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 .
Response to Amendment
Examiner acknowledges the reply filed on 02/11/2026 in which claims 1 and 15 have been amended, claim 14 has been canceled, and claims 21-24 have been added. Currently, claims 1-5, 7-8, 10-13, 15-16, and 18-24 are pending for examination in this application.
Response to Arguments
Applicant has resolved the objection to the claims.
Applicant's arguments, see Remarks pg. 7-9, filed 02/11/2026, have been fully considered but they are not persuasive. Applicant argues that Rao does not teach determining the amount of the oxygen to be released to the user by calculating an oxygen delivery value based on a combination of the pre-determined amount of oxygen and the physiological parameter, specifically Rao does not teach the pre-determined amount of oxygen. Examiner disagrees as the FiO2 delivery value is based upon the pre-set parameters and the measured oxygen-saturation level of the patient, as established by [0026]. Additionally, [0027] discloses “The data received from the oxygen saturation sensor is processed by the microcontroller and sends instructions to the stepper motor driver which, in turn, drives the stepper motor in the desired direction to obtain desired mixture of oxygen/air in the inspired gases to keep the patient's oxygen saturation in the normal range.” which means the controller has a pre-set range for oxygen saturation that is at a “normal” range and/or a pre-set range for oxygen saturation that is out of a “normal” range. Thus, the FiO2 delivery value is based upon the pre-set parameters, which indicate the normal range and/or out of normal range for oxygen saturation, and the measured oxygen-saturation level of the patient.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-5, 7-8, 10-13, 15-16, 18-20, and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hutchon (WO 2022234238 A1) and Rao et al. (US 20090133695 A1).
Regarding claim 1, Hutchon discloses an oxygen production unit (oxygen concentrator 202; figures 3-4) comprising:
a separation unit (combination of pump 402, compressor 404, and chambers 405 and 406; figure 4) configured to separate oxygen from nitrogen in received gaseous particles (see [0074]; pump 402 and compressor 404 draw air in and chambers 405 and 406 separates the nitrogen and oxygen);
a control unit (electronic control unit 411; figure 4) comprising a processor configured to control an amount of the separated oxygen to be released to a user of the oxygen production unit ([0077] The control unit 411 adjusts the valves 408 and 409 to provide air or a set concentration of 0.sub.2 as determined by the clinical situation. The control unit 411 may be a microprocessor, CPU or any other suitable interface which maintains the frequency of the PSA to maintain the selected oxygen concentrations); and
a nitrogen release unit (first chamber (sieve bed) 405 and second chamber (sieve bed) 406; figure 4) configured to facilitate release of the separated nitrogen into an environment where the oxygen production unit is located ([0075] The first chamber (sieve bed) is vented to allow it to return to atmospheric pressure, this drop in pressure causes the zeolite adsorbent to release the adsorbed nitrogen to the atmosphere and the sieve bed is reset and capable of adsorbing further nitrogen); and, wherein the control unit (411) is configured to (see [0021] and [0029]-[0030]:
receive a value indicating pre-determined amount of oxygen to be released to the user ([0064] The level of oxygen delivered to the neonate or infant can be selected, displayed and recorded by a control unit 206 and visual indicator 207 which are components of the oxygen concentrator 202; also see 701 in figure 7);
receive a value indicating a physiological parameter measured directly from the user, including at least one of oxygen saturation (SpO2), using a physiological sensor associated with the user ([0084] the closed loop feedback controlling the oxygen concentration in the gas output can be determined by the oxygen saturation of the tissues using an oximeter 602 which measured the tissues oxygen saturation (SpO¾, typically in the a hand or foot of the infant or neonate; figure 6. [0086] feedback 702 from the oxygen sensor at the gas outlet, an oximeter or NIRS is received and recognized by the software algorithm; figure 7); and
determine the amount of the oxygen to be released to the user based on a combination of the pre-determined amount of oxygen and the physiological parameter ([0084] The software sensors for the Sp0.sub.2 and NIRS can be integrated into the control unit 411 or provided separately. The parameter and required range for the feedback is selectable by the clinician using the equipment. The switching software uses a value from the sensor 413, 601, 602 or 603 which represents the oxygen concentration (or Sp0.sub.2 or NIRS) to modify the switching frequency until the oxygen concentration falls within the selected and desired range; see 701 and 703 figure 7. [0087] The detected oxygen values 703 are computed by the microprocessor and appropriate action selected 704. The software enters a feedback loop which detects the analogue input from the oxygen sensor, oximeter or NIRS. If the input data is below the required mean oxygen concentration, the frequency of the switching/alternating is adjusted accordingly. The positive feedback loop continues and a second sensor reading is detected by the microprocessor, if necessary the alternating frequency is further adjusted. If the detected mean oxygen concentration data received from the oxygen sensor at the gas outlet, an oximeter or NIRS is within the required clinical range no change in the switching frequency is made. If the mean oxygen concentration is still too low a further adjustment to the alternation of frequency/switching is made until the required oxygen concentration is reached. This process is repeated until the optimal frequency switching is reached for the required oxygen concentration; figure 7. Examiner notes that the switching of the chambers controls the concentration of oxygen delivered, higher switching frequency reduces the amount of oxygen being delivered as supported by [0072] and [0078]).
Hutchon does not disclose calculating an oxygen delivery value based on a combination of the pre-determined amount of oxygen and the physiological parameter, and wherein the oxygen production unit further comprise a mix unit configured to: receive a value indicating the amount of the oxygen to be released to the user from the control unit; and mixing the separated oxygen with a corresponding amount of gas to produce a customized oxygen-air mixture that achieves the calculated delivery value.
However, Rao teaches a mechanical ventilator system (title; figure 1) wherein the control unit ([0026] FiO.sub.2 autoregulator 22; figure 1) is configured to: determine the amount of the oxygen to be released to the user by calculating an oxygen delivery value ([0026-0028] FiO.sub.2) based on a combination of a pre-determined amount of oxygen ([0026] depending upon pre-set parameters. [0027] keep the patient's oxygen saturation in the normal range) and a physiological parameter ([0026] A suitable sensor or measuring device, such as an infrared pulse-oxygen probe 20 is used for measuring oxygen saturation in a patient's blood. The sensor is in communication with a controller that regulates the fraction of inspired oxygen (FiO.sub.2) of the output oxygen from the air-oxygen blender. [0027] The real-time autoregulation of blended oxygen is achieved through the use of an oxygen saturation measuring device, such as a pulse-oxygen sensor, which is well-known in the art. Preferably, a miniaturized pulse-oxygen sensor is incorporated in the microprocessor controlled stepper motor driver unit 22, to be described below. The data received from the oxygen saturation sensor is processed by the microcontroller and sends instructions to the stepper motor driver which, in turn, drives the stepper motor in the desired direction to obtain desired mixture of oxygen/air in the inspired gases to keep the patient's oxygen saturation in the normal range); and further comprising a mix unit ([0028] air-oxygen blender 24; figure 1) configured to:
receive a value indicating the amount of the oxygen to be released to the user from the control unit ([0026] Depending upon the measured oxygen-saturation level in patient P, measured by sensor 20, the FiO.sub.2 autoregulator 22 generates control signals, which are received by air-oxygen blender 24 to produce an FiO.sub.2 mix having the desired and necessary proportion of oxygen, depending upon pre-set parameters); and
mixing oxygen with a corresponding amount of gas to produce a customized oxygen-air mixture that achieves the calculated delivery value ([0028] The air-oxygen blender 24 receives air from the environment and oxygen from a pure oxygen source (such as bottled, pressurized oxygen, for example) and outputs the FiO.sub.2 mix, as indicated by the directional arrow in FIG. 1. The FiO.sub.2 mix is delivered to the patient P by the negative pressure vortex generator 26, along a flow path which feeds directly to the patient P; figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the control unit of Hutchon to calculate an FiO2 value based on the predetermined level of oxygen and the measured SpO2 from the oximeter and implement an air-oxygen blender to receive the FiO2 value and output an FiO2 mix comprising the separated oxygen and air to achieve the desired FiO2, in order to provide real-time autoregulation of blended oxygen as taught by Rao [0027].
Regarding claim 3, the modified invention of Hutchon discloses the oxygen production unit of claim 1, Hutchon teaches wherein the nitrogen release unit (405 and 406) comprises an outlet (nitrogen vents 410; figure 4) openable to the ambient environment ([0075] when the valves are closed and gas is vented to the atmosphere via nitrogen vents 410), and is configured to facilitate the release of the separated nitrogen into the environment ([0075] The first chamber (sieve bed) is vented to allow it to return to atmospheric pressure, this drop in pressure causes the zeolite adsorbent to release the adsorbed nitrogen to the atmosphere and the sieve bed is reset and capable of adsorbing further nitrogen…when the valves are closed and gas is vented to the atmosphere via nitrogen vents 410).
Regarding claim 4, the modified invention of Hutchon discloses the oxygen production unit of claim 1, Hutchon teaches wherein the nitrogen release unit comprises a container (chambers 405 and 406) configured to house a piece absorbed with the separated nitrogen ([0074] first 405 and second 406 chambers each containing the microporous, six-sided aluminosilicate, zeolite, or any other suitable material, which provides a molecular sieve bed that adsorbs nitrogen from atmospheric air); and, wherein facilitating the release of the nitrogen comprises:
generating a pressure difference in the container to facilitate the separated nitrogen to be released into the environment ([0075] Once air has been forced through the first chamber 405, the first sieve bed is filled up with adsorbed nitrogen and oxygen rich air is expelled from the device. Subsequently, when the first sieve bed is saturated, the gas flow is switched and compressed air is moved to the second sieve bed. The first chamber (sieve bed) is vented to allow it to return to atmospheric pressure, this drop in pressure causes the zeolite adsorbent to release the adsorbed nitrogen to the atmosphere and the sieve bed is reset and capable of adsorbing further nitrogen).
Regarding claim 5, the modified invention of Hutchon discloses the oxygen production unit of claim 4, Hutchon teaches wherein the nitrogen release unit (chambers 405 and 406) comprises an outlet openable to the ambient environment (nitrogen vents 410; figure 4); and, wherein the separated nitrogen is released from the container to the ambient environment through the outlet ([0075] when the valves are closed and gas is vented to the atmosphere via nitrogen vents 410).
Regarding claim 7, the modified invention of Hutchon discloses the oxygen production unit of claim 1, Hutchon teaches wherein determining the amount of the oxygen to be released to the user based on the pre-determined amount of oxygen and the physiological parameter (see [0087]) comprises:
determining an adjustment value in the amount of the oxygen to be released to the user based on the pre-determined amount of oxygen and the physiological parameter to obtain (see [0087] the adjustment value is the frequency of switching which directly correlates to the concentration of oxygen being delivered as supported by [0072] and [0078]).
Regarding claim 8, the modified invention of Hutchon discloses the oxygen production unit of claim 4, Hutchon teaches wherein the control unit is further configured to determine a nitrogen level in the piece exceeds a threshold level and generate a signal to alert that nitrogen level in the piece has exceeded the threshold level ([0075] Once air has been forced through the first chamber 405, the first sieve bed is filled up with adsorbed nitrogen and oxygen rich air is expelled from the device. Subsequently, when the first sieve bed is saturated, the gas flow is switched and compressed air is moved to the second sieve bed. Additionally, see [0078] The control unit 411 is capable of detecting when the zeolite needs replacing). Examiner notes that the nitrogen level exceeds a threshold level when the sieve bed is saturated, and the signal to alert that nitrogen level in the piece has exceeded the threshold level is the controller switching the gas flow to the second sieve bed.
Regarding claim 10, the modified invention of Hutchon discloses the oxygen production unit of claim 1, Hutchon teaches further comprising a humidification unit configured to humidify the separated oxygen before being released to the user ([0055] Optionally, the device may include a humidifier to humidify the gas expelled by the device).
Regarding claim 11, the modified invention of Hutchon discloses the oxygen production unit of claim 1, Hutchon teaches further comprising a heat unit configured to heat the separated oxygen before being released to the user ([0055] The device may also include a warmer or heating means to heat the gas expelled by the device).
Regarding claim 12, the modified invention of Hutchon discloses the oxygen production unit of claim 1, Hutchon teaches further comprising a physiological parameter measurement unit including one or more measurement instruments configured to measure one or more physiological parameters of the user ([0084] the closed loop feedback controlling the oxygen concentration in the gas output can be determined by the oxygen saturation of the tissues using an oximeter 602 which measured the tissues oxygen saturation (SpO?, typically in the a hand or foot of the infant or neonate); and, wherein the control unit is configured to control the amount of the separated oxygen to be released to the user based on the physiological parameters ([0084] The parameter and required range for the feedback is selectable by the clinician using the equipment. The switching software uses a value from the sensor 413, 601, 602 or 603 which represents the oxygen concentration (or Sp0.sub.2 or NIRS) to modify the switching frequency until the oxygen concentration falls within the selected and desired range).
Regarding claim 13, the modified invention of Hutchon discloses the oxygen production unit of claim 12, Hutchon teaches further comprising a physiological determination unit (microprocessor of the control unit 411) configured to determine an upper physiological limit and a lower physiological limit based on a pre-determined amount of oxygen ([0087] The detected oxygen values 703 are computed by the microprocessor and appropriate action selected 704. The software enters a feedback loop which detects the analogue input from the oxygen sensor, oximeter or NIRS; figure 7. Upper physiological limit is at “oxygen sensor high” lower physiological limit is at “oxygen sensor low”); and, wherein the control unit is configured to control the amount of the separated oxygen to be released to the user based on the upper physiological limit and the lower physiological limit ([0087] If the input data is below the required mean oxygen concentration, the frequency of the switching/alternating is adjusted accordingly. The positive feedback loop continues and a second sensor reading is detected by the microprocessor, if necessary the alternating frequency is further adjusted. Examiner notes that the switching of the chambers controls the concentration of oxygen delivered, higher switching frequency reduces the amount of oxygen being delivered as supported by [0072] and [0078]).
Regarding claim 15, Hutchon discloses a method for producing oxygen (figure 7), the method being implemented by a processor in an oxygen production unit (electronic control unit 411; figure 4; see [0077]), the method comprising: controlling separation of oxygen from nitrogen in gaseous particles received by the oxygen production unit ([0074] Air enters the air inlet 403 under the action of a motorized pump 402 of an oil free compressor 404 which is located within the housing 401. The compressor draws in ambient air, increases the air pressure to approximately 2-3 atmospheres to deliver a continuous stream of compressed (pressurised) air to the first 405 and second 406 chambers each containing the microporous, six-sided aluminosilicate, zeolite, or any other suitable material, which provides a molecular sieve bed that adsorbs nitrogen from atmospheric air so that the relative quantities of oxygen leaving the chamber are higher than those entering the chamber. The sieve beds function to increase the oxygen concentration of gas leaving the chamber; figure 4); controlling an amount of the separated oxygen to be released to a user of the oxygen production unit ([0075] Once air has been forced through the first chamber 405, the first sieve bed is filled up with adsorbed nitrogen and oxygen rich air is expelled from the device. [0077] The control unit 411 may be a microprocessor, CPU or any other suitable interface which maintains the frequency of the PSA to maintain the selected oxygen concentrations); facilitating release of the separated nitrogen into an environment where the oxygen production unit is located ([0075] The first chamber (sieve bed) is vented to allow it to return to atmospheric pressure, this drop in pressure causes the zeolite adsorbent to release the adsorbed nitrogen to the atmosphere and the sieve bed is reset and capable of adsorbing further nitrogen…when the valves are closed and gas is vented to the atmosphere via nitrogen vents 410); and, wherein controlling the amount of the separated oxygen to be released to the user of the oxygen production unit comprises:
receiving a value indicating pre-determined amount of oxygen to be released to the user ([0064] The level of oxygen delivered to the neonate or infant can be selected, displayed and recorded by a control unit 206 and visual indicator 207 which are components of the oxygen concentrator 202; also see 701 in figure 7);
receiving a value indicating a physiological parameter measured from the user, including oxygen saturation using a physiological sensor directly associated with the user([0084] the closed loop feedback controlling the oxygen concentration in the gas output can be determined by the oxygen saturation of the tissues using an oximeter 602 which measured the tissues oxygen saturation (SpO¾, typically in the a hand or foot of the infant or neonate; figure 6. [0086] feedback 702 from the oxygen sensor at the gas outlet, an oximeter or NIRS is received and recognized by the software algorithm; figure 7); and
determining the amount of the oxygen to be released to the user based on a combination of the pre-determined amount of oxygen and the physiological parameter([0084] The software sensors for the Sp0.sub.2 and NIRS can be integrated into the control unit 411 or provided separately. The parameter and required range for the feedback is selectable by the clinician using the equipment. The switching software uses a value from the sensor 413, 601, 602 or 603 which represents the oxygen concentration (or Sp0.sub.2 or NIRS) to modify the switching frequency until the oxygen concentration falls within the selected and desired range; see 701 and 703 figure 7. [0087] The detected oxygen values 703 are computed by the microprocessor and appropriate action selected 704. The software enters a feedback loop which detects the analogue input from the oxygen sensor, oximeter or NIRS. If the input data is below the required mean oxygen concentration, the frequency of the switching/alternating is adjusted accordingly. The positive feedback loop continues and a second sensor reading is detected by the microprocessor, if necessary the alternating frequency is further adjusted. If the detected mean oxygen concentration data received from the oxygen sensor at the gas outlet, an oximeter or NIRS is within the required clinical range no change in the switching frequency is made. If the mean oxygen concentration is still too low a further adjustment to the alternation of frequency/switching is made until the required oxygen concentration is reached. This process is repeated until the optimal frequency switching is reached for the required oxygen concentration; figure 7. Examiner notes that the switching of the chambers controls the concentration of oxygen delivered, higher switching frequency reduces the amount of oxygen being delivered as supported by [0072] and [0078]); and wherein the method further comprises:
receiving a value indicating the amount of the oxygen to be released to the user ([0064] The level of oxygen delivered to the neonate or infant can be selected, displayed and recorded by a control unit 206 and visual indicator 207 which are components of the oxygen concentrator 202; also see 701 in figure 7).
Hutchon does not disclose calculating an oxygen delivery value based on a combination of the pre-determined amount of oxygen and the physiological parameter; and mixing the separated oxygen a corresponding amount of gas to produce a customized oxygen-air mixture that achieves the calculated delivery value.
However, Rao teaches a mechanical ventilator system (title; figure 1) comprising a method implemented by a processor ([0026] FiO.sub.2 autoregulator 22; figure 1) the method comprising: determining the amount of the oxygen to be released to the user by calculating an oxygen delivery value ([0026-0028] FiO.sub.2) based on a combination of a pre-determined amount of oxygen ([0026] depending upon pre-set parameters. [0027] keep the patient's oxygen saturation in the normal range) and a physiological parameter ([0026] A suitable sensor or measuring device, such as an infrared pulse-oxygen probe 20 is used for measuring oxygen saturation in a patient's blood. The sensor is in communication with a controller that regulates the fraction of inspired oxygen (FiO.sub.2) of the output oxygen from the air-oxygen blender. [0027] The real-time autoregulation of blended oxygen is achieved through the use of an oxygen saturation measuring device, such as a pulse-oxygen sensor, which is well-known in the art. Preferably, a miniaturized pulse-oxygen sensor is incorporated in the microprocessor controlled stepper motor driver unit 22, to be described below. The data received from the oxygen saturation sensor is processed by the microcontroller and sends instructions to the stepper motor driver which, in turn, drives the stepper motor in the desired direction to obtain desired mixture of oxygen/air in the inspired gases to keep the patient's oxygen saturation in the normal range); and further comprising a mix unit ([0028] air-oxygen blender 24; figure 1) configured to:
receive a value indicating the amount of the oxygen to be released to the user from the control unit ([0026] Depending upon the measured oxygen-saturation level in patient P, measured by sensor 20, the FiO.sub.2 autoregulator 22 generates control signals, which are received by air-oxygen blender 24 to produce an FiO.sub.2 mix having the desired and necessary proportion of oxygen, depending upon pre-set parameters); and
mixing oxygen with a corresponding amount of gas to produce a customized oxygen-air mixture that achieves the calculated delivery value ([0028] The air-oxygen blender 24 receives air from the environment and oxygen from a pure oxygen source (such as bottled, pressurized oxygen, for example) and outputs the FiO.sub.2 mix, as indicated by the directional arrow in FIG. 1. The FiO.sub.2 mix is delivered to the patient P by the negative pressure vortex generator 26, along a flow path which feeds directly to the patient P; figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the processor of Hutchon to calculate an FiO2 value based on the predetermined level of oxygen and the measured SpO2 from the oximeter an implement an air-oxygen blender to receive the FiO2 value and output an FiO2 mix comprising the separated oxygen and air to achieve the desired FiO2, in order to provide real-time autoregulation of blended oxygen as taught by Rao [0027].
Regarding claim 16, the modified invention of Hutchon discloses the method of claim 15, Hutchon teaches wherein oxygen production unit comprises a container (chambers 405 and 406) configured to house a piece absorbed with the separated nitrogen ([0074] first 405 and second 406 chambers each containing the microporous, six-sided aluminosilicate, zeolite, or any other suitable material, which provides a molecular sieve bed that adsorbs nitrogen from atmospheric air); and, wherein facilitating the release of the nitrogen comprises: generating a pressure difference in the container to facilitate the separated nitrogen to be released into the environment ([0075] Once air has been forced through the first chamber 405, the first sieve bed is filled up with adsorbed nitrogen and oxygen rich air is expelled from the device. Subsequently, when the first sieve bed is saturated, the gas flow is switched and compressed air is moved to the second sieve bed. The first chamber (sieve bed) is vented to allow it to return to atmospheric pressure, this drop in pressure causes the zeolite adsorbent to release the adsorbed nitrogen to the atmosphere and the sieve bed is reset and capable of adsorbing further nitrogen).
Regarding claim 18, the modified invention of Hutchon discloses the method of claim 1, Hutchon teaches determining the amount of the oxygen to be released to the user based on the pre-determined amount of oxygen and the physiological parameter (see [0087]) comprises: determining an adjustment value in the amount of the oxygen to be released to the user based on the pre-determined amount of oxygen and the physiological parameter to obtain (see [0087] the adjustment value is the frequency of switching which directly correlates to the concentration of oxygen being delivered as supported by [0072] and [0078]).
Regarding claim 19, the modified invention of Hutchon discloses the method of claim 16, Hutchon teaches wherein facilitating the release of the separated nitrogen into the environment where the oxygen production unit is located comprises: determining a nitrogen level in the piece exceeds a threshold level and generate a signal to alert that nitrogen level in the piece has exceeded the threshold level ([0075] Once air has been forced through the first chamber 405, the first sieve bed is filled up with adsorbed nitrogen and oxygen rich air is expelled from the device. Subsequently, when the first sieve bed is saturated, the gas flow is switched and compressed air is moved to the second sieve bed. Additionally, see [0078] The control unit 411 is capable of detecting when the zeolite needs replacing). Examiner notes that the nitrogen level exceeds a threshold level when the sieve bed is saturated, and the signal to alert that nitrogen level in the piece has exceeded the threshold level is the controller switching the gas flow to the second sieve bed.
Regarding claim 20, the modified invention of Hutchon discloses the method of claim 15, Hutchon teaches further comprising: determining an upper physiological limit and a lower physiological limit based on a pre-determined amount of oxygen ([0087] The detected oxygen values 703 are computed by the microprocessor and appropriate action selected 704. The software enters a feedback loop which detects the analogue input from the oxygen sensor, oximeter or NIRS; figure 7. Upper physiological limit is at “oxygen sensor high” lower physiological limit is at “oxygen sensor low”); and, wherein the control the amount of the separated oxygen to be released to the user is based on the upper physiological limit and the lower physiological limit ([0087] If the input data is below the required mean oxygen concentration, the frequency of the switching/alternating is adjusted accordingly. The positive feedback loop continues and a second sensor reading is detected by the microprocessor, if necessary the alternating frequency is further adjusted. Examiner notes that the switching of the chambers controls the concentration of oxygen delivered, higher switching frequency reduces the amount of oxygen being delivered as supported by [0072] and [0078]).
Regarding claim 22, the modified invention of Hutchon discloses the oxygen production unit of claim 1, Rao teaches wherein the mix unit ([0028] air-oxygen blender 24; figure 1) includes an oxygen sensor and a feedback loop ([0026] The real-time FiO.sub.2 autoregulator 22 communicates directly with the air-oxygen blender 24 through wires, cables, a wireless electromagnetic interface or the like. Depending upon the measured oxygen-saturation level in patient P, measured by sensor 20, the FiO.sub.2 autoregulator 22 generates control signals, which are received by air-oxygen blender 24 to produce an FiO.sub.2 mix having the desired and necessary proportion of oxygen, depending upon pre-set parameters) to maintain a preset oxygen-to-air ratio in the released gas ([0028] The air-oxygen blender 24 receives air from the environment and oxygen from a pure oxygen source (such as bottled, pressurized oxygen, for example) and outputs the FiO.sub.2 mix, as indicated by the directional arrow in FIG. 1. The FiO.sub.2 mix is delivered to the patient P by the negative pressure vortex generator 26, along a flow path which feeds directly to the patient P; figure 1. Examiner notes that the FiO.sub.2 mix is determined and therefore preset by the FiO.sub.2 autoregulator 22 before the air-oxygen blender 24 produces the released mixture of gas).
Regarding claim 23, the modified invention of Hutchon discloses the oxygen production unit of claim 3, Hutchon teaches wherein the nitrogen release unit (405 and 406; figure 4) is further configured to reduce ambient oxygen concentration around the user ([0075] Once air has been forced through the first chamber 405, the first sieve bed is filled up with adsorbed nitrogen and oxygen rich air is expelled from the device. Subsequently, when the first sieve bed is saturated, the gas flow is switched and compressed air is moved to the second sieve bed. The first chamber (sieve bed) is vented to allow it to return to atmospheric pressure, this drop in pressure causes the zeolite adsorbent to release the adsorbed nitrogen to the atmosphere and the sieve bed is reset and capable of adsorbing further nitrogen) to mitigate fire hazards (this is a functional limitation: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). According to applicant’s specifications [0035] releasing nitrogen to the ambient air reduces risk of fire hazards caused by high oxygen density in the ambient air. As such, Hutchon discloses releasing nitrogen to the atmosphere and achieves the effect of mitigating fire hazards).
Regarding claim 24, the modified invention of Hutchon discloses the oxygen production unit of claim 4, Hutchon teaches further comprising an adsorbent swapping unit ([0075] The control of flow between first and second chambers (interchangeably called sieve beds) is regulated by two solenoid valves 408 and 409, or alternatively a four-way solenoid valve, each controlled by an electronic control unit 411; figure 4) operatively connected to the container (chambers 405 and 406; figure 4), wherein the swapping unit automatically replaces a saturated adsorbent piece with a fresh adsorbent piece upon detection of nitrogen saturation ([0075] Once air has been forced through the first chamber 405, the first sieve bed is filled up with adsorbed nitrogen and oxygen rich air is expelled from the device. Subsequently, when the first sieve bed is saturated, the gas flow is switched and compressed air is moved to the second sieve bed. The first chamber (sieve bed) is vented to allow it to return to atmospheric pressure, this drop in pressure causes the zeolite adsorbent to release the adsorbed nitrogen to the atmosphere and the sieve bed is reset and capable of adsorbing further nitrogen. The control of flow between first and second chambers (interchangeably called sieve beds) is regulated by two solenoid valves 408 and 409, or alternatively a four-way solenoid valve, each controlled by an electronic control unit 411. [0076] The presence of two of more chambers 405 and 406 permits the near continuous production of concentrated oxygen if so required. This arrangement also allows pressure equalization between the two chambers. The first 408 and second 409 valves alternate so that the first 405 and second 406 chambers are filled sequentially).
Claim(s) 1-2 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20220241540 A1) and Rao et al. (US 20090133695 A1).
Regarding claim 1, Wang discloses an oxygen production unit (portable oxygen concentrator; figures 1-3) comprising:
a separation unit (combination of pump and zeolite beds A and B; figures 2A-2D) configured to separate oxygen from nitrogen in received gaseous particles ([0092] compressed air is fed into zeolite bed A. Nitrogen and argon molecules are trapped in zeolite bed A, while oxygen is allowed to flow through zeolite bed A);
a control unit (circuit board; figure 3) comprising a processor ([0019] In another embodiment, the portable oxygen concentrator may further comprise at least one sensor and a processor) configured to control an amount of the separated oxygen to be released to a user of the oxygen production unit ([0019] The sensor may be configured to detect at least one physiological parameter of the user. The processor may be configured to adjust an amount of oxygen released to the user based on the detected at least one physiological parameter);
a nitrogen release unit (column 1 and 2; figure 3/zeolite bed A and B; figure 2A-2D) configured to facilitate release of the separated nitrogen into an environment where the oxygen production unit is located (see [0092] and figures 2A-2B and 2C-2D); and wherein the control unit is configured to:
receive a value indicating pre-determined amount of oxygen to be released to the user ([0019] the processor may be configured to generate an alarm when the detected at least one physiological parameter is above or below a predetermined threshold. Examiner notes that the predetermined threshold is the value indicating a pre-determined amount of oxygen to be released to the user, also see [0055], [0070], and [0076]);
receive a value indicating a physiological parameter measured directly from the user, including at least one of oxygen saturation (SpO2), or heart rate, using a physiological sensor associated with the user ([0019] In some embodiments, the sensor may comprise at least one of a pulse oximeter, differential pressure sensor, ECG, EEG, gyroscope, accelerometer, or any combination thereof. The physiological parameter of the user detected may comprise at least one of volume of air breath, CO.sub.2concentration in air exhaled, SpO.sub.2 concentration, heart rate, pulse rate, average breaths per minute, inhale pressure, exhale pressure, sound of breath, or any combination thereof); and
determine the amount of the oxygen to be released to the user by calculating an oxygen delivery value based on a combination of the pre-determined amount and the physiological parameter (see [0153] describes thresholds for oxygen saturation. [0154] To run the adaptive device, the device's adaptive algorithm relies on third party SpO.sub.2 to be the primary controlling variable for its operation. If the SpO.sub.2 is high or normal, then the device will adjust itself to save power and if a low SpO.sub.2 was detected then this would be a key indicator of low oxygen and signal an increase in oxygen production requirements to the user).
Wang does not disclose calculating an oxygen delivery value based on a combination of the pre-determined amount of oxygen and the physiological parameter, and wherein the oxygen production unit further comprise a mix unit configured to: receive a value indicating the amount of the oxygen to be released to the user from the control unit; and mixing the separated oxygen with a corresponding amount of gas to produce a customized oxygen-air mixture that achieves the calculated delivery value.
However, Rao teaches a mechanical ventilator system (title; figure 1) wherein the control unit ([0026] FiO.sub.2 autoregulator 22; figure 1) is configured to: determine the amount of the oxygen to be released to the user by calculating an oxygen delivery value ([0026-0028] FiO.sub.2) based on a combination of a pre-determined amount of oxygen ([0026] depending upon pre-set parameters. [0027] keep the patient's oxygen saturation in the normal range) and a physiological parameter ([0026] A suitable sensor or measuring device, such as an infrared pulse-oxygen probe 20 is used for measuring oxygen saturation in a patient's blood. The sensor is in communication with a controller that regulates the fraction of inspired oxygen (FiO.sub.2) of the output oxygen from the air-oxygen blender. [0027] The real-time autoregulation of blended oxygen is achieved through the use of an oxygen saturation measuring device, such as a pulse-oxygen sensor, which is well-known in the art. Preferably, a miniaturized pulse-oxygen sensor is incorporated in the microprocessor controlled stepper motor driver unit 22, to be described below. The data received from the oxygen saturation sensor is processed by the microcontroller and sends instructions to the stepper motor driver which, in turn, drives the stepper motor in the desired direction to obtain desired mixture of oxygen/air in the inspired gases to keep the patient's oxygen saturation in the normal range); and further comprising a mix unit ([0028] air-oxygen blender 24; figure 1) configured to:
receive a value indicating the amount of the oxygen to be released to the user from the control unit ([0026] Depending upon the measured oxygen-saturation level in patient P, measured by sensor 20, the FiO.sub.2 autoregulator 22 generates control signals, which are received by air-oxygen blender 24 to produce an FiO.sub.2 mix having the desired and necessary proportion of oxygen, depending upon pre-set parameters); and
mixing oxygen with a corresponding amount of gas to produce a customized oxygen-air mixture that achieves the calculated delivery value ([0028] The air-oxygen blender 24 receives air from the environment and oxygen from a pure oxygen source (such as bottled, pressurized oxygen, for example) and outputs the FiO.sub.2 mix, as indicated by the directional arrow in FIG. 1. The FiO.sub.2 mix is delivered to the patient P by the negative pressure vortex generator 26, along a flow path which feeds directly to the patient P; figure 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the control unit of Wang to calculate an FiO2 value based on the predetermined level of oxygen and the measured SpO2 from the oximeter an implement an air-oxygen blender to receive the FiO2 value and output an FiO2 mix comprising the separated oxygen and air to achieve the desired FiO2, in order to provide real-time autoregulation of blended oxygen as taught by Rao [0027].
Regarding claim 2, the modified invention of Wang discloses the oxygen production unit of claim 1, Wang teaches wherein the nitrogen release unit comprises a first outlet connectable to a first inlet of a cannula to form a first channel, and a second outlet connectable to a second inlet of the cannula to form a second channel (see [0128]; figures 2A-2D and 15, and Examiner Annotations 1), wherein the first channel facilitates releasing the separated nitrogen into the ambient environment through the cannula (see figure 2B), and the second channel facilitates the separated oxygen into a nose of the user through the cannula (see figure 2B and [0129] patient interface at oxygen outlet), the first channel and the second channel are insulated from each other (see [0128] the channels are insulated from each other via the set of valves).
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Examiner Annotations 1
Regarding claim 21, the modified invention of Wang discloses the oxygen production unit of claim 1, further comprising a remote communication module ([0071] In some embodiments, the POC may comprise a wireless receiver in order to receive data from various remote devices. The remote devices may include, but are not limited to, a computer, a smartphone, or a wearable device; figure 1) configured to receive adjustment commands for oxygen delivery parameters from an external respiratory therapist ([0070] As illustrated in FIG. 1, the portable oxygen concentrator (POC) may store user health diagnostics. Practitioners and clinicians, for example “doctor” in FIG. 1, may be able to retrieve this stored user health data and prescribe better oxygen flow presets for the user. In another embodiment, the POC may be able to couple to various remote devices, including smart phone, computer, tablet, smart bands, or other wearable devices. The POC may connect to other remote devices wirelessly or via cables, such as a USB cable; figure 1).
Conclusion
THIS ACTION IS MADE FINAL. 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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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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