DETAILED ACTION
This Office Action is in response to the amendment, filed on June 12, 2026. Primary Examiner acknowledges Claims 1-20 are pending in this application, with Claims 1, 3, 5, 8, and 10 having been currently amended.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dantanarayana et al. (2004/0094157) in view of Jones et al. (2005/0199845) and Pei et al. (6,891,317).
As to Claim 1, Dantanarayana discloses a respiratory assistance component (best seen Figures 1-8) in the form of an anti-asphyxia valve (10, “The flow regulation vent 10 is constructed from a unitary sheet of material and includes a movable portion 12 pivotally attached at one end to a fixed portion 14 by unitary hinge 16.” Para 0070; also see: “The operation of the flow regulation vent 10 will now be described. At the minimum safe gas flow at the lowest operating CPAP pressure of, say, 2-4 cm H.sub.20, the movable portion 12 is biased by the force from the spring hinge 16 into a relaxed position pivoted away from the fixed portion 14 and toward the pressurized gas supply. See FIGS. 3, 7 and 8. … This design can also act as an anti-asphyxia valve designed to be open with a large flow area to the atmosphere at low or no pressure.” Para 0073), comprising: at least one portion (12, “The flow regulation vent 10 is constructed from a unitary sheet of material and includes a movable portion 12 pivotally attached at one end to a fixed portion 14 by unitary hinge 16. Movable portion 12 has an outer perimeter 18, which, in the embodiment shown, is substantially circular. … Movable portion 12 can optionally include one or more bleed orifices 24 and fixed portion 14 can optionally include one or more bleed orifices 26.” Para 0070) that changes shape and/or size (via non-planar shape as shown in Figure 3) between a first non-energized state (as shown in Figure 2) and a second energized state (as shown in Figure 3), wherein a change between the first non-energized state (as shown in Figure 2) and the second energized state (as shown in Figure 3), or vice versa, changes in shape and/or size in at least one dimension (shape from a planar straight configuration to a non-planar bent configuration thereby changing the flow profile) associated with the at least one portion (12) so as to modify an aspect (flow profile, as a function of the opening or closing of the valve) or provide information (“This design can also act as an anti-asphyxia valve designed to be open with a large flow area to the atmosphere at low or no pressure. For instance, if the flow generator stops working due to a malfunction, the vent 10 remains open, allowing the patient to continue breathing while reducing the risk of asphyxiation, or even the perception thereof, by the patient.” Para 0073) of the respiratory assistance (breathing gas flow profile, as a function of the opening or closing of the valve) provided to the patient.
Yet, Dantanarayana does not expressly disclose the construction of the respiratory assistance component (best seen Figures 1-8) in the form of an anti-asphyxia valve (10) “formed at least in part out of an electro active polymer that changes shape and/or size between a first non-energized state when no electrical current is applied to electro active polymer and a second energized state when current is applied to the electro active polymer” nor the configuration whereby “the electro active polymer is configured to sense at least one parameter associated with providing the respiratory assistance to the patient based on a measured change in at least one electrical characteristic associated with the electro active polymer.”
Regarding the construction of the respiratory assistance component to be “formed at least in part out of an electro active polymer that changes shape and/or size between a first non-energized state when no electrical current is applied to electro active polymer and a second energized state when current is applied to the electro active polymer”, Jones teaches an alternative respiratory assistance component (Figures 7 and 8), in the form of a valve (80 of Figure 7 / 90 of Figure 8 – “FIG. 7 depicts an active pressure relief valve 80 generally comprising a flap 82 formed of the active material.” Para 0042; “FIG. 8 depicts an active pressure relief valve 90 in accordance with another embodiment.” Para 0043) to modulate the flow of gas through the valve (80/90).
Regarding the remaining limitations of the claims, Jones teaches the valve (80/90) having at least one portion (82/92, “flap 82” Para 0042; “flap 92” Para 0043) formed at least in part out of an electro active polymer (“For example, flap 82 can be formed of a magnetorheological rubber, that can be engineered to bend upon activation (e.g., an applied magnetic field) so as to open the flap 82 and then straighten and close upon removal of the magnetic field. Likewise, the flap can be formed of an electroactive polymer or piezoceramic composite material so as to create an opening upon application of a voltage.” Para 0042; “the flap 92 is formed of a piezoceramic bimorph material, which can be embedded within a flexible material. Activation of the piezoceramic bimorph material with an effective voltage causes the flap to undergo a change in shape from a planar configuration (closed position) to a curled configuration (open position). Discontinuation of the voltage signal causes the flap 92 to return to the planar configuration.” Para 0043) that changes shape and/or size (“can be engineered to bend upon activation (e.g., an applied magnetic field) so as to open the flap 82 and then straighten and close upon removal of the magnetic field.” Para 0042; “causes the flap to undergo a change in shape from a planar configuration (closed position) to a curled configuration (open position).” Para 0043) between a first non-energized state (“straighten and close upon removal of the magnetic field” Para 0042; “a planar configuration (closed position)” Para 0043) when no electrical current (“close upon removal of the magnetic field” Para 0042; “Discontinuation of the voltage signal” Para 0043) is applied to the electro active polymer and a second energized state (“bend upon activation (e.g., an applied magnetic field) so as to open the flap 82” Para 0042; “to a curled configuration (open position)” Para 0043) when current (“bend upon activation (e.g., an applied magnetic field) so as to open the flap 82” Para 0042; “an effective voltage causes the flap to undergo a change in shape from a planar configuration (closed position) to a curled configuration (open position).” Para 0043) is applied to the electro active polymer, wherein the change from the first non-energized state (“straighten and close upon removal of the magnetic field” Para 0042; “a planar configuration (closed position)” Para 0043) and the second energized state (“bend upon activation (e.g., an applied magnetic field) so as to open the flap 82” Para 0042; “to a curled configuration (open position)” Para 0043), or vice versa, changes the shape and/or size (“can be engineered to bend upon activation (e.g., an applied magnetic field) so as to open the flap 82 and then straighten and close upon removal of the magnetic field.” Para 0042; “causes the flap to undergo a change in shape from a planar configuration (closed position) to a curled configuration (open position).” Para 0043) in at least one dimension associated with the at least one portion (82/92) so as to modify an aspect or provide information (flow profile, as a function of the opening or closing of the valve) of the respiratory assistance component (80/90) provided to the patient.
With respect to the specific usage of “electro active polymer” and the stimulus through “electrical current”, Jones teaches each of the following are known active materials responsive to the application/removal of stimulus – “ Suitable active materials include, without limitation, shape memory alloys, ferromagnetic shape memory alloys, shape memory polymers, piezoelectric materials, electroactive polymers, magnetorheological fluids and elastomers, electrorheological fluids, composites of one or more of the foregoing materials with non-active materials, combinations comprising at least one of the foregoing materials, and the like. Depending on the particular active material, the activation signal can take the form of, without limitation, an electric current, a temperature change, a magnetic field, a mechanical loading or stressing, or the like.” (Abstract, also see: “Active materials in this category include, but are not limited to, piezoelectric materials, electroactive polymers (EAP), magnetorheological fluids and elastomers (MR), electrorheological fluids (ER), composites of one or more of the foregoing materials with non-active materials, combinations comprising at least one of the foregoing materials, and the like. Depending on the particular active material, the activation signal can take the form of, without limitation, an electric current, a temperature change, a magnetic field, a mechanical loading or stressing, or the like.” Para 0029 and Paras 0066-0070 which explicitly discusses additional aspects of “Electroactive polymers”). Hence, it appears the claimed “electroactive polymers” are functionally equivalent alternative materials of the “active material”, “shape memory polymers”, “magnetorheological fluids and elastomers” – described as “magnetorheological rubber”, and “piezoelectric materials” – described as “piezoceramic composite material” - as referenced in Jones Para 0042; and the “shape memory alloys”, “piezoelectric materials” – described as “piezoceramic bimorph material” - as referenced in Jones Para 0043; while, it appears the claimed “electrical current” are functionally equivalent alternative stimulus of the “temperature change”, “magnetic field”, “an electric current” – described as “voltage” – as referenced in Jones Para 0042; and the “temperature change” – described as “resistive heating”, and “an electric current” – described as “voltage” – as referenced in Jones Para 0042. Note: Regarding the term “current” as related to “voltage” it is well-known, routine, and conventional practice that the relationship between voltage (V) and current (I) is primarily defined by Ohm's Law, which states that current is directly proportional to voltage and inversely proportional to resistance (R).
In light of the teachings of Jones, the decision to modify the material composition of at least one portion of the respiratory assistance component – in the form of a valve – to be constructed of an active material such as the claimed “electro active polymer” would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to control the operation of the valve -- whereby the active material of the claimed “electro active polymer” is responsive to a stimulus such as the claimed “electrical current” in order to modulate the operation of the valve from a first non-energized state whereby the portion of the valve is in a planar straight configuration to a second energized state whereby the portion of the valve is in a non-planar bent configuration.
Regarding the configuration of the “the electro active polymer is configured to sense at least one parameter associated with providing the respiratory assistance to the patient based on a measured change in at least one electrical characteristic associated with the electro active polymer”, Pei teaches components constructed of “Electroactive polymers have many functional uses. In addition to actuation, active areas of the present invention may also be used for generation and production of electrical energy, sensing, stiffness control, or damping control.” (Column 19, Lines 35-45). In this operation, “As polymer 12 changes in size, the changing electrical properties and voltage may be detected, dissipated, and/or used.” (Column 20, Lines 10-25), whereby the “Electroactive polymers of the present invention may also be configured as a sensor … [to] detect a "parameter" and/or changes in the parameter. The parameter is usually a physical property of an object such as its temperature, density, strain, deformation, velocity, location, contact, acceleration, vibration, volume, pressure, mass, opacity, concentration, chemical state, conductivity, magnetization, dielectric constant, size, etc.” (Column 21, Lines 20-35).
Further, Pei teaches when the “electroactive polymer sensor is configured such that a portion of the electroactive polymer deflects in response to the change in a parameter being sensed. The electrical energy state and deflection state of the polymer are related. The change in electrical energy or a change in the electrical impedance of an active area resulting from the deflection may then be detected by sensing electronics in electrical communication with the active area electrodes. This change may comprise a capacitance change of the polymer, a resistance change of the polymer, and/or resistance change of the electrodes, or a combination thereof. Electronic circuits in electrical communication with electrodes detect the electrical property change. If a change in capacitance or resistance of the transducer is being measured for example, one applies electrical energy to electrodes included in the transducer and observes a change in the electrical parameters.” (Column 21, Lines 30-50). In this configuration, “a logic device in electrical communication with sensing electronics of sensor quantifies the electrical change to provide a digital or other measure of the changing parameter being sensed.” (Column 21, Lines 50-70), and the “Sensing electronics may then detect and measure the high frequency response of the polymer to allow sensor performance that does not interfere with polymer actuation. Similarly, if impedance changes are detected and measured while the electroactive polymer transducer is being used as a generator, a small, high-frequency AC signal may be superimposed on the lower-frequency generation voltage signal.” (Column 22, Lines 1-25).
Hence, returning to the claim limitations, Pei teaches the electro active polymer is configured to sense (“Electroactive polymers of the present invention may also be configured as a sensor … [to] detect a "parameter" and/or changes in the parameter.” Column 21, Lines 20-35) at least one parameter (changes in size and/or shape resulting in change in flow profile of gas through the respiratory assistance component – “As polymer 12 changes in size” Column 20, Lines 10-25) associated with providing the respiratory assistance to the patient based on a measured change in at least one electrical characteristic (“strain … conductivity, magnetization, dielectric constant” Column 21, Lines 20-35; also see: “change in electrical energy or a change in the electrical impedance … capacitance change of the polymer, a resistance change of the polymer, and/or resistance change of the electrodes, or a combination thereof.” Column 21, Lines 30-50) associated with the electro active polymer (12).
The resultant effect of utilizing the electro active polymer of the modified Dantanarayana to further act as a sensor, as taught by Pei provides the ability to impart the desired “stiffness and/or damping control” (Column 22, Lines 20-40) thereby modulating the operational parameters of the respiratory assistance provided by the respiratory assistance component to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the respiratory assistance component – in the form of a valve – of Dantanarayana to be formed from an electro active polymer responsive to electrical current stimulus, as taught by Jones to provide operational control of the valve as desired, and further to modify the modified Dantanarayana to operate with the electro active polymer as a sensor is the ability to impart the desired “stiffness and/or damping control” as taught by Pei to modulate the operational parameters of the respiratory assistance provided by the respiratory assistance component to the patient.
As to Claims 2, 11, 12, and 17, the modified Dantanarayana, specifically Dantanarayana discloses the respiratory assistance component (best seen Figures 1-8) comprises an anti-asphyxia valve (10, “The flow regulation vent 10 is constructed from a unitary sheet of material and includes a movable portion 12 pivotally attached at one end to a fixed portion 14 by unitary hinge 16.” Para 0070; also see: “The operation of the flow regulation vent 10 will now be described. At the minimum safe gas flow at the lowest operating CPAP pressure of, say, 2-4 cm H.sub.20, the movable portion 12 is biased by the force from the spring hinge 16 into a relaxed position pivoted away from the fixed portion 14 and toward the pressurized gas supply. See FIGS. 3, 7 and 8. … This design can also act as an anti-asphyxia valve designed to be open with a large flow area to the atmosphere at low or no pressure.” Para 0073).
Regarding the material composition of the valve, the modified Dantanarayana, specifically Jones teaches a flap (82/92, “flap 82” Para 0042; “flap 92” Para 0043) formed at least in part out of an electro active polymer (“For example, flap 82 can be formed of a magnetorheological rubber, that can be engineered to bend upon activation (e.g., an applied magnetic field) so as to open the flap 82 and then straighten and close upon removal of the magnetic field. Likewise, the flap can be formed of an electroactive polymer or piezoceramic composite material so as to create an opening upon application of a voltage.” Para 0042; “the flap 92 is formed of a piezoceramic bimorph material, which can be embedded within a flexible material. Activation of the piezoceramic bimorph material with an effective voltage causes the flap to undergo a change in shape from a planar configuration (closed position) to a curled configuration (open position). Discontinuation of the voltage signal causes the flap 92 to return to the planar configuration.” Para 0043) formed, at least partially, of an electro active polymer layer.
As to Claims 3 and 16, the modified Dantanarayana, specifically Jones teaches the flap (82/92) is arranged to change between a first straight configuration (“straighten and close upon removal of the magnetic field” Para 0042; “a planar configuration (closed position)” Para 0043), in which the anti-asphyxia valve is open, and a second bent configuration (“bend upon activation (e.g., an applied magnetic field) so as to open the flap 82” Para 0042; “to a curled configuration (open position)” Para 0043), in which the anti-asphyxia valve is closed, wherein the first non-energized state (“straighten and close upon removal of the magnetic field” Para 0042; “a planar configuration (closed position)” Para 0043) corresponds to the first straight configuration (“straighten and close upon removal of the magnetic field” Para 0042; “a planar configuration (closed position)” Para 0043), and the second energized state (“bend upon activation (e.g., an applied magnetic field) so as to open the flap 82” Para 0042; “to a curled configuration (open position)” Para 0043) corresponds to the second bent configuration (“bend upon activation (e.g., an applied magnetic field) so as to open the flap 82” Para 0042; “to a curled configuration (open position)” Para 0043).
Regarding the open configuration vs closed configuration, the modified Dantanarayana, specifically Jones teaches the first straight configuration is a function of the removal of the stimulus to operate the valve, whilst the second bent configuration is a function of the application of the stimulus to operate the valve. Consequently, based on the physical characteristics of the valve seat upon which the flap (82/92) is applied, the first straight configuration resulting from the removal of the stimulus to the operate the valve can yield the claimed construction of the open anti-asphyxia valve, whilst the second bent configuration resulting from the application of the stimulus to operate the valve can yield the claimed construction of the closed anti-asphyxia valve.
Specifically, regarding Claim 16’s reference to “the at least one airflow path to outside atmosphere”, the modified Dantanarayana, specifically Dantanarayana discloses the operation of the respiratory assistance component (10) in the form of a valve, results in the operation by which gases are directed to the atmosphere ( “One side of the flap is exposed to an interior of the mask shell or gas flow conduit that is pressurized when the CPAP system mask is in use and another side is positioned toward an atmosphere side of the vent.” Para 0022; “Thus, by the present invention, a gas flow area for allowing gas to escape from the CPAP system to atmosphere is reduced as the pressure of the gas supply increases. In this way, the total flow rate for gas from the CPAP system is reduced (as compared to a fixed gas flow area vent) even though the pressure of the gas is increasing. Through appropriate tuning of the flow regulation vent 10 within a specified operating pressure range of the CPAP system, a desired flow rate curve can be obtained, including a flow rate curve that is substantially flat across the specified operating pressure range.” Para 0075).
As to Claim 4, the modified Dantanarayana, specifically Jones teaches the flap (82/92) comprises a constraining layer (“Various types of electrodes suitable for use with the present disclosure include structured electrodes comprising metal traces and charge distribution layers” Para 0069) attached to the polymer layer (“As electroactive polymers may deflect at high strains, electrodes attached to the polymers should also deflect without compromising mechanical or electrical performance.” Para 0069) so that when the polymer layer is energized, at least one dimension at one side of the polymer layer is constrained (“The electrodes may be only applied to a portion of an electroactive polymer and define an active area according to their geometry.” Para 0069), causing the flap to bend in a direction of the side that is constrained.
Regarding the bending action about the constrained layer, as the modified Dantanarayana, specifically Jones teaches portions of the electroactive polymer having the electrodes attached thereto, wherein the electrodes the vehicle for the stimulus to result in the activation of the electroactive polymer to a specific change in shape as a function of the application of the stimulus, the resultant effect is the configuration whereby the flap will bend in relation to the direction of the stimulus.
As to Claim 5, the modified Dantanarayana, specifically Pei teaches the measured change in at least one electrical characteristic includes a measured change in an electrical impedance (“The change in electrical energy or a change in the electrical impedance of an active area resulting from the deflection may then be detected by sensing electronics in electrical communication with the active area electrodes.” Column 21, Lines 30-50; “Similarly, if impedance changes are detected and measured while the electroactive polymer transducer is being used as a generator, a small, high-frequency AC signal may be superimposed on the lower-frequency generation voltage signal.” Column 22, Lines 1-25) of the electro active polymer wherein the measured change in the electrical impedance indicates an associated change in the at least one parameter (changes in size and/or shape resulting in change in flow profile of gas through the respiratory assistance component – “As polymer 12 changes in size” Column 20, Lines 10-25).
As to Claims 6 and 19, the modified Dantanarayana, specifically Jones the application of an “air pressure” sensory input to direct the selective opening and closing the flap, through the activation of the stimulus as a manner by which the selective opening and closing the flap, through the activation of the stimulus may occur.
As to Claim 7, the modified Dantanarayana, specifically Jones teaches the electroactive polymer is a dielectric electro active polymer (“Materials used as an electroactive polymer may be selected based on one or more material properties such as a high electrical breakdown strength, a low modulus of elasticity--(for large or small deformations), a high dielectric constant, and the like. … In another embodiment, the polymer is selected such that is has a dielectric constant between about 2 and about 20, and preferably between about 2.5 and about 12. The present disclosure is not intended to be limited to these ranges. Ideally, materials with a higher dielectric constant than the ranges given above would be desirable if the materials had both a high dielectric constant and a high dielectric strength.” Para 0068).
As to Claim 8, the modified Dantanarayana, specifically both Dantanarayana and Jones state the respiratory assistance component is a valve (Dantanarayana: Figures 1-8 -- 10, “The flow regulation vent 10 is constructed from a unitary sheet of material and includes a movable portion 12 pivotally attached at one end to a fixed portion 14 by unitary hinge 16.” Para 0070; also see: “The operation of the flow regulation vent 10 will now be described. At the minimum safe gas flow at the lowest operating CPAP pressure of, say, 2-4 cm H.sub.20, the movable portion 12 is biased by the force from the spring hinge 16 into a relaxed position pivoted away from the fixed portion 14 and toward the pressurized gas supply. See FIGS. 3, 7 and 8. … This design can also act as an anti-asphyxia valve designed to be open with a large flow area to the atmosphere at low or no pressure.” Para 0073; AND Jones: Figures 7 and 8 -- 80 of Figure 7 / 90 of Figure 8 – “FIG. 7 depicts an active pressure relief valve 80 generally comprising a flap 82 formed of the active material.” Para 0042; “FIG. 8 depicts an active pressure relief valve 90 in accordance with another embodiment.” Para 0043).
As to Claims 9 and 20, please see the rejection of Claims 1 and 10, respectively, for the recited features of the respiratory assistance component.
Regarding the “patient interface”, the modified Dantanarayana, specifically Dantanarayana discloses the application of the respiratory assistance component (Figures 1-8) configured upon a patient interface (mask and/or mask component - best seen Figures 7 and 8, “As can be seen in FIGS. 5, 7 and 8, in the relaxed position, the movable portion 12 of vent 10 (shown in phantom) is pivoted away from the fixed portion 14 toward the mask shell 32 or gas supply tube 34, i.e. towards the pressurized gas supply and away from the atmosphere.” Para 0072).
As to Claim 10, Dantanarayana discloses a respiratory assistance component (best seen Figures 1-8) in the form of an anti-asphyxia valve (10, “The flow regulation vent 10 is constructed from a unitary sheet of material and includes a movable portion 12 pivotally attached at one end to a fixed portion 14 by unitary hinge 16.” Para 0070; also see: “The operation of the flow regulation vent 10 will now be described. At the minimum safe gas flow at the lowest operating CPAP pressure of, say, 2-4 cm H.sub.20, the movable portion 12 is biased by the force from the spring hinge 16 into a relaxed position pivoted away from the fixed portion 14 and toward the pressurized gas supply. See FIGS. 3, 7 and 8. … This design can also act as an anti-asphyxia valve designed to be open with a large flow area to the atmosphere at low or no pressure.” Para 0073) associated with a respiratory assistance system (“CPAP” – “The invention has been developed primarily for use in controlling the venting of washout gas in a continuous positive airway pressure (CPAP) gas delivery systems used, for example, in the treatment of obstructive sleep apnea (OSA) and similar sleep disordered breathing conditions.” Para 0003; “Treatment of OSA by CPAP gas delivery systems involves the continuous delivery of air (or breathable gas) pressurized above atmospheric pressure to a patient's airways via a conduit and a mask. CPAP pressures of 4 cm H.sub.20 to 30 cm H.sub.20 are typically used for treatment of sleep disordered breathing due to OSA and/or central apnea, depending on patient requirements.” Para 0005; also see: “One side of the flap is exposed to an interior of the mask shell or gas flow conduit that is pressurized when the CPAP system mask is in use and another side is positioned toward an atmosphere side of the vent.” Para 0022; “The flow regulation vent reduces operating noise of the CPAP system by reducing the volume of gas flow required from the flow generator at high pressures, as well as thus reducing the work output of the flow generator. The vent also reduces rebreathing of CO.sub.2 and other exhaled gas and provides for faster air pressure rise time, increasing the effectiveness of the CPAP system and patient compliance with CPAP treatment.” Para 0026; “The operation of the flow regulation vent 10 will now be described. At the minimum safe gas flow at the lowest operating CPAP pressure of, say, 2-4 cm H.sub.20, the movable portion 12 is biased by the force from the spring hinge 16 into a relaxed position pivoted away from the fixed portion 14 and toward the pressurized gas supply. … That specific flow area would then close somewhat when the CPAP system is operating as intended at the lowest/lower pressure range and from there the movable portion continues to reduce the flow area as designed with increasing pressure.” Para 0073; “Thus, by the present invention, a gas flow area for allowing gas to escape from the CPAP system to atmosphere is reduced as the pressure of the gas supply increases. In this way, the total flow rate for gas from the CPAP system is reduced (as compared to a fixed gas flow area vent) even though the pressure of the gas is increasing. Through appropriate tuning of the flow regulation vent 10 within a specified operating pressure range of the CPAP system, a desired flow rate curve can be obtained, including a flow rate curve that is substantially flat across the specified operating pressure range.” Para 0075) that is configured to provide positive air pressure (“CPAP pressure” – “At the minimum safe gas flow at the lowest operating CPAP pressure of, say, 2-4 cm H.sub.20, the movable portion 12 is biased by the force from the spring hinge 16 into a relaxed position pivoted away from the fixed portion 14 and toward the pressurized gas supply. See FIGS. 3, 7 and 8.” Para 0073) to a patient, the respiratory assistance component (best seen Figures 1-8) comprising: at least one valve (12, “The flow regulation vent 10 is constructed from a unitary sheet of material and includes a movable portion 12 pivotally attached at one end to a fixed portion 14 by unitary hinge 16. Movable portion 12 has an outer perimeter 18, which, in the embodiment shown, is substantially circular. … Movable portion 12 can optionally include one or more bleed orifices 24 and fixed portion 14 can optionally include one or more bleed orifices 26.” Para 0070) configured to control at least one air flow path (defined as the passage of gas through 20 as controlled via 12, “Fixed portion 14 includes an orifice 20, which, in the embodiment shown, is also substantially circular and which is slightly larger in diameter than the diameter of the outer perimeter 18 to provide a gap 22 therebetween when the movable portion is in a fully pressurized position. See FIG. 2, which shows a side view of the vent 10 when in the fully pressurized position. Movable portion 12 can optionally include one or more bleed orifices 24 and fixed portion 14 can optionally include one or more bleed orifices 26.” Para 0070) in order to modulate the respiratory assistance (breathing gas flow profile, as a function of the opening or closing of the valve) provided to the patient.
Yet, Dantanarayana does not expressly disclose the construction of the respiratory assistance component (best seen Figures 1-8) in the form of an anti-asphyxia valve (10) “formed at least in part out of an electro active polymer that changes shape, size, and/or position between a first non-energized state when no electrical current is applied to electro active polymer and a second energized state when current is applied to the electro active polymer” nor the configuration whereby “an electrical circuit [is] configured to generate, based on a measured change in at least one electrical characteristic associated with the electro active polymer, a value for at least one parameter of the respiratory assistance provided to the patient.”
Regarding the construction of the respiratory assistance component to be “formed at least in part out of an electro active polymer that changes shape, size, and/or position between a first non-energized state when no electrical current is applied to electro active polymer and a second energized state when current is applied to the electro active polymer”, Jones teaches an alternative respiratory assistance component (Figures 7 and 8), in the form of a valve (80 of Figure 7 / 90 of Figure 8 – “FIG. 7 depicts an active pressure relief valve 80 generally comprising a flap 82 formed of the active material.” Para 0042; “FIG. 8 depicts an active pressure relief valve 90 in accordance with another embodiment.” Para 0043) to modulate the flow of gas through the valve (80/90).
Regarding the remaining limitations of the claims, Jones teaches the valve (80/90) having at least one portion (82/92, “flap 82” Para 0042; “flap 92” Para 0043) formed at least in part out of an electro active polymer (“For example, flap 82 can be formed of a magnetorheological rubber, that can be engineered to bend upon activation (e.g., an applied magnetic field) so as to open the flap 82 and then straighten and close upon removal of the magnetic field. Likewise, the flap can be formed of an electroactive polymer or piezoceramic composite material so as to create an opening upon application of a voltage.” Para 0042; “the flap 92 is formed of a piezoceramic bimorph material, which can be embedded within a flexible material. Activation of the piezoceramic bimorph material with an effective voltage causes the flap to undergo a change in shape from a planar configuration (closed position) to a curled configuration (open position). Discontinuation of the voltage signal causes the flap 92 to return to the planar configuration.” Para 0043) that changes shape, size, and/or position (“can be engineered to bend upon activation (e.g., an applied magnetic field) so as to open the flap 82 and then straighten and close upon removal of the magnetic field.” Para 0042; “causes the flap to undergo a change in shape from a planar configuration (closed position) to a curled configuration (open position).” Para 0043) between a first non-energized state (“straighten and close upon removal of the magnetic field” Para 0042; “a planar configuration (closed position)” Para 0043) when no electrical current (“close upon removal of the magnetic field” Para 0042; “Discontinuation of the voltage signal” Para 0043) is applied to the electro active polymer and a second energized state (“bend upon activation (e.g., an applied magnetic field) so as to open the flap 82” Para 0042; “to a curled configuration (open position)” Para 0043) when current (“bend upon activation (e.g., an applied magnetic field) so as to open the flap 82” Para 0042; “an effective voltage causes the flap to undergo a change in shape from a planar configuration (closed position) to a curled configuration (open position).” Para 0043) is applied to the electro active polymer, wherein the change from the first non-energized state (“straighten and close upon removal of the magnetic field” Para 0042; “a planar configuration (closed position)” Para 0043) and the second energized state (“bend upon activation (e.g., an applied magnetic field) so as to open the flap 82” Para 0042; “to a curled configuration (open position)” Para 0043), or vice versa, changes the shape and/or size (“can be engineered to bend upon activation (e.g., an applied magnetic field) so as to open the flap 82 and then straighten and close upon removal of the magnetic field.” Para 0042; “causes the flap to undergo a change in shape from a planar configuration (closed position) to a curled configuration (open position).” Para 0043) in at least one dimension associated with the at least one portion (82/92) so as to modify an aspect or provide information (flow profile, as a function of the opening or closing of the valve) of the respiratory assistance component (80/90) provided to the patient.
With respect to the specific usage of “electro active polymer” and the stimulus through “electrical current”, Jones teaches each of the following are known active materials responsive to the application/removal of stimulus – “ Suitable active materials include, without limitation, shape memory alloys, ferromagnetic shape memory alloys, shape memory polymers, piezoelectric materials, electroactive polymers, magnetorheological fluids and elastomers, electrorheological fluids, composites of one or more of the foregoing materials with non-active materials, combinations comprising at least one of the foregoing materials, and the like. Depending on the particular active material, the activation signal can take the form of, without limitation, an electric current, a temperature change, a magnetic field, a mechanical loading or stressing, or the like.” (Abstract, also see: “Active materials in this category include, but are not limited to, piezoelectric materials, electroactive polymers (EAP), magnetorheological fluids and elastomers (MR), electrorheological fluids (ER), composites of one or more of the foregoing materials with non-active materials, combinations comprising at least one of the foregoing materials, and the like. Depending on the particular active material, the activation signal can take the form of, without limitation, an electric current, a temperature change, a magnetic field, a mechanical loading or stressing, or the like.” Para 0029 and Paras 0066-0070 which explicitly discusses additional aspects of “Electroactive polymers”). Hence, it appears the claimed “electroactive polymers” are functionally equivalent alternative materials of the “active material”, “shape memory polymers”, “magnetorheological fluids and elastomers” – described as “magnetorheological rubber”, and “piezoelectric materials” – described as “piezoceramic composite material” - as referenced in Jones Para 0042; and the “shape memory alloys”, “piezoelectric materials” – described as “piezoceramic bimorph material” - as referenced in Jones Para 0043; while, it appears the claimed “electrical current” are functionally equivalent alternative stimulus of the “temperature change”, “magnetic field”, “an electric current” – described as “voltage” – as referenced in Jones Para 0042; and the “temperature change” – described as “resistive heating”, and “an electric current” – described as “voltage” – as referenced in Jones Para 0042. Note: Regarding the term “current” as related to “voltage” it is well-known, routine, and conventional practice that the relationship between voltage (V) and current (I) is primarily defined by Ohm's Law, which states that current is directly proportional to voltage and inversely proportional to resistance (R).
In light of the teachings of Jones, the decision to modify the material composition of at least one portion of the respiratory assistance component – in the form of a valve – to be constructed of an active material such as the claimed “electro active polymer” would be obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability to control the operation of the valve -- whereby the active material of the claimed “electro active polymer” is responsive to a stimulus such as the claimed “electrical current” in order to modulate the operation of the valve from a first non-energized state whereby the portion of the valve is in a planar straight configuration to a second energized state whereby the portion of the valve is in a non-planar bent configuration.
Regarding the configuration of the “an electrical circuit [is] configured to generate, based on a measured change in at least one electrical characteristic associated with the electro active polymer, a value for at least one parameter of the respiratory assistance provided to the patient”, Pei teaches components constructed of “Electroactive polymers have many functional uses. In addition to actuation, active areas of the present invention may also be used for generation and production of electrical energy, sensing, stiffness control, or damping control.” (Column 19, Lines 35-45). In this operation, “As polymer 12 changes in size, the changing electrical properties and voltage may be detected, dissipated, and/or used.” (Column 20, Lines 10-25), whereby the “Electroactive polymers of the present invention may also be configured as a sensor … [to] detect a "parameter" and/or changes in the parameter. The parameter is usually a physical property of an object such as its temperature, density, strain, deformation, velocity, location, contact, acceleration, vibration, volume, pressure, mass, opacity, concentration, chemical state, conductivity, magnetization, dielectric constant, size, etc.” (Column 21, Lines 20-35).
Further, Pei teaches when the “electroactive polymer sensor is configured such that a portion of the electroactive polymer deflects in response to the change in a parameter being sensed. The electrical energy state and deflection state of the polymer are related. The change in electrical energy or a change in the electrical impedance of an active area resulting from the deflection may then be detected by sensing electronics in electrical communication with the active area electrodes. This change may comprise a capacitance change of the polymer, a resistance change of the polymer, and/or resistance change of the electrodes, or a combination thereof. Electronic circuits in electrical communication with electrodes detect the electrical property change. If a change in capacitance or resistance of the transducer is being measured for example, one applies electrical energy to electrodes included in the transducer and observes a change in the electrical parameters.” (Column 21, Lines 30-50). In this configuration, “a logic device in electrical communication with sensing electronics of sensor quantifies the electrical change to provide a digital or other measure of the changing parameter being sensed.” (Column 21, Lines 50-70), and the “Sensing electronics may then detect and measure the high frequency response of the polymer to allow sensor performance that does not interfere with polymer actuation. Similarly, if impedance changes are detected and measured while the electroactive polymer transducer is being used as a generator, a small, high-frequency AC signal may be superimposed on the lower-frequency generation voltage signal.” (Column 22, Lines 1-25).
Hence, returning to the claim limitations, Pei teaches the electro active polymer includes an electrical circuit (“Electronic circuits”, “Electronic circuits in electrical communication with electrodes detect the electrical property change. If a change in capacitance or resistance of the transducer is being measured for example, one applies electrical energy to electrodes included in the transducer and observes a change in the electrical parameters.” Column 21, Lines 30-50) configured to generate (via “sensor” – “Electroactive polymers of the present invention may also be configured as a sensor … [to] detect a "parameter" and/or changes in the parameter.” Column 21, Lines 20-35), based on a measured change in at least one electrical characteristic (“strain … conductivity, magnetization, dielectric constant” Column 21, Lines 20-35; also see: “change in electrical energy or a change in the electrical impedance … capacitance change of the polymer, a resistance change of the polymer, and/or resistance change of the electrodes, or a combination thereof.” Column 21, Lines 30-50) associated with the electro active polymer (12), a value for at least one parameter (changes in shape/size/position resulting in change in flow profile of gas through the respiratory assistance component – “As polymer 12 changes in size” Column 20, Lines 10-25) of the respiratory assistance provided to the patient.
The resultant effect of utilizing the electro active polymer of the modified Dantanarayana to further act as a sensor, as taught by Pei provides the ability to impart the desired “stiffness and/or damping control” (Column 22, Lines 20-40) thereby modulating the operational parameters of the respiratory assistance provided by the respiratory assistance component to the patient.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the respiratory assistance component – in the form of a valve – of Dantanarayana to be formed from an electro active polymer responsive to electrical current stimulus, as taught by Jones to provide operational control of the valve as desired, and further to modify the modified Dantanarayana to operate with the electro active polymer as a sensor is the ability to impart the desired “stiffness and/or damping control” as taught by Pei to modulate the operational parameters of the respiratory assistance provided by the respiratory assistance component to the patient.
As to Claim 13, the modified Dantanarayana, specifically Dantanarayana discloses the anti-asphyxia valve (10) having one or more openings (20, best seen Figure 1, “Movable portion 12 has an outer perimeter 18, which, in the embodiment shown, is substantially circular. Fixed portion 14 includes an orifice 20, which, in the embodiment shown, is also substantially circular and which is slightly larger in diameter than the diameter of the outer perimeter 18 to provide a gap 22 therebetween when the movable portion is in a fully pressurized position.” Para 0070; ALTERNATIVELY, 24/26, best seen Figure 1, “one or more bleed orifices 24 and/or 26 can be provided in the movable and fixed portions, respectively.” Para 0077; also see: “Movable portion 12 can optionally include one or more bleed orifices 24 and fixed portion 14 can optionally include one or more bleed orifices 26.” Para 0070).
As to Claim 14, the modified Dantanarayana, specifically Dantanarayana discloses the flap (12, “Movable portion 12” Para 0070) is configured to close off the one or more openings (20) based on the electro active polymer of the flap portion being charged.
As to Claim 15, the modified Dantanarayana, specifically Dantanarayana discloses the one or more openings (20) includes a plurality of openings (24/26, best seen Figure 1, “one or more bleed orifices 24 and/or 26 can be provided in the movable and fixed portions, respectively.” Para 0077; also see: “Movable portion 12 can optionally include one or more bleed orifices 24 and fixed portion 14 can optionally include one or more bleed orifices 26.” Para 0070). ALTERNATIVELY, the modified Dantanarayana, specifically Dantanarayana discloses the one or more openings (24/26, best seen Figure 1, “one or more bleed orifices 24 and/or 26 can be provided in the movable and fixed portions, respectively.” Para 0077) includes a plurality of openings (“Movable portion 12 can optionally include one or more bleed orifices 24 and fixed portion 14 can optionally include one or more bleed orifices 26.” Para 0070).
As to Claim 18, the modified Dantanarayana, specifically Jones teaches the flap (82/92) comprises a constraining layer (“Various types of electrodes suitable for use with the present disclosure include structured electrodes comprising metal traces and charge distribution layers” Para 0069) attached to the polymer layer (“As electroactive polymers may deflect at high strains, electrodes attached to the polymers should also deflect without compromising mechanical or electrical performance.” Para 0069) so that when the polymer layer is energized, at least one dimension at one side of the polymer layer is constrained (“The electrodes may be only applied to a portion of an electroactive polymer and define an active area according to their geometry.” Para 0069), causing the flap to bend in a direction of the side that is constrained.
Regarding the bending action about the constrained layer, as the modified Dantanarayana, specifically Jones teaches portions of the electroactive polymer having the electrodes attached thereto, wherein the electrodes the vehicle for the stimulus to result in the activation of the electroactive polymer to a specific change in shape as a function of the application of the stimulus, the resultant effect is the configuration whereby the flap will bend in relation to the direction of the stimulus.
Yet, the modified Dantanarayana does not expressly disclose the specific orientation of “a polymer layer between at least two electrodes”.
In light of the teachings of the modified Dantanarayana, the specific orientation of “between” is obvious to try choosing from a finite number of identified, predictable solutions with a reasonable expectation of success, whereby success would be defined by the ability of the polymer layer to bend in response to the electrodes as attached via the constraining layer to the desired geometry.
Applicant has not asserted the specific orientation of “between” provides a particular advantage, solves a stated problem, or serves a particular purpose different from that of forming a flap portion that is able to undergo bending movement in response to a stimulus applied; thus, the use of the specific construction of “between” appears to lack criticality in its design. Consequently, one of ordinary skill in the art would have expected Applicant’s invention to perform equally well with the modified Dantanarayana, as the construction would yield the predictable results of the ability of the flap to bend to the desired geometry.
Therefore, it would have been obvious to one having ordinary skill in the art to modify the specific orientation of the polymer layer to be positioned between at least two electrodes, a known result effective variable in order to control the bending action of the flap to the desired geometry.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot.
Although Primary Examiner appreciates Applicant’s amendment to further develop the concept whereby the “the electro active polymer is configured to sense at least one parameter associated with providing the respiratory assistance to the patient based on a measured change in at least one electrical characteristic associated with the electro active polymer” as incorporated into the independent claims, Claims 1 and 10, this limitation does not overcome the new grounds of rejection Dantanarayana et al. (2004/0094157) in view of Jones et al. (2005/0199845) and Pei et al. (6,891,317), whereby Pei teaches the newly added features.
Explicitly, Pei teaches components constructed of “Electroactive polymers have many functional uses. In addition to actuation, active areas of the present invention may also be used for generation and production of electrical energy, sensing, stiffness control, or damping control.” (Column 19, Lines 35-45). In this operation, “As polymer 12 changes in size, the changing electrical properties and voltage may be detected, dissipated, and/or used.” (Column 20, Lines 10-25), whereby the “Electroactive polymers of the present invention may also be configured as a sensor … [to] detect a "parameter" and/or changes in the parameter. The parameter is usually a physical property of an object such as its temperature, density, strain, deformation, velocity, location, contact, acceleration, vibration, volume, pressure, mass, opacity, concentration, chemical state, conductivity, magnetization, dielectric constant, size, etc.” (Column 21, Lines 20-35).
Further, Pei teaches when the “electroactive polymer sensor is configured such that a portion of the electroactive polymer deflects in response to the change in a parameter being sensed. The electrical energy state and deflection state of the polymer are related. The change in electrical energy or a change in the electrical impedance of an active area resulting from the deflection may then be detected by sensing electronics in electrical communication with the active area electrodes. This change may comprise a capacitance change of the polymer, a resistance change of the polymer, and/or resistance change of the electrodes, or a combination thereof. Electronic circuits in electrical communication with electrodes detect the electrical property change. If a change in capacitance or resistance of the transducer is being measured for example, one applies electrical energy to electrodes included in the transducer and observes a change in the electrical parameters.” (Column 21, Lines 30-50). In this configuration, “a logic device in electrical communication with sensing electronics of sensor quantifies the electrical change to provide a digital or other measure of the changing parameter being sensed.” (Column 21, Lines 50-70), and the “Sensing electronics may then detect and measure the high frequency response of the polymer to allow sensor performance that does not interfere with polymer actuation. Similarly, if impedance changes are detected and measured while the electroactive polymer transducer is being used as a generator, a small, high-frequency AC signal may be superimposed on the lower-frequency generation voltage signal.” (Column 22, Lines 1-25).
Hence, returning to the claim limitations, Pei teaches the electro active polymer is configured to sense (“Electroactive polymers of the present invention may also be configured as a sensor … [to] detect a "parameter" and/or changes in the parameter.” Column 21, Lines 20-35) at least one parameter (changes in size and/or shape resulting in change in flow profile of gas through the respiratory assistance component – “As polymer 12 changes in size” Column 20, Lines 10-25) associated with providing the respiratory assistance to the patient based on a measured change in at least one electrical characteristic (“strain … conductivity, magnetization, dielectric constant” Column 21, Lines 20-35; also see: “change in electrical energy or a change in the electrical impedance … capacitance change of the polymer, a resistance change of the polymer, and/or resistance change of the electrodes, or a combination thereof.” Column 21, Lines 30-50) associated with the electro active polymer (12).
The resultant effect of utilizing the electro active polymer of the modified Dantanarayana to further act as a sensor, as taught by Pei provides the ability to impart the desired “stiffness and/or damping control” (Column 22, Lines 20-40) thereby modulating the operational parameters of the respiratory assistance provided by the respiratory assistance component to the patient.
In light of the aforementioned reasoning, the non-final rejection of the claims has been maintained and made FINAL.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNETTE F DIXON whose telephone number is (571)272-3392. The examiner can normally be reached M-F 9-5 EST with flexible hours.
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ANNETTE FREDRICKA DIXON
Primary Examiner
Art Unit 3782
/Annette Dixon/Primary Examiner, Art Unit 3785
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