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
This Office Action is in response to the amendment filed on 01/21/2026. Per the amendment, claims 1-47 remain canceled; claims 48-52, 55, 57-62, 64-65, 67-68, 70-72, and 74 are as currently amended; and claims 53-53, 56, 63, 66, 69, 73, and 75-76 are as previously presented. As such, claims 48-76 are pending in the instant application.
All objections and rejections pursuant to 35 U.S.C. 112(b) made in the Office Action mailed on 10/22/2025 are withdrawn in light if the amendments.
Claim Objections
Claims 48, 57, 59, 71-72, and 74 are objected to because of the following informalities:
Claim 48, line 11: “the change” should read “a change” to establish antecedent basis.
Claim 57, line 4: “the exchangeable breathing gas tube” should read “the interchangeable breathing gas tube” for clarity and consistency.
Claim 59, lines 2-3: “the HFT mode of ventilation” should read “the constant breathing has flow (HFT) mode of ventilation” for clarity and consistency.
Claim 71, lines 8 and 11: “the pressure sensor or flow sensor” should read “the pressure sensor or the flow sensor” for clarity.
Claim 72, line 2: “for the first or further therapy mode” should read “for the first therapy mode of ventilation or the further therapy mode” for clarity and consistency.
Claim 74, line 1: “the replaceable breathing gas tube” should read “the interchangeable breathing gas tube” for clarity and consistency.
Appropriate correction is required.
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.
Claims 60, 70, and 74 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 60 recites the limitation "the interchangeable breathing gas tube has the patient valve and remains on the apparatus during the change from ventilation to HFT, and for the HFT mode of ventilation the patient valve is closed" in lines 1-4. There is insufficient antecedent basis for this limitation in the claim as a change from ventilation to HFT and an HFT mode of ventilation have not been previously disclosed. For the purpose of examination, the above limitation will be interpreted as – the interchangeable breathing gas tube has the patient valve and remains on the apparatus during a change from the first mode of ventilation to an HFT mode of ventilation, and for the HFT mode of ventilation the patient valve is closed – based on claim 48 and the specification.
Claim 60 recites the limitation “sent by the breathing gas source through a pressure tube to the patient valve and/or a humidifier and a heater are activated” in lines 4-5. It is unclear what limitations are included in the “and/or” statement. For the purpose of examination, the above limitation will be interpreted as – sent by the breathing gas source through a pressure tube to the patient valve and/or both a humidifier and a heater are activated – based on [0028] of Applicant’s specification (see PGPub US 2023/0355915 A1).
Claim 70 recites the limitation "the tube" in lines 11-12. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, the above limitation will be interpreted as – the interchangeable breathing gas tube.
Claim 74 recites the limitation "the assigned patient valve" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the assigned patient valve is a recitation of the patient valve disclosed in claim 48, or if Applicant was attempting to disclose a new limitation. For the purpose of examination, the above limitation will be interpreted as the disclosure of a new limitation based on Applicant’s specification.
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 48-51, 53-56, 63, 64, 66, and 76 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rapoport et al. (US 20140000610 A1), hereinafter Rapoport.
Regarding claim 48, Rapoport discloses an apparatus for breathing gas supply (breathing gases supply system; Fig. 2; [0178], lines 1-3), wherein the apparatus (breathing gases supply system; Fig. 2; [0178], lines 1-3) comprises a breathing gas source (gas supply device 200; Fig. 2), a control unit (controller 224; Fig. 2), a memory (control program storage; [0183], lines 6-9; [0186], lines 12-17), a pressure sensor instrument (pressure sensor 232; Fig. 2) and/or a flow sensor instrument (flow sensor 230; Fig. 2), an interchangeable breathing gas tube (supply conduit 202, where supply conduit 202 is connected to user interface 204 via a connector, [0180], lines 3-4, hence supply conduit 202 is connectable and can be removed from user interface 204 to be replaced; Fig. 2), at least one connection fitting for the interchangeable breathing gas tube (connection fitting connecting supply conduit 202 to user interface 204; [0180], lines 3-4), a patient interface (user interface 204; Fig. 2) and a patient valve (flow diversion device 250; Fig. 2), wherein the control unit (controller 224; Fig. 2) activates a first therapy mode of ventilation for a first period of time ([0010], lines 12-17, where controller 224 activates flow diversion device 250 such that a first mode of ventilation is activated for a period of time; [0139], lines 3-6, where controller 224 is the only controller interacting with flow diversion device 250 via the control and adjustment of flow and pressure), 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 ([0010], lines 15-16, where the controller is controller 224 and the flow generator is gas supply device 200), and wherein the control unit activates a further therapy mode of ventilation for a second period of time ([0128], lines 1-4; [0129], lines 4-6, where the flow generator 200 is controlled by controller 224, [0142], lines 3-4), 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 ([0010], lines 12-14, where controller 224 drives gas supply device 200 to specify a pressure specific for the second mode), the interchangeable breathing gas tube (supply conduit 202, where supply conduit 202 is connected to user interface 204 via a connector, [0180], lines 3-4, hence supply conduit 202 is connectable and can be removed from user interface 204 to be replaced; Fig. 2) remaining on the apparatus during the change from the first therapy mode of ventilation to the further therapy mode of ventilation ([0120], lines 1-6, where the user receives breathing gas during transition from first mode of ventilation to second mode of ventilation, hence the supply conduit 202 must be connected to the apparatus during the change from first mode of ventilation to second mode of ventilation), and the patient valve (flow diversion device 250; Fig. 2) being switched for the further therapy mode of ventilation by the control unit ([0128], lines 1-4, where controller 224 monitors and adjusts pressure and flow conditions).
Regarding claim 49, Rapoport discloses the claimed invention as set forth in claim 48, wherein the control unit (controller 224; Fig. 2) activates a CPAP mode ([0119], last sentence of paragraph, where controller 224 stores control programs and control algorithms, see [0183], last sentence of paragraph; [0120], lines 6-9, where controller 224 monitors and adjusts flow and pressure conditions) or an MPV mode or an HFT mode as the further therapy mode of ventilation and wherein the interchangeable breathing gas tube is a single tube valve system (supply conduit 202, see Fig. 2).
Regarding claim 50, Rapoport discloses the claimed invention as set forth in claim 48, wherein the control unit (controller 224; Fig. 2) activates the further therapy mode of ventilation ([0129], lines 4-6, where the flow generator 200 is controlled by controller 224, [0142], lines 3-4), and in this case drives the breathing gas source in order to specify a constant breathing gas parameter ([0138], lines 1-5, where pressure control maintains a constant pressure, and where the therapeutic CPAP mode is the second ventilation mode) independent of or dependent on a breathing phase ([0138], lines 4-11, where the pressure is maintained at a constant pressure, and said maintenance of the constant pressure is independent of a breathing phase).
Regarding claim 51, Rapoport discloses the claimed invention as set forth in claim 48, wherein the further therapy mode of ventilation is a constant CPAP pressure ([0138], lines 1-5, where the therapeutic CPAP mode is the second ventilation mode and the pressure control maintains a constant pressure), which is maintained independently of a breathing phase ([0138], lines 4-11, where the pressure is maintained at a constant pressure, and said maintenance of the constant pressure is independent of a breathing phase).
Regarding claim 53, Rapoport et al. discloses the claimed 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 ([0195], lines 5-6, where the control program is implemented by controller 224; [0185], where controller 224 receives input from flow sensor 230, and flow sensor 230 monitors flow output by flow generator 200), and the patient valve (flow diversion device 250; Fig. 2) is actuated as a function of the flow signal ([0119], last sentence of paragraph, where change in valve 250 behavior is in response to signal generated by an algorithm, the algorithm is implemented by controller 224, and controller 224 receives input from flow sensor 230, hence controller 224 receives flow input from flow sensor 230 and generates a flow signal to actuate valve 250) (as a trigger).
Regarding claim 54, Rapoport et al. discloses the claimed invention as set forth in claim 48, wherein the control unit (controller 224; Fig. 2) drives the breathing gas source in order to deliver breathing gas ([0136], lines 15-16, where the control method is implemented by controller 224), in order to ensure maintenance of a CPAP pressure level during switching processes of the patient valve ([0138]).
Regarding claim 55, Rapoport discloses the claimed invention as set forth in claim 48, wherein the control unit (controller 224; Fig. 2) raises the CPAP pressure at least temporarily ([0138], lines 7-8) when patient breathing is identified by the control unit as expiration from a profile of a flow signal of the flow sensor instrument ([0195], lines 5-8 and last sentence of paragraph, where controller 224 is capable of identifying an inhalation, hence the controller 224 is capable of identifying an exhalation).
Regarding claim 56, Rapoport et al. discloses the claimed invention as set forth in claim 48, wherein the control unit may specify a CPAP pressure at pressure values below 4 hPa ([0141], lines 5-9, where a pressure value of 4 cm H2O is approximately 3.92 hPa and the controller 224 adjusts pressure conditions and values of the apparatus; [0119], lines 1-7, where pressure is adjusted by controller 224 based on a desired CPAP pressure in the sub-therapeutic mode), since purging of CO2 from exhaled air by the patient valve takes place reliably 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]).
Regarding claim 63, Rapoport et al. discloses the claimed invention as set forth in claim 48, wherein the control unit (controller 224; Fig. 2) drives the breathing gas source in order to specify a breathing gas flow ([0135], lines 7-9, where the pressure control and output of the flow generator is driven by controller 224) or breathing gas volume or a pressurized breathing gas for inspiration and switches the patient valve into a permanently closed position ([0135], lines 9-13).
Regarding claim 64, Rapoport et al. discloses the claimed invention as set forth in claim 48, wherein a breathing effort (inspiration attempt) of a patient is identified by the control unit (controller 224; Fig. 2) from a profile of a flow signal ([0195], lines 5-8 and last sentence of paragraph) or of a pressure signal, and the control unit (controller 224; Fig. 2) drives the breathing gas source 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 ([0195], lines 1-5) or of the pressure signal.
Regarding claim 66, Rapoport et al. discloses the claimed invention as set forth in claim 48, wherein limit values (threshold values; [0019]) are stored or adjustable ([0162], lines 6-9, where the threshold value can be adjusted with values from a table that correspond to an appropriate situation of use) for a flow signal ([0162], lines 10-11, where the threshold can be a lower flow threshold) /or pressure signal ([0164], where the threshold can be a pressure threshold), the limit values (threshold values; [0019]) being a trigger sensitivity ([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 the trigger sensitivity being adjustable ([0162], lines 6-9, where threshold values are adjustable).
Regarding claim 76, Rapoport et al. discloses the claimed invention as set forth in claim 48, wherein the control unit (controller 224; Fig. 2) drives the breathing gas source during daytime in order to specify a breathing gas flow ([0161], lines 1-6, where controller 224 carries out the method and controls flow conditions of the flow generator 200) and during nighttime in order to specify a varying breathing gas pressure ([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).
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 52, 57, and 74 are rejected under 35 U.S.C. 103 as being unpatentable over Rapoport as applied to claim 48 above, and further in view of Adametz & Mehnert (US 20170368277 A1), hereinafter Adametz.
Regarding claim 52, Rapoport discloses the claimed invention as set forth in claim 48, wherein the patient valve (flow diversion device 250; Fig. 2) is opened or closed as a function of a breathing phase ([0131], lines 4-5), but fails to disclose 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 and being operated electrically.
However, Adametz teaches an exhalation valve that is closed during inhalation and open during exhalation ([0004], lines 2-4), where the exhalation valve is driven in a controlled way via a monitoring device ([0043], lines 3-4).
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 Rapoport with Adametz such that the patient valve (flow diversion device 250; Fig. 2) is closed during the inspiration (Adametz: [0004], lines 2-4), and being driven in a controlled way (Adametz: [0043], liens 3-4), and temporarily opened in order to ensure exhalation, during an expiration (Adametz: [0004], lines 2-4) and being operated electrically (Adametz: [0043], lines 3-4) to prevent rebreathing of exhaled gases (Adametz: [0043], lines 6-9).
Regarding claim 57, Rapoport as modified teaches the claimed invention as set forth in claim 48, wherein the control unit (controller 224; Fig. 2) activates a further CPAP therapy mode of ventilation in response to user selection or automatically (see claim 49 above), and in this case drives the breathing gas source in order to specify a CPAP pressure ([0138], lines 1-5, where pressure control maintains a constant pressure, and where the therapeutic CPAP mode is the second ventilation mode), the exchangeable breathing gas tube (supply conduit 202; Fig. 2) 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 ([0120], lines 1-6, where the user receives breathing gas during transition from first mode of ventilation to second mode of ventilation, hence the supply conduit 202 must be connected to the apparatus during the change from first mode of ventilation to second mode of ventilation, where a CPAP mode is the further therapy mode), and the patient valve (flow diversion device 250; Fig. 2) being closed during inspiration (Adametz: [0004], lines 2-4), and being driven in a controlled way (Adametz: [0043], liens 3-4), and temporarily opened in order to ensure exhalation, during expiration (Adametz: [0004], lines 2-4), patient breathing being identified by the control unit from a profile of a flow signal of the flow sensor instrument (see claim 53 above), and the patient valve being actuated as a function of the flow signal (see claim 53 above) (as a trigger), the breathing gas source being driven in order to ensure maintenance of the CPAP pressure level during switching processes of the patient valve ([0138]), the CPAP pressure being specifiable at pressure values below 4 hPa ([0141], lines 5-9, where a pressure value of 4 cm H2O is approximately 3.92 hPa and the controller 224 adjusts pressure conditions and values of the apparatus; [0119], lines 1-7, where pressure is adjusted by controller 224 based on a desired CPAP pressure in the sub-therapeutic mode).
Regarding claim 74, Rapoport as modified teaches the claimed invention as set forth in claim 48, but is silent to wherein the replaceable breathing gas tube is a double tube system having the assigned patient valve, the patient valve being located next to the fitting in an apparatus housing.
However, Adametz teaches a respiratory therapy device (Fig. 1) with a double patient circuit (tubing device 25; Fig. 1; [0062], lines 1-5), where a patient valve (101) is located next to a fitting of an apparatus housing ([0062], lines 8-11; Fig. 1).
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 Rapoport with Adametz such that the breathing gas tube (Adametz & Mehnert: tubing device 25; Fig. 1) is a double tube system (Adametz: [0062], lines 1-5) having an assigned patient valve (Adametz: 101; Fig. 1), the assigned patient valve (Adametz: 101; Fig. 1) being located next to a fitting in an apparatus housing (Adametz: [0062], lines 8-11; Fig. 1) to reliably determine expiratory volume for further therapy quality monitoring and adjustments (Adametz: [0062], lines 7-8).
Claims 58, 60, 65, 72, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Rapoport as applied to claim 48 above, and further in view of Landis et al. (US 20160367779 A1), hereinafter Landis.
Regarding claim 58, Rapoport discloses the claimed invention as set forth in claim 48. Rapoport further discloses the controller (224; Fig. 2) including one or more therapy modes ([0010], last sentence of paragraph) in which the controller (224; Fig. 2) may cause the flow generator (200; Fig. 2) to deliver flow of gases to the user ([0010], lines 14-16), wherein a sub-therapeutic mode of ventilation where the controller (224; Fig. 2) maintains a steady and constant flow ([0149], lines 1-6), where a change in patient flow (i.e. patient breathing) does not cause a change in the constant flow being delivered to the patient ([0149], lines 4-8; [0149], lines 12-15). Further, Rapoport discloses the controller (224; Fig. 2) drives the gas supply device (200; Fig. 2) to specify a constant breathing gas flow ([0149], lines 1-2, where the output of the flow generator 200 is driven by controller 224) and switches the patient valve (250; Fig. 2) into a permanently closed position ([0135], lines 9-13). Rapoport et al. does not explicitly disclose the further therapy mode of ventilation is High-Flow Therapy (HFT).
However, Landis teaches a respiratory therapy system with High-Flow Therapy (HFT) ([0186], lines 1-2) that generates flows that are substantially constant ([0186], lines 21-22).
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 apparatus of Rapoport to include the HFT mode as taught by Landis such that wherein the further therapy mode of ventilation ([0128], lines 1-4; [0129], lines 4-6, where the flow generator 200 is controlled by controller 224, [0142], lines 3-4) is a constant breathing gas flow ([0149], lines 1-6) (HFT) (Landis: [0186], lines 1-2) to improve patient comfort when receiving therapy as HFT provides respiratory therapy without the need for a sealing patient interface (Landis: [0009], lines 1-8).
Regarding claim 60, Rapoport as modified teaches the claimed invention as set forth in claim 48, wherein the interchangeable breathing gas tube (supply conduit 202; Fig. 2) has the patient valve (flow diversion device 250; Fig. 2) and remains on the apparatus during the change from ventilation to HFT ([0120], lines 1-6, where the user receives breathing gas during transition from first mode of ventilation to second mode of ventilation, hence the supply conduit 202 must be connected to the apparatus during the change from first mode of ventilation to second mode of ventilation, where HFT, as taught by Landis, is adapted as one of the one or more therapy modes, see claim 58 above), and for the HFT mode of ventilation (Landis: [0186], lines 1-2) the patient valve (flow diversion device 250; Fig. 2) is closed by a control pressure being sent by the breathing gas source through a pressure tube to the patient valve and/or a humidifier and a heater are activated (Landis: [0186], lines 19-21, where the heater and humidifier must be activated to delivery humidified and heated respiratory gases to a user).
Regarding claim 65, Rapoport as modified teaches the claimed invention as set forth in claim 48, but is silent to wherein a pressure of a breathing assistance gas and a volume are adjustable, or wherein the pressure of the breathing assistance gas and an inspiration time Ti are adjustable.
However, Landis teaches a high flow therapy device that controls and adjusts a volume of gas delivered to a patient ([0154], last sentence of paragraph).
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 Rapoport with Landis such that a volume is adjustable (Landis: [0154], last sentence of paragraph) to maintain sufficient pressure levels during therapy (Landis: [0130], lines 5-15).
Regarding claim 72, Rapoport as modified teaches the claimed invention as set forth in claim 48. Rapoport as modified further discloses the controller (224; Fig. 2) monitoring breath volume of a user ([0191], lines 4-5), but is silent to wherein the control unit drives the breathing gas source in order to specify a tidal volume for the first or 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 controller (224; Fig. 2) of Rapoport with Landis such that the control unit (controller 224; Fig. 2) drives the breathing gas source (gas supply device 200; Fig. 2) in order to specify a tidal volume for the first or further therapy mode of ventilation (Landis: [0217], lines 9-12) to increase the accuracy of adjustment of the flow rate delivered to the patient to improve the quality of therapy (Landis et al.: [0130], lines 1-8).
Regarding claim 73, Rapoport as modified teaches the claimed invention as set forth in claim 48, wherein the apparatus (breathing gases supply system; Fig. 2; [0178], lines 1-3) comprises at least one pressure tube (supply conduit 202; Fig. 2), which sends a control pressure to the patient valve ([0181], lines 4-5, where supply conduit 202 delivers pressurized air to the user; [0178], lines 5-9, where the supply conduit 202 is connected to valve 250, hence controlled pressure from supply conduit 202 is sent to the valve 250), but is silent to wherein the apparatus (breathing gases supply system; Fig. 2; [0178], lines 1-3) comprises a compressed gas source.
However, Landis teaches a high flow therapy 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 Rapoport with Landis such that the apparatus (breathing gases supply system; Fig. 2; [0178], lines 1-3) comprises a compressed gas source (Landis: [0191], lines 2-3) to successfully deliver and supply gas to a patient through a non-sealing patient interface (Landis: [0015], lines 10-13).
Claims 59 and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Rapoport in view of Landis as applied above, and further in view of Holyoake et al. (US 20180085544 A1), hereinafter Holyoake.
Regarding claim 59, Rapoport as modified teaches the claimed invention as set forth in claim 58. Rapoport as modified further teaches the controller (224; Fig. 2) configured to control the gas supply device (200; Fig. 2) to lower a flow for exhalation ([0195], lines 1-5), but does not explicitly teach the control unit (controller 224; Fig. 2) is designed and configured to control the breathing gas source for the HFT mode of ventilation in such a way that a patient flow decreases at a start during expiration, while a mask pressure simultaneously increases.
However, Holyoake teaches a high flow respiratory therapy system where a control unit adjusts a breathing gas source to lower a 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).
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 Rapoport with Holyoake such that wherein the control unit (controller 224; Fig. 2) is designed and configured to control the breathing gas source for the HFT mode of ventilation (see claim 58 above) in such a way that a patient flow decreases at a start during expiration (Holyoake: [0876], lines 1-2 and 5; [0882], lines 8-9), while a mask pressure simultaneously increases (Holyoake: [0880], lines 2-5 and 12-13) to ensure gas is not delivered to the patient at a pressure higher than a desired pressure level (Holyoake: [0876]).
Regarding claim 61, Rapoport as modified teaches the claimed invention as set forth in claim 48, wherein the control unit (controller 224; Fig. 2) specifies a HFT mode of ventilation with a consistent high flow of breathing gas (see claim 58 above), which is applied via the patient interface (user interface 204; Fig. 2) into both nostrils of a patient ([0179], lines 5-9, where any of these user interfaces may be used as user interface 204 and it is well known in the art that nasal masks can apply a delivered flow to both nostrils of a user), and a setpoint flow during HFT ventilation being kept consistent at a pre-adjusted level (Landis et al.: [0192], lines 1-3, where a set flow is delivered to a patient; [0186], lines 21-22, where the delivered flows are substantially continuous), the patient valve (flow diversion device 250; Fig. 2) 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 ([0027], lines 1-4, where HFT is one of the positive pressure modes, see claim 58 above). Rapoport as modified fails to disclose a consistent high flow of breathing gas (see claim 58 above), which is applied via the patient interface (user interface 204; Fig. 2) into both nostrils of a patient ([0179], lines 5-9, where any of these user interfaces may be used as user interface 204 and it is well known in the art that nasal masks can apply a delivered flow to both nostrils of a user) in such a way that the consistent high flow flushes a nasal dead space, the patient interface (user interface 204; Fig. 2) in this case not sealing tightly with a nasal wall so that exhalation past the patient interface is possible.
However, Holyoake teaches high flow therapy flushing the anatomical dead space off the upper airways with the delivered high gas flow ([0655], lines 4-7) and a non-sealing patient interface (200; [0661], lines 9-10) where 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 further modify Rapoport with Holyoake such that a consistent high flow of breathing gas (see claim 58 above), which is applied via the patient interface (user interface 204; Fig. 2) into both nostrils of a patient ([0179], lines 5-9, where any of these user interfaces may be used as user interface 204 and it is well known in the art that nasal masks can apply a delivered flow to both nostrils of a user) in such a way that the consistent high flow flushes a nasal dead space (Holyoake: [0655], lines 4-7), the patient interface (user interface 204; Fig. 2) in this case not sealing tightly with a nasal wall so that exhalation past the patient interface is possible (Holyoake: 200; [0661], lines 9-10; [0916], line 7) to minimize the rebreathing of exhaled gas (Holyoake: [0655], lines 7-9).
Claims 62, 68, and 71 are rejected under 35 U.S.C. 103 as being unpatentable over Rapoport as applied to claim 48 above, and further in view of Thiessen (US 20130000644 A1).
Regarding claim 62, Rapoport discloses the claimed invention as set forth in claim 48, but is silent to 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.
However, Thiessen teaches an MPV therapy mode ([0013], lines 12-13) which delivers a breathing gas flow or a pressurized breathing gas to a patient for inspiration as required ([0014]; [0013], lines 12-13).
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 one or more therapy modes of Rapoport to include an MPV therapy mode as taught by Thiessen such that wherein the further therapy mode of ventilation is an MPV mode (Thiessen: [0013], lines 12-13), which delivers a breathing gas volume or a breathing gas flow or a pressurized breathing gas to a patient for inspiration as required (Thiessen: [0014]; [0013], lines 12-13) to increase patient comfort by only providing therapy when the patient requires (Thiessen: [0001], lines 8-10).
Regarding claim 68, Rapoport as modified teaches the claimed invention as set forth in claim 48, wherein the control unit (controller 224; Fig. 2) being designed and configured to control the breathing gas source in such a way that a mask pressure has an increasing profile during inspiration (Thiessen: [0028], lines 4-6) and the mask pressure falls more slowly than a setpoint pressure during the expiration (Thiessen: [0028], lines 6-9). Rapoport as modified is silent to an MPV interface (mouthpiece), which is configured in such a way that it is inserted at least partially into a mouth, is used as the patient interface for an MPV mode of ventilation.
However, Thiessen teaches a 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]).
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 Rapoport with the patient interface taught by Thiessen as Rapoport discloses the user interface (204) can be an oral mask or oral interface ([0179], lines 5-9) and a mouthpiece patient interface (28) as taught by Thiessen is a known oral interface in the art, where the substitution of the patient interface (28) as taught by Thiessen would predictably function as any other patient interface and would successfully deliver pressurized gas or a gas flow to a user.
Regarding claim 71, Rapoport as modified teaches the claimed invention as set forth in claim 48, wherein the further therapy mode of ventilation is an MPV mode (Thiessen: [0013], lines 12-13), which temporarily sends a pressurized breathing gas flow to a patient (Thiessen: [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), the apparatus (breathing gases supply system; Fig. 2; [0178], lines 1-3) consisting of the following: a breathing gas source (gas supply device 200; Fig. 2), which temporarily sends a pressurized breathing gas flow to airways (Thiessen: [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); a patient interface in the form of a mouthpiece (see claim 68 above), which can be at least partially inserted into an airway opening of the patient and removed again (see claim 68 above), the patient interface (Thiessen: patient interface 28, see claim 68 above) furthermore being configured so that the breathing gas flow is sent into airways of the patient ([0042], lines 2-3); at least one sensor (flow sensor 230; Fig. 2), 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 ([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), the sensor (flow sensor 230; Fig. 2) being designed to establish whether the patient has performed breathing efforts (h [0195], lines 5-8 and last sentence of paragraph); and at least one control unit (controller 224; Fig. 2), 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 ([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), the control unit (controller 224; Fig. 2) 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 ([0163]; Thiessen: [0078], lines 3-8), the control unit (controller 224; Fig. 2) then activating the temporary pressurized breathing gas flow for an inspiration of the patient ([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; Thiessen: [0014]; [0013], lines 12-13, where the pressurized gas is delivered as required).
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport as applied to claim 48 above, and further in view of Brodkin et al. (US 20120118291 A1), hereinafter Brodkin.
Regarding claim 67, Rapoport discloses the claimed invention as set forth in claim 48, but fails to disclose wherein 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 Rapoport with Brodkin such that a trigger blocking time in a range of from 0.1 to 10 seconds (Brodkin: [0062], lines 1-5, where pump 16 controls airflow levels) 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 (Brodkin: [0062], lines 1-5) 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).
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport in view of Thiessen as applied to claim 68 above, and further in view of Adametz & Mehnert (US 20170368277 A1), hereinafter Adametz.
Regarding claim 69, Rapoport as modified teaches the claimed invention as set forth in claim 68, but fails to disclose wherein the patient valve (flow diversion device 250; Fig. 2) is briefly opened for an expiration so that a pressure at the mouthpiece is lowered, and the patient valve is subsequently closed.
However, Adametz teaches an exhalation valve that is closed during inhalation and open during exhalation ([0004], lines 2-4), where the exhalation valve is driven in a controlled way via a monitoring device ([0043], lines 3-4). Adametz further teaches an exhalation valve (101) controlled by a monitoring device (6) is actuated to be opened during expiration such that exhaled air can be completely flushed out from a patient interface during the exhalation phase ([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.
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 Rapoport with Adametz such that the patient valve (flow diversion device 250; Fig. 2) is briefly opened for an expiration (Adametz: [0004], lines 2-4) so that a pressure at the mouthpiece is lowered (Adametz: [0085], lines 1-6) to ensure CO2-rich exhaled air is completely flushed from a patient interface to prevent rebreathing of exhaled air (Adametz: [0085], lines 7-8; [0012], lines 5-6).
Claim 70 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport as applied to claim 48 above, and in further view of Thiessen (US 20130000644 A1), Landis et al. (US 20160367779 A1) hereinafter Landis, and Adametz & Mehnert (US 20170368277 A1) hereinafter Adametz.
Regarding claim 70, Rapoport discloses the claimed invention as set forth in claim 48, but fails to disclose wherein the further therapy mode of ventilation is an MPV mode, which delivers breathing gas to a patient for inspiration as required, a breathing gas pressure being adjustable and/or a breathing gas volume or an inspiration time Ti furthermore being specified, a mouthpiece being used as the patient interface 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, the patient being able to keep the mouthpiece in its mouth for expiration, and the control unit then at least temporarily opening the patient valve for the expiration, and the control unit then 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, the control unit activating the breathing gas source during the expiration in order to specify a flushing flow to assist flushing of exhaled air out from the tube.
However, Thiessen teaches an MPV therapy mode ([0013], lines 12-13) which delivers a breathing gas flow or a pressurized breathing gas to a patient for inspiration as required ([0014]; [0013], lines 12-13).
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 one or more therapy modes of Rapoport to include an MPV therapy mode as taught by Thiessen such that the further therapy mode of ventilation is an MPV mode (Thiessen: [0013], lines 12-13), which delivers a breathing gas volume or a breathing gas flow or a pressurized breathing gas to a patient for inspiration as required (Thiessen: [0014]; [0013], lines 12-13) to increase patient comfort by only providing therapy when the patient requires (Thiessen: [0001], lines 8-10).
Thiessen further teaches a 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]).
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 Rapoport with the patient interface taught by Thiessen as Rapoport discloses the user interface (204) can be an oral mask or oral interface ([0179], lines 5-9) and a mouthpiece patient interface (28) as taught by Thiessen is a known oral interface in the art, where the substitution of the patient interface (28) as taught by Thiessen such that a mouthpiece being used as the patient interface 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 (Thiessen: [0013], lines 15-18, where the patient latches onto and closes their mouth around patient interface 28 to engage said patient interface, see [0028]), the patient being able to keep the mouthpiece in its mouth for expiration ([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, as the mouthpiece taught by Thiessen would predictably function as any other patient interface and would successfully deliver pressurized gas or a gas flow to a user.
Rapoport as modified by Thiessen fails to teach a breathing gas pressure being adjustable and/or a breathing gas volume or an inspiration time Ti furthermore being specified.
However, Landis teaches a respiratory therapy device that controls and adjusts a volume of gas delivered to a patient ([0154], last sentence of paragraph).
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 Rapoport with Landis such that a breathing gas volume is adjustable (Landis: [0154], last sentence of paragraph) to maintain sufficient pressure levels during therapy (Landis: [0130], lines 5-15).
Rapoport as modified fails to teach the control unit (controller 224; Fig. 2 ) then 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, the control unit activating the breathing gas source during the expiration in order to specify a flushing flow to assist flushing of exhaled air out from the tube.
However, Adametz teaches an exhalation valve that is closed during inhalation and open during exhalation ([0004], lines 2-4), where the exhalation valve is driven in a controlled way via a monitoring device ([0043], lines 3-4).
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 Rapoport with Adametz such that the patient valve (flow diversion device 250; Fig. 2) is closed during the inspiration (Adametz: [0004], lines 2-4), and being driven in a controlled way (Adametz: [0043], liens 3-4), and temporarily opened in order to ensure exhalation, during the expiration (Adametz: [0004], lines 2-4) and being operated electrically (Adametz: [0043], lines 3-4) to prevent rebreathing of exhaled gases (Adametz: [0043], lines 6-9).
Adametz further teaches exhaled air can flow into surroundings when the valve (101) is open during exhalation ([0004], lines 4-5) and the opening of valve (101) allows exhaled air to be completely flushed out ([0086], lines 5-10).
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 Rapoport with Adametz such that the control unit (controller 224; Fig. 2 ) then at least temporarily opening the patient valve for the expiration (Adametz: [0004], lines 2-4) so that the patient can exhale its expiratory air through the fully or partially opened patient valve to the environment (Adametz: [0004], lines 4-5), the control unit activating the breathing gas source during the expiration in order to specify a flushing flow to assist flushing of exhaled air out from the tube (Adametz: [0086], lines 5-10) to minimize the amount of exhaled gas being rebreathed.
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Rapoport as applied to claim 48 above, and further in view of Dantanarayana et al. (US 20190351173 A1), hereinafter Dantanarayana.
Regarding claim 75, Rapoport discloses the claimed invention as set forth in claim 48, wherein the control pressure being generated by the breathing gas source ([0139], lines 3-6, where controller 224 controls the flow diversion device 250 to adjust a level of pressure being delivered to a user) and sent to the patient valve (flow diversion device 250; Fig. 2) through a control tube (supply conduit 202; Fig. 2), but fails to disclose the patient valve is configured to be removable from a compartment of a housing, the patient valve 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 valve (Fig. 7D) for a patient interface of a respiratory pressure therapy system (Abstract) that is capable of being removable from a housing ([0096], lines 10-11), where the vent assembly 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 Rapoport with Dantanarayana such that the patient valve (Dantanarayana: valve; Fig. 7D) is configured to be removable from a compartment of a housing (Dantanarayana: [0096], lines 10-11), the patient valve (Dantanarayana: valve; Fig. 7D) comprising a membrane (Dantanarayana: flap 9140; [0096], line 21) to which a control pressure can be applied in order to block or release a breathing gas flow through the patient valve (Dantanarayana: Fig. 7D; [0297], lines 2-13), the control pressure being generated by the breathing gas source ([0139], lines 3-6, where controller 224 controls the flow diversion device 250 to adjust a level of pressure being delivered to a user) and sent to the patient valve (Dantanarayana: valve, where valve taught by Dantanarayana replaces flow diversion device 250 disclosed by Rapoport) through a control tube (supply conduit 202; Fig. 2) 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 filed on 01/21/2026 have been fully considered but they are not persuasive.
On page 17 of the Remarks (filed on 01/21/2026), Applicant argues “Rapoport neither teaches nor suggests a ventilation apparatus in which one tube system can be exchanged with a different tube system, let alone a ventilation apparatus in which the interchangeable breathing gas tube remains on the apparatus during the change from a first therapy mode of ventilation to a further therapy mode of ventilation”. In response to applicant's argument that the reference fails to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., one tube system can be exchanged with a different tube system) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Rapoport discloses a supply tube that is detachably connected to a user interface via a connector (see 102 rejection of claim 48 above), hence the supply tube is capable of being removed from the user interface and interchanged, or replaced, with a new tube. Therefore, the supply tube disclosed by Rapoport can be broadly interpreted as an interchangeable breathing gas tube.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gulliver et al. (US 20150021909 A1): Regarding a conduit connector for a patient breathing device to allow for interchangeable connection of various supply conduits.
Doshi et al. (US 20090194109 A1): Regarding a patient breathing device with an adapter as a tubing component that provides interchangeability of various interface devices and gas supply sources.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799