DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on 11/14/2025 is acknowledged.
Claim Objections
Claims 8 and 11 are objected to because of the following informalities:
i. Regarding Claim 8, the claim is missing a connecting “wherein” between “The medical device of Claim 4” and “the threshold…”
ii. Regarding Claim 11, the claim is missing a connecting “wherein” between “The medical device of Claim 4” and “the threshold…”
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 4-6, 8-9, 13-15, 17, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Publication 20180104426 awarded to Oldfield et al, hereinafter Oldfield.
Regarding Claim 4, Oldfield teaches a medical device, comprising: a sensor configured to detect measurements of a physiological parameter of a patient (Para. 0049, “The apparatus may additionally comprise one or more sensors for measuring one or more physiological parameters of a patient, and/or one or more inputs for receiving a signal from one or more sensors for measuring physiological parameters of a patient, wherein the one or more physiological parameters are one or more of: heart activity, oxygen saturation, partial pressure of oxygen in the blood, respiratory rate, partial pressure of CO2 in the blood, exhaled CO2”); an output device (I/O device 20); and a processor configured to: identify a sub-interval of time beginning at a time at which the patient is administered an anesthesia or at which the patient is intubated (Para. 0142, “The apparatus can also be operated to determine dose/oxygenation requirements (hereinafter “oxygen requirements”) of a patient for/in relation to anaesthesia (that is, the oxygen requirements pre-anaesthesia during a pre-oxygenation phase and/or the oxygen requirements during anaesthesia—which might include when the patient is apnoeic or when the patient is breathing), as well as after such a procedure, which may include the extubation period”); identify a portion of the measurements of the physiological parameter detected during the sub-interval of time (see Para. 0142, apnoeic or non-apnoeic phases after anaesthesia); determine an index (patient oxygen requirement) by analyzing the portion of the measurements of the physiological parameter detected during the sub-interval of time (Para. 0288, “From that input and/or stored data (such as look up tables, historical data, parameters, relationships, the graphs or the like) the controller determines the oxygenation requirement, step 21. The determination could take place through any processing, look up table, relationship (empirical or mathematical) or the like. Non-exhaustive examples of such input and determination processing are as follows. One or more alone or in combination could be used to make the oxygen requirement determination); determine that the index is greater than a threshold (Para. 0308 discusses monitoring measured oxygen and the oxygen required by a patient at a moment in time) and in response to determining that the hypoxemia dose index is greater than the threshold, cause the screen to output an alert when the patient is being transported to the care location (Para. 0289, “The controller then determines oxygenation requirements, step 21, based on the level of risk and/or the user (e.g. anaesthetist or clinician) provides input indicative of the actual oxygenation requirement and/or dose/therapy settings and/or the actual parameter settings for the high flow gas delivery. Any of the input could be provided as a setting or range of settings or as one or more input values. The system could alert the user of the recommended settings or control the system to provide the settings, as to be described later”).
Regarding 13, Oldfield teaches a system and method of detecting a physiological parameter comprising: an oxygen saturation sensor configured to detect measurements of a blood oxygen saturation/physiological parameter of a patient (Para. 0049, “The apparatus may additionally comprise one or more sensors for measuring one or more physiological parameters of a patient, and/or one or more inputs for receiving a signal from one or more sensors for measuring physiological parameters of a patient, wherein the one or more physiological parameters are one or more of: heart activity, oxygen saturation, partial pressure of oxygen in the blood, respiratory rate, partial pressure of CO2 in the blood, exhaled CO2”); a screen configured to output a waveform indicative of the measurements of the blood oxygen saturation of the patient (Para. 0142, “An input/output interface 20 (such as a display and/or input device) is provided”, Para. 0218 states that a PPG blood oxygenation signal can be an output); an endotracheal (ET) tube configured to be disposed in an airway of the patient (Para. 0018); a ventilation device coupled to the ET tube and configured to administer assisted ventilation to the patient (flow source 12, Para. 0018); and a processor configured to: identify a time at which an anesthesia is being administered to the patient that is before the patient is intubated (Para. 0142, “The apparatus can also be operated to determine dose/oxygenation requirements (hereinafter “oxygen requirements”) of a patient for/in relation to anaesthesia (that is, the oxygen requirements pre-anaesthesia during a pre-oxygenation phase and/or the oxygen requirements during anaesthesia—which might include when the patient is apnoeic or when the patient is breathing), as well as after such a procedure, which may include the extubation period”); define a sub-interval of time that begins at the time (see Para. 0142, apnoeic or non-apnoeic phases after anaesthesia); identify a portion of the measurement of the blood oxygen saturation of the patient detected during the sub-interval of time (Para. 0247, “Sensing the oxygen saturation level and providing that to the controller enables automatic adjustment of the gas flow components to optimise the condition of the patient. The flow rate can be increased or decreased as oxygen saturation respectively decreases or increases”); determine a hypoxemia dose index (oxygenation requirement) by: determining a metric comprising a difference between the measurement of the blood oxygen saturation and a threshold (Para. 0307 discusses monitoring measured oxygen and the oxygen required by a patient at a moment in time); and determining an integral of the metric with respect to the sub-interval of time (Para. 0274, “The initial clearance rate was calculated as the gradient of the concentration-time curve for the first five minutes of therapy and multiplied by the lung volume to obtain gas exchange data in millilitres per minute. The data in the following examples have been normalised to that without oscillations to calculate the enhancement factor”); determine that the hypoxemia dose index is greater than a threshold (Para. 0288, “From that input and/or stored data (such as look up tables, historical data, parameters, relationships, the graphs or the like) the controller determines the oxygenation requirement, step 21. The determination could take place through any processing, look up table, relationship (empirical or mathematical) or the like. Non-exhaustive examples of such input and determination processing are as follows. One or more alone or in combination could be used to make the oxygen requirement determination) and in response to determining that the hypoxemia dose index is greater than the threshold, cause the screen to output an alert when the patient is being transported to the care location (Para. 0289, “The controller then determines oxygenation requirements, step 21 , based on the level of risk and/or the user (e.g. anaesthetist or clinician) provides input indicative of the actual oxygenation requirement and/or dose/therapy settings and/or the actual parameter settings for the high flow gas delivery. Any of the input could be provided as a setting or range of settings or as one or more input values. The system could alert the user of the recommended settings or control the system to provide the settings, as to be described later”).
Regarding Claims 5 and 14, Oldfield teaches the medical device of Claim 4 and method of Claim 13, wherein the sensor comprises a blood oxygenation sensor and wherein the physiological parameter comprises a blood oxygen saturation of the patient (Para. 0214, “Using the plesythmograph signal from a pulse oximeter probe”).
Regarding Claims 6 and 15, Oldfield teaches the medical device of Claim 4 and method of Claim 13, wherein the sensor comprises a carbon dioxide sensor, and wherein the physiological parameter comprises an amount of CO2 in an airway of the patient (Para. 0224, “The oscillations 51/54 are synchronised so that as the heart expands, an increase in gas flow is delivered, flushing the CO2 from the airway and displacing it with oxygen from the flow source. As gas moves up the trachea as a result of the cardiogenic oscillation the gas flow is reduced to facilitate it coming up. As the gas goes down the trachea as a result of the cardiogenic oscillation the gas flow is increased. [0225] The oscillations 51/54 are synchronised so that as the heart expands, a decrease in gas flow is delivered (this could be positive, zero, or negative), causing a suction effect on the CO2 drawing it out from the airway and allowing oxygen to replace it when the flow is increased again”).
Regarding Claims 8 and 17, Oldfield teaches the medical device of Claim 4 and method of Claim 13, wherein the threshold being a first threshold (upper bounds of oxygenation requirement Para. 0155, “In one example, the base component is 30 litres/min to 105 litres/min, but could be 50 litres/min to 120 litres/min for an adult with BMI>40. The maximum and minimum flow rates can still fall within the instantaneous flow rate range, and the instantaneous flow rate range can still fall within the overall waveform flow rate range”), wherein determining the index by analyzing the portion of the measurements of the physiological parameter detected during the sub-interval of time comprises: determining a metric comprising a difference between the portion of the measurements of the physiological parameter detected during the sub-interval of time (Para. 0307 discusses monitoring measured oxygen and the oxygen required by a patient at a moment in time, and reoxygenating based on the difference between the hypoxic level and determined oxygenation requirement) and a second threshold (lower bounds of oxygenation requirement, Para. 0155, “In one example, the base component is 30 litres/min to 105 litres/min, but could be 50 litres/min to 120 litres/min for an adult with BMI>40. The maximum and minimum flow rates can still fall within the instantaneous flow rate range, and the instantaneous flow rate range can still fall within the overall waveform flow rate range”); and integrating the metric over a time interval at which the portion of the measurements of the physiological parameter detected during the sub-interval of time is below the second threshold (Para. 0276, “The initial clearance rate was calculated as the gradient of the concentration-time curve for the first five minutes of therapy and multiplied by the lung volume to obtain gas exchange data in millilitres per minute. The data in the following examples have been normalised to that without oscillations to calculate the enhancement factor”).
Regarding Claim 9, Oldfield teaches the medical device of Claim 4, the threshold being a first threshold (upper bound or lower bound of the determined oxygenation requirement), wherein the index is a function of: a maximum percentage change of the portion of the measurements of the physiological parameter (Para. 0318, “For example, if the SpO2 starts to decrease past 90%, the flow and or oxygen concentration (if not already at 100%) could increase to provide a higher level of support, step 25. If the end-tidal CO2 value or trend shows an increase, the therapy support could increase as a higher level of support is needed, step 25”).
Regarding Claim 20, Oldfield teaches the method of claim 13, further comprising: administering assisted ventilation to the patient (Para. 0258).
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.
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, 7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20180104426 awarded to Oldfield et al, hereinafter Oldfield, in view of U.S. Patent Publication 20170337338 awarded to Dunn et al, hereinafter Dunn.
Regarding Claim 1, Oldfield teaches a system and method of detecting a physiological parameter comprising: an oxygen saturation sensor configured to detect measurements of a blood oxygen saturation/physiological parameter of a patient (Para. 0049, “The apparatus may additionally comprise one or more sensors for measuring one or more physiological parameters of a patient, and/or one or more inputs for receiving a signal from one or more sensors for measuring physiological parameters of a patient, wherein the one or more physiological parameters are one or more of: heart activity, oxygen saturation, partial pressure of oxygen in the blood, respiratory rate, partial pressure of CO2 in the blood, exhaled CO2”); a screen configured to output a waveform indicative of the measurements of the blood oxygen saturation of the patient (Para. 0141, “An input/output interface 20 (such as a display and/or input device) is provided”, Para. 0213 states that a PPG blood oxygenation signal can be an output); an endotracheal (ET) tube configured to be disposed in an airway of the patient (Para. 0018); a ventilation device coupled to the ET tube and configured to administer assisted ventilation to the patient (flow source 12, Para. 0018); and a processor configured to: identify a time at which an anesthesia is being administered to the patient that is before the patient is intubated (Para. 0142, “The apparatus can also be operated to determine dose/oxygenation requirements (hereinafter “oxygen requirements”) of a patient for/in relation to anaesthesia (that is, the oxygen requirements pre-anaesthesia during a pre-oxygenation phase and/or the oxygen requirements during anaesthesia—which might include when the patient is apnoeic or when the patient is breathing), as well as after such a procedure, which may include the extubation period”); define a sub-interval of time that begins at the time (see Para. 0142, apnoeic or non-apnoeic phases after anaesthesia); identify a portion of the measurement of the blood oxygen saturation of the patient detected during the sub-interval of time (Para. 0249, “Sensing the oxygen saturation level and providing that to the controller enables automatic adjustment of the gas flow components to optimise the condition of the patient. The flow rate can be increased or decreased as oxygen saturation respectively decreases or increases”); determine a hypoxemia dose index (patient oxygen requirement) determining a metric comprising a difference between the portion of the measurements of the physiological parameter detected during the sub-interval of time (Para. 0307 discusses monitoring measured oxygen and the oxygen required by a patient at a moment in time, and reoxygenating based on the difference between the hypoxic level and determined oxygenation requirement) and a second threshold (lower bounds of oxygenation requirement, Para. 0155, “In one example, the base component is 30 litres/min to 105 litres/min, but could be 50 litres/min to 120 litres/min for an adult with BMI>40. The maximum and minimum flow rates can still fall within the instantaneous flow rate range, and the instantaneous flow rate range can still fall within the overall waveform flow rate range”); and integrating the metric over a time interval at which the portion of the measurements of the physiological parameter detected during the sub-interval of time is below the second threshold (Para. 0276, “The initial clearance rate was calculated as the gradient of the concentration-time curve for the first five minutes of therapy and multiplied by the lung volume to obtain gas exchange data in millilitres per minute. The data in the following examples have been normalised to that without oscillations to calculate the enhancement factor”) determine that the hypoxemia index is greater than a threshold (Para. 0308 discusses monitoring measured oxygen and the oxygen required by a patient at a moment in time) and in response to determining that the hypoxemia dose index is greater than the threshold, cause the screen to output an alert when the patient is being transported to the care location (Para. 0289, “The controller then determines oxygenation requirements, step 21, based on the level of risk and/or the user (e.g. anaesthetist or clinician) provides input indicative of the actual oxygenation requirement and/or dose/therapy settings and/or the actual parameter settings for the high flow gas delivery. Any of the input could be provided as a setting or range of settings or as one or more input values. The system could alert the user of the recommended settings or control the system to provide the settings, as to be described later”). Oldfield does not teach wherein the oxygen or the alert are determined when the patient is being transported to the care location.
However, in the art of patient intubation, Dunn teaches monitoring a patient during transport to a care center for the purpose of providing updated information about the state of a subject’s intubation (Paras. 0039-0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oldfield by Dunn, i.e. by providing an emergency intubation report as in Dunn in the intubation system of Oldfield, for the predictable purpose of improving intubation monitoring in the system of Oldfield as in Dunn.
Regarding Claims 7 and 16, Oldfield teaches the medical device of Claim 7 and the method of Claim 13. Oldfield does not teach wherein the sub-interval of time ends at a time at which the patient arrives at a care location while intubated.
However, in the art of patient intubation, Dunn teaches monitoring a patient during a sub-interval of time ending at the arrival at a care center for the purpose of providing updated information about the state of a subject’s intubation (Paras. 0039-0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oldfield by Dunn, i.e. by providing an emergency intubation report as in Dunn in the intubation system of Oldfield, for the predictable purpose of improving intubation monitoring in the system of Oldfield as in Dunn.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20230177882 awarded to Oldfield et al, hereinafter Oldfield, in view of U.S. Patent Publication 20170337338 awarded to Dunn et al, hereinafter Dunn, further in view of U.S. Patent Publication 20120041279 awarded to Freeman et al, hereinafter Freeman.
Regarding Claim 2, Oldfield modified by Dunn makes obvious the device of Claim 1. Oldfield further teaches a detection circuit configured to detect an electrocardiogram (ECG) of the patient (Para. 0211), wherein the screen is further configured to output a waveform indicative of the ECG of the patient (Para. 0211 states that ECG can be an output, Para. 0228 states that heart rate can control oxygenation parameters). Oldfield does not teach wherein the processor is further configured to: determine that the ECG is indicative of an arrhythmia during the sub-interval of time; and wherein the processor is further configured to: determine that the ECG is indicative of an arrhythmia during the sub-interval of time; and in response to determining that the ECG is indicative of the arrhythmia during the sub-interval of time, increasing the hypoxemia dose index.
However, in the art of intubation monitoring (Para. 0054), Freeman teaches monitoring EKG data for signs of arrhythmia to determine a subject’s respiration volume (Para. 0219).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oldfield by Freeman, i.e. by using signs of arrhythmia to monitor the respiration and respiration scores of Oldfield’s patients as in Freeman, for the predictable purpose of improving the monitoring of Oldfield in the same manner as in Freeman.
Regarding Claim 3, Oldfield modified by Dunn makes obvious the device of Claim 1. Oldfield further teaches the device further comprising detecting blood pressure and modulating a hypoxemia dose based on a detected blood pressure (Para. 0318). Oldfield does not teach wherein the screen is further configured to output an indication of the blood pressure of the patient, and wherein the processor is further configured to: determine that the blood pressure of the patient is below a threshold; and in response to determining that the blood pressure of the patient is below the threshold, increasing the hypoxemia dose index.
However, Freeman teaches detecting blood pressure measurements (Para. 0173) and comparing thresholds alongside further respiratory data to identify respiratory distress (Para. 0196).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oldfield by Freeman, i.e. by using blood pressure thresholds to monitor the respiration and respiration scores of Oldfield’s patients as in Freeman, for the predictable purpose of improving the monitoring of Oldfield in the same manner as in Freeman.
Claims 10-12 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20180104426 awarded to Oldfield et al, hereinafter Oldfield, in view of U.S. Patent Publication 20120041279 awarded to Freeman et al, hereinafter Freeman.
Regarding Claims 10 and 18, Oldfield teaches the system of Claim 4 and method of Claim 13, further comprising: a detection circuit configured to detect an electrocardiogram (ECG) of the patient (Para. 0211), wherein the screen is further configured to output a waveform indicative of the ECG of the patient (Para. 0211 states that ECG can be an output, Para. 0224 states that heart rate can control oxygenation parameters). Oldfield does not teach wherein the processor is further configured to: determine that the ECG is indicative of an arrhythmia during the sub-interval of time; and wherein the processor is further configured to: determine that the ECG is indicative of an arrhythmia during the sub-interval of time; and in response to determining that the ECG is indicative of the arrhythmia during the sub-interval of time, increasing the hypoxemia dose index.
However, in the art of intubation monitoring (Para. 0054), Freeman teaches monitoring EKG data for signs of arrhythmia to determine a subject’s respiration volume (Para. 0219).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oldfield by Freeman, i.e. by using signs of arrhythmia to monitor the respiration and respiration scores of Oldfield’s patients as in Freeman, for the predictable purpose of improving the monitoring of Oldfield in the same manner as in Freeman.
Regarding Claims 11 and 19, Oldfield teaches the device of Claim 4 and the method of Claim 13, further comprising detecting blood pressure and modulating a hypoxemia dose based on a detected blood pressure (Para. 0318). Oldfield does not teach wherein the screen is further configured to output an indication of the blood pressure of the patient, and wherein the processor is further configured to: determine that the blood pressure of the patient is below a threshold; and in response to determining that the blood pressure of the patient is below the threshold, increasing the hypoxemia dose index.
However, Freeman teaches detecting blood pressure measurements (Para. 0173) and comparing thresholds alongside further respiratory data to identify respiratory distress (Para. 0196).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oldfield by Freeman, i.e. by using blood pressure thresholds to monitor the respiration and respiration scores of Oldfield’s patients as in Freeman, for the predictable purpose of improving the monitoring of Oldfield in the same manner as in Freeman.
Regarding Claim 12, Oldfield teaches the medical device of claim 4, wherein the processor is further configured to: determine that the patient has a medical condition (Para. 0297, “The user enters pre-existing patient conditions. For example, if a patient is at risk of barotrauma the flow could be minimised to meet peak inspiratory demand but not deliver excess flow”), and in response to determining that the patient has the medical condition, increase the index (Para. 0297, “Examples of user input for determining oxygenation requirements and the resultant parameter settings are as follows”). Oldfield does not teach wherein the medical condition comprises anemia, cardiac disease, or pulmonary disease.
However, Freeman teaches the need to monitor the respiratory parameters of those with pulmonary disease and the differences between diseased and non-diseased individuals (Para. 0033-0034) for the purposes of determining appropriate extubation times (Para. 0036).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Oldfield by Freeman, i.e. by determining if a patient has pulmonary disease and adjusting the monitoring as appropriate in the system of Oldfield as in Freeman, for the predictable purpose of improving the monitoring of Oldfield as taught by Freeman.
Conclusion
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/JLM/
Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792