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
The amendment filed 3/4/2026 has been entered. Applicant's amendments overcome the previous 35 USC § 102 rejections. Claims 1, 19, and 27 have been amended. Claims 1-31 remain pending.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-2, 18, and 30, and claims 3-17 by dependency, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “wherein the manifold comprises a first hose line and a second hose line fluidly coupled to the breathing component and respectively coupled to the normoxia fluid source and the hypoxia fluid source, the first hose line and the second hose line being separate to the manifold”, ln 10-13. This limitation is indefinite because it is unclear if the first hose line and the second hose line are part of the manifold or if the first hose line and the second hose line are separate to the manifold. For the purposes of this Office Action, this limitation will be interpreted as the first hose line and the second hose line being part of the manifold.
Claim 2 recites “a first hose and a second hose”, line 1-2. It is unclear if these correspond to the first hose line and second hose line in claim one. For the purposes of this Office Action, “a first hose and a second hose” is interpreted as referring to the first hose line and the second hose line, respectively.
Claim 18 recites the limitation “a normoxia fluid line” in line 2 and “a hypoxia fluid line” in line 3. It is unclear if these are referring to the first hose line and the second hose line of claim 1 or different fluid lines. For the purposes of this Office Action, “a normoxia fluid line” and “a hypoxia fluid line” are interpreted as referring to the first hose line and the second hose line, respectively.
Claim 30 recites “a hypoxia fluid line and a normoxia fluid line”, line 1-2. It is unclear if these are referring to the first hose and second hose introduced in claim 27. For the purposes of this Office Action, “a hypoxia fluid line and a normoxia fluid line” is interpreted as referring to the first hose and second hose of claim 27.
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 1-7, 11-14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch (US 20060185669 A1), in view of Squibb (US 20190126096 A1), and further in view of Burton et al. (US 6349724 B1), hereafter Burton.
Regarding claim 1, as best understood based on the 35 U.S.C. 112(b) issue identified above, Bassovitch discloses an apparatus for providing intermittent normoxia and hypoxia intervals to a subject (par. 0001 ln 4-10), the apparatus comprising: a breathing component configured to engage the subject to deliver at least one fluid to the subject for breathing (Fig. 9, mask 23; par. 0058); a normoxia fluid source coupled to the breathing component (Fig. 9, ambient air supply; par. 0059); a hypoxia fluid source coupled to the breathing component (Fig. 9, hypoxic air supply; par. 0059); a manifold fluidly coupled to the breathing component (Fig. 9, 3/2 port switch 18 serves as a manifold) and arranged between the normoxia fluid source and the breathing component (Fig. 9, 3/2 port switch is between ambient air supply and mask 23) and the hypoxia fluid source and the breathing component (Fig. 9, 3/2 port switch is between hypoxic air supply and mask 23) to deliver fluid from the normoxia fluid source to the breathing component and deliver fluid from the hypoxia fluid source to the breathing component (3/2 port switch delivers of hypoxic and ambient air to user, par. 0060); at least one valve configured to disrupt a flow of fluid from at least one of the normoxia fluid source and the hypoxia fluid source (3/2 port switch comprises a valve which regulates flow of ambient and hypoxic air; par. 0060); and a control system configured to: cause the at least one valve to switch between delivery of fluid from the normoxia fluid source and the hypoxia fluid source (Fig. 9, controller 2 sends control signal to 3/2 port switch 18).
Bassovitch does not disclose maintaining a positive fluid pressure at the breathing component over a range of breathing by the subject with varying breathing frequencies and tidal volumes.
Squibb teaches an apparatus for providing normoxic and hypoxic air (apparatus switches between providing high oxygen concentration air and low oxygen concentration air, par. 0002; inhalation air is provided at a first and second concentration, par. 0028; a first concentration of inhalation air can be 20.9% while a second concentration of inhalation air is below 20.9%, par. 0129) configured to maintain a positive fluid pressure at the breathing component over a range of breathing by the subject with varying breathing frequencies and tidal volumes [higher oxygen concentration compartment and lower oxygen concentration compartment both provide positive pressure to the user, par. 0057; one of ordinary skill in the art would recognize that a breathing frequency and tidal volume of a subject varies and does not remain exactly consistent over time, therefore the positive pressure provided by both compartments would be maintained over a range of breathing by the subject with varying breathing frequencies and tidal volumes; the apparatus can also be used for athletic training (par. 0185) in which case the breathing frequency and tidal volume of a subject would vary with exertion] for the purpose of supporting inhalation and increasing comfort for individuals with compromised respiratory systems by making them feel like it is easier to breathe (par. 0045-0046).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Bassovitch to maintain a positive fluid pressure at the breathing component as taught by Squibb for the purpose of supporting inhalation and increasing comfort for individuals with compromised respiratory systems by making them feel like it is easier to breathe (Squibb par. 0045-0046).
The modified Bassovitch does not disclose wherein the manifold comprises a first hose line and a second hose line fluidly coupled to the breathing component and respectively coupled to the normoxia fluid source and the hypoxia fluid source, the first hose line and the second hose line being separate to the manifold.
Burton teaches a respiratory apparatus (abstract ln 1-2) wherein a manifold (dual pressure hose 50; Fig. 1, col. 5 ln 41-44) comprises a first hose line (high pressure side 51; Fig. 1, col. 5 ln 41-44) and a second hose line (low pressure side 52; Fig. 1, col. 5 ln 41-44) fluidly coupled to a breathing component (mask 70; Fig. 1, col. 5 ln 41-44) and respectively coupled to a first fluid source (high pressure side 51 coupled to a high pressure chamber 45 to deliver high pressure air 47; Fig. 1, col. 5 ln 24-28) and a second fluid source (low pressure side 52 coupled to a low pressure chamber 35 to deliver low pressure air 37; Fig. 1, col. 5 ln 24-28) for the purpose of providing fast transitions between two fluid sources (col. 1 ln 23-26, col. 2 ln 28-30).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bassovitch wherein the manifold comprises a first hose line and a second hose line fluidly coupled to the breathing component as taught by Burton for the purpose of providing fast transitions between the two fluid sources to reduce lag time of fluid delivery to the user (Burton col. 1 ln 23-26, col. 2 ln 28-30).
Regarding claim 2, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above), wherein the manifold includes a first hose and a second hose configured to be coupled to the normoxia fluid source and the hypoxia fluid source, respectively, (Bassovitch Fig. 9, 3/2 port switch 18 is connected to ambient air supply and hypoxic air supply; Burton’s first and second hose lines) and wherein fluid is injected into at least one of the first hose and the second hose at a flow rate that is greater than a breathing flow rate of the subject (hypoxic air is provided through an air pump which would create a flow rate greater than a breathing flow rate; Bassovitch par. 0027).
Regarding claim 3, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above), wherein the normoxia fluid source includes a blower that intakes ambient air (feeder pump; Bassovitch par. 0027).
Regarding claim 4, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above), wherein the hypoxia fluid source includes a mix chamber that is fluidly coupled with the manifold (variable orifice mixer, Bassovitch par. 0026) to reduce a ripple in a fraction of inspired oxygen received by the subject during hypoxia (variable orifice mixer keeps oxygen concentration substantially constant, Bassovitch par. 0026).
Regarding claim 5, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above), wherein the hypoxia source includes a reservoir bag that is fluidly coupled to the manifold to provide a temporary increased hypoxia inspiration rate (par. 0025, 0055).
The modified Bassovitch does not disclose a plurality of reservoir bags. However, the duplication of parts has no patentable significance unless a new and unexpected result is produced (see MPEP 2144.04(VI)(B)).
Regarding claim 6, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified apparatus of Bassovitch discloses the apparatus of claim 1 (shown above), wherein the hypoxia source includes at least one of a low-O2-concentration, O2 source or at least one oxygen scrubber fluidly coupled to the manifold to deliver the hypoxia fluid to the breathing component (Bassovitch Fig. 8, pressure swing adsorption device produces hypoxic air delivered to user, par. 0020-0021).
Regarding claim 7, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above), wherein hypoxia fluid source is configured provide a range of prescribed O2 concentrations (oxygen concentration in the hypoxic air is varied in the range of 15% and 8%, Bassovitch par. 0029) under positive pressure (hypoxic air is provided at positive pressure; Squibb par. 0057).
Regarding claim 11, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above), wherein the control system further comprises a user interface (data input means, Bassovitch par. 0017) configured to receive at least one of operational parameters, physiological parameters, or dosing intervals, (a physiologically measurable parameter is monitored, Bassovitch par. 0013-0017) and control operation of the apparatus based on the at least one of operational parameters, physiological parameters, or dosing intervals (hypoxic air delivery is adjusted based on the parameters; Bassovitch par. 0013-0017).
Regarding claim 12, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above), further comprising at least one physiological sensor configured to monitor the subject (Bassovitch Fig. 9, pulse oximeter 4) and provide physiological feedback to the control system based on monitoring of the subject (control signal is sent to control unit based on data from sensor 4; Bassovitch par. 0048).
Regarding claim 13, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 12 (shown above), wherein the control system is further configured to cause the at least one valve to actuate based on the physiological feedback (Bassovitch Fig. 9, flow controller 15 is controlled by controller 2 which receives signal from sensor 4; par. 0053) and wherein the physiological feedback includes at least one of heart rate, oxygen saturation level, or blood pressure (Bassovitch Fig. 9, physiological feedback is oxygen saturation from pulse oximeter sensor 4).
Regarding claim 14, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 12 (shown above), wherein the control system further includes a user interface configured to receive safety thresholds (control means includes a input means for entering a pre-set target value, Bassovitch par. 0017) and compare the physiological feedback with the safety thresholds to control operation of the apparatus to maintain the subject within the safety thresholds (oxygen concentration in the hypoxic air is adjusted based on measured value of physiological parameter, Bassovitch par. 0012-0017, 0063).
Regarding claim 16, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above), wherein the control system is programmable to provide a range of prescribed oxygen levels to the subject (oxygen concentration in the hypoxic air is varied in the range of 15% and 8%, Bassovitch par. 0029).
Regarding claim 17, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above), wherein the normoxia fluid source includes an oxygen concentration between 19% and 23% (ambient air has an oxygen concentration of approximately 21%) or the hypoxia fluid source includes an oxygen concentration between 8% and 12% (oxygen concentration in the hypoxic air is varied in the range of 15% and 8%, Bassovitch par. 0029).
Regarding claim 18, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above), further comprising: a normoxia fluid line connecting the normoxia fluid source to the breathing component (Bassovitch Fig. 9, line connecting ambient air to 3/2 port switch 18 which connects to breathing component 23); a hypoxia fluid line connecting the hypoxia fluid source to the breathing component (Bassovitch Fig. 9, line connecting hypoxic air source to 3/2 port switch 18 which connects to breathing component 23); and wherein the normoxia fluid line and the hypoxia fluid line are separate and distinct fluid lines with no shared fluid flow paths (Bassovitch Fig. 9, normoxia and hypoxia fluid lines are separate and distinct upstream of 3/2 port switch 18; Burton’s first and second hose lines).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Squibb in view of Burton as applied to claim 1 above, and further in view of Av-Gay et al. (US 20160228670 A1), hereafter Av-Gay.
Regarding claim 8, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above).
The modified Bassovitch does not explicitly disclose wherein the breathing component includes a mask that comprises a fluid sensor configured to measure a fraction of inspired oxygen at the mask.
Av-Gay teaches a system for inhalation (abstract ln 1; Fig. 1) wherein the breathing component includes a mask (Fig. 1, mask 18 and assembly 25) that comprises a fluid sensor (Fig. 1, sensor 17) configured to measure a fraction of inspired oxygen at the mask (the right-most sensor 17 is an FiO2 sensor which measures an oxygen level of the fluid delivered to the mask; Fig. 1, par. 0108) for the purpose of controlling the apparatus to maintain a desired FiO2 (FiO2 sensor is monitored to keep FiO2 at a desired range; par. 0208).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the breathing component of the modified Bassovitch to include a mask with a fluid sensor configured to measure a fraction of inspired oxygen as taught by Av-Gay for the purpose of controlling the apparatus to maintain a desired FiO2 (Av-Gay par. 0208).
Claims 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Squibb in view of Burton as applied to claim 1 above, and further in view of Currin et al. (US 20160095994 A1), hereafter Currin.
Regarding claim 9, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above).
The modified Bassovitch does not disclose wherein the control system is further configured to switch the at least one valve so that the normoxia fluid source is fluidly coupled to the breathing component if the blood oxygen level of the subject is below 70%.
Currin teaches a hypoxic breathing apparatus (abstract) wherein the control system (controller, par. 0036) is further configured to switch the at least one valve (valves, par. 0037) so that the normoxia fluid source is fluidly coupled to the breathing component if the blood oxygen level of the subject is below 70% (Fig. 6A/B, if oxygen saturation drops below 70%, maximum oxygen is set; par. 0043, 0052) for the purpose of maintaining a safety minimum (par. 0043).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the control system of the modified Bassovitch to switch to the normoxia source if the blood oxygen level is below 70% for the purpose of maintaining a safety minimum.
Regarding claim 15, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above).
The modified Bassovitch does not disclose further comprising at least one of: a filter configured to filter fluid prior to delivery to the breathing component or filter fluid exhaled by the subject; a disposable interface of the breathing component forming a mask to engage the subject; or a backflow control system.
Currin teaches a hypoxic breathing apparatus (abstract) further comprising at least one of: a filter configured to filter fluid prior to delivery to the breathing component (Fig. 10, particulate filter 74 located in the inspiratory flow path; par. 0086) or filter fluid exhaled by the subject; a disposable interface of the breathing component forming a mask to engage the subject; or a backflow control system.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the apparatus of Bassovitch to comprise a filter as taught by Currin for the purpose of preventing inhalation of harmful particles.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Squibb in view of Burton as applied to claim 1 above, and further in view of Miller (US 20140283829 A1).
Regarding claim 10, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the apparatus of claim 1 (shown above).
The modified Bassovitch does not disclose further comprising at least one of a temperature sensor or a humidity sensor configured to monitor a temperature or humidity of fluid delivered to the subject and wherein the control system is configured to receive feedback from the at least one of the temperature sensor or the humidity sensor and control operation of the apparatus based on the feedback.
Miller teaches a respiratory gas delivery system (abstract ln 1) comprising at least one of a temperature sensor or a humidity sensor configured to monitor a temperature or humidity of fluid delivered to the subject (gas temperature sensor measures the temperature of the gas flow through the wearer interface; par. 0009, 0017) and wherein the control system is configured to receive feedback from the at least one of the temperature sensor or the humidity sensor (controller receives sensor readings, par. 0024) and control operation of the apparatus based on the feedback (controller adjusts operation of the system based on sensor data, par. 0024) for the purpose of preventing discomfort of the subject from undesirable gas temperature (par. 0005).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the apparatus of Bassovitch to further comprise a temperature sensor and control system configured to receive feedback from the temperature sensor as taught by Miller for the purpose of preventing discomfort of the subject from undesirable gas temperature.
Claims 19, 25-26 are is rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Burton.
Regarding claim 19, Bassovitch discloses a hypoxia delivery system (par. 0001 ln 4-10) comprising: a breathing component configured to engage a face of a subject (Fig. 9, mask 23; par. 0058); a subject monitoring system (monitoring means, par. 0013) that includes a sensor configured to track a physiological parameter of the subject (Fig. 9, pulse oximeter sensor 4); a normoxia source (Fig. 9, ambient air supplied to upper portion of 3/2 port switch 18; par. 0059); a hypoxia source (Fig. 9, hypoxic air supplied to lower portion of 3/2 port switch 18; par. 0059); a first hose line in fluid communication with the breathing component and the normoxia source (Fig. 9, ambient air line leading into upper portion 3/2 port switch 18); a second hose line in fluid communication with the breathing component and the hypoxia source (Fig. 9, hypoxic air line leading into lower portion of 3/2 port switch), wherein the first hose line and the second hose line are separate (Fig. 9 shows a separate ambient air line and hypoxic air line leading into 3/2 port switch 18); a valve system (3/2 port switch 18 and variable orifice flow controller 15; Fig 9) configured to control fluid flow from the normoxia source through the first hose line to the breathing component or from the hypoxia source through the second hose line to the breathing component (Fig. 9, 3/2 port switch 18 switches between delivery of hypoxic air and ambient air; par. 0060); a controller in communication with the subject monitoring system (Fig. 9, controller 2 receives signals from pulse oximeter sensor 4) and configured to control operation of the valve system using feedback from the subject monitoring system (Fig. 9, controller 2 sends control signal to the variable orifice flow controller 15 based on pulse oximeter sensor data; par. 0062-0063).
Bassovitch does not disclose the first hose line and the second hose line join at the breathing component.
Burton teaches a respiratory apparatus (abstract ln 1-2) wherein a manifold (dual pressure hose 50; Fig. 1, col. 5 ln 41-44) comprises a first hose line (high pressure side 51; Fig. 1, col. 5 ln 41-44) and a second hose line (low pressure side 52; Fig. 1, col. 5 ln 41-44) fluidly coupled to a breathing component (mask 70; Fig. 1, col. 5 ln 41-44) and respectively coupled to a first fluid source (high pressure side 51 coupled to a high pressure chamber 45 to deliver high pressure air 47; Fig. 1, col. 5 ln 24-28) and a second fluid source (low pressure side 52 coupled to a low pressure chamber 35 to deliver low pressure air 37; Fig. 1, col. 5 ln 24-28) for the purpose of providing fast transitions between two fluid sources (col. 1 ln 23-26, col. 2 ln 28-30).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bassovitch wherein the manifold comprises a first hose line and a second hose line fluidly joining at the breathing component as taught by Burton for the purpose of providing fast transitions between the two fluid sources to reduce lag time of fluid delivery to the user (Burton col. 1 ln 23-26, col. 2 ln 28-30).
Regarding claim 25, the modified Bassovitch discloses the system of claim 19 (shown above), wherein the subject monitoring system is configured to measure at least one of a heart rate, a blood pressure, and an oxygen saturation level of the subject (pulse oximeter measures oxygen saturation and heart rate, par. 0006).
Regarding claim 26, the modified Bassovitch discloses the system of claim 19 (shown above), wherein the subject monitoring system is configured to sense at least one property of inspiratory and expiratory fluid from the subject (monitoring means can be a spirometer, par. 0028) and the controller is configured to provide at least one period of normoxia fluid supply to the subject and at least one period of hypoxia fluid supply to the subject (Fig. 9, 3/2 port switch 18 switches between hypoxic and normoxic air delivery; par. 0060).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Burton, and further in view of Av-Gay.
Regarding claim 20, the modified Bassovitch discloses the system of claim 19 (shown above).
Bassovitch does not disclose wherein the sensor is configured to operate as a fraction of inspired oxygen sensor.
Av-Gay teaches a system for inhalation (abstract ln 1; Fig. 1) comprising a sensor (Fig. 1, right-most of sensors 17) configured to operate as a fraction of inspired oxygen sensor (the right-most sensor 17 is an FiO2 sensor which measures an oxygen level of the fluid delivered to the mask; Fig. 1, par. 0108) for the purpose of controlling the apparatus to maintain a desired FiO2 (FiO2 sensor is monitored to keep FiO2 at a desired range; par. 0208).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the breathing component of the modified Bassovitch to include a mask with a fluid sensor configured to measure a fraction of inspired oxygen as taught by Av-Gay for the purpose of controlling the apparatus to maintain a desired FiO2 (Av-Gay par. 0208).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Burton, and further in view of Spirina et al. (DE 102012010806 A1, machine translation accessed February 13, 2025 relied upon herein), hereafter Spirina.
Regarding claim 21, the modified Bassovitch discloses the system of claim 19 (shown above), wherein the controller is configured to control the valve system (Fig. 9, controller 2 sends control signal to 3/2 port switch 18) to simultaneously switch between fluid flow from the normoxia source and fluid flow from the hypoxia source (3/2 port switch regulates flow of ambient and hypoxic air, par. 0060).
Bassovitch does not disclose that fluid flows from only one of the normoxia source and the hypoxia source at a time.
Spirina teaches a device for hypoxia (par. 0008) in which fluid flows from only one of the normoxia source and the hypoxia source at a time (device switches between normoxic gas and hypoxic gas mixture, par. 0011, 0013).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Bassovitch such that fluid flows from only one of the normoxia source and the hypoxia source at a time as taught by Spirina for the purpose of providing precise hypoxia intervals.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Burton in view of Spirina as applied to claim 21 above, and further in view of Gobel (US 20030000526 A1).
Regarding claim 22, the modified Bassovitch discloses the system of claim 21 (shown above).
The modified Bassovitch does not explicitly disclose wherein the controller is configured to control the valve system to perform switching between fluid flow between the normoxia source and the hypoxia source to create a settling time of the gas concentration delivered to the mask that is less than 1 second.
Gobel teaches a method of controlling breathing gas flow (abstract ln 1-2) wherein the valves switch immediately (par. 0053 ln 1-5) for the purpose of providing an immediate response to the user (par. 0053).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the system of Bassovitch to switch valves immediately as taught by Gobel for the purpose of providing an immediate response to the user.
However, the modified Bassovitch does not expressly disclose a settling time that is less than 1 second as required by the claim.
The modified Bassovitch discloses that the valve switches to provide immediate relief (Gobel par. 0053 ln 1-5). It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the modified Bassovitch to have a settling time that is within the claimed range, as it involves only adjusting the valve. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the system of Bassovitch to have a settling time that is less than 1 second as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Burton, and further in view of Armond (US 4065272 A).
Regarding claim 23, the modified Bassovitch discloses the system of claim 19 (shown above). Bassovitch discloses a pressure swing adsorption mechanism as the hypoxia source (par. 0051).
Bassovitch does not explicitly disclose wherein the hypoxia source includes a first oxygen scrubber, a second oxygen scrubber, and a mix chamber, and wherein, the mix chamber is configured to maintain an output flow rate provided by the first and second oxygen scrubbers.
Armond teaches a pressure swing adsorption mechanism comprising a first and second scrubber (Fig. 2, adsorption beds 21 and 23) and a mix chamber (Fig. 2, reservoir 29) wherein, the mix chamber is configured to maintain an output flow rate provided by the first and second scrubbers (Fig. 2, outlet line 31) for the purpose of ensuring a continuous supply of air (col. 2 ln 30-35).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the pressure swing adsorption mechanism of Bassovitch to include a first and second oxygen scrubber and a mix chamber as taught by Armond for the purpose of ensuring a continuous supply of air.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Burton, and further in view of Vacchiano et al. (US 20050247311 A1), hereafter Vacchiano.
Regarding claim 24, Bassovitch discloses the system of claim 19 (shown above).
Bassovitch does not explicitly disclose wherein the valve system includes a first solenoid gas valve dedicated to the first hose line and a second solenoid gas valve dedicated to the second hose line.
Vacchiano teaches a reduced oxygen breathing device (abstract ln 1-3) wherein the valve system includes a first solenoid gas valve dedicated to the first hose line (a solenoid valve is connected to oxygen source, par. 0057 ln 19-22) and a second solenoid gas valve dedicated to the second hose line (a solenoid valve is connected to a nitrogen source, par. 0057 ln 16-19) for the purpose of facilitating software control of gas flow and target delivery of gas (par. 0057).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Bassovitch to include solenoid valves as taught by Vacchiano for the purpose of facilitating software control of gas flow and target delivery of gas.
Claim(s) 27 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Burton, in view of Av-Gay.
Regarding claim 27, Bassovitch discloses a method of providing intermittent normoxia and hypoxia intervals to a subject (par. 0001), the method comprising: securing a breathing component to the face of the subject (Fig. 9, mask 23 on the face of user), the breathing component including a hose manifold (Fig. 9, 3/2 port switch 18 acts as a manifold) and at least one fluid sensor (spirometer, par. 0028); providing a normoxia fluid source (Fig. 9, ambient air supply; par. 0059); connecting the normoxia fluid source to the hose manifold (Fig. 9, ambient air is provided to 3/2 port switch 18); providing a hypoxia fluid source that is configured to provide a predetermined concentration of oxygen (hypoxic air is provided at a target oxygen concentration, par. 0012, 0017); connecting the hypoxia fluid source to the hose manifold (Fig. 9, hypoxic air supply is connected to 3/2 port switch 18); sensing at least one property of inspiratory fluid to the subject with the at least one fluid sensor (a spirometer measures a volume of inspired air); and controlling normoxia and hypoxia control valves that are in fluid communication with the respective normoxia and hypoxia fluid sources to provide at least one period of normoxia fluid supply to the subject and at least one period of hypoxia fluid supply to the subject (Fig. 9, 3/2 port switch comprises valves to switch between delivery of hypoxic air and ambient air; par. 0060).
Bassovitch does not disclose a first hose line and a second hose line connected to the normoxia fluid source and the hypoxia fluid source, respectively, that are separate and join at the breathing component.
Burton teaches a respiratory apparatus (abstract ln 1-2) wherein a manifold (dual pressure hose 50; Fig. 1, col. 5 ln 41-44) comprises a first hose line (high pressure side 51; Fig. 1, col. 5 ln 41-44) and a second hose line (low pressure side 52; Fig. 1, col. 5 ln 41-44) fluidly coupled to a breathing component (mask 70; Fig. 1, col. 5 ln 41-44) and respectively coupled to a first fluid source (high pressure side 51 coupled to a high pressure chamber 45 to deliver high pressure air 47; Fig. 1, col. 5 ln 24-28) and a second fluid source (low pressure side 52 coupled to a low pressure chamber 35 to deliver low pressure air 37; Fig. 1, col. 5 ln 24-28) for the purpose of providing fast transitions between two fluid sources (col. 1 ln 23-26, col. 2 ln 28-30).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bassovitch wherein the manifold comprises a first hose line and a second hose line joining at the breathing component as taught by Burton for the purpose of providing fast transitions between the two fluid sources to reduce lag time of fluid delivery to the user (Burton col. 1 ln 23-26, col. 2 ln 28-30).
The modified Bassovitch does not disclose the at least one fluid sensor configured to measure a fraction of inspired oxygen at the breathing component.
Av-Gay teaches a system for inhalation (abstract ln 1; Fig. 1) wherein the breathing component (Fig. 1, mask 18 and assembly 25) comprises a fluid sensor (Fig. 1, right-most of sensors 17) configured to measure a fraction of inspired oxygen at the mask (the right-most sensor 17 is an FiO2 sensor which measures an oxygen level of the fluid delivered to the mask; Fig. 1, par. 0108) for the purpose of controlling the apparatus to maintain a desired FiO2 (FiO2 sensor is monitored to keep FiO2 at a desired range; par. 0208).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Bassovitch to include a fluid sensor configured to measure a fraction of inspired oxygen at the breathing component as taught by Av-Gay for the purpose of controlling the apparatus to maintain a desired FiO2 (Av-Gay par. 0208).
Regarding claim 30, as best understood based on the 35 U.S.C. 112(b) issue identified above, the modified Bassovitch discloses the method of claim 27 (shown above), wherein the hose manifold includes a hypoxia fluid and a normoxia fluid line (Fig. 9, hypoxic and normoxic lines connected to 3/2 port switch 18); and wherein the normoxia fluid line and the hypoxia fluid line are separate and distinct fluid lines (Fig. 9, hypoxic and normoxic lines are separate and distinct upstream of 3/2 port switch 18; Burton’s first and second hose).
Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Burton in view of Av-Gay, as applied to claim 27 above, and further in view of Currin.
Regarding claim 28, the modified Bassovitch discloses the method of claim 27 (shown above), further comprising: measuring at least one of a heart rate, a blood pressure, and an oxygen saturation level of the subject (Bassovitch Fig. 9, pulse oximeter 4 measures oxygen saturation and heart rate; par. 0006).
The modified Bassovitch does not disclose instantaneously switching to a period of normoxia if a threshold level of the measured one of the heart rate, the blood pressure, and the oxygen saturation level is crossed.
Currin teaches a hypoxic breathing apparatus (abstract) instantaneously switching to a period of normoxia if a threshold level of the measured one of the heart rate, the blood pressure, and the oxygen saturation level is crossed (Fig. 6A/B, if oxygen saturation drops below a threshold, maximum oxygen is set; par. 0043, 0052) for the purpose of maintaining a safety minimum (par. 0043).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Bassovitch to instantaneously switch to a period of normoxia if a threshold is crossed as taught by Currin for the purpose of maintaining a safety minimum.
Regarding claim 29, the modified Bassovitch discloses the method of claim 28 (shown above), wherein the period of normoxia if a threshold level of the measured one of the heart rate, the blood pressure, and the oxygen saturation level is crossed is a programmable time period (Currin Fig. 6B, period of time 130 is programmable; par. 0043, 0052, 0059).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Bassovitch in view of Burton in view of Av-Gay, as applied to claim 27 above, and further in view of Squibb.
Regarding claim 31, the modified Bassovitch discloses the method of claim 27 (shown above).
The modified Bassovitch does not disclose wherein a positive pressure is maintained at the breathing component during the at least one period of normoxia fluid supply and during the at least one period of hypoxia fluid supply.
Squibb teaches an apparatus for providing normoxic and hypoxic air (apparatus switches between providing high oxygen concentration air and low oxygen concentration air, par. 0002; inhalation air is provided at a first and second concentration, par. 0028; a first concentration of inhalation air can be 20.9% while a second concentration of inhalation air is below 20.9%, par. 0129) wherein a positive pressure is maintained at the breathing component during the at least one period of normoxia fluid supply and during the at least one period of hypoxia fluid supply (higher oxygen concentration compartment and lower oxygen concentration compartment both provide positive pressure to the user, par. 0057) for the purpose of supporting inhalation and increasing comfort for individuals with compromised respiratory systems by making them feel like it is easier to breathe (par. 0045-0046).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Bassovitch to maintain a positive fluid pressure at the breathing component during delivery of both normoxic air and hypoxic air as taught by Squibb for the purpose of supporting inhalation and increasing comfort for individuals with compromised respiratory systems by making them feel like it is easier to breathe (Squibb par. 0045-0046).
Response to Arguments
Applicant's arguments filed 3/4/2026 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant argues Squibb does not teach switching between delivery of fluid from the normoxia fluid source and the hypoxia fluid source while maintaining a positive fluid pressure at the breathing component over a range of breathing by the subject with varying breathing frequencies and tidal volumes. Squibb explicitly discloses providing positive pressure to the user from both the normoxia fluid source and hypoxia fluid source, in the paragraph cited above (par. 0057, both compartments provide positive pressure to the user), for easing the breathing of those with compromised respiratory systems (par. 0045-0046, as cited above). In view of the teaching of Squibb, one having ordinary skill in the art before the effective filing date of the invention would have been motivated to provide Bassovitch with positive pressure from both the normoxic and hypoxic fluid sources to ease the breathing of those with compromised respiratory systems. Therefore, a positive pressure would have been provided while switching between the two fluid sources as Bassovitch discloses. As also stated in the rejection above, a person’s breathing will naturally vary in frequency and tidal volume. It can be understood that to deliver the benefits of easing breathing, the positive pressure is set at a level that accounts for minor variations in breathing frequency and tidal volume. Applicant’s arguments make a reference to a full range of breathing on the second paragraph of page 12 and deep breaths on page 13 ln 5. However, neither of these features is specifically claimed.
Applicant argues that Squibb discloses negative pressure is preferable for athletic individuals. However, the apparatus of Bassovitch is not limited to athletic individuals. Bassovitch discloses the use of intermittent hypoxia for general health and wellbeing and for the treatment of various degenerative disorders (par. 0003), in which situations one of ordinary skill in the art would have recognized a positive pressure to ease breathing may be preferable or necessary.
Applicant’s arguments with respect to claim(s) 19 and 27 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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/K.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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