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 .
Status of Claims
This Office Action is in response to the remarks and amendments filed on October 8th, 2025. Claims 27, 29, 31, 39, 41, 43, and 44 have been canceled as such claims 26, 28, 30, 32-38, 40, are pending consideration in this Office Action.
Response to Amendment
The objection to the claim 39 is withdrawn in light of the amendments.
Information Disclosure Statement
The information disclosure statement filed December 29th, 2022 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because JP 2007530079 does not have an English translation and all other references/ pages that are lined through have no copy in the file wrapper. Therefore, it fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the two or more superposed frequencies must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 28 and 33 are objected to because of the following informalities:
Claim 28, line 1, “Claim 26” should read “claim 26”
Claim 33, line 1, “Claim 26” should read “claim 26”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 26, 28, 30, 32-34, 36-38, 45-48, and 50-53 are rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 4821709) in view of a second embodiment of Jensen (US 4821709).
Regarding claim 26, Jensen discloses
a method of promoting gas exchange in a patient's airway (produce sufficient gas exchange in the lungs; col. 3, lines 10-20), the method comprising:
receiving a gas (fig. 2; compressed air and oxygen are supplies to line 69 via valves 67, 68 which is connected to ventilator line 65; Col. 13, lines 61-65); and
varying the gas about a base flow rate (fig. 2; high frequency generator 10a has systems A and B which provide oscillating diaphragms that create pressure waves in the gas flow provided; col. 3, lines 27-35, col. 8, lines 6-23, and col. 14, lines 16-26) to provide to the patient a gas flow with a non-random unidirectional (fig. 2; gas flows through line 65 to a connected endotracheal tube 66 to supply gas to the patient; col. 6, lines 2-4 and col. 13, lines 57-60)
varying flow rate having an oscillation comprising two or more superposed frequencies (fig. 2; the dual system A and B can be operated such that “a high frequency wave can be superimposed on a low frequency wave” and “valves 64 and 64a allow any combination of superimposed waves within the limits of the individual systems”; col. 14, lines 32-39 and 44-46);
providing the gas flow to the patient's airway via a non-sealing patient interface (fig. 2; gas flows through line 65 to endotracheal tube 66; col. 6, lines 2-4 and col. 13, lines 57-60; as shown by fig. 2 endotracheal tube 66 does not have a cuff or balloon; therefore, it is a non-sealing patient interface)
Jensen does not disclose the method comprising: controlling the base flow rate greater than 15 litres per minute.
However, a second embodiment of Jensen discloses a high frequency ventilator which includes a volume ventilator
controlling the base flow rate greater than 15 litres per minute (fig. 7; the flow control knob 265 varies the speed that air flows from the ventilator to the patient during inspiration. This speed is adjustable from zero to 150 liters per minute; col. 20, lines 54-60; therefore, the operator would be able to set a base flow rate greater than 15 liters per minute).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of using the high frequency ventilator and air supply line of the first embodiment of Jensen with the volume ventilator and controls knobs/switches of the second embodiment of Jensen to selectively vary the speed that air flows from the ventilator to the patient during inspiration and have standard breathing rates be combined with high frequency rates; therefore, receiving the benefit of both ventilators simultaneously (Jensen: col. 19, lines 17-23 and col. 20, lines 43-60).
Regarding claim 28, the first embodiment of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator) according to Claim 26, further comprising
heating (fig. 2; “gas in the ventilator is heated by a heater 75 which is controlled by control knob 76”; col. 14, lines 5-6) and humidifying the gas (fig. 2; “humidity of the gas is increased by humidity generator 71 which is controlled by control knob 72”; col. 14, lines 1-2).
Regarding claim 30, the first embodiment of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator) according to claim 26,
wherein the gas flow provides a net positive flow to the patient (fig. 2; “control knobs 54 and 55 allow the inspiration to expiration ratio (I:E) to be varied according to the needs of a patient, capable of varying the I:E ratio from about 80:20 to 20:80”; col. 12, lines 66-68 and col. 5, lines 5-14; therefore, the apparatus is capable of varying the I:E ratio to 80:20 which is a net positive flow).
Regarding claim 32, the modified method of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator; second embodiment of Jensen: volume ventilator and control knobs) according to claim 26, further comprising,
specifying, through a user interface (fig. 2 and 7; control knobs/switches on ventilators), at least one of:
an amplitude of the two or more superposed frequencies of the non-random unidirectional varying flow rate,
a frequency of the two or more superposed frequencies of the non-random unidirectional varying flow rate (first embodiment of Jensen: fig. 2; systems A, B has potentiometer controls 51, 52, 51a, and 52a to control the frequency of channels 1, 2, 3, and 4 (respectively); col. 12, lines 55-60 and col. 13, lines 26-31; valves 64 and 64a allow any combination of superimposed waves; col. 14, line 45), or
the base flow rate of the gas flow (second embodiment of Jensen: flow control knob 265 used so select/vary speed of air flow from zero to 150 liters per minute; col. 20, lines 54-60).
Regarding claim 33, the first embodiment of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator) according to Claim 26,
wherein the two or more superposed frequencies of the non-random unidirectional varying flow rate (fig. 2; valves 64 and 64a allow any combination of superimposed waves; col. 14, line 45) includes a frequency (channels can produce a frequency of about 0.5-50 Hz, channel 1 may provide a frequency of 3 Hz or greater; col. 6, lines 7-10, col. 8, lines 40-49, col. 15, lines 58-59) higher than a breathing frequency of the patient (breathing frequencies of humans are less than 1 Hz; therefore, the superimposed waves from the knob controlled channels are able to provide frequencies that are higher than 1 Hz such as a frequency of 3 Hz or greater).
Regarding claim 34, the first embodiment of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator) according to claim 26,
wherein the two or more superposed frequencies of the non-random unidirectional varying flow rate (superimposed frequency waves allowed by valves 64 and 64; col. 14, lines 32-39 and 44-46) includes at least one frequency that promotes CO2 washout of the patient's airway of the patient (fig. 2; vibrational energy added through the diaphragms (62, 62a) enhances diffusion such that the respiration gas reaches the subjects lungs and replaces the carbon dioxide; col. 6, lines 38-56) and/or increases O2 in the patient's airway of the patient (fig. 2; what the ventilator of the present invention does is to promote the diffusion of these gases throughout the tube, lines and lungs of the subject to such an extent that a large portion of the oxygen reaches the alveolar sacs of the patient; col. 6, lines 38-56).
Regarding claim 36, the modified method of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator; second embodiment of Jensen: volume ventilator and control knobs) according to claim 26, further comprising
generating the base flow rate by a flow generator (second embodiment of Jensen: fig. 7; the flow control knob 265 of the volume ventilator section varies the speed that air flows from the ventilator to the patient during inspiration; col. 20, lines 54-56; volume ventilator (flow generator) is capable of generating/setting base flow rate (air flow speed) using flow control knob 265).
Regarding claim 37, the modified method of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator; second embodiment of Jensen: volume ventilator and control knobs) according to claim 26,
wherein the base flow rate (second embodiment of Jensen: zero to 150 liters per minute; col. 20, lines 54-60) is at least one of:
offset from zero (second embodiment of Jensen: the flow control knob 265 varies the speed that air flows and is adjustable from zero to 150 liters per minute; col. 20, lines 54-60; therefore, the base flow rate (air flow speed) can be set to flow rates that are offset from zero such as 50 liters per minute) or
constant.
Regarding claim 38, the modified method of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator; second embodiment of Jensen: volume ventilator and control knobs) according to claim 26,
wherein the base flow rate is in a range of 20-90 litres per minute (second embodiment of Jensen: flow control knob 265 used so select/vary speed of air flow (base flow rate) from zero to 150 liters per minute; col. 20, lines 54-60).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a base flow rate in a range of 20-90 litres per minute since this fall within the workable air flow speed of 0-150 litres per minute (see MPEP 2144.05). Furthermore, there is no allegation of criticality or any evidence demonstrating any difference across the range.
Regarding claim 45, the modified method of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator; second embodiment of Jensen: volume ventilator and control knobs) according to claim 26,
wherein the base flow rate provides a high flow rate of gas to the patient (second embodiment of Jensen: flow control knob 265 is used so select/vary speed of air flow (base flow rate) from zero to 150 liters per minute; col. 20, lines 54-60; therefore, a high flow rate (speed of air flow) such as 50 liter per minute may be selected).
Regarding claim 46, the modified method of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator; second embodiment of Jensen: volume ventilator and control knobs) according to claim 26,
wherein the base flow rate (control knobs 54, 54a, 55, 55a, allow inspiration to expiration ratio to be varied according to the needs of the patient; col. 12, lines 66-68; and second embodiment of Jensen: control knob 265 varies the air flow speed, which can be adjusted from zero to 150 liters per minute; col. 20, lines 54-60) meets an inspiratory demand of the patient (the control knob 265 can be “adjusted to give the patient a comfortable inspiration rate” in other words meets an inspiratory demand) or exceed an inspiratory demand of the patient.
Regarding claim 47, the first embodiment of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator) according to claim 26, further comprising
receiving input from a user for selection of each of the two or more superposed frequencies via a user interface (fig. 2; systems A has potentiometer controls 51 and 52 to control the frequency of channels 1 and 2 (respectively); col. 12, lines 55-60; systems A, B has potentiometer controls 51a and 52a to control the frequency of channels 3 and 4 (respectively); col. 13, lines 26-31; valves 64 and 64a allow any combination of superimposed waves; col. 14, line 45).
Regarding claim 48, the modified method of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator; second embodiment of Jensen: volume ventilator and control knobs) according to claim 26,
wherein the gas received comprises the base flow rate (first embodiment of Jensen: fig. 2; compressed air and oxygen are supplied to line 69 via valves 67, 68; Col. 13, lines 61-65; using second embodiment of Jensen: fig. 7; the flow control knob 265 varies the speed that air flows (base flow rate) from the ventilator to the patient during inspiration; col. 20, lines 54-60; volume ventilator sets base flow rate of compressed air and oxygen gas supplied to line 69 using flow control knob 265).
Regarding claim 50, the first embodiment of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator) according to claim 26,
wherein a gas flow modulating device is configured to vary the gas about the base flow rate (fig. 2; high frequency generator 10a has systems A and B which provide oscillating diaphragms 62, 62a that create pressure waves in the gas flow provided; col. 3, lines 27-35, col. 8, lines 6-23, and col. 14, lines 16-26).
Regarding claim 51, the first embodiment of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator) according to claim 26,
wherein the non-random unidirectional varying flow rate (fig. 2; systems A and B provide oscillating diaphragms that create pressure waves in the gas flow provided from line 65 to endotracheal tube 66; col. 3, lines 27-35, col. 8, lines 6-23, and col. 14, lines 16-26) having the oscillation comprises two superimposed frequencies (fig. 2; the dual system A and B can be operated such that “a high frequency wave can be superimposed on a low frequency wave” and “valves 64 and 64a allow any combination of superimposed waves within the limits of the individual systems”; col. 14, lines 32-39 and 44-46).
Regarding claim 52, the first embodiment of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator) according to claim 50,
wherein the gas flow modulating device (fig. 2; high frequency generator 10a; col. 3, lines 27-35, col. 8, lines 6-23, and col. 14, lines 16-26) comprises at least one of:
an oscillatable diaphragm device (fig. 2; high frequency generator 10a comprises linear motors 61, 61a and diaphragms 62, 62a which converts mechanical motion to pressure waves (movement of diaphragm back and forth in both directions/oscillating diaphragm); col. 5, lines 53-56, col. 7, lines 6-10 and col. 14, lines 16-26), inline line actuator, a flow chopper, an aerodynamic flutter valve, a mechanical flutter valve, or a compressed gas source.
Regarding claim 53, the first embodiment of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator) according to claim 50, further comprising
varying a speed of the gas flow modulating device to vary the gas about the base flow rate (fig. 2; potentiometer control knobs 51, 52, 51a, 52a controls frequency of systems A and B which dictates (oscillating) diaphragms 62, 62a, col. 12, lines 55-60 and col. 13, lines 14-31; by increasing or decreasing the frequency using the knobs the diaphragms would oscillate with more or less frequency; therefore, increasing or decreasing the movement speed of the diaphragm)
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 4821709) in view of a second embodiment of Jensen (US 4821709) and further in view of Mackie (20050178383).
Regarding claim 35, the modified method of Jensen discloses
the method according (first embodiment of Jensen: method of using a high frequency ventilator; second embodiment of Jensen: volume ventilator and control knobs) to claim 26,
the two or more superposed frequencies of the non-random unidirectional varying flow rate (superimposed frequency waves allowed by valves 64 and 64; col. 14, lines 32-39 and 44-46)
The modified method of Jensen is silent as to wherein the two or more superposed frequencies of the non-random unidirectional varying flow rate includes at least one frequency based on a resonant frequency of the patient's airway.
Cortez discloses a method for providing respiratory therapy by varying the flow rate
wherein varying flow rate includes at least one frequency based on a resonant frequency of the patient's airway (“flow control device (flow control device 150 which is
an oscillating fluidic flip valve; [0023]) may vary the flow of breathing gas at a frequency of equal to or less than half of the breathing rate of the patient”; [0022]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the channels of the modified method of Jensen to be able to vary the frequency of equal to or less than half of the breathing rate of the patient as taught in Cortez so as to cause a change in functional residual capacity of the patient, as opposed to an augmentation of tidal volume (Cortez: [0022]).
It directly follows that the resultant superimposed waves of Jensen combined with the specific frequencies of Cortez would meet the claimed structural limitations since:
the two or more superposed frequencies of the non-random unidirectional varying flow rate (Jensen: superimposed frequency waves allowed by valves 64 and 64; col. 14, lines 32-39 and 44-46) includes at least one frequency based on a resonant frequency of the patient's airway (Jensen: potentiometer control knobs 51, 52, 51a, 52a controls frequency of systems A and B which dictates (oscillating) diaphragms 62, 62a, col. 12, lines 55-60 and col. 13, lines 14-31; Cortez: “flow control device (flow control device 150 which is an oscillating fluidic flip valve; [0023]) may vary the flow of breathing gas at a frequency of equal to or less than half of the breathing rate of the patient”; [0022]).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Jensen (US 4821709) in view of a second embodiment of Jensen (US 4821709) and further in view of Mackie (20050178383).
Regarding claim 49, the modified method of Jensen discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator; second embodiment of Jensen: volume ventilator and control knobs) according to claim 26,
The modified device of Jensen does not disclose wherein the non-sealing patient interface comprises a nasal cannula.
Mackie discloses a methods of delivering high flow oxygen/air to a patient
wherein the non-sealing patient interface comprises a nasal cannula (figs. 8 and 9; nasal cannula does not create a seal against the nares; abstract and [0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the endotracheal tube of the modified method of Jensen with the nasal cannula to Mackie to yield the predictable results of delivering high flow gas to the patient while providing a less invasive interface that is more comfortable to the patient and ensures barotrauma is not inflicted upon the patient (Mackie: Abstract, [0003], [0043]).
Claims 26, 40, 42, 50, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Hete (US 6708690) in view of Jensen (US 4821709) and further in view of Mackie (US 20050178383).
Regarding claim 26, Hete discloses
a method of promoting gas exchange in a patient's airway (method using high frequency ventilation to provide diffusion of gases in the patient’s airways; col. 1, lines 60-67 and col. 2, lines 1-10; col. 4, lines 25-35 and 56-60), the method comprising:
receiving a gas (fig. 8 and 10; “an inlet 154 of second blower 142 receives breathing gas from a source of breathing gas, as indicated by arrow 156”, col. 12, lines 50-56; sources of breathing gas can include ambient atmosphere, breathing gas containing medicated aerosol, oxygen or an oxygen mixture provided from a storage tank or a pressure generating device; col. 12, lines 50-56 and col. 6, lines 4-15); and
varying the gas about a base flow rate to provide to the patient a gas flow with a non-random unidirectional (figs. 8 and 10; motors 170 drive blowers/fans 134, 142 which create pressure oscillations applied to the gas flow; col. 9, lines 50-54, col. 10, lines 42-44; provides periodic or oscillating pressure to the patient about a mean level of pressure with amplitudes and oscillations have equal magnitudes in both positive and negative directions, in other words oscillate around a base flow; col. 11, lines 30-39);
varying flow rate having an oscillation comprising two or more superposed frequencies (figs. 8 and 10; high frequency pressure oscillation device 140 provides the ability to superimpose the oscillating pressure of a first wave signal onto a second pressure waveform signal using two blowers ; col. 11, lines 40-54; oscillating pressure in the airway directly causes variation/oscillation of the gas flow rate); and
providing the gas flow to the patient's airway (fig. 10; “a fourth conduit 200 couples a second end of the valve chamber to the airway of a patient, as indicated by arrows 202”; col. 13, lines 38-40).
Hete does not disclose controlling the base flow rate greater than 15 litres per minute; and providing the gas flow to the patient's airway via a non-sealing patient interface.
Jensen discloses a high frequency ventilator with a volume ventilator
controlling the base flow rate greater than 15 litres per minute (fig. 7; the flow control knob 265 varies the speed that air flows from the ventilator to the patient during inspiration. This speed is adjustable from zero to 150 liters per minute; col. 20, lines 54-60; therefore, the operator would be able to set a base flow rate greater than 15 liters per minute).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of using the high frequency ventilator and inlet of the second blower of the first embodiment of Jensen with the volume ventilator and controls knobs/switches of the second embodiment of Jensen to selectively vary the speed that air flows from the ventilator to the patient during inspiration and have standard breathing rates be combined with high frequency rates; therefore, receiving the benefit of both ventilators simultaneously (Jensen: col. 19, lines 17-23 and col. 20, lines 43-60).
The modified method of Hete is silent as to providing the gas flow to the patient's airway via a non-sealing patient interface.
Mackie discloses a methods of using a breathing assistance apparatus
providing the gas flow to the patient's airway (delivering high flow oxygen/air to a patient; abstract, [0013]) via a non-sealing patient interface (figs. 8 and 9; nasal cannula does not create a seal against the nares; abstract and [0043])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fourth conduit of the modified method of Hete with the nasal cannula of Mackie to deliver high flow gas to the patient while providing an interface that is more comfortable to the patient and ensures barotrauma is not inflicted upon the patient (Mackie: Abstract, [0003], [0043]).
Regarding claim 40, the modified method of Hete further discloses
the method (Hete: high frequency ventilator; Jensen: volume ventilator with control knobs; Mackie: nasal cannula) according to claim 26,
wherein receiving the gas comprises receiving a first gas flow at a first flow rate having a first frequency component (Hete: figs. 8 and 10; gas is received through inlet 154 and motors 170 drives blower/fan 142 which create pressure oscillations applied to the gas flow; col. 9, lines 50-54, col. 10, lines 42-44; col. 11, lines 47-60 and col. 12, lines 50-62; Jensen: fig. 7; base flow rate adjusted from 0-150 liters per minutes using control knob 265; col. 20, lines 54-60) and
receiving a second gas flow at a second flow rate having a second frequency component (Hete: figs. 8 and 10; motors 170 drives blower/fan 134 which create pressure oscillations applied to the gas flow received from the second blower; col. 11, lines 47-60 and col. 12, lines 50-62; receives gas flow at a second rate as the blower/fan 134 changes the gas flow),
the two or more superposed frequencies comprising the first frequency component and the second frequency component (in fig. 8 ground is replaced with a second pressure support signal so that the oscillating pressures created by first fan 134 are superimposed on the output of second fan 142 (or vice versa as shown in fig. 10); col. 11, lines 47-60).
Regarding claim 42, the modified method of Hete further discloses
the method (Hete: high frequency ventilator; Jensen: volume ventilator with control knobs; Mackie: nasal cannula) according to claim 40,
wherein the first gas flow is at least one of:
provided at a constant rate; varied during a therapy session (Jensen: fig. 7; the flow control knob 265 varies the speed that air flows from the ventilator to the patient during inspiration. This speed is adjustable from zero to 150 liters per minute; col. 20, lines 54-60; therefore, the operator is able to either use the flow control knob to set the flow rate or change/vary it during the session); or
in response to expiratory and inspiratory transitions.
Regarding claim 50, Hete further discloses
the method (Hete: high frequency ventilator) according to claim 26,
wherein a gas flow modulating device is configured to vary the gas about the base flow rate (figs. 8 and 10; motors 170 drive blowers/fans 134, 142 which create pressure oscillations applied to the gas flow; col. 9, lines 50-54, col. 10, lines 42-44; provides periodic or oscillating pressure to the patient about a mean level of pressure with amplitudes and oscillations have equal magnitudes in both positive and negative directions, in other words oscillate around a base flow; col. 11, lines 30-39).
Regarding claim 53, the first embodiment of Jensen further discloses
the method (first embodiment of Jensen: method of using a high frequency ventilator) according to claim 50, further comprising
varying a speed of the gas flow modulating device (the ranges of frequencies of the pressure oscillations is limited by the range by which the speed of the motor can be varied; col. 9, lines 50-54 and col. 10, lines 42-44; therefore, the speed of the motor/blower is varied) to vary the gas about the base flow rate (fig. 10; motors 170 drive blowers/fans 134, 142 which create pressure oscillations applied to the gas flow; col. 11, lines 47-60 and col. 12, lines 50-62).
Response to Arguments
Applicant’s arguments with respect to claim 26 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
(DE 202011110133) – a device for ventilation with a high frequency superimposed supply of the breathing gas mixture to the predetermined basic frequency of the breathing gas mixture
Schindler (WO 2014012127) – a super positioned jet ventilation which provides two jet ventilation forms with different frequencies to be combined
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SYDNEY REYES RUSSELL whose telephone number is (703)756-4567. The examiner can normally be reached M-F 730am -5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.R.R./Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785