DETAILED ACTION
Applicant’s arguments, filed on 04/10/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 04/10/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-8, 10-11, 14-18, and 20-24 are the current claims hereby under examination.
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 .
Claim Objections
Claim 3 is objected to because of the following informalities:
In claim 3, line 2, a period must be placed after the word “data”
Appropriate correction is required.
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, 20-21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Widman (US 20110105912) in view of Benni (US 20120271130) and Al-Ali (US 20150099955).
Regarding independent claim 1, Widman teaches a system for displaying patient oxygenation ([0009]: “Described below are various systems and methods of monitoring autoregulation in a patient.”), 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 ([0022]: “System 100 includes a sensor 104 that is arranged proximate to an external position of the patient's head 106. In one example, sensor 104 is a cerebral oximeter”; [0077]: “To continuously monitor the state of Cerebral Autoregulation (CA) regional cerebral oxygen saturation rSO2 measured by NIRS is commonly used”. The sensor 104 is a cerebral oximeter, which measures cerebral oxygen saturation which is a type of regional oximetry.);
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 ([0059]: “a second cerebral oximetry sensor 110 placed in a periphery location of the body to acquire a pleth waveform by continuously measuring optical absorption changes in the near-infrared range”);
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 ([0022]: “a pulse oximeter sensor 110 may be attached to a patent's hand or finger”. The pulse oximeter measures SpO2 data);
a processor (Signal processing unit 112) configured to:
calculate fractional tissue oxygenation extraction (FTOE) data ([0092]: “Another means of reducing variations caused by fluctuating arterial oxygen saturation may be through the use of fractional tissue oxygen extraction (FTOE) for correlation with arterial blood pressure. FTOE is defined as the arteriovenous oxygen difference (SaO2-rSO2) divided by SaO2”); and
map the FTOE data, the first rSO2 data, the second rSO2 data, and the SpO2 data into a combined oxygenation value ([0092]: “FTOE is defined as the arteriovenous oxygen difference (SaO2-rSO2) divided by SaO2 and this calculated parameter can be correlated with arterial blood pressure to produce an index of autoregulation while reducing variations caused by changing SaO2.”. The index of autoregulation is the combined oxygenation value. FTOE is calculated using rSO2 data and SpO2 data, therefore using all these data to determine the combined oxygenation value.); and
a display device ([0095]: “The monitor has the capability to display rSO2, systolic, diastolic and mean blood pressure, CBFi and a representation of autoregulation index at multiple blood pressure levels.”).
However, Widman does not teach the display device configured to display a plot having a scale of rSO2 units versus SpO2 units, the plot including: an indicator representing the combined oxygenation value at a current position on the plot.
Benni discloses a method and apparatus for determining an oxygen desaturation event. Specifically, Benni teaches the display device configured to display a plot having a scale of rSO2 units versus SpO2 units ([0032]: “The determination of the index (e.g., by comparison of the SctO.sub.2 and SpO.sub.2 values) can be performed with the values organized in a variety of different forms. For example, a graphical solution can be used wherein the mean SctO.sub.2 versus the SpO.sub.2 values are plotted, as is shown in FIG. 5”. The SctO2 value is the same as an rSO2 value, and the index that is a comparison of the values is analogous to the combined oxygenation value.), the plot including: an indicator representing the combined oxygenation value at a current position on the plot (Fig. 5 shows the dots representing the values as the indicator.). Widman and Benni are analogous art as they are both in the same field of endeavor of monitoring oxygen saturation 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 plot from Benni into the system from Widman 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 Widman/Benni combination does not teach a historical trace representing a plurality of previous combined oxygenation values at a plurality of previous positions, respectively, on the plot.
Al-Ali discloses a regional oximetry user interface. Specifically, Al-Ali teaches the display having a historical trace representing a plurality of previous combined oxygenation values at a plurality of previous positions, respectively, on the plot ([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.”). Widman, Benni, and Al-Ali are analogous art as they are related to the same field of endeavor of monitoring the oxygen saturation 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 historical trace from Al-Ali into the Widman/Benni combination as it allows the display to not only show the current measurement, but allows the user to track the measurements over time, which can further help them identify trends or any deviations from a normal value that could indicate a possible health risk.
Regarding claim 2, the Widman/Benni/Al-Ali 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, [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.”. The display of the numerical format of the measurements includes the rSO2 data and the SpO2 data.).
Regarding claim 3, the Widman/Benni/Al-Ali 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 (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.”. The display of the numerical format of the measurements includes the FTOE data.).
Regarding claim 6, the Widman/Benni/Al-Ali combination teaches the system in accordance with claim 1.
However, the Widman/Benni/Al-Ali combination does not teach wherein the plot having the scale of rSO2 units versus SpO2 units additionally shows an SpO2 threshold or alarm limit, and wherein the processor is further configured to activate an alarm when the SpO2 data falls below the threshold or alarm limit.
Al-Ali teaches wherein the plot having the scale of rSO2 units versus SpO2 units 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 Widman/Benni/Al-Ali 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 Widman/Benni/Al-Ali combination teaches the system in accordance with claim 6.
However, the Widman/Benni/Al-Ali 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 combined oxygenation value at the current position with respect to the SpO2 threshold or alarm limit.
Al-Ali teaches 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 combined 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 Widman/Benni/Al-Ali 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 Widman/Benni/Al-Ali combination teaches the system in accordance with claim 1.
However, the Widman/Benni/Al-Ali 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 the plot having the scale of rSO2 units versus SpO2 units additionally shows a preset rSO2 baseline ([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 Widman/Benni/Al-Ali 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 Widman/Benni/Al-Ali 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 combined 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 independent claim 11, Widman teaches a method for displaying patient oxygenation ([0009]: “Described below are various systems and methods of monitoring autoregulation in a patient.”), 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 ([0022]: “System 100 includes a sensor 104 that is arranged proximate to an external position of the patient's head 106. In one example, sensor 104 is a cerebral oximeter”; [0077]: “To continuously monitor the state of Cerebral Autoregulation (CA) regional cerebral oxygen saturation rSO2 measured by NIRS is commonly used”. The sensor 104 is a cerebral oximeter, which measures cerebral oxygen saturation which is a type of regional oximetry.);
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 ([0059]: “a second cerebral oximetry sensor 110 placed in a periphery location of the body to acquire a pleth waveform by continuously measuring optical absorption changes in the near-infrared range”);
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 ([0022]: “a pulse oximeter sensor 110 may be attached to a patent's hand or finger”. The pulse oximeter measures SpO2 data);
calculating, by a processor (Signal processing unit 112), fractional tissue oxygenation extraction (FTOE) data based at least in part on the first rSO2 data, the second rSO2 data, and the SpO2 data ([0092]: “Another means of reducing variations caused by fluctuating arterial oxygen saturation may be through the use of fractional tissue oxygen extraction (FTOE) for correlation with arterial blood pressure. FTOE is defined as the arteriovenous oxygen difference (SaO2-rSO2) divided by SaO2”);
mapping the FTOE data, the first rSO2 data, the second rSO2 data, and the SpO2 data into a combined oxygenation value ([0092]: “FTOE is defined as the arteriovenous oxygen difference (SaO2-rSO2) divided by SaO2 and this calculated parameter can be correlated with arterial blood pressure to produce an index of autoregulation while reducing variations caused by changing SaO2.”. The index of autoregulation is the combined oxygenation value. FTOE is calculated using rSO2 data and SpO2 data, therefore using all these data to determine the combined oxygenation value.); and
a display device ([0095]: “The monitor has the capability to display rSO2, systolic, diastolic and mean blood pressure, CBFi and a representation of autoregulation index at multiple blood pressure levels.”).
However, Widman does not teach the display device configured to display a plot having a scale of rSO2 units versus SpO2 units, the plot including: an indicator representing the combined oxygenation value at a current position on the plot.
Benni discloses a method and apparatus for determining an oxygen desaturation event. Specifically, Benni teaches causing display of a plot having a scale of rSO2 units versus SpO2 units ([0032]: “The determination of the index (e.g., by comparison of the SctO.sub.2 and SpO.sub.2 values) can be performed with the values organized in a variety of different forms. For example, a graphical solution can be used wherein the mean SctO.sub.2 versus the SpO.sub.2 values are plotted, as is shown in FIG. 5”. The SctO2 value is the same as an rSO2 value, and the index that is a comparison of the values is analogous to the combined oxygenation value.), the plot including: an indicator representing the combined oxygenation value at a current position on the plot (Fig. 5 shows the dots representing the values as the indicator.). Widman and Benni are analogous art as they are both in the same field of endeavor of monitoring oxygen saturation 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 plot from Benni into the method from Widman 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 Widman/Benni combination does not teach a historical trace representing a plurality of previous combined oxygenation values at a plurality of previous positions, respectively, on the plot.
Al-Ali discloses a regional oximetry user interface. Specifically, Al-Ali teaches the display having a historical trace representing a plurality of previous combined oxygenation values at a plurality of previous positions, respectively, on the plot ([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.”). Widman, Benni, and Al-Ali are analogous art as they are related to the same field of endeavor of monitoring the oxygen saturation 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 historical trace from Al-Ali into the Widman/Benni combination as it allows the display to not only show the current measurement, but allows the user to track the measurements over time, which can further help them identify trends or any deviations from a normal value that could indicate a possible health risk.
Regarding claim 16, the Widman/Benni/Al-Ali combination teaches the method in accordance with claim 11.
However, the Widman/Benni/Al-Ali combination does not teach wherein the plot having the scale of rSO2 units versus SpO2 units additionally shows an SpO2 threshold or alarm limit, and wherein the processor is further configured to activate an alarm when the SpO2 data falls below the threshold or alarm limit.
Al-Ali teaches further comprising: 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 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 Widman/Benni/Al-Ali 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 Widman/Benni/Al-Ali combination teaches the method in accordance with claim 16.
However, the Widman/Benni/Al-Ali 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 combined 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 to visually emphasize a relative position of the indicator representing the combined 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 Widman/Benni/Al-Ali 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 Widman/Benni/Al-Ali combination teaches the method in accordance with claim 11.
However, the Widman/Benni/Al-Ali 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 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 Widman/Benni/Al-Ali 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 Widman/Benni/Al-Ali 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 combined 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 Widman/Benni/Al-Ali 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 (Benni, Fig. 5. rSO2 and SpO2 are measured in percentage, therefore the plot is rSO2 percentage and SpO2 percentage.).
Regarding claim 23, the Widman/Benni/Al-Ali 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 (Benni, Fig. 5. rSO2 and SpO2 are measured in percentage, therefore the plot is rSO2 percentage and SpO2 percentage.)..
Claims 4-5 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over the Widman/Benni/Al-Ali combination as applied to claims 1 and 11 above, and further in view of Freeman (US 11272889).
Regarding claim 4, the Widman/Benni/Al-Ali 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 (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 Widman/Benni/Al-Ali 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”). Widman, Benni, Al-Ali and Freeman are analogous art as they are related to solving a similar problem of displaying measurement results to 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 Widman/Benni/Al-Ali 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 Widman/Benni/Al-Ali/Freeman combination teaches the system in accordance with claim 4.
However, the Widman/Benni/Al-Ali/Freeman combination does not teach wherein the FTOE display lines are shaded according to high and low values.
Al-Ali teaches wherein the FTOE display lines are shaded according to high and low values (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.).
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 from Al-Ali into the Widman/Benni/Al-Ali/Freeman combination as it allows further distinction in the regions being displayed on the plot, which can allow the user to easily identify the values and the differences between the values.
Regarding claim 14, the Widman/Benni/Al-Ali combination teaches the method in accordance with claim 11, further comprising causing display, via the display device, of FTOE display lines on the plot (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 Widman/Benni/Al-Ali 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”). Widman, Benni, Al-Ali and Freeman are analogous art as they are related to solving a similar problem of displaying measurement results to 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 Widman/Benni/Al-Ali 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 Widman/Benni/Al-Ali/Freeman combination teaches the method in accordance with claim 14.
However, the Widman/Benni/Al-Ali/Freeman combination does not teach wherein the FTOE display lines are shaded according to high and low values.
Al-Ali teaches further comprising causing display, via the display device, of shading high FTOE values or low FTOE values with respect to the FTOE display lines on the plot (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.).
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 from Al-Ali into the Widman/Benni/Al-Ali/Freeman combination as it allows further distinction in the regions being displayed on the plot, which can allow the user to easily identify the values and the differences between the values.
Claims 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over the Widman/Benni/Al-Ali combination as applied to claims 1 and 11 above, and further in view of Saidara (US 20080255438).
Regarding claim 22, the Widman/Benni/Al-Ali combination teaches the system in accordance with claim 1.
However, the Widman/Benni/Al-Ali combination does not teach wherein the historical trace is displayed in a different color than the indicator representing the combined oxygenation value.
Saidara discloses a system for monitoring physiological characteristics. Specifically, Saidara teaches wherein the historical trace is displayed in a different color than the indicator representing the combined oxygenation value. Widman, Benni, Al-Ali and Saidara are analogous art as they are related to solving a similar problem of displaying measurement results to 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 color coded indicators from Saidara into the Widman/Benni/Al-Ali combination as it allows the combination to further clarify what the current value is.
Regarding claim 24, the Widman/Benni/Al-Ali combination teaches the method in accordance with claim 11.
However, the Widman/Benni/Al-Ali combination does not teach wherein the historical trace is displayed in a different color than the indicator representing the combined oxygenation value.
Saidara discloses a system for monitoring physiological characteristics. Specifically, Saidara teaches further comprising causing display, via the display device, of the historical trace in a different color than the indicator representing the combined oxygenation value. Widman, Benni, Al-Ali and Saidara are analogous art as they are related to solving a similar problem of displaying measurement results to 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 color coded indicators from Saidara into the Widman/Benni/Al-Ali combination as it allows the combination to further clarify what the current value is.
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 the 103 rejections 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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