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 Appeal Brief
In view of the appeal brief filed on 07/21/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/BRANDY S LEE/ Supervisory Patent Examiner, Art Unit 3785
Response to Amendment
This Office Action is in response to the amendment filed 04/23/2026 and the appeal brief filed 07/21/2026. Claims 1-47 are canceled. Claims 48, 57, 59-60, 70-71, and 74 are as currently amended. Claims 49-56, 58, 61-69, 73, and 75-76 are as previously presented. As such, claims 48-76 are pending in the instant application.
The objections to claims 57, 59, 71-72, and 74 are withdrawn in light of the amendments.
All rejections pursuant of 35 U.S.C. 112(b) in the Office Action mailed 02/24/2026 are withdrawn in light of the amendments.
Claim Objections
Claims 48 and 65 are objected to because of the following informalities:
Claim 48, line 11: “a first therapy mode” should read “the first therapy mode” for consistency and clarity.
Claim 48, line 11: “the change” should read “a change” for clarity and to establish antecedent basis.
Claim 65, line 2: “and a volume” should read “and a volume of the breathing assistance gas” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 48-55, 62, 64-65, and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adametz & Mehnert (US 20170368277 A1; hereinafter “Adametz”).
Regarding claim 48, Adametz discloses apparatus (1; Fig. 1) for breathing gas supply (first sentence of [0052]), wherein the apparatus comprises
a breathing gas source (blower device 3; Fig. 1),
a control unit (16; Fig. 1),
a memory (“The ventilation parameters required for adjusting the ventilation device 2 or the blower device 3 as well as the device configuration and/or device software are stored in a memory device of the control device 16”, [0056]),
a pressure sensor instrument (27; Fig. 2; [0072]) and/or a flow sensor instrument (17; Fig. 2; [0072]),
an interchangeable breathing gas tube (25; Fig. 1; “… by way of example, three different types of tubing devices 25 are shown, which are connectable to the ventilation device 2”, [0052]),
at least one connection fitting (4, 14, 24; Fig. 1) for the interchangeable breathing gas tube (“The desired tubing device 25 is connected to the ventilation device 2 via a coupling device 4 …tubing device 25 comprises coupling elements at the particular ends, in order to be connected at the breathing interface 102 and at the coupling device 4”, [0060]),
a patient interface (102, 105; Fig. 1; “The breathing interface 102 is preferably designed as a patient interface and can be configured, for example, as a full-face mask, as a nasal pillow, as a tube, or as a larynx mask. The breathing interface 102 shown here is a breathing mask 105 designed as a nasal mask”, [0059]) and a patient valve (101; Fig. 1),
wherein the control unit activates a first therapy mode of ventilation for a first period of time (first ventilation pressure 18 built up and delivered during a patient’s inhalation phase; Figs. 3-4; second sentence of [0087], where control device 16 provides and controls the ventilation pressure and/or flow, see [0055]), and in this case drives the breathing gas source in order to specify a varying breathing gas parameter for the first therapy mode of ventilation (Figs. 3-4; “… a first ventilation pressure 18 is built up during a patient's inhalation phase, in order to supply the patient with a required volume of fresh respiratory gas under a required pressure.”, [0087]), and
wherein the control unit activates a further therapy mode of ventilation for a second period of time (second ventilation pressure 28 to support patient’s exhalation process, see [0087]; Figs. 3-4; back pressure 8; Fig. 4; [0089]; control device 16 provides and controls the ventilation pressure and/or flow, see [0055]), and in this case drives the breathing gas source in order to specify a breathing gas parameter specific for the further therapy mode of ventilation (“The second ventilation pressure is adjusted by means of the monitoring device 6 to a setpoint pressure required for the ventilation”, [0088]; “… the level and/or the duration of the back pressure and/or the point in time of the generation of the back pressure are/is adjusted with consideration for the detected variable.”, [0017]),
the interchangeable breathing gas tube remaining on the apparatus during the change from a first therapy mode of ventilation to the further therapy mode of ventilation (based on [0011] and Figs. 3-4, it would be well-understood by one of ordinary skill in the art that the tube 25 stays connected to the ventilation device 2 during a switch from the first ventilation pressure 18 to the second ventilation pressure 28 and/or the back pressure 8 as there is a constant supply of a flow of pressurized gas to the patient, and characteristics of the flow within the flow connection is constantly detected to monitor the backflowing exhaled air; [0093]), and the patient valve being switched for the further therapy mode of ventilation by the control unit ([0026]-[0027]; [0030]; [0065]; [0076]; [0086]).
Regarding claim 49, Adametz discloses the invention as set forth in claim 48, wherein the control unit (16) activates a CPAP mode (ventilator constantly supplies positive pressure flow to patient in and the second ventilation pressure 28 is at least one set point pressure corresponding to a PEEP or EPAP, [0027]; [0029]; [0033]; [0058]; [0081]; [0088]; Examiner’s Note: Interpretation of “CPAP mode” based on paragraphs [0012], [0018]-[0019], and [0073] of Applicant’s specification, see PGPub US 20230355915 A1) or an MPV mode (ventilator delivers a flow of pressurized gas to the patient according to the patient’s breathing phases, [0082], where the patient valve 101 temporarily opens during the patient’s exhalation phase, [0083]-[0085]; [0058]; [0072]; [0059], where breathing interface 102 can be a tube and/or a larynx mask; Examiner’s Note: Interpretation of “MPV mode” based on paragraphs [0031], [0039], [0070], and [0072] of Applicant’s specification, see PGPub US 20230355915 A1) or an HFT mode as the further therapy mode of ventilation and wherein the interchangeable breathing gas tube is a single tube valve system (see single tube 25, 45 with patient valve 101 in Fig. 1).
Regarding claim 50, Adametz discloses the invention as set forth in claim 48, wherein the control unit (16) activates the further therapy mode of ventilation ([0087]; [0089]; [0055], where control device 16 provides and controls the ventilation pressure and/or flow), and in this case drives the breathing gas source in order to specify a constant breathing gas parameter independent of or dependent on a breathing phase ([0019], where the at least one threshold valve may be a constant therapeutic pressure value; [0090]).
Regarding claim 51, Adametz discloses the invention as set forth in claim 48, wherein the further therapy mode of ventilation is a constant CPAP pressure ([0019], where the at least one threshold valve may be a constant therapeutic pressure value; [0027]; [0033]; [0058]; [0081]; [0088]), which is maintained independently of a breathing phase ([0090]).
Regarding claim 52, Adametz discloses the invention as set forth in claim 48, wherein the patient valve (101) is opened or closed as a function of a breathing phase ([0026]; [0058]; [0082] and [0085]-[0086]), the patient valve being closed during an inspiration, and being driven in a controlled way, and temporarily opened in order to ensure exhalation, during an expiration ([0004], where patient valve 101 is a controlled exhalation valve; [0065]-[0066]) and being operated electrically (patient valve 101 is driven in a controlled way and electrically operated by control device 16; [0065]; [0076]; patient valve 101 can also be electrically operated and controlled by the monitoring device 6, see [0085]).
Regarding claim 53, Adametz discloses the invention as set forth in claim 48, wherein patient breathing is identified by the control unit from a profile of a flow signal of the flow sensor instrument, and the patient valve is actuated as a function of the flow signal (as a trigger) ([0058], where flow sensor 17 is a sensor device, see [0054]; [0084]-[0086]).
Regarding claim 54, Adametz discloses the invention as set forth in claim 48, wherein the control unit (16) drives the breathing gas source in order to deliver breathing gas ([0053]), in order to ensure maintenance of a CPAP pressure level during switching processes of the patient valve ([0055]; [0057]; [0072]; [0076]; [0019], where the at least one threshold valve may be a constant therapeutic pressure value).
Regarding claim 55, Adametz discloses the invention as set forth in claim 48, wherein the control unit (16) lowers a CPAP pressure at least temporarily or raises the CPAP pressure at least temporarily when patient breathing is identified by the control unit as expiration ([0058]; first sentence of [0090]) from a profile of a flow signal of the flow sensor instrument ([0058], where breathing phase is detected via a sensor device 7, and flow sensor 17 is a flow device, see [0054]).
Regarding claim 62, Adametz discloses the invention as set forth in claim 48, wherein the further therapy mode of ventilation is an MPV mode, which delivers a breathing gas volume or a breathing gas flow or a pressurized breathing gas to a patient for inspiration as required (ventilator delivers a flow of pressurized gas to the patient according to the patient’s breathing phases, [0082], where the patient valve 101 temporarily opens during the patient’s exhalation phase, [0083]-[0085]; [0058] and [0072], where at least the gas flow and the gas pressure are adjusted based on the needs and requirements of the patient and their quality of breathing, hence at least the gas flow and the pressurized gas are delivered to the patient for inspiration as required; [0059], where breathing interface 102 can be a tube and/or a larynx mask).
Regarding claim 64, Adametz discloses the invention as set forth in claim 48, wherein a breathing effort (inspiration attempt) of a patient is identified by the control unit from a profile of a flow signal or of a pressure signal, and the control unit (16) drives the breathing gas source (3) specifying a breathing gas flow or breathing gas volume when an inspiration attempt by the patient is identified from a profile of the flow signal or of the pressure signal ([0055]; [0057]; [0058], where flow sensor 17 is a sensor device, see [0054]).
Regarding claim 65, Adametz discloses the invention as set forth in claim 48, wherein a pressure of a breathing assistance gas ([0055]; [0058]; [0076]; [0081]) and a volume are adjustable (see [0087], [0078], and [0072], hence the volume of the breathing assistance gas is adjustable such that a required volume of the breathing assistance gas is delivered to the patient), or wherein the pressure of the breathing assistance gas and an inspiration time Ti are adjustable.
Regarding claim 74, Adametz discloses the invention as set forth in claim 48, wherein the interchangeable breathing gas tube (25) is a double tube system having an assigned patient valve (double tube system in Fig. 1 with a ventilation tube 45, an exhalation tube 55, and a patient valve 101), the assigned patient valve being located next to a fitting in an apparatus housing (see Fig. 1, where patient valve 101 of exhalation tube 55 connects to the second coupling 24 of the ventilation device 2).
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.
Claims 56-57, 66, and 76 are rejected under 35 U.S.C. 103 as being unpatentable over Adametz (US 20170368277 A1) in view of Rapoport et al. (US 20140000610 A1; hereinafter “Rapoport”).
Regarding claim 56, Adametz discloses the invention as set forth in claim 48, but fails to explicitly disclose the control unit may specify a CPAP pressure at pressure values below 4 hPa, since purging of CO2 from exhaled air by the patient valve takes place reliably even at low pressures.
However, Rapoport teaches an analogous apparatus for supplying gas to a patient (Abstract) with a valve that, when operating in a second mode that is a pressure support mode, can remain stable at pressures of about 3 cm H2O or lower ([0021]; [0139]) such that purging of CO2 from exhaled air via the valve can reliably take place, even at low pressures ([0119], lines 5-7, where controller 224 adjusts pressure to trigger a leak, where air vented via the triggered leak is exhaled carbon dioxide, [0117], lines 6-7; [0187]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Adametz such that the control unit (16) may specify a CPAP pressure level as low as about 2-3 cm H2O (equivalent to about 1.96 hPa to 2.94 hPa) so the flushing of CO2 from exhaled air via the patient valve (101) can reliably take place, even at low pressures, as taught by Rapoport above, to minimize patient rebreathing of CO2 in the exhaled air (Rapoport [0187]).
Regarding claim 57, Adametz discloses the invention as set forth in claim 48, wherein the control unit (16) activates a further CPAP therapy mode of ventilation in response to user selection or automatically ([0057]; [0088]; [0018] and [0037]), and in this case drives the breathing gas source in order to specify a CPAP pressure ([0055]; [0057]; [0072]; [0076]; [0019], where the at least one threshold valve may be a constant therapeutic pressure value), the interchangeable breathing gas tube (25) remaining at the at least one connection fitting on the apparatus during a change from the first therapy mode of ventilation to the further CPAP therapy mode of ventilation (based on [0011] and Figs. 3-4, it would be well-understood by one of ordinary skill in the art that the tube 25 stays connected to the ventilation device 2 during a switch from the first ventilation pressure 18 to the CPAP pressure of a second ventilation pressure 28 and/or a back pressure 8 as there is a constant supply of a flow of pressurized gas to the patient, and characteristics of the flow within the flow connection is constantly detected to monitor the backflowing exhaled air; [0093]), and the patient valve being closed during inspiration, and being driven in a controlled way, and temporarily opened in order to ensure exhalation, during expiration ([0004], where patient valve 101 is a controlled exhalation valve; [0065]-[0066]), patient breathing being identified by the control unit from a profile of a flow signal of the flow sensor instrument, and the patient valve being actuated as a function of the flow signal (as a trigger) ([0058], where flow sensor 17 is a sensor device, see [0054]; [0084]-[0086]), the breathing gas source being driven in order to ensure maintenance of the CPAP pressure level during switching processes of the patient valve ([0055]; [0057]; [0072]; [0076]; [0019], where the at least one threshold valve may be a constant therapeutic pressure value). Adametz fails to explicitly disclose the CPAP pressure being specifiable at pressure values below 4 hPa.
However, Rapoport teaches an analogous apparatus for supplying gas to a patient (Abstract) with a valve that, when operating in a second mode that is a pressure support mode, can remain stable at pressures of about 3 cm H2O or lower ([0021]; [0139]) such that purging of CO2 from exhaled air via the valve can reliably take place, even at low pressures ([0119], lines 5-7, where controller 224 adjusts pressure to trigger a leak, where air vented via the triggered leak is exhaled carbon dioxide, [0117], lines 6-7; [0187]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Adametz such that the control unit (16) may specify a CPAP pressure level as low as about 2-3 cm H2O (equivalent to about 1.96 hPa to 2.94 hPa), as taught by Rapoport above, to reliably flush CO2 from exhaled air via the patient valve (101) at low pressures (Rapoport [0119], lines 5-7; Rapoport [0117], lines 6-7; Rapoport [0187]) and minimize patient rebreathing of CO2 in the exhaled air (Rapoport [0187]).
Regarding claim 66, Adametz discloses the invention as set forth in claim 48, wherein limit values are stored or adjustable for a flow signal (monitoring device 6 monitors flow signal from flow sensor 17 to detect when a volumetric flow rate is below a threshold value, see [0078])/or pressure signal, the limit values being a trigger sensitivity (when volumetric flow rate is detected to be below the threshold value, the monitoring device regulates the blower device 3 accordingly, see [0078]), but fails to explicitly disclose the trigger sensitivity being adjustable.
However, Rapoport teaches an analogous apparatus for supplying gas to a patient (Abstract) and threshold values that are stored and adjustable for a flow signal ([0019]; [0162], lines 6-9, where the threshold value can be adjusted with values from a table that correspond to an appropriate situation of use; [0162], lines 10-11, where the threshold can be a lower flow threshold) or a pressure signal ([0164], where the threshold can be a pressure threshold), where the threshold values can trigger a valve (250) to switch modes of therapy being supplied to a patient ([0019], lines 1-4, where the valve 250 is actuated to switch modes when a flow/pressure value increases above a first threshold of flow/pressure and when a flow/pressure value decreases below a second threshold of flow/pressure), where the ranges and values of the threshold values, and thus the trigger sensitivity correlated to said threshold values, can be adjusted based on specific characteristics of the apparatus and provided therapy ([0162], lines 6-9, where threshold values are adjustable).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the trigger sensitivity of the limit values taught by Adametz to be adjustable, as taught by Rapoport above, to improve patient comfort without compromising patient safety (last sentence of Rapoport [0162]).
Regarding claim 76, Adametz discloses the invention as set forth in claim 48, but fails to explicitly disclose the control unit (16) drives the breathing gas source during daytime in order to specify a breathing gas flow and during nighttime in order to specify a varying breathing gas pressure.
However, Rapoport teaches a controller (224) that carries out a method of determining if a user is awake or asleep, and supplies a specified breathing gas flow to the patient if it is determined the patient is awake ([0161], lines 1-6, where controller 224 carries out the method and controls flow conditions of the flow generator 200) and supplies a specified and varying breathing gas pressure if the patient is asleep ([0160], lines 1-2, where the therapeutic pressure is the pressure provided when the apparatus is in the therapeutic mode, and controller 224 controls the pressure condition when the apparatus is in the therapeutic mode, see [0158], lines 1-4; where it would be recognized by one of ordinary skill in the art that an individual is normally awake during the day and asleep during the night).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the controller of Adametz with the controller of Rapoport, as taught above, to improve patient comfort when receiving therapy in a transition between sleep and wake (Rapoport [0159]).
Claims 58-59, 61, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Adametz (US 20170368277 A1) in view of Holyoake et al. (US 20180085544 A1; hereinafter “Holyoake”).
Regarding claim 58, Adametz discloses the invention as set forth in claim 48, but fails to explicitly disclose wherein the further therapy mode of ventilation is a constant breathing gas flow (HFT), which is maintained independently of a breathing phase, the control unit driving the breathing gas source in order to specify a constant breathing gas flow and switching the patient valve into a permanently closed position.
However, Holyoake teaches an analogous apparatus to supply gas to a patient in a high flow mode ([0143]; [0148]; [0721]), which is maintained based on a predetermined value and a sampled or measured pressure to supply a constant flow of gas to the patient ([0267]; [0270]; [0276]; [0321], hence, flow of gas being maintained at a high flow is independent of a breathing phase), where the constant flow of gas to the patient is adjusted to a lower flow at the start of expiration ([0876], lines 1-2 and 5; [0882], lines 8-9) while a mask pressure simultaneously increases ([0880], lines 2-5 and 12-13), and where a valve member is biased to a closed position ([0279]; [0316]; [0766], hence the valve is permanently closed unless otherwise acted upon).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Adametz with the high flow operation mode and corresponding valve behavior, as taught by Holyoake above, to reduce the work of breathing of the patient and minimize rebreathing of exhaled air (Holyoake [0655]), and to ensure gas is not delivered to the patient at a pressure higher than a desired pressure level (Holyoake [0876]).
Regarding claim 59, Adametz as modified teaches the invention as set forth in claim 58, wherein the control unit is designed and configured to control the breathing gas source for the constant breathing gas flow (HFT) mode of ventilation in such a way that a patient flow decreases at a start during expiration, while a mask pressure simultaneously increases ([0876], lines 1-2 and 5; [0882], lines 8-9; [0880], lines 2-5 and 12-13; see claim 58 above).
Regarding claim 60, Adametz discloses the invention as set forth in claim 48, wherein the interchangeable breathing gas tube (25) has the patient valve (101, see Fig. 1) and remains on the apparatus during the change from the first mode of ventilation to a second mode of ventilation (see [0011] and Figs. 3-4, where it would be well-understood by one of ordinary skill in the art that the tube 25 stays connected to the ventilation device 2 during a switch from the first ventilation pressure 18 to the second ventilation pressure 28 and/or the back pressure 8 as there is a constant supply of a flow of pressurized gas to the patient, and characteristics of the flow within the flow connection is constantly detected to monitor the backflowing exhaled air; [0093]), and for the second mode of ventilation the patient valve is closed by a control pressure being sent by the breathing gas source through a pressure tube to the patient valve (control tube 109; Fig. 1; [0065]), but fails to explicitly disclose the apparatus changes from the first mode of ventilation to an HFT mode of ventilation.
However, Holyoake teaches an analogous apparatus to supply gas to a patient (Abstract), where the apparatus can switch into a high flow mode ([0143]; [0148]; [0721]), which is maintained based on a predetermined value and a sampled or measured pressure to supply a constant flow of gas to the patient ([0267]; [0270]; [0276]; [0321], hence, flow of gas being maintained at a high flow is independent of a breathing phase), and wherein the apparatus further includes a humidifier to heat and humidify the high flow of gas from a flow generator ([0652]; [0659]).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Adametz to include a further therapy mode of HFT and a humidifier, as taught by Holyoake above, to reduce the work of breathing of the patient and minimize rebreathing of exhaled air (Holyoake [0655]) and to increase patient comfort while receiving the high flow therapy.
Regarding claim 61, Adametz discloses the invention as set forth in claim 48, but fails to explicitly disclose the control unit specifies a HFT mode of ventilation with a consistent high flow of breathing gas, which is applied via the patient interface into both nostrils of a patient in such a way that the consistent high flow flushes a nasal dead space, the patient interface in this case not sealing tightly with a nasal wall so that exhalation past the patient interface is possible, a setpoint flow during HFT ventilation being kept consistent at a pre-adjusted level, the patient valve being kept in a closed state during the HFT mode of ventilation since breathing gas is not intended to escape progressively from the patient valve but is continuously conveyed during inspiration and expiration to the patient interface.
However, Holyoake teaches an analogous apparatus to supply gas to a patient (Abstract), where the apparatus can switch into a high flow mode ([0143]; [0148]; [0721]), where the high flow is maintained based on a predetermined value and a sampled or measured pressure to supply a constant flow of gas to the patient ([0267]; [0270]; [0276]; [0321], hence, flow of gas being maintained at a high flow is independent of a breathing phase) that is continuously conveyed during inspiration and expiration (see cannula flow over time in Fig. 44D, where the cannula flow being delivered is high flow, see [0880]), and where a valve member is biased to a closed position ([0279]; [0316]; [0766], hence the valve is permanently closed unless otherwise acted upon). Holyoake further teaches the high flow of gas is supplied to the nares of the patient via non-sealing patient interface (200; [0661], lines 9-10) such that the high flow supplied to the patient can flush the anatomical dead space of the patient’s upper airways ([0655]) and the patient may exhale past the patient interface ([0916], line 7).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Adametz with the high flow therapy mode and non-sealing patient interface taught by Holyoake above to reduce the patient’s work of breathing and minimize rebreathing exhaled air (first sentence of Holyoake [0655]; last sentence of Holyoake [0655]).
Regarding claim 63, Adametz discloses the invention as set forth in claim 48, wherein the control unit (16) drives the breathing gas source in order to specify a breathing gas flow or breathing gas volume or a pressurized breathing gas for inspiration ([0055]; [0057]; [0072]; [0076]), but fails to explicitly disclose the control unit switches the patient valve into a permanently closed position.
However, Holyoake teaches an analogous apparatus to supply gas to a patient (Abstract), that includes a valve member being biased to a closed position to supply the gas to the patient ([0279]; [0316]; [0753]; [0766], hence the valve is permanently closed unless otherwise acted upon).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Adametz with the controls and valve behavior taught by Holyoake above to ensure the patient receives a constant and continuous supply of gas during treatment and to improve the accuracy of the specified gas volume, gas pressure, and/or gas flow to the patient (Holyoake [0793], line 10 to end of paragraph).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Adametz (US 20170368277 A1) in view of Brodkin et al. (US 20120118291 A1; hereinafter “Brodkin”).
Regarding claim 67, Adametz discloses the invention as set forth in claim 48, but fails to explicitly disclose a trigger blocking time in a range of from 0.1 to 10 seconds can be specified, breathing efforts by a patient, registered by sensing, being ignored by the control unit for a duration of the trigger blocking time.
However, Brodkin teaches a trigger delay of one second where the operation of a pump (16, where said pump controls airflow levels, [0046], lines 5-6) is delayed for 0.2 seconds after the identification of the start of patient inhalation ([0062], lines 1-5).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Adametz with trigger delay taught by Brodkin above to ensure the apparatus samples and monitors parameter values associated with a breathing phase accurately within the duration of a respective breathing phase (Brodkin: [0062], lines 5-7).
Claims 68-70 are rejected under 35 U.S.C. 103 as being unpatentable over Adametz (US 20170368277 A1) in view of Thiessen (US 20130000644 A1).
Regarding claim 68, Adametz discloses the invention as set forth in claim 48, wherein an MPV interface (mouthpiece) ([0059], where breathing interface 102 can be a tube and/or a larynx mask), which is configured in such a way that it is inserted at least partially into a mouth (it would be recognized by one of ordinary skill in the art that at least a larynx mask is at least partially inserted into the patient’s mouth), is used as the patient interface for an MPV mode of ventilation ([0059]; ventilator delivers a flow of pressurized gas to the patient according to the patient’s breathing phases, [0082], where the patient valve 101 temporarily opens during the patient’s exhalation phase, [0083]-[0085]; [0058]; [0072]). Adametz fails to explicitly disclose the control unit (16) being designed and configured to control the breathing gas source in such a way that a mask pressure has an increasing profile during inspiration and the mask pressure falls more slowly than a setpoint pressure during the expiration.
However, Thiessen teaches an analogous MPV therapy mode for the supply of breathing gas to a patient ([0013], lines 12-13) with a controller (50) controlling and adjusting flowrates and pressures of the breathing gas delivered to the patient (last sentence of [0014]) such that increasing a mask pressure during inspiration ([0028], lines 4-6), where the mask pressure falls more slowly than a setpoint pressure during expiration ([0028], lines 6-9).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the control device of Adametz with the controller and control methods taught by Thiessen above to improve patient comfort by providing pressurized flow to the patient only when the patient is connected to the breathing interface and requires such pressurized breathing assistance to facilitate their breathing (Thiessen [0028], lines 7-9 and last sentence of [0028]).
Regarding claim 69, Adametz discloses the invention as set forth in claim 68, wherein the patient valve (101) is briefly opened for an expiration ([0004], lines 2-4) so that a pressure at the mouthpiece is lowered ([0085], lines 1-6, where it would have been readily understood by one of ordinary skill in the art that the flushing of exhaled air contained within the patient interface would lower the pressure at the patient interface), and the patient valve is subsequently closed ([0004] and [0066], hence the patient valve 101 is subsequently closed for the following inhalation phase).
Regarding claim 70, Adametz discloses the invention as set forth in claim 48, wherein the further therapy mode of ventilation is an MPV mode, which delivers breathing gas to a patient for inspiration as required (ventilator delivers a flow of pressurized gas to the patient according to the patient’s breathing phases, [0082], where the patient valve 101 temporarily opens during the patient’s exhalation phase, [0083]-[0085]; [0058] and [0072], where at least the gas flow and the gas pressure are adjusted based on the needs and requirements of the patient and their quality of breathing, hence at least the gas flow and the pressurized gas are delivered to the patient for inspiration as required; [0059], where breathing interface 102 can be a tube and/or a larynx mask), a breathing gas pressure being adjustable ([0055]; [0058]; [0076]; [0081]) and/or a breathing gas volume (see [0087], [0078], and [0072], hence the volume of the breathing assistance gas is adjustable such that a required volume of the breathing assistance gas is delivered to the patient) or an inspiration time Ti furthermore being specified, a mouthpiece being used as the patient interface ([0059], where breathing interface 102 can be a tube and/or a larynx mask). Adametz further discloses the control unit at least temporarily opening the patient valve for the expiration so that the patient can exhale its expiratory air through the fully or partially opened patient valve to the environment ([0082], where the patient valve 101 temporarily opens during the patient’s exhalation phase, [0083]-[0085]; [0004], where patient valve 101 is a controlled exhalation valve; [0065]), the control unit (16) activating the breathing gas source (3) during the expiration in order to specify a flushing flow to assist flushing of exhaled air out from the interchangeable breathing gas tube ([0085]-[0086]; [0026]). Adametz fails to explicitly disclose and breathing signals of the patient being registered by sensing when the mouthpiece is in a mouth as a pressure trigger and/or flow trigger in order to start MPV ventilation, and the patient being able to keep the mouthpiece in its mouth for expiration.
However, Thiessen teaches an analogous patient interface (28) which includes a rigid, semi-rigid, or flexible tube a patient may selectively engage and disengage via at least partial insertion into the patient’s mouth ([0013], lines 15-18, where the patient latches onto and closes their mouth around patient interface 28 to engage said patient interface, see [0028]; [0262], lines 6-9, where the user is connected to the patient interface during expiration; Thiessen: [0013], lines 15-18 and [0014], lines 5-6, where the patient is not required to remove the mouthpiece from their mouth for expiration).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the user interface of Adametz with the patient interface taught by Thiessen above, as the mouthpiece taught by Thiessen would predictably function the same as the breathing interface taught by Adametz, and would successfully deliver pressurized gas or a gas flow to a user.
Claim 71 is rejected under 35 U.S.C. 103 as being unpatentable over Adametz (US 20170368277 A1) in view of Thiessen (US 20130000644 A1) and in further view of Rapoport (US 20140000610 A1).
Regarding claim 71, Adametz discloses the invention as set forth in claim 48, wherein the further therapy mode of ventilation is an MPV mode of ventilation (ventilator delivers a flow of pressurized gas to the patient according to the patient’s breathing phases, [0082], where the patient valve 101 temporarily opens during the patient’s exhalation phase, [0083]-[0085]; [0058]; [0072]; [0059], where breathing interface 102 can be a tube and/or a larynx mask), the apparatus consisting of the following: the breathing gas source (3, see Fig. 1), the patient interface in the form of a mouthpiece ([0059], where breathing interface 102 can be a tube and/or a larynx mask), which can be at least partially inserted into an airway opening of the patient and removed again (it would be well-understood by one of ordinary skill in the art that at least a larynx mask can be at least partially inserted into an airway opening of the patient and removed), the patient interface (102, 105) furthermore being configured so that the breathing gas flow is sent into airways of the patient (a larynx mask inherently sends air directly to the airways of a patient); at least one of the pressure sensor (27) or the flow sensor (17) being designed to establish whether the patient has performed breathing efforts ([0055], where the pressure sensor 27 and the flow sensor 17 are a sensor device; [0058]). Adametz fails to explicitly teach the breathing gas source (3, see Fig. 1), which temporarily sends a pressurized breathing gas flow to airways.
However, Thiessen teaches an analogous MPV mode of ventilation ([0013], lines 12-13) to temporarily send pressurized gas to the patient via a mouthpiece ([0014]; [0013], lines 12-13, where the pressurized gas is delivered as required, hence the delivery of the pressurized gas is not constant and is temporary, or only when the patient requires), wherein when the mouthpiece is at least partially inserted into the patient’s airway
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Adametz with the MPV mode taught by Thiessen above to above to improve patient comfort by providing pressurized flow to the patient only when the patient is connected to the breathing interface and requires such pressurized breathing assistance to facilitate their breathing (Thiessen [0028], lines 7-9 and last sentence of [0028]).
Adametz fails to explicitly disclose at least one of the pressure sensor (27) or the flow sensor (17), which generates output signals that, when the mouthpiece is at least partially inserted into an airway opening of the patient, indicate that the patient is ready to receive a breathing gas flow through the mouthpiece; and the control unit (16), which analyzes the sensor signal in order to ascertain whether the patient has performed a breathing effort that exceeds or falls below a limit value for initiating the sending of a temporary pressurized breathing gas flow, the control unit activating the breathing gas source when the limit value for initiating the sending of a temporary pressurized breathing gas flow is reached or exceeded, before specifying a temporary pressurized breathing gas flow, the control unit then activating the temporary pressurized breathing gas flow for an inspiration of the patient.
However, Rapoport teaches a flow sensor (230; Fig. 2) that generates an output signal when the patient is connected to a patient interface, and thus is ready to receive a flow of breathing gas ([0195], lines 1-8 and last sentence of paragraph, where an inspiration attempt is identified via an output flow signal from flow sensor 230 to specify a breathing gas flow), where a controller (224; Fig. 2) to analyze the generated signal from the flow sensor to determine if the breathing effort performed by the patient exceeds or falls below a threshold to determine if a temporary flow of pressurized gas should be sent to the patient ([0019], lines 1-4, where the valve 250 is actuated to switch modes when a flow/pressure value increases above a first threshold of flow/pressure and when a flow/pressure value decreases below a second threshold of flow/pressure), and activating a flow generator when the breathing effort of the patient falls outside of the threshold ([0163]). Rapoport further teaches the subsequent supply of pressurized gas flow to the patient for inspiration ([0164], lines 1-4, where the pressure check occurs after a flow check; [0135], lines 7-9, where the pressure control and output of the flow generator is driven by controller 224).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Adametz with controller and flow sensor taught by Rapoport above, such that the apparatus of Adametz as modified may identify when the patient has positioned the mouthpiece and is ready to receive the flow of breathing gas (see above), and to temporarily send a flow of pressurized breathing gas to the patient (Thiessen [0014]; [0013], lines 12-13, see above) when it is determined by at least a flow sensor that a breathing effort of the patient has fallen outside of a predetermined threshold (see above) to improve patient comfort and safety (Rapoport [0162]).
Claims 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Adametz (US 20170368277 A1) in view of Landis et al. (US 20160367779 A1; hereinafter “Landis”).
Regarding claim 72, Adametz discloses the invention as set forth in claim 48. Adametz fails to explicitly disclose the control unit drives the breathing gas source in order to specify a tidal volume for the first therapy mode or the further therapy mode of ventilation.
However, Landis teaches an adjustment of gas flow to obtain a desired tidal volume ([0217], lines 9-12), where the flow is controlled by a microprocessor ([0192], lines 3-5).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the control device (16) of Adametz to obtain and specify a desired tidal volume, as taught by Landis above, to increase the accuracy of adjustment of the flow rate delivered to the patient to improve the quality of therapy (Landis [0130], lines 1-8).
Regarding claim 73, Adametz discloses the invention as set forth in claim 48. Adametz further discloses a control tube (109; Fig. 1) that is fluidically connected to the patient valve (101, see Fig. 1), where the patient valve (101) receives a control pressure from a blower device (3) of the ventilation device (2) via the control line ([0065]-[0066]). Adametz fails to explicitly disclose the apparatus comprises a compressed gas source.
However, Landis teaches an analogous breathing gas supply device with one or more compressed gas tanks ([0191], lines 2-3).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Adametz with the one or more compressed gas tanks taught by Landis to successfully deliver and supply gas to a patient through a non-sealing patient interface (Landis: [0015], lines 10-13).
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Adametz (US 20170368277 A1) in view of Dantanarayana et al. (US 20190351173 A1; hereinafter “Dantanarayana”).
Regarding claim 75, Adametz discloses the invention as set forth in claim 48, wherein the patient valve (101) is configured to be removable from a compartment of a housing ([0062], where it would be well-understood by one of ordinary skill in the art that the patient valve 101 is removably connected to the second coupling 24 on the ventilation device 2 such that the various models of the tubing devices 25, depicted in Fig. 1, may be interchangeably connected to the ventilation device 2), a control pressure being generated by the breathing gas source and sent to the patient valve through a control tube (control tube 109; Fig. 1; [0065]). Adametz fails to explicitly disclose the patient valve (101) comprising a membrane to which a control pressure can be applied in order to block or release a breathing gas flow through the patient valve.
However, Dantanarayana teaches a vent assembly that includes a membrane (flap 9140; [0096], line 21) to which the membrane (flap 9140; [0096], line 21) responds to a control pressure to block or release breathing gas flow through the valve (Fig. 7D; [0297], lines 2-13).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the patient valve taught by Adametz with the vent assembly and membrane taught by Dantanarayana above to reduce the amount of power the system requires to operate by providing a self-sealing action with a flap seal (Dantanarayana: [0035], lines 1-4).
Response to Arguments
Applicant’s arguments with respect to claims 48-51, 53-56, 58-68, 71-73, and 75-76 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.
Regarding claim 48, Applicant argues the Examiner’s rejection provided in the Office Action mailed 02/24/2026 rests on an unreasonably broad construction of “interchangeable breathing gas tube” as the term “interchangeable” makes it clear that the breathing gas tube cannot merely be removed from the gas supply and replace by another of the same type, but is interchangeable with one or more different breathing gas tubes, as supported by the specification (see Appeal Brief pg. 10). While Applicant’s specification does provide support for the breathing gas tube being capable of being removed and replaced with a breathing gas tube of a different model/type, the specification does not equate this functionality of the breathing gas tube to being “interchangeable” as the language of “interchangeable” is not within Applicant’s specification. Hence, the interpretation of “interchangeable” provided in the Office Action mailed 02/24/2026 is a reasonably broad interpretation of “interchangeable”. Furthermore, Applicant’s argument with respect to claim 48 has been considered but is 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. Specifically, Adametz (US 20170368277 A1) is now relied upon for the rejection of claim 48, where Adametz discloses a tube (25) that may be of different models/types (see Fig.1) that may interchangeably connect to a ventilation device (see 102(a)(1) rejection of claim 48 above).
Regarding claim 48, Applicant argues Rapoport fails to disclose a patient valve that is actively switched for a further therapy mode by a control unit (Appeal Brief pg. 11). While the Examiner agrees the valve disclosed by Rapoport functions in a passive manner, Applicant’s argument is moot as 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. Adametz has been provided to teach a valve that is actively switched to a further therapy mode by a control unit (see 102(a)(1) rejection of claim 48 above).
On page 13 of the Appeal Brief, Applicant argues claims 49-51, 53-56, 63, 64, 66, and 76 each depend, directly or indirectly, from claim 48, and thus are not anticipated by Rapoport for at least the same reasons. Applicant’s argument is moot as new ground(s) of rejection have been presented for claim 48 (see 102(a)(1) rejection of claim 48).
On page 14 of the Appeal Brief, Applicant argues claims 58, 60, 65, 72, and 73 are not obvious over Rapoport in view of Landis for at least the same reasons as above (see above remarks in regard to independent claim 48) as Landis fails to remedy the deficiencies of Rapoport (i.e., interchangeable breathing gas tube and a patient valve that is actively switched to a further mode of therapy via a control unit). However, Applicant’s argument is moot as new ground(s) of rejection have been presented for claim 48 (see 102(a)(1) rejection of claim 48 above).
On page 15 of the Appeal Brief, Applicant argues claims 59 and 61 are not obvious over Rapoport in view of Landis and Holyoake for at least the same reasons as above (see above remarks in regard to independent claim 48) as Landis and Holyoake fail to remedy the deficiencies of Rapoport (i.e., interchangeable breathing gas tube and a patient valve that is actively switched to a further mode of therapy via a control unit). However, Applicant’s argument is moot as new ground(s) of rejection have been presented for claim 48 (see 102(a)(1) rejection of claim 48 above).
On page 16 of the Appeal Brief, Applicant argues claims 62, 68, and 71 are not obvious over Rapoport in view of Thiessen for at least the same reasons as above (see above remarks in regard to independent claim 48) as Thiessen fails to remedy the deficiencies of Rapoport (i.e., interchangeable breathing gas tube and a patient valve that is actively switched to a further mode of therapy via a control unit). However, Applicant’s argument is moot as new ground(s) of rejection have been presented for claim 48 (see 102(a)(1) rejection of claim 48 above).
On page 17 of the Appeal Brief, Applicant argues claim 67 is not obvious over Rapoport in view of Brodkin for at least the same reasons as above (see above remarks in regard to independent claim 48) as Brodkin fails to remedy the deficiencies of Rapoport (i.e., interchangeable breathing gas tube and a patient valve that is actively switched to a further mode of therapy via a control unit). However, Applicant’s argument is moot as new ground(s) of rejection have been presented for claim 48 (see 102(a)(1) rejection of claim 48 above).
On page 20 of the Appeal Brief, Applicant argues claim 75 is not obvious over Rapoport in view of Dantanarayana for at least the same reasons as above (see above remarks in regard to independent claim 48) as Dantanarayana fails to remedy the deficiencies of Rapoport (i.e., interchangeable breathing gas tube and a patient valve that is actively switched to a further mode of therapy via a control unit). However, Applicant’s argument is moot as new ground(s) of rejection have been presented for claim 48 (see 102(a)(1) rejection of claim 48 above).
Applicant's arguments filed 07/21/2026 with regard to claims 52, 57, 69, 70, and 74 have been fully considered but they are not persuasive.
On page 13 of the Appeal Brief, Applicant argues claims 52, 57, and 74 are not obvious over Rapoport in view of Adametz for at least the same reasons as above (see above remarks in regard to independent claim 48) as Adametz does not cure the deficiencies of Rapoport. Applicant’s argument is not persuasive as Adametz does cure the deficiencies of Rapoport (i.e., interchangeable breathing gas tube and a patient valve that is actively switched to a further mode of therapy via a control unit) (see 102(a)(1) rejection of claim 48 above).
On page 18 of the Appeal Brief, Applicant argues claim 69 is not obvious over Rapoport in view of Thiessen and Adametz for at least the same reasons as above (see above remarks in regard to independent claim 48) as Thiessen and Adametz fail to remedy the deficiencies of Rapoport. Applicant’s argument is not persuasive as Adametz does cure the deficiencies of Rapoport (i.e., interchangeable breathing gas tube and a patient valve that is actively switched to a further mode of therapy via a control unit) (see 102(a)(1) rejection of claim 48 above).
On page 19 of the Appeal Brief, Applicant argues claim 70 is not obvious over Rapoport in view of Thiessen, Landis, and Adametz for at least the same reasons as above (see above remarks in regard to independent claim 48) as Thiessen, Landis, and Adametz fail to remedy the deficiencies of Rapoport. Applicant’s argument is not persuasive as Adametz does cure the deficiencies of Rapoport (i.e., interchangeable breathing gas tube and a patient valve that is actively switched to a further mode of therapy via a control unit) (see 102(a)(1) rejection of claim 48 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Thomas et al. (US 20150136135 A1): Regarding a system to control the flow of exhalation gas in a respiratory support system via a controlled valve.
Jalde (US 6564798 B1): Regarding a method to control the actuation and switching of an expiratory valve in a ventilator.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
