry module is configured by applying one or more regional oximetry sensors to the patient, for example, the patient's forehead, and by connecting the module(s) to the hub 100. In an embodiment the regional oximetry module has as few as one and as many as four sensors.”; Figs. 6A-6B);
a second rSO2 sensor configured to be positioned on the patient at a second, different location, the second rSO2 sensor configured to determine second rSO2 data of the patient ([0087]: “In an embodiment the regional oximetry platform uses near-infrared spectroscopy (NIRS) to continuously and simultaneously measure regional oxygen saturation (rSO.sub.2) and arterial oxygen saturation (SpO.sub.2), enabling the regional oximetry platform to automatically derive the differential analysis of a patient's regional-to-central oxygen saturation.” [0086]: “the regional oximetry module is configured by applying one or more regional oximetry sensors to the patient, for example, the patient's forehead, and by connecting the module(s) to the hub 100. In an embodiment the regional oximetry module has as few as one and as many as four sensors.”; Figs. 6A-6B);
a pulse oximetry (SpO2) sensor configured to be positioned on the patient at a third, different location, the SpO2 sensor configured to determine SpO2 data of the patient ([0087]: “In an embodiment the regional oximetry platform uses near-infrared spectroscopy (NIRS) to continuously and simultaneously measure regional oxygen saturation (rSO.sub.2) and arterial oxygen saturation (SpO.sub.2), enabling the regional oximetry platform to automatically derive the differential analysis of a patient's regional-to-central oxygen saturation. In an embodiment the hub 100 derives the differential analysis of a patient's regional-to-central oxygenation saturation by comparing measurements provided to the hub 100 from two sources, such as a pulse oximetry measurement device and a regional oximetry measurement device.”; Figs. 6A-6B);
a processor ([0009]: “the present disclosure provides a regional oximetry system with improved user interaction. In one aspect of the regional oximetry system, a display is provided, and a processor is provided causing a plurality of views to be displayed on the display.”).
However, Al-Ali does not teach calculating fractional tissue oxygenation extraction (FTOE) data.
Bruckner discloses methods for monitoring oxygenation parameters. Specifically, Bruckner teaches calculating fractional tissue oxygenation extraction (FTOE) data (Page 1562: “The cerebral and peripheral fractional oxygen extractions were calculated as follows: cerebral FTOE = [(SpO2- cerebral regional SO2)/SpO2]; peripheral FTOE = [(SpO2- peripheral regionalSO2)/SpO2]”). Al-Ali and Bruckner are analogous arts as they are both related to monitoring oxygenation of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the calculation of FTOE, as it is an important oxygenation parameter that can affect the user’s oxygenation values, which is a useful measurement to be used in the analysis of the user’s oxygenation levels.
The Al-Ali/Bruckner combination teaches the steps of calculating a current oxygenation value based on a combination of the FTOE data, the first rSO2 data, the second rSO2 data, and the SpO2 data (Bruckner, Page 1561: “Tissue oxygenation depends on oxygen delivery and oxygen consumption”; Page 1561: “Regional tissue oxygen saturation and fractional tissue oxygen extraction (FTOE) give information about dynamic changes of oxygen delivery and oxygen consumption, supporting healthcare professionals to respond directly to changing clinical conditions”; Page 1562:“Mean values of heart rate, SpO2, cerebral regional SO2, cerebral FTOE, peripheral regional SO2 and peripheral FTOE, which were assessed during the prospective observational study,17 were calculated for each hour after birth. The mean 1-hour values of cerebral regional SO2, cerebral FTOE, peripheral regional SO2, peripheral FTOE, heart rate and SpO2 when echocardiography was performed were used for the present analysis”. FTOE is calculated using rSO2 and SpSO2, and the mean FTOE values were calculated using multiple FTOE calculations, therefore the mean FTOE calculation is the current oxygenation value.); and
a display device (Al-Ali, [0009]: “In one aspect of the regional oximetry system, a display is provided, and a processor is provided causing a plurality of views to be displayed on the display”).
However, the Al-Ali/Bruckner combination does not specifically teach a plot having a scale of rSO2 units versus SpO2 units, Al-Ali only teaches graphically comparing the two measurements ([0104]: “the hub 100 displays a differential analysis of a patient's regional-to-central oxygen saturation, also referred to as .DELTA.SpO.sub.2, where measurement of the patient's arterial oxygen saturation is compared with one or more measurements of regional oxygen saturation.”).
Addison discloses a system and method for monitoring oxygen saturation. Specifically, Addison teaches the display device configured to display a plot having a scale of rSO2 units versus SpO2 units (Figure 2). Al-Ali, Bruckner, and Addison are analogous arts as they are all related to systems that measure and analyze oxygen saturation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plot from Addison into the system from the Al-Ali/Bruckner combination as it allows for visual representation of the relationship between the measured values, which can provide the information to the user in a different, effective way. It also allows for further analysis, which can provide a more comprehensive analysis of the user’s health.
However, the Al-Ali/Bruckner/Addison combination does not teach an indicator representing the current oxygenation value at a current position on the plot.
Saidara discloses a system for monitoring physiological characteristics. Specifically, Saidara teaches an indicator representing the current value at a current position on the plot ([0184]: “in embodiments of the invention where the graphical representation comprises one or more trend indicators, the trend indicators can include an indicator of a past measurement, a current measurement or a combination thereof”). Al-Ali, Bruckner, Addison, and Saidara are analogous devices as they are all related to systems used to monitor physiological characteristics of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the indicator from Saidara into the Al-Ali/Bruckner/Addison combination as it allows the plot to show where the current position is, which can allow the user to know the exact value of their oxygenation at the present time.
The Al-Ali/Bruckner/Addison/Saidara combination teaches a historical trace representing a plurality of previous oxygenation values at a plurality of previous positions, respectively, on the plot (Al-Ali; [0083]: “the display 104 is configurable to permit the user to adjust the manner by which the physiologic parameters are presented on the display 104. In particular, physiologic measurements of greater interest or importance to the clinician may be displayed in larger format and may also be displayed in both numerical and graphical formats to convey the current measurement as well as the historical trend of measurements for a period of time, such as, for example, the preceding hour.”).
Regarding claim 2, the Al-Ali/Bruckner/Addison/Saidara combination teaches the system in accordance with claim 1, wherein the display device is also configured to display current numerical values of the first rSO2 data, the second rSO2 data, and the SpO2 data (Al-Ali; [0109]: “FIG. 15A illustrates an embodiment of a monitor display 1500A in which, among other things, the patient's regional-to-central oxygenation saturation measurements, or SpO.sub.2 delta, are presented”).
Regarding claim 3, the Al-Ali/Bruckner/Addison/Saidara combination teaches the system in accordance with claim 2, wherein the display device is also configured to display a current numerical value of the FTOE data. Bruckner discloses the calculation of FTOE data (Bruckner, Page 1562: “Mean values of heart rate, SpO2, cerebral regional SO2, cerebral FTOE, peripheral regional SO2 and peripheral FTOE, which were assessed during the prospective observational study,17 were calculated for each hour after birth”) and Al-Ali discloses displaying the measurements on the display (Al-Ali; [0083]: “the display 104 is configurable to permit the user to adjust the manner by which the physiologic parameters are presented on the display 104. In particular, physiologic measurements of greater interest or importance to the clinician may be displayed in larger format and may also be displayed in both numerical and graphical formats to convey the current measurement as well as the historical trend of measurements for a period of time, such as, for example, the preceding hour.”). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the FTOE data displayed on the display, as it allows the user to see the FTOE data displayed along with the rSO2 data and SpO2 data, which can inform the user of their FTOE level in a simple visual display,
Regarding claim 6, the Al-Ali/Bruckner/Addison/Saidara combination teaches the system in accordance with claim 1, the plot having the scale of rSO2 units versus SpO2 units (Addison, Figure 2).
However, the Al-Ali/Bruckner/Addison/Saidara combination does not teach the plot having the scale of rSO2 units versus SpO2 units additionally showing an SpO2 threshold or alarm limit.
Al-Ali discloses wherein a plot additionally shows an SpO2 threshold or alarm limit ([0112]: “a dotted line 1534 indicates the alarm limit as set by the user.”), and wherein the processor is further configured to activate an alarm when the SpO2 data falls below the threshold or alarm limit ([0107]: “In an embodiment the alarms include high limit, low limit, high caution range, low caution range, rapid desaturation, alarm delay and silence duration. The action screen 1318 features buttons to turn on or off various alarms, sliders by which the user can set parameters, such as limits, ranges and durations, to establish alarm triggering conditions for a given patient. “; [0111]: “FIG. 15B illustrates an embodiment of a monitor display 1500B configured as the one in FIG. 15A, however multiple alarms are triggered. These include an alarm that the patient's left forehead regional oxygen saturation is less than 50 percent 1520, an alarm that the regional-to-central oxygen saturation measurements of the patient's left forehead region differ by 55 percentage points 1522, and an alarm that the patient's left forehead regional oxygen saturation is 43 percentage points below the patient's baseline 1524.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the alarm limit from Al-Ali into the plot from the Al-Ali/Bruckner/Addison/Saidara combination as it allows the plot to indicate when the levels reach a level that could be dangerous, therefore alerting the user of the possible health condition and ensuring they are informed of any possible concerns.
Regarding claim 7, the Al-Ali/Bruckner/Addison/Saidara combination teaches the system in accordance with claim 6.
However, the Al-Ali/Bruckner/Addison/Saidara combination does not teach wherein the plot having the scale of rSO2 units versus SpO2 units additionally shades or colors areas above or below the threshold or alarm limit to visually emphasize a relative position of the indicator representing the current oxygenation value at the current position with respect to the SpO2 threshold or alarm limit.
Al-Ali teaches wherein a plot additionally shades or colors areas above or below the threshold or alarm limit to visually emphasize a relative position of the indicator representing the current oxygenation value at the current position with respect to the SpO2 threshold or alarm limit (Al-Ali; [0100]: “Advantageously the area 1528 between the first line representing measured arterial oxygen saturation 1514 and the second line representing regional oxygen saturation 1516 is shaded with varying colors to visually indicate the state of the metric, in this case, the patient's regional-to-central oxygenation saturation measurements, or SpO.sub.2 delta. In an embodiment the area 1528 is shaded with, for example, a green color when no alarm or caution range is met, a yellow color when a caution range is met, and a red color when an alarm limit is met or exceeded, thereby visually alerting the user to circumstances that might require attention or clinical action.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the shading above and below the alarm limit from Al-Ali into the plot from the Al-Ali/Bruckner/Addison/Saidara combination as it allows the user to easily see what regions of the plot are underneath the alarm or above the alarm, allowing them to clearly see where their current level is.
Regarding claim 8, the Al-Ali/Bruckner/Addison/Saidara combination teaches the system in accordance with claim 1.
However, the Al-Ali/Bruckner/Addison/Saidara combination does not teach wherein the plot having the scale of rSO2 units versus SpO2 units additionally shows a preset rSO2 baseline.
Al-Ali teaches wherein a plot additionally shows a preset rSO2 baseline (Al-Ali; [0108]: “A baseline view icon 1412 is selected which results in formatting the patient's measured data to be presented graphically, with a baseline that has been set by the user, at the trend displays 1404,1408.”; [0107]: “Advantageously the alarm conditions can be used to graphically represent the status of the delta baseline metric on a trend view, as described below with respect to FIGS. 15A-B.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the baseline from Al-Ali into the plot from the Al-Ali/Bruckner/Addison/Saidara combination as it allows the user to easily identify the baseline, showing the user how close their current value is to the baseline value.
Regarding claim 10, the Al-Ali/Bruckner/Addison/Saidara combination teaches the system in accordance with claim 1, wherein an amount of time represented by the historical trace is customizable, and wherein the indicator representing the current oxygenation value at the current position is visually emphasized on the display (Al-Ali; [0083]: “the display 104 is configurable to permit the user to adjust the manner by which the physiologic parameters are presented on the display 104. In particular, physiologic measurements of greater interest or importance to the clinician may be displayed in larger format and may also be displayed in both numerical and graphical formats to convey the current measurement as well as the historical trend of measurements for a period of time, such as, for example, the preceding hour.”; Saidara, [001084]: “in embodiments of the invention where the graphical representation comprises one or more trend indicators, the trend indicators can include an indicator of a past measurement, a current measurement or a combination thereof”).
Regarding independent claim 11, Al-Ali teaches a method for displaying patient oxygenation ([0116]: “the apparatuses and methods described herein may be implemented by one or more computer programs executed by one or more processors.”), comprising:
receiving from a first regional oximetry (rSO2) sensor configured to be positioned on a patient at a first location, the first rSO2 sensor configured to determine first rSO2 data of the patient ([0087]: “In an embodiment the regional oximetry platform uses near-infrared spectroscopy (NIRS) to continuously and simultaneously measure regional oxygen saturation (rSO.sub.2) and arterial oxygen saturation (SpO.sub.2), enabling the regional oximetry platform to automatically derive the differential analysis of a patient's regional-to-central oxygen saturation.”; [0086]: “the regional oximetry module is configured by applying one or more regional oximetry sensors to the patient, for example, the patient's forehead, and by connecting the module(s) to the hub 100. In an embodiment the regional oximetry module has as few as one and as many as four sensors.”; Figs. 6A-6B);
receiving from a second rSO2 sensor configured to be positioned on the patient at a second, different location, the second rSO2 sensor configured to determine second rSO2 data of the patient ([0087]: “In an embodiment the regional oximetry platform uses near-infrared spectroscopy (NIRS) to continuously and simultaneously measure regional oxygen saturation (rSO.sub.2) and arterial oxygen saturation (SpO.sub.2), enabling the regional oximetry platform to automatically derive the differential analysis of a patient's regional-to-central oxygen saturation.” [0086]: “the regional oximetry module is configured by applying one or more regional oximetry sensors to the patient, for example, the patient's forehead, and by connecting the module(s) to the hub 100. In an embodiment the regional oximetry module has as few as one and as many as four sensors.”; Figs. 6A-6B);
receiving from a pulse oximetry (SpO2) sensor configured to be positioned on the patient at a third, different location, the SpO2 sensor configured to determine SpO2 data of the patient ([0087]: “In an embodiment the regional oximetry platform uses near-infrared spectroscopy (NIRS) to continuously and simultaneously measure regional oxygen saturation (rSO.sub.2) and arterial oxygen saturation (SpO.sub.2), enabling the regional oximetry platform to automatically derive the differential analysis of a patient's regional-to-central oxygen saturation. In an embodiment the hub 100 derives the differential analysis of a patient's regional-to-central oxygenation saturation by comparing measurements provided to the hub 100 from two sources, such as a pulse oximetry measurement device and a regional oximetry measurement device.”; Figs. 6A-6B);
a processor ([0009]: “the present disclosure provides a regional oximetry system with improved user interaction. In one aspect of the regional oximetry system, a display is provided, and a processor is provided causing a plurality of views to be displayed on the display.”).
However, Al-Ali does not teach calculating fractional tissue oxygenation extraction (FTOE) data based at least in part on the first rSO2 data, the second rSO2 data, and the SpO2 data.
Bruckner discloses methods for monitoring oxygenation parameters. Specifically, Bruckner teaches calculating fractional tissue oxygenation extraction (FTOE) data based at least in part on the first rSO2 data, the second rSO2 data, and the SpO2 data (Page 1562: “The cerebral and peripheral fractional oxygen extractions were calculated as follows: cerebral FTOE = [(SpO2- cerebral regional SO2)/SpO2]; peripheral FTOE = [(SpO2- peripheral regionalSO2)/SpO2]”). Al-Ali and Bruckner are analogous arts as they are both related to monitoring oxygenation of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the calculation of FTOE, as it is an important oxygenation parameter that can affect the user’s oxygenation values, which is a useful measurement to be used in the analysis of the user’s oxygenation levels.
The Al-Ali/Bruckner combination teaches the steps of calculating, by the processor, a current oxygenation value based on a combination of the FTOE data, the first rSO2 data, the second rSO2 data, and the SpO2 data (Bruckner, Page 1561: “Tissue oxygenation depends on oxygen delivery and oxygen consumption”; Page 1561: “Regional tissue oxygen saturation and fractional tissue oxygen extraction (FTOE) give information about dynamic changes of oxygen delivery and oxygen consumption, supporting healthcare professionals to respond directly to changing clinical conditions”; Page 1562:“Mean values of heart rate, SpO2, cerebral regional SO2, cerebral FTOE, peripheral regional SO2 and peripheral FTOE, which were assessed during the prospective observational study,17 were calculated for each hour after birth. The mean 1-hour values of cerebral regional SO2, cerebral FTOE, peripheral regional SO2, peripheral FTOE, heart rate and SpO2 when echocardiography was performed were used for the present analysis”. FTOE is calculated using rSO2 and SpSO2, and the mean FTOE values were calculated using multiple FTOE calculations, therefore the mean FTOE calculation is the current oxygenation value.); and
a display device (Al-Ali, [0009]: “In one aspect of the regional oximetry system, a display is provided, and a processor is provided causing a plurality of views to be displayed on the display”).
However, the Al-Ali/Bruckner combination does not specifically teach a plot having a scale of rSO2 units versus SpO2 units, Al-Ali only teaches graphically comparing the two measurements ([0104]: “the hub 100 displays a differential analysis of a patient's regional-to-central oxygen saturation, also referred to as .DELTA.SpO.sub.2, where measurement of the patient's arterial oxygen saturation is compared with one or more measurements of regional oxygen saturation.”).
Addison discloses a system and method for monitoring oxygen saturation. Specifically, Addison teaches the display device causing display of a plot having a scale of rSO2 units versus SpO2 units (Figure 2). Al-Ali, Bruckner, and Addison are analogous arts as they are all related to systems that measure and analyze oxygen saturation.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the plot from Addison into the system from the Al-Ali/Bruckner combination as it allows for visual representation of the relationship between the measured values, which can provide the information to the user in a different, effective way. It also allows for further analysis, which can provide a more comprehensive analysis of the user’s health.
However, the Al-Ali/Bruckner/Addison combination does not teach an indicator representing the current oxygenation value at a current position on the plot.
Saidara discloses a system for monitoring physiological characteristics. Specifically, Saidara teaches an indicator representing the current value at a current position on the plot ([0184]: “in embodiments of the invention where the graphical representation comprises one or more trend indicators, the trend indicators can include an indicator of a past measurement, a current measurement or a combination thereof”). Al-Ali, Bruckner, Addison, and Saidara are analogous devices as they are all related to systems used to monitor physiological characteristics of a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the indicator from Saidara into the Al-Ali/Bruckner/Addison combination as it allows the plot to show where the current position is, which can allow the user to know the exact value of their oxygenation at the present time.
The Al-Ali/Bruckner/Addison/Saidara combination teaches a historical trace representing a plurality of previous oxygenation values at a plurality of previous positions, respectively, on the plot (Al-Ali; [0083]: “the display 104 is configurable to permit the user to adjust the manner by which the physiologic parameters are presented on the display 104. In particular, physiologic measurements of greater interest or importance to the clinician may be displayed in larger format and may also be displayed in both numerical and graphical formats to convey the current measurement as well as the historical trend of measurements for a period of time, such as, for example, the preceding hour.”).
Regarding claim 16, the Al-Ali/Bruckner/Addison/Saidara combination teaches the method in accordance with claim 11.
However, the Al-Ali/Bruckner/Addison/Saidara combination does not teach an SpO2 threshold or alarm limit on the plot.
Al-Ali discloses wherein a plot causing display, via the display device, of an SpO2 threshold or alarm limit on the plot ([0112]: “a dotted line 1534 indicates the alarm limit as set by the user.”), and activating an alarm when the SpO2 data falls below the SpO2 threshold or alarm limit ([0107]: “In an embodiment the alarms include high limit, low limit, high caution range, low caution range, rapid desaturation, alarm delay and silence duration. The action screen 1318 features buttons to turn on or off various alarms, sliders by which the user can set parameters, such as limits, ranges and durations, to establish alarm triggering conditions for a given patient. “; [0111]: “FIG. 15B illustrates an embodiment of a monitor display 1500B configured as the one in FIG. 15A, however multiple alarms are triggered. These include an alarm that the patient's left forehead regional oxygen saturation is less than 50 percent 1520, an alarm that the regional-to-central oxygen saturation measurements of the patient's left forehead region differ by 55 percentage points 1522, and an alarm that the patient's left forehead regional oxygen saturation is 43 percentage points below the patient's baseline 1524.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the alarm limit from Al-Ali into the plot from the Al-Ali/Bruckner/Addison/Saidara combination as it allows the plot to indicate when the levels reach a level that could be dangerous, therefore alerting the user of the possible health condition and ensuring they are informed of any possible concerns.
Regarding claim 17, the Al-Ali/Bruckner/Addison/Saidara combination teaches the method in accordance with claim 16.
However, the Al-Ali/Bruckner/Addison/Saidara combination does not teach causing display, via the display device, of shading or colored areas above or below the SpO2 threshold or alarm limit on the plot to visually emphasize a relative position of indicator representing the current oxygenation value at the current position with respect to the SpO2 threshold or alarm limit.
Al-Ali teaches further comprising causing display, via the display device, of shading or colored areas above or below the SpO2 threshold or alarm limit on the plot to visually emphasize a relative position of indicator representing the current oxygenation value at the current position with respect to the SpO2 threshold or alarm limit ([0100]: “Advantageously the area 1528 between the first line representing measured arterial oxygen saturation 1514 and the second line representing regional oxygen saturation 1516 is shaded with varying colors to visually indicate the state of the metric, in this case, the patient's regional-to-central oxygenation saturation measurements, or SpO.sub.2 delta. In an embodiment the area 1528 is shaded with, for example, a green color when no alarm or caution range is met, a yellow color when a caution range is met, and a red color when an alarm limit is met or exceeded, thereby visually alerting the user to circumstances that might require attention or clinical action.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the shading above and below the alarm limit from Al-Ali into the plot from the Al-Ali/Bruckner/Addison/Saidara combination as it allows the user to easily see what regions of the plot are underneath the alarm or above the alarm, allowing them to clearly see where their current level is.
Regarding claim 18, the Al-Ali/Bruckner/Addison/Saidara combination teaches the method in accordance with claim 11.
However, the Al-Ali/Bruckner/Addison/Saidara combination does not teach further comprising causing display, via the display device, of a preset rSO2 baseline on the plot.
Al-Ali teaches further comprising causing display, via the display device, of a preset rSO2 baseline on the plot ([0108]: “A baseline view icon 1412 is selected which results in formatting the patient's measured data to be presented graphically, with a baseline that has been set by the user, at the trend displays 1404,1408.”; [0107]: “Advantageously the alarm conditions can be used to graphically represent the status of the delta baseline metric on a trend view, as described below with respect to FIGS. 15A-B.”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the baseline from Al-Ali into the plot from the Al-Ali/Bruckner/Addison/Saidara combination as it allows the user to easily identify the baseline, showing the user how close their current value is to the baseline value.
Regarding claim 20, the Al-Ali/Bruckner/Addison/Saidara combination teaches the method in accordance with claim 11, wherein an amount of time represented by the historical trace is customizable, and wherein the indicator representing the current oxygenation value at the current position is visually emphasized on the display (Al-Ali; [0083]: “the display 104 is configurable to permit the user to adjust the manner by which the physiologic parameters are presented on the display 104. In particular, physiologic measurements of greater interest or importance to the clinician may be displayed in larger format and may also be displayed in both numerical and graphical formats to convey the current measurement as well as the historical trend of measurements for a period of time, such as, for example, the preceding hour.”).
Regarding claim 21, the Al-Ali/Bruckner/Addison/Saidara combination teaches the system in accordance with claim 1, wherein the rSO2 unit of the plot is an rSO2 percentage, and wherein the SpO2 unit of the plot is an SpO2 percentage (Addison, Fig 7).
Regarding claim 22, the Al-Ali/Bruckner/Addison/Saidara combination teaches the system in accordance with claim 1.
However, Al-Ali/Bruckner/Addison/Saidara combination does not disclose wherein the historical trace is displayed in a different color than the indicator representing the current oxygenation value.
Saidara discloses wherein the historical trace is displayed in a different color than the indicator representing the current oxygenation value ([0016]: “the graphical representation can comprise a color coded set of one or more indicators of the status of the physiological characteristic”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the color coded indicators from Saidara into the Al-Ali/Bruckner/Addison/Saidara combination as it allows the combination to further clarify what the current value is.
Regarding claim 23, the Al-Ali/Bruckner/Addison/Saidara combination teaches the method in accordance with claim 11, wherein the rSO2 unit of the plot is an rSO2 percentage, and wherein the SpO2 unit of the plot is an SpO2 percentage (Addison, Fig 7).
Regarding claim 24, the Al-Ali/Bruckner/Addison/Saidara combination teaches the method in accordance with claim 11.
However, Al-Ali/Bruckner/Addison/Saidara combination does not disclose wherein the historical trace is displayed in a different color than the indicator representing the current oxygenation value.
Saidara discloses further comprising causing display, via the display device, of the historical trace in a different color than the indicator representing the current oxygenation value ([0016]: “the graphical representation can comprise a color coded set of one or more indicators of the status of the physiological characteristic”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the color coded indicators from Saidara into the Al-Ali/Bruckner/Addison/Saidara combination as it allows the combination to further clarify what the current value is.
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over the Al-Ali/Bruckner/Addison/Saidara combination as applied to claims 1 and 11 above, and further in view of Freeman (11272889).
Regarding claim 4, the Al-Ali/Bruckner/Addison/Saidara combination teaches the system in accordance with claim 1, wherein the plot having the scale of rSO2 units versus SpO2 units additionally shows FTOE display lines. Bruckner discloses the calculation of FTOE data (Bruckner, Page 1562: “Mean values of heart rate, SpO2, cerebral regional SO2, cerebral FTOE, peripheral regional SO2 and peripheral FTOE, which were assessed during the prospective observational study,17 were calculated for each hour after birth”) and Al-Ali discloses displaying the measurements on the display as lines (Al-Ali; [0083]: “the display 104 is configurable to permit the user to adjust the manner by which the physiologic parameters are presented on the display 104. In particular, physiologic measurements of greater interest or importance to the clinician may be displayed in larger format and may also be displayed in both numerical and graphical formats to convey the current measurement as well as the historical trend of measurements for a period of time, such as, for example, the preceding hour.”; Fig. 7, therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the FTOE data displayed on the display, as it allows the user to see the FTOE data displayed along with the rSO2 data and SpO2 data, which can inform the user of their FTOE level in a simple visual display.
However, the Al-Ali/Bruckner/Addison/Saidara combination does not teach displaying the lines as an overlay.
Freeman discloses systems and methods for monitoring respiratory status of a user. Specifically, Freeman teaches displaying lines as an overlay (Column 5, lines 18-19: “Supplemental O.sub.2 is displayed as a solid red line overlaid on top of the dashed blue”). Al-Ali, Bruckner, Addison, Saidara, and Freeman are analogous arts as they are all related to displaying parameters measured from a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the lines as an overlay since the Al-Ali/Bruckner/Addison/Saidara combination is silent on how the lines are added into the plot, and Freeman discloses a suitable way for the lines to be added to a plot.
Regarding claim 5, the Al-Ali/Bruckner/Addison/Saidara/Freeman combination teaches the system in accordance with claim 4, wherein the FTOE display lines are shaded according to high and low values. Bruckner discloses the calculation of FTOE data (Bruckner, Page 1562: “Mean values of heart rate, SpO2, cerebral regional SO2, cerebral FTOE, peripheral regional SO2 and peripheral FTOE, which were assessed during the prospective observational study,17 were calculated for each hour after birth”) and Al-Ali discloses displaying the measurements as lines on the display and shading areas according to high and low values (Al-Ali; [0110]: “Advantageously the area 1528 between the first line representing measured arterial oxygen saturation 1514 and the second line representing regional oxygen saturation 1516 is shaded with varying colors to visually indicate the state of the metric, in this case, the patient's regional-to-central oxygenation saturation measurements, or SpO.sub.2 delta. In an embodiment the area 1528 is shaded with, for example, a green color when no alarm or caution range is met, a yellow color when a caution range is met, and a red color when an alarm limit is met or exceeded, thereby visually alerting the user to circumstances that might require attention or clinical action.”, therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the FTOE display lines shaded according to high and low values, as it allows the user to see the FTOE data displayed in a simple visual way where they can easily determine the high and low values of the FTOE data.
Regarding claim 14, the Al-Ali/Bruckner/Addison/Saidara combination teaches the method in accordance with claim 11, further comprising causing display, via the display device, of FTOE display lines as an overlay on the plot. Bruckner discloses the calculation of FTOE data (Bruckner, Page 1562: “Mean values of heart rate, SpO2, cerebral regional SO2, cerebral FTOE, peripheral regional SO2 and peripheral FTOE, which were assessed during the prospective observational study,17 were calculated for each hour after birth”) and Al-Ali discloses displaying the measurements on the display as lines (Al-Ali; [0083]: “the display 104 is configurable to permit the user to adjust the manner by which the physiologic parameters are presented on the display 104. In particular, physiologic measurements of greater interest or importance to the clinician may be displayed in larger format and may also be displayed in both numerical and graphical formats to convey the current measurement as well as the historical trend of measurements for a period of time, such as, for example, the preceding hour.”; Fig. 7, therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the FTOE data displayed on the display, as it allows the user to see the FTOE data displayed along with the rSO2 data and SpO2 data, which can inform the user of their FTOE level in a simple visual display.
However, the Al-Ali/Bruckner/Addison/Saidara combination does not teach displaying the lines as an overlay.
Freeman discloses systems and methods for monitoring respiratory status of a user. Specifically, Freeman teaches displaying lines as an overlay (Column 5, lines 18-19: “Supplemental O.sub.2 is displayed as a solid red line overlaid on top of the dashed blue”). Al-Ali, Bruckner, Addison, Saidara, and Freeman are analogous arts as they are all related to displaying parameters measured from a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the lines as an overlay since the Al-Ali/Bruckner/Addison/Saidara combination is silent on how the lines are added into the plot, and Freeman discloses a suitable way for the lines to be added to a plot.
Regarding claim 15, the Al-Ali/Bruckner/Addison/Saidara/Freeman combination teaches the method in accordance with claim 14, further comprising causing display, via the display device, of shading of high FTOE values or low FTOE values with respect to the FTOE display lines on the plot. Bruckner discloses the calculation of FTOE data (Bruckner, Page 1562: “Mean values of heart rate, SpO2, cerebral regional SO2, cerebral FTOE, peripheral regional SO2 and peripheral FTOE, which were assessed during the prospective observational study,17 were calculated for each hour after birth”) and Al-Ali discloses displaying the measurements as lines on the display and shading areas according to high and low values (Al-Ali; [0110]: “Advantageously the area 1528 between the first line representing measured arterial oxygen saturation 1514 and the second line representing regional oxygen saturation 1516 is shaded with varying colors to visually indicate the state of the metric, in this case, the patient's regional-to-central oxygenation saturation measurements, or SpO.sub.2 delta. In an embodiment the area 1528 is shaded with, for example, a green color when no alarm or caution range is met, a yellow color when a caution range is met, and a red color when an alarm limit is met or exceeded, thereby visually alerting the user to circumstances that might require attention or clinical action.”, therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the FTOE display lines shaded according to high and low values, as it allows the user to see the FTOE data displayed in a simple visual way where they can easily determine the high and low values of the FTOE data.
Response to Arguments
All of applicant’s argument regarding the rejections and objections previously set forth have been fully considered and are persuasive unless directly addressed subsequently.
Applicant’s arguments with respect to claims 1-8, 10-11, 14-18, and 20-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791