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 Arguments
Applicant's arguments filed June 29, 2026 have been fully considered but they are not persuasive. The 35 USC 103 rejection of Independent Claim 1 as presented in the previous Office Action is maintained, as are all subsequent rejections of dependent Claims 2-20.
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e. “without conversion measures or without an adapter”) are not recited in the rejected claim. 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).
The Applicant’s proposed narrower interpretation improperly imports limitations from the specification into the claim. Currently, there is no claim language to support the argument that the ventilator must be capable of operating “without conversion or adapter with a fundamentally different type of tube system”. Amending the claim to more explicitly define the exchangeable respiration gas tube would help to overcome the prior art of record.
The term “exchangeable respiration gas tube” is open-ended in the Applicant's specification and is amenable to a broader ordinary meaning, namely a respiration gas tube that is capable of being substituted, replaced, or reconfigured.
In view of this broader interpretation, Buechi teaches a tube system with interchangeable and/or reversible sections, and thus, at least partially meets the definition.
“It is especially advantageous to configure the ventilator tubing system as a medical-grade, single-use or disposable article” (Column 3, lines 31-33)
This embodiment of the tube system disclosed by Buechi does not require the conversion of the connection region, as argued by the Applicant. The tubing system is capable of being substituted with an alternative, disposable tube as needed, without any conversions or additional adapters required.
Column 2, lines 32-39, “Thus, the tube is usable as a combination of the first section with the second section in several configurations in a versatile manner. The entire tube or only a part of it can be heated without any change to the (external) settings of the heating system; that is, by simply turning the second section around (exchanging the connectors) the other heating configuration is achieved”
This embodiment of the tube system disclosed by Buechi allows for various different configurations that do not require any changes to the heating system in order to function. The tube arrangement is rearrangeable and reconfigurable without the need for an additional adapter element.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Whether or not the Applicant agrees that the combination discloses their intended interpretation of the claim limitation, there still exists motivation and teachings to suggest combining the references. Both Buechi and Pittman disclose respirator systems and ventilator assemblies. Incorporating Buechi’s reconfigurable and disposable tube system would allow for both better user accommodation and better overall hygienic practices. In response to Applicant's argument that Pittman’s system is intended for an at-home user, Pittman does not explicitly state the self-ventilation system is intended for at-home use. However, even if it was solely intended for that purpose, that does not negate the added benefit of the system have substitutable elements and changeable configurations based on a user’s comfort and needs. Regardless of whether the apparatus is intended for use in a monitored medical setting or through self-administration at-home, the different envisioned embodiments of suitable configurations provide the same advantages to a user.
In regards to Claim 15, the Applicant argues that it would not be obvious to one of ordinary skill in the art to configure the control unit of Pittman to set the CPAP pressure to values below 4 hPa “regardless of whether or not the respiration drops by 20%”. However, that added limitation is not incorporated in the claim language. As with Claim 1, amending the claim to more explicitly define the intended limitation would help to overcome the prior art of record.
The claim as it currently stands does not state whether or not the configuration is independent of respiratory changes, only that the control unit “is configured to set the CPAP pressure to values below 4hPA.” In the present disclosure, the Applicant states that “the control unit 3 can also set the CPAP pressure to pressure limits below 4 hPa since, by virtue of valve 17, in accordance with the degree of opening of the valve, C02 in the exhaled air is reliably flushed out even at low pressures” (Page 18, lines 28-30). As with the claim language, there is no explicit mention of configuring the control unit independent of respiratory changes, or that the final pressure value has to be lower than 4hPa
Schwaibold teaches a range of possible pressure values that the system can be adjusted to (Column 9, lines 15-17, can be set from 2 to 15 cm H2O), (Column 9, lines 15-17, increase of the ventilation pressure in the region of 0.5-4 hPa). Thus, it is capable of being configured to values less than 4 hPa, such as 2.5 hPa. See MPEP 2131.03. As stated in the previous actions, it would have been obvious to test and incorporate different ranges of pressure values through routine experimentation.
Furthermore, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Pittman in view of Schwaibold and Buechi is capable of setting CPAP pressure values to the desired range claimed by the Applicant.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 13-15, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Pittman et al. (US 9833583 B2, hereinafter “Pittman”) in view of Schwaibold et al. (US 10500359 B2, hereinafter “Schwaibold”), further in view of Buechi et al. (US 9517321 B2, hereinafter “Buechi”)
Regarding Claim 1, Pittman discloses: A ventilator for respiration gas supply (Column 2, lines 52-58, In one embodiment, device 14 includes a positive pressure support device. A positive pressure support device is well-known and is disclosed, for example, in U.S. Pat. No. 6,105,575 [Estes et al., hereinafter “Estes”], hereby incorporated by reference in its entirety. In this embodiment, device 14 is configured to deliver a pressurized flow of breathable gas to the airway of subject 12), wherein the ventilator comprises:
a respiration gas source (Column 3, lines 26-30, The pressurized flow of breathable gas is delivered to the airway of subject 12 via a subject interface 24. Subject interface 24 is configured to communicate the pressurized flow of breathable gas generated by device 14 to the airway of subject 12)
a control unit, a memory (Column 3, lines 57-61, Electronic storage 16 may store software algorithms, information determined by processor 22, information received via user interface 18, and/or other information that enables system 10 to function properly),
a pressure sensor device and/or a flow sensor device (Column 4, lines 30-41, One or more sensors 20 are configured to generate one or more output signals conveying information related to one or more gas parameters of the gas breathed by subject 12. The one or more parameters may include, for example, one or more of a flow rate, a volume, a pressure, a composition[…] humidity, temperature, acceleration, velocity, acoustics, changes in a parameter indicative of respiration, and/or other gas parameters),
a respiration gas tube (Estes, Column 9, lines 3-17, The gas flow from flow generator 14 is passed via a delivery conduit 18 to a breathing appliance or patient interface 20 of any suitable construction that is worn by patient 12. In an exemplary embodiment of the present invention, the conduit 18 is a large bore flexible tube and the patient interface 20 is either a nasal mask or a full face mask, as shown. Other breathing appliances that may be used in lieu of a mask include a mouthpiece, a nasal seal, nasal prongs or cannulae, an endotracheal tube, a trachea adapter or any other suitable appliance for interfacing between a source of breathing gas and a patient. Also, the phrase "patient interface" can encompass more than the interface worn by the patient. For example, the patient interface can include delivery conduit 18 and any other structures that connect the source of pressurized breathing gas to the patient)
wherein the control unit is configured to initially drive the respiration gas source to provide a Continuous Positive Airway Pressure (CPAP) which is delivered independently of a patient's respiration phase (Column 2, lines 59-67, Device 14 may be configured to generate the pressurized flow of breathable gas according to one or more modes. A non-limiting example of one such mode is Continuous Positive Airway Pressure (CPAP) […] Another mode for generating the pressurized flow of breathable gas is Inspiratory Positive Air Pressure (IPAP). One example of the IPAP mode is bi-level positive air pressure (BiPAP)),
and wherein the control unit is configured to use signals (Column 4, lines 58-61, in one embodiment, processor 22 includes a parameter determination module 30, a comparison module 32, a control module 34, a target module 36, a timing module 38, an alternative mode module 40 and/or other modules) from the pressure sensor device and/or the flow sensor device (Column 5, lines 15-17, Parameter determination module 30 is configured to determine a breathing parameter from the one or more output signals generated by sensors 20):
to ascertain the patient's respiration phase - inhalation and exhalation (Column 1, lines 30-39, For example, U.S. patent application Ser. No. 11/836,292 to Kirby et al. “Kirby”), which is hereby incorporated into this disclosure in its entirety, discloses a system for modifying the timing and/or duration of inhalation and exhalation of a subject through breathing cues.),
to ascertain the patient's tidal volume during successive inhalations and exhalations (Column 5, lines 35-40, If the breathing parameter is a parameter of individual breaths (e.g., tidal volume, peak flow, etc.), determining the breathing parameter may include aggregating the value of the breathing parameter over several breaths. For example, determined values of the breathing parameter over several breaths may be averaged),
to compare at least a first set volume threshold for a tidal volume with a current tidal volume (Column 2, lines 45-49, To adjust the tidal volume of the breathing of subject 12, system 10 may provide breathing cues to subject 12 that encourage subject 12 to maintain a tidal volume that is at or above a target tidal volume), (Column 5, lines 41-47, Comparison module 32 is configured to compare the breathing parameter determined by parameter determination module 30 to a target threshold. If the breathing parameter is tidal volume, the target threshold is a target tidal volume. If the breathing parameter is a gas parameter related to tidal volume, the target threshold is a threshold that corresponds to the target tidal volume), (Column 7, lines 2-4, the target tidal volume is received from a user (e.g., a caregiver, subject 12, etc.). The user may input the target tidal volume via user interface 18),
to determine whether the current tidal volume is below the first set volume threshold (Column 6, lines 43-46, comparison module 32 determines that the breathing parameter is below the target threshold (and/or has remained under the target threshold for a predetermined period of time)), and if so to react by
driving the respiration gas source to set a second pressure (Inspiratory Positive Airway Pressure, IPAP) for a respiration gas for inhalation (Columns 5-6, lines 64-10 control module 34 may control device 14 to adjust the pressure, flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the HI pressure (e.g, during inhalation). Increasing the pressure, flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the HI pressure will increase the volume of gas inhaled by subject 12, thereby increasing the tidal volume of respiration of subject 12. Similarly, decreasing the pressure, flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the HI pressure will prompt subject 12 to decrease the tidal volume of respiration), and
driving the respiration gas source to set the CPAP pressure for a respiration gas for exhalation (Column 6, lines 13-26, control module 34 may control device to adjust the pressure flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the LO pressure (e.g., during exhalation). Decreasing the pressure, flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the LO pressure may increase the volume gas that is exhaled by subject 12, thereby increasing the tidal volume of respiration of subject 12. Increasing the pressure, flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the LO pressure will prompt subject 12 to decrease the tidal volume of respiration).
Though Pittman does not explicitly teach at least one connection stub for the respiration gas tube and a patient interface, it is common practice in the art of respiratory devices to incorporate a connection means between a patient interface and a gas tube. Pittman teaches the use of “any other structures that connect the source of pressurized breathing gas to the patient” (Estes, Column 9, lines 15-18).
One such example of a coupling means is taught by Schwaibold, “FIG. 1 moreover shows a patient interface, which is embodied as a ventilation mask (10) and implemented as nasal mask. Attachment in the region of the head of a patient can be brought about by way of headgear (11). In the region of the extent thereof facing the connecting tube (5), the patient interface (10) has a coupling element (12)” (Column 3, lines 1-6).
It would have been obvious to one skilled in the art before the effective filing date to modify the conduit taught by Pittman to explicitly include a specific connection stub, such as the “coupling element (12)” taught by Schwaibold in order to provide a secure coupling means between the gas tube and patient interface.
Pittman in view of Schwaibold discloses a respiration gas tube that is capable of being exchanged, as demonstrated by Figure 1 of Schwaibold that depicts a separable patient interface system, and further reinforced by the following passage from Pittman that describes a variety of patient interfaces and conduits that can be implemented (Estes, Column 9, lines 3-17, The gas flow from flow generator 14 is passed via a delivery conduit 18 to a breathing appliance or patient interface 20 of any suitable construction that is worn by patient 12. In an exemplary embodiment of the present invention, the conduit 18 is a large bore flexible tube and the patient interface 20 is either a nasal mask or a full face mask, as shown. Other breathing appliances that may be used in lieu of a mask include a mouthpiece, a nasal seal, nasal prongs or cannulae, an endotracheal tube, a trachea adapter or any other suitable appliance for interfacing between a source of breathing gas and a patient. Also, the phrase "patient interface" can encompass more than the interface worn by the patient. For example, the patient interface can include delivery conduit 18 and any other structures that connect the source of pressurized breathing gas to the patient).
However, if the Applicant is not convinced, Buechi more explicitly discloses an exchangeable respiration gas tube (Column 3, lines 31-41, It is especially advantageous to configure the ventilator tubing system as a medical-grade, single-use or disposable article. This takes account of the hygienic requirements in a hospital), (Column 2, lines 33-39, Thus, the tube is usable as a combination of the first section with the second section in several configurations in a versatile manner. The entire tube or only a part of it can be heated without any change to the (external) settings of the heating system; that is, by simply turning the second section around (exchanging the connectors) the other heating configuration is achieved).
Buechi teaches a gas tube that is detachable and disposable, and thus can be exchanged for an additional gas tube, either in the same configuration or a different one. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Buechi with the system disclosed by Pittman in view of Schwaibold, so as to provide a gas tube that can be easily modified and rearranged to accommodate different treatment needs. Moreover, it is well-known in the art of respiratory devices to provide disposable elements to meet hygienic standards and minimize cross-contamination.
Regarding Claim 2, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 1. Pittman further discloses: wherein the control unit is configured to increase the second pressure (IPAP) (Column 6, lines 36-48, adjustments to the parameters of the pressurized flow of breathable gas made by control module 34 are made in a feedback manner. In this embodiment, adjustments to the parameters of the pressurized flow of breathable gas may be determined based on the comparison between the breathing parameter and the target threshold made by comparison module 32. For example, if comparison module 32 determines that the breathing parameter is below the target threshold […] control module 34 may increase the pressure, flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the HI pressure) stepwise until the set threshold for the tidal volume has been attained (Column 7, lines 16-22, target module 36 sets the target tidal volume at an initial level, and then slowly increases the target tidal volume over time. The initial level may be based on the baseline tidal volume of subject 12, and/or may be a preset value. The baseline tidal volume of subject 12 may be determined prior to a period of deeper respiration. The target tidal volume may be increased over time until it reaches a final target tidal volume)
Regarding Claim 3, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 2. Pittman further discloses: wherein the control unit is configured to increase the second pressure (IPAP) from one inhalation to an immediately subsequent inhalation (Column 6, lines 31-35, As can be seen in FIG. 2, as the pressure at which the pressurized flow of breathable gas is delivered to the subject is increased during the HI pressure periods, the tidal volume of the breaths tends to be increased by the user voluntarily through deeper breathing).
Regarding Claim 4, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 3. Pittman further discloses: wherein the control unit is configured to lower the second pressure (IPAP) stepwise when the tidal volume has exceeded the set volume threshold (Column 6, lines 6-10, Similarly, decreasing the pressure, flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the HI pressure will prompt subject 12 to decrease the tidal volume of respiration), (Column 6, lines 49-55, If comparison module 32 determines that the breathing parameter is above the target threshold by a predetermined amount and/or for a predetermined period of time, control module 34 may reduce the pressure flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the HI pressure)
Regarding Claim 5, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 1. Pittman further discloses: wherein the control unit is configured to lower the second pressure (IPAP) to the CPAP pressure level when the tidal volume has exceeded the set volume threshold (Column 6, lines 49-55, If comparison module 32 determines that the breathing parameter is above the target threshold by a predetermined amount and/or for a predetermined period of time, control module 34 may reduce the pressure flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the HI pressure) to drive the respiration gas source to set a CPAP pressure which is delivered independently of the patient’s respiration phase (Column 2, lines 59-67, Device 14 may be configured to generate the pressurized flow of breathable gas according to one or more modes. A non-limiting example of one such mode is Continuous Positive Airway Pressure (CPAP) […] Another mode for generating the pressurized flow of breathable gas is Inspiratory Positive Air Pressure (IPAP). One example of the IPAP mode is bi-level positive air pressure (BiPAP))
Regarding Claim 6, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 1. Pittman further discloses: wherein the ventilator has at least one valve disposed in a respiration gas tube or in the ventilator (Estes, Column 10, lines 18-24, Pressure controller 24 controls the pressure of breathing gas within conduit 18 and thus within the airway of the patient. Pressure controller 24 is located preferably, although not necessarily, downstream of flow generator 14 and may take the form of an adjustable, electronically-controlled valve).
Regarding Claim 13, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 1. Pittman further discloses: wherein the control unit is configured to lower the CPAP pressure when the patient's respiration is identified as exhalation by the control unit from a progression of the flow signal from the flow sensor device (Column 3, lines 4-7, Generally, the timing of the HI and LO levels of pressure are controlled such that the HI level of positive air pressure is delivered to subject 12 during inhalation and the LO level of pressure is delivered to subject 12 during exhalation), (Column 4, lines 30-41, One or more sensors 20 are configured to generate one or more output signals conveying information related to one or more gas parameters of the gas breathed by subject 12. The one or more parameters may include, for example, one or more of a flow rate […] In an embodiment in which a pressurized flow of breathable gas is delivered to subject 12 from device 14, sensors 20 include sensors in communication with gas within subject interface 24).
Regarding Claim 14, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 1. Pittman further discloses: wherein the control unit is configured to raise the CPAP pressure when the patient's respiration is identified as exhalation by the control unit from a progression of the flow signal from the flow sensor device (Column 3, lines 4-7, Generally, the timing of the HI and LO levels of pressure are controlled such that the HI level of positive air pressure is delivered to subject 12 during inhalation and the LO level of pressure is delivered to subject 12 during exhalation), (Column 4, lines 30-41, One or more sensors 20 are configured to generate one or more output signals conveying information related to one or more gas parameters of the gas breathed by subject 12. The one or more parameters may include, for example, one or more of a flow rate […] In an embodiment in which a pressurized flow of breathable gas is delivered to subject 12 from device 14, sensors 20 include sensors in communication with gas within subject interface 24).
Regarding Claim 15, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 6. Pittman does not disclose explicitly disclose a set range of CPAP pressure values. Schwaibold discloses: wherein the control unit is configured to set the CPAP pressure to values below 4 hPa (Column 9, lines 15-17, the ventilator according to at least one of the preceding items, wherein the expiratory positive airway pressure (EPAP) can be set from 2 to 15 cm H2O [1.96 to 14.71 hPa]), (Column 6, lines 52-56, the ventilation is controlled anti-cyclically in relation to the value of the respiratory exertion of the patient, for example with an increase of the ventilation pressure in the region of 0.5-4 hPa when the respiration drops by 20%)
Schwaibold discloses a range of values that encompass the claimed limitation of below 4 hPa, see MPEP 2131.03. It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of Schwaibold with the controlled ventilation system taught by Pittman. It is common practice in the art of respiratory devices to incorporate preset pressure value ranges in accordance with the needs of the user. It would have been obvious to test and incorporate different ranges of pressure values through routine experimentation, and thus configure the control unit taught by Pittman to adopt a value under 4 hPa.
Regarding Claim 18, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 1. Pittman further discloses: wherein a pressure of a respiration assistance (Column 6, lines 42-49, adjustments to the parameters of the pressurized flow of breathable gas made by control module 34 are made in a feedback manner.… if comparison module 32 determines that the breathing parameter is below the target threshold (and/or has remained under the target threshold for a predetermined period of time), control module 34 may increase the pressure, flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the HI pressure) and a volume are adjustable (Column 2, lines 38-44, The adjustment of tidal volume accomplished through use of system 10 may reduce hypertension (e.g., lower blood pressure), reduce stress and/or anxiety (and related maladies), improve relaxation, decrease sleep latency, improve sleep quality, address other sleep disorders, and/or provide other health benefits)
Regarding Claim 19, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 1. Pittman further discloses: wherein a pressure of a respiration assistance (Column 6, lines 42-49, adjustments to the parameters of the pressurized flow of breathable gas made by control module 34 are made in a feedback manner.… if comparison module 32 determines that the breathing parameter is below the target threshold (and/or has remained under the target threshold for a predetermined period of time), control module 34 may increase the pressure, flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the HI pressure) and an inhalation time Ti are adjustable (Figure 1, timing module 38), (Column 1, lines 30-34, For example, U.S. patent application Ser. No. 11/836,292 to Kirby et al. (“Kirby”), which is hereby incorporated into this disclosure in its entirety, discloses a system for modifying the timing and/or duration of inhalation and exhalation of a subject through breathing cues)
Claims 8-9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Pittman (US 9833583 B2, in view of Schwaibold (US 10500359 B2), in view of Buechi (US 9517321 B2), further in view of Angelico et al. (US 9027552 B2, hereinafter “Angelico”).
Regarding Claim 8, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 6. Pittman discloses the valve controlling flow and pressure during respiration phases (Estes, Column 5, lines 10-15, The measured values are converted into electrical signals and the flow and pressure of the respiration gas are controlled during the inspiration and expiration portions of the respiration cycle via a valve arranged between a respiration gas source and the measuring device), but does not explicitly disclose closing or driving the valve based on respiratory phases.
Angelico does disclose: wherein the valve is opened or closed depending on the respiration phase (Column 20, lines 29-31, expiratory and inspiratory valves are closed briefly at the end of inspiration for measuring the PPlat at zero flow)
It would have been obvious to one skilled in the art before the effective filing date to modify the valve element taught by Pittman with an art-recognized mechanism of actuating a valve in accordance with a respiratory phase beginning or ending.
Regarding Claim 9, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 6. Pittman further discloses the valve driven in a controlled manner (Estes, Column 5, lines 10-15, The measured values are converted into electrical signals and the flow and pressure of the respiration gas are controlled during the inspiration and expiration portions of the respiration cycle via a valve arranged between a respiration gas source and the measuring device), but does not explicitly disclose wherein the valve is closed in an inhalation and is driven in a controlled manner in an exhalation, being opened intermittently to assure exhalation.
Angelico does disclose: wherein the valve is closed in an inhalation and is driven in a controlled manner in an exhalation, being opened intermittently to assure exhalation (Column 11, lines 17-33, exhalation module 216 may correspond to expiratory module 108 or may otherwise be associated with and/or controlling an expiratory valve for releasing gases from the patient … Upon initiating the expiratory phase, exhalation module 216 may allow the patient to exhale by opening an expiratory valve… Although expiratory flow is passive, it may be regulated by the ventilator based on the size of the expiratory valve opening. In some embodiments, exhalation is regulated based on a selected breath type).
It would have been obvious to one skilled in the art before the effective filing date to modify the valve element taught by Pittman with an art-recognized mechanism of actuating a valve in accordance with a respiratory phase.
Regarding Claim 20, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 6. Pittman is silent regarding the valve opening for pressure release. However, Angelico does disclose: wherein, for exhalation, the valve is opened briefly, such that pressure is released, and the valve is then closed (Column 11, lines 17-33, exhalation module 216 may correspond to expiratory module 108 or may otherwise be associated with and/or controlling an expiratory valve for releasing gases from the patient … Upon initiating the expiratory phase, exhalation module 216 may allow the patient to exhale by opening an expiratory valve… Although expiratory flow is passive, it may be regulated by the ventilator based on the size of the expiratory valve opening).
It would have been obvious to one skilled in the art before the effective filing date to modify the valve element taught by Pittman with an art-recognized mechanism of actuating a valve during expiratory durations.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pittman (US 9833583 B2) in view of Schwaibold (US 10500359 B2), in view of Buechi (US 9517321 B2), further in view of Nicolazzi et al. (US 20080097234 A1, hereinafter “Nicolazzi”)
Regarding Claim 17, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 1. Pittman further discloses wherein a patient’s breathing is identified by the control unit from a progression of the flow signal or of the pressure signal (Figure 1, sensors 20, processor 22), and the control unit is configured to drive the respiration gas source at a set respiration gas flow or respiration gas pressure (Column 6, lines 36-42, Returning to FIG. 1, in one embodiment, adjustments to the parameters of the pressurized flow of breathable gas made by control module 34 are made in a feedback manner. In this embodiment, adjustments to the parameters of the pressurized flow of breathable gas may be determined based on the comparison between the breathing parameter and the target threshold made by comparison module 32)
Though Pittman describes the use of the system to provide respiratory treatment to a patient (Column 2, lines 39-49, The adjustment of tidal volume accomplished through use of system 10 may reduce hypertension (e.g., lower blood pressure), reduce stress and/or anxiety (and related maladies), improve relaxation, decrease sleep latency, improve sleep quality, address other sleep disorders, and/or provide other health benefits. System 10 is effective in adjusting tidal volume while subject 12 is awake and/or asleep. To adjust the tidal volume of the breathing of subject 12, system 10 may provide breathing cues to subject 12 that encourage subject 12 to maintain a tidal volume that is at or above a target tidal volume), Pittman does not explicitly disclose identifying difficulty in breathing or effortful inhalation.
Nicolazzi does disclose:
wherein a patient having difficulty in breathing is identified by the control unit from a progression of the flow signal or of the pressure signal (Paragraph 0033, Respiratory events may include any breathing phenomena including, for example, an apnea, a hypopnea, snoring, any flow limitation, and/or any combination thereof. Event detection device 140 may communicate one or more detected respiratory events to control controller 160, which may then control gas delivery apparatus 150 to control respiratory therapy delivered to patient 20 based at least on such one or more detected respiratory events. For example, as discussed in greater detail below, controller 160 may control gas delivery apparatus 150 to increase (e.g., ramp up) the pressure of gas delivered to patient 20 from a first pressure level to a second pressure level in response to signals received from event detection device 140 indicating one or more detected respiratory events),
and the control unit is configured to drive the respiration gas source at a set respiration gas flow or respiration gas pressure when a progression of the flow signal or of the pressure signal leads to identification of effortful inhalation by the patient (Paragraph 0034, Controller 160 may be generally operable to control gas delivery apparatus 150. For example, controller 160 may control the pressure, flow rate, temperature, etc. of gas delivered gas delivery apparatus 150. Controller 160 may include any variety of analog or digital switches, actuators, or control devices suitable to control gas delivery apparatus 150. Controller 160 may receive data from event detection device 140 and/or events accumulator 170 indicating one or more detected respiratory events, and may control gas delivery apparatus 150 based at least on such data)
It is recognized in the art to utilize ventilators as treatment means for various respiratory-related conditions, and Pittman discloses various modules for monitoring respiratory behavior of a patient. Thus, it would have been obvious to one skilled in the art before the effective filing date to modify the ventilator system and control unit taught by Pittman to explicitly incorporate the event detection device taught by Nicolazzi.
Claims 7 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Pittman (US 9833583 B2) in view of Schwaibold (US 10500359 B2), in view of Buechi (US 9517321 B2), further in view of Richard et al. (US 6041780 A, hereinafter “Richard”)
Regarding Claim 7, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 6. Pittman further discloses: wherein the respiration gas tube in the event of a changeover from a CPAP mode to an IPAP mode is configured to remain on the ventilator (Column 2, lines 59-67, Device 14 may be configured to generate the pressurized flow of breathable gas according to one or more modes. A non-limiting example of one such mode is Continuous Positive Airway Pressure (CPAP) […] Another mode for generating the pressurized flow of breathable gas is Inspiratory Positive Air Pressure (IPAP). One example of the IPAP mode is bi-level positive air pressure (BiPAP)), (Column 5, lines 64-67, control module 34 may control device 14 to adjust the pressure, flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the HI pressure (e.g, during inhalation)), (Column 6, lines 13-17, control module 34 may control device to adjust the pressure flow rate, and/or volume of gas delivered to the airway of subject 12 while the pressurized flow of breathable gas is being generated at the LO pressure (e.g., during exhalation)).
Pittman also discloses a respiratory gas tube and valve mechanism in communication with the control unit (Estes, Column 10, lines 18-24, Pressure controller 24 controls the pressure of breathing gas within conduit 18 and thus within the airway of the patient. Pressure controller 24 is located preferably, although not necessarily, downstream of flow generator 14 and may take the form of an adjustable, electronically-controlled valve), (Column 5, lines 10-15, The measured values are converted into electrical signals and the flow and pressure of the respiration gas are controlled during the inspiration and expiration portions of the respiration cycle via a valve arranged between a respiration gas source and the measuring device). However, Pittman not explicitly disclose wherein the valve is switched by the control unit for IPAP mode
Richard does disclose: wherein the respiration gas tube (Figure 1, ventilation system 12) in the event of a changeover from a CPAP mode to an IPAP mode is configured to remain on the ventilator, and the valve (Figure 1, relief valve 20, valve 21) is switched by the control unit for IPAP mode (Columns 3-4, lines 65-4, The function of the controller is additionally subject to various parameters that are input such as through keyboard 30. The controller is also operative to control the position of valve 21 which is closed when relief valve 20 is opened and to tailor the output of blower 14 in relation to pressure demands), (Column 4, lines 37-42, At step 44, the blower motor 14 is energized and the relief valve 20 is actuated to maintain the initial IPAP setting during inhalation and the EPAP setting during exhalation. The onset of each respiratory phase is sensed by methods well known in the art).
It would have been obvious to one skilled in the art before the effective filing date to modify the valve and control unit taught by Pittman to adjust in accordance with the changing respiratory modes, as taught by Richard. Doing so would provide an additional degree of pressure control during the different modes.
Regarding Claim 10, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 6. Pittman further discloses wherein the patient's respiration is identified by the control unit from a progression of a flow signal from the flow sensor device (Column 1, lines 30-39, For example, U.S. patent application Ser. No. 11/836,292 to Kirby et al. “Kirby”), which is hereby incorporated into this disclosure in its entirety, discloses a system for modifying the timing and/or duration of inhalation and exhalation of a subject through breathing cues), (Column 5, lines 15-17, Parameter determination module 30 is configured to determine a breathing parameter from the one or more output signals generated by sensors 20)
Pittman also discloses that the valve is controlled by the control unit (Estes, Column 10, lines 18-24, Pressure controller 24 controls the pressure of breathing gas within conduit 18 and thus within the airway of the patient. Pressure controller 24 is located preferably, although not necessarily, downstream of flow generator 14 and may take the form of an adjustable, electronically-controlled valve). However, Pittman does not explicitly disclose that the valve is configured to be actuated depending on the flow signal
Richard does disclose: wherein the patient's respiration is identified by the control unit from a progression of a flow signal from the flow sensor device, and the valve is configured to be actuated depending on the flow signal (Column 3, lines 61-66, The position of the relief valve is in turn controlled by controller 24 pursuant to a number of different signals. Flow meter 26 provides information as to the volume of air inhaled by the patient, while pressure sensor 28 provides information as to the pressurization of the system at any given moment), (Column 6, lines 37-43, a controller for operating said relief valve to periodically adjust said preselected level of air pressure during subsequent inspiratory phases so as to cause the minute volume of air inhaled by the patient as measured by said flow meter to gradually conform to a preselected target value).
It would have been obvious to one skilled in the art before the effective filing date to modify the valve element taught by Pittman with an art-recognized mechanism of actuating a valve based on flow signals, as taught by Richard.
Regarding Claim 11, Pittman in view of Schwaibold, Buechi, and Richard discloses all of the limitations of Claim 10. Richard further discloses: wherein limits are recorded or can be set for the flow signal and/or for a pressure signal, where the limits a trigger sensitivity (Figures 2a-2c, By considering various physiological parameters, the sleep professional first determines a minute volume target and breath rate target for a particular patient along with the EPAP, the initial IPAP and the maximum deviation from IPAP. These values are input into the controller 24 … At step 44, the blower motor 14 is energized and the relief valve 20 is actuated to maintain the initial IPAP setting during inhalation and the EPAP setting during exhalation).
Regarding Claim 12, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 6. Pittman further discloses: wherein the control unit drives the respiration gas source to assure maintenance of the CPAP pressure level (Column 3, lines 26-30, The pressurized flow of breathable gas is delivered to the airway of subject 12 via a subject interface 24. Subject interface 24 is configured to communicate the pressurized flow of breathable gas generated by device 14 to the airway of subject 12), (Column 2, lines 59-67, Device 14 may be configured to generate the pressurized flow of breathable gas according to one or more modes. A non-limiting example of one such mode is Continuous Positive Airway Pressure (CPAP) […] Another mode for generating the pressurized flow of breathable gas is Inspiratory Positive Air Pressure (IPAP). One example of the IPAP mode is bi-level positive air pressure (BiPAP)) but is silent regarding maintenance of CPAP pressure level during switching operations of the valve.
Richard does disclose: switching operations of the valve (Column 4, lines 37-42, At step 44, the blower motor 14 is energized and the relief valve 20 is actuated to maintain the initial IPAP setting during inhalation and the EPAP setting during exhalation. The onset of each respiratory phase is sensed by methods well known in the art)
It would have been obvious to one skilled in the art before the effective filing date to modify the valve and control unit taught by Pittman to adjust in accordance with the changing respiratory modes, as taught by Richard. Doing so would provide an additional degree of pressure control during the different modes.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Pittman (US 9833583 B2) in view of Schwaibold (US 10500359 B2), in view of Buechi (US 9517321 B2), in view of Angelico (US 9027552 B2), further in view of Richard (US 6041780 A).
Regarding Claim 16, Pittman in view of Schwaibold and Buechi discloses all of the limitations of Claim 6. Pittman discloses: wherein the control unit drives the respiration gas source to assure maintenance of the CPAP pressure level (Column 3, lines 26-30, The pressurized flow of breathable gas is delivered to the airway of subject 12 via a subject interface 24. Subject interface 24 is configured to communicate the pressurized flow of breathable gas generated by device 14 to the airway of subject 12), (Column 2, lines 59-67, Device 14 may be configured to generate the pressurized flow of breathable gas according to one or more modes. A non-limiting example of one such mode is Continuous Positive Airway Pressure (CPAP) […] Another mode for generating the pressurized flow of breathable gas is Inspiratory Positive Air Pressure (IPAP). One example of the IPAP mode is bi-level positive air pressure (BiPAP)),
Pittman also discloses that the valve is controlled by the control unit (Estes, Column 10, lines 18-24, Pressure controller 24 controls the pressure of breathing gas within conduit 18 and thus within the airway of the patient. Pressure controller 24 is located preferably, although not necessarily, downstream of flow generator 14 and may take the form of an adjustable, electronically-controlled valve), but does not explicitly disclose intermittently opening the valve
Angelico discloses: wherein the control unit for CPAP mode is configured to keep the valve closed in an inhalation (Column 20, lines 29-31, expiratory and inspiratory valves are closed briefly at the end of inspiration for measuring the PPlat at zero flow) and to drive it in a controlled manner in an exhalation and open it intermittently in order to assure exhalation (Column 11, lines 17-33, exhalation module 216 may correspond to expiratory module 108 or may otherwise be associated with and/or controlling an expiratory valve for releasing gases from the patient … Upon initiating the expiratory phase, exhalation module 216 may allow the patient to exhale by opening an expiratory valve… Although expiratory flow is passive, it may be regulated by the ventilator based on the size of the expiratory valve opening. In some embodiments, exhalation is regulated based on a selected breath type),
It would have been obvious to one skilled in the art before the effective filing date to modify the valve element taught by Pittman with an art-recognized mechanism of actuating a valve in accordance with a respiratory phase beginning or ending.
The combination does not disclose the valve actuated depending on the flow signal. Richard, however, does disclose:
where the patient's respiration is identified by the control unit from a progression of the flow signal from the flow sensor device and the valve is actuated depending on the flow signal (Column 3, lines 61-66, The position of the relief valve is in turn controlled by controller 24 pursuant to a number of different signals. Flow meter 26 provides information as to the volume of air inhaled by the patient, while pressure sensor 28 provides information as to the pressurization of the system at any given moment), (Column 6, lines 37-43, a controller for operating said relief valve to periodically adjust said preselected level of air pressure during subsequent inspiratory phases so as to cause the minute volume of air inhaled by the patient as measured by said flow meter to gradually conform to a preselected target value),
where a maintenance of the CPAP pressure level is assured during switching operations of the valve (Column 4, lines 37-42, At step 44, the blower motor 14 is energized and the relief valve 20 is actuated to maintain the initial IPAP setting during inhalation and the EPAP setting during exhalation. The onset of each respiratory phase is sensed by methods well known in the art)
It would have been obvious to one skilled in the art before the effective filing date to modify the valve element taught by Pittman and Angelico with an art-recognized mechanism of actuating a valve based on flow signals, as taught by Richard. Likewise, it would have been obvious to one skilled in the art before the effective filing date to modify the valve and control unit to adjust in accordance with the changing respiratory modes, as taught by Richard. Doing so would provide an additional degree of pressure control during the different modes.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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