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 .
Information Disclosure Statement
The information disclosure statement (IDS) dated August 17, 2026, has been received and fully considered by the Examiner.
Response to Arguments
The following section is in reference to the Applicant’s Arguments, filed July 30, 2026:
The Applicant’s arguments regarding the objection to Claim 8 have been fully considered and are persuasive. The objection have been withdrawn in light of the amended claim language.
The Applicant's arguments regarding the 35 U.S.C. 103 rejection of independent Claim 1 have been fully considered but they are not persuasive. The rejection, as presented in the previous Office Action, is maintained, as are all subsequent rejections of the dependent Claims.
The following section is in reference to Claim 1:
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Zwolinksy discloses various possible placements for a plurality of pressure sensors in a blower/filtration unit (Paragraphs 0073-0074, It will, of course, be recognized that the pressure differential sensor may be used in other parts of the system, for example either side of the filter, in the fan assembly or in the headtop. Two completely separate pressure sensors could also be used instead of a single pressure differential sensor. The pressure sensors of the described system could also be used to provide a breath responsive PAPR unit).
Though Zwolinksy does not explicitly use the terms “inlet” or “outlet”, it can be argued that “either side of the filter” or “in the fan assembly” could be interpreted as various possible inlets and outlets within the overall system.
Nevertheless, prior claim rejection utilized a combination of Zwolinksy and Fabian to teach the claim limitations. Fabian describes the first and second pressure sensors placement as being preferably positioned to the “outside of the inlet filter and inlet fan” and “the inside of the inlet filter and inlet fan”, respectively, or additionally “in the enclosed space” of the mask body. This is depicted in Figure 9, in which:
sensor P1 is positioned by the inlet filter 909 that is “held external to the fan box 911, 912” (Paragraph 0214),
sensor P2 is positioned by the inlet fan 910 and fan box 912
sensor P3 is positioned in the enclosed space 095, near outlet valve 916 (Paragraph 0212)
Currently, the present claim language states that the first and second sensors are “positioned at” an inlet and outlet, respectively. This phraseology can be understood broadly, as “presence or occurrence in, on, or near”, as per the Merriam-Webster dictionary. The Applicant does not identify a specific outlet in the structure of the blower/filtration unit, and thus, any elements external to an inlet or near an outlet could be interpreted as being “positioned at” the claimed location. Based on this definition, both Zwolinksy and Fabian encompass the limitations of the 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). Amending the claim to more explicitly define the arrangement and positioning of the sensors would help to overcome the prior art of record. For example, defining the outlet and inlet locations in relation to the blower/filtration unit housing as disclosed in the Specification (Page 5, lines 29-32), (Page 6, lines 5-8) would narrow possible interpretations of the claim.
In response to applicant's argument that Fabian does not disclose the claimed control relationship, and that determining filter resistance is not equivalent to determining motor speed, 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.
Fabian discloses a control system for determining and varying the motor speed/power input of the fan based on pressure sensor data:
Paragraph 0248, “the fan as a dynamic sensor allows sensing and control to take place through the variable of the fan motion (speed and acceleration, deceleration or holding of a particular speed can all be varied and sensed). The value of the fan power input can be raised or decreased based on a predetermined pattern or information from the pressure sensors or other information such as user input, or data or instructions from external sources. The fan can be used to sense flow, but also be actively driven to change what is being sensed”
Paragraph 0165, “Fans assisting inhaled or exhaled air can overcome the pressure drop of a filter. Control systems implemented in the microcontroller can be used to control the fan(s) to eliminate constant positive pressure and increase comfort”
Fabian also discloses controlling the fan to maintain an airflow rate based on the pressure sensor data:
Paragraph 0042, Preferably the controller is configured to control one or more of: […] the inlet fan such that sufficient pressure is generated to cause airflow into the enclosed space such that pressure acting outwards from the enclosed space causes the outlet valve to open or to remain open; a power level of the inlet fan”
Paragraph 0274, “In general, there may be three levels of control. At a local control level, the controller within the mask may receive data from the sensors and control the fans and valves in accordance with stored control data or parameters and the sensed data”
Regardless of whether the pressure sensors may be used to determine filter resistance, they are also capable of being used to influence motor controls. However, if the Applicant is not convinced that Fabian fully encompasses the limitation regarding the motor control algorithm, Zwolinksy also does discloses a close loop system for controlling motor speed and maintaining an air flow rate based on sensor data (Paragraph 0016, Advantageously, a closed loop system is used to alter the motor speed based on the flow rate measurement to adjust the flow rate to reach or maintain the target value), (Paragraph 0070, A motor drive and speed control 4 is also provided as the closed loop part of the system that controls the motor speed to reach or maintain a targeted air flow).
As stated above, the rejections of the claims are based on the combination of references. 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).
In this case, both Zwolinksy and Fabian disclose wearable respiratory filtration systems that incorporate controllers that are communicatively coupled to fan/motor and sensor elements. Both references teach adjusting the power and speed of the fan/motor in relation to detected sensor signals. Fabian also discloses use of pressure differential measurements (Paragraph 0248, the load on one or more fans (which may be determined by measurement of electrical impedance or another suitable electrical characteristic of the fan) allows flow characterization to be achieved by analysis of pressure differentials). Incorporating an alternative pressure sensor arrangement would not impede the functionality of Zwolinksy, who already teaches various viable sensor placements, nor would it negate the control or closed loop systems taught by the combination of references.
The following section is in reference to Claims 3 and 6:
In response to Applicant's argument regarding Claim 3 that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., placement of the temperature sensor and how it is functionally integrated) 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.
Fabian also describes the temperature sensor and its arrangement throughout the reference, not merely as a “generalized listing” as argued by the Applicant, but as an integrated feature within the device:
Claim 78, “A self-contained respiratory mask as claimed in claim 77, wherein the physiological sensors comprise one or more of: temperature sensors; a body temperature sensor; an air temperature sensor positioned to sense temperature of exhaled air; an air pressure sensor”
Paragraph 0131, “The receiver/holder of the heart rate and temperature sensor components is built into the back side connector edges of the mask back part. The micro controller and removable battery are built into the back edge of the back frame in the preferred embodiment. The wiring to connect to the front of the mask and the side sensors are built into the frame of the mask connector and connected between the front and back frame by connector elements”
Paragraph 0132, “The temperature sensor 422 can be positioned to measure the temperature of air being inhaled or exhaled”
Paragraph 0128, “The physiological sensors 410 can include, for example, a skin or body temperature sensor 412”
Amending the claim to more explicitly define the arrangement and positioning of the temperature sensor would help to overcome the prior art of record. For example, defining the location in relation to the blower helmet as disclosed in the Specification (Page 9, lines 6-9) would narrow possible interpretations of the claim.
In response to the Applicant’s argument regarding the combination of Zwolinksy and Fabian, it is well-known in the art of powered respiratory devices to incorporate physiological sensors to monitor user breathing parameters and device functionality. Incorporating the sensor parameters and control features taught by Fabian into the motor control algorithm disclosed by Zwolinksy would provide an art-recognized means for additional measurement and assessment of flow rate in the overall system.
In response to applicant's argument regarding Fabian not disclosing a communication component capable of sending and receiving signals in the rejection of Claim 6, 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. Fabian discloses transmitting stored data to a device through one or more communication modules (Paragraph 0082), said stored data being gathered by the physiological sensors (Paragraph 0081). Figure 4 demonstrates the various bidirectional communications between the sensors, control unit, user input, and the different communication modules (Paragraph 0136, The communications modules 460 can include one or more of: a Bluetooth module 462, a WiFi module 464, an optical (e.g. wireless infrared or fiber optic) transceiver module 466, and an electrical communications module 468). Fabian also teaches the control unit being “configured to receive signals from the sensors and user input modules in digital and/or analog format. The data processing module 480 can be configured to process the received signals to produce data in a format that can be stored and transmitted”, (Paragraph 0274).
Based on these described structures, the device electronic system of Fabian is capable of receiving, storing, and transmitting signals to a second device.
In response to the Applicant’s argument regarding the combination of Zwolinksy and Fabian, it is well-known in the art of powered respiratory devices to incorporate communication and control elements for receiving and/or sending signals between electronic components. Both Zwolinksy and Fabian disclose wearable respiratory filtration systems that incorporate controllers that are communicatively coupled to fan/motor and sensor elements. Both references also teach adjusting the power and speed of the fan/motor in relation to received sensor signals, and data storage features within the system (Zwolinksy, Paragraphs 0023-0026, 0070).
The following section is in reference to Claims 4, 11, and 15:
In response to the Applicant’s argument that Shissler only provides a “general discussion of correcting motor speed based on air density”, it is noted that the claim language itself is also broad and open-ended. Shissler clearly discloses multiple different equations for measuring and calculating air density compensation in relation to variables of pressure, temperature, density, etc… (Paragraph 0031, In order to determine the density correction factor according to one of the relationships expressed in equations (2) or (3), the processor module 32 first calculates either a measured absolute pressure (Eqn. 2) or a measured air density (Eqn. 3)), (Paragraph 0034, This enables processor module 32 to implement equation (5) to determine the current atmospheric pressure from the measurements of pressure sensor 21, tachometer 48, and a temperature sensor (or with an assumed temperature if patient treatment system 10 does not include a temperature sensor)).
The arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The following section is in reference to Claims 8 and 9:
In response to the Applicant’s argument that Bilger does not disclose “a second device providing a motor control value for correction”, it is noted that the Fabian does disclose a second device, as stated in the rejection of Claim 6. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. Furthermore, claim language itself is fairly broad, and Bilger does disclose using a base or “motor control” value to make adjustments and corrections to the motor speed (Paragraph 0053, The software uses the pressure reading (Pr) to normalize the RPM [Rotation per Minute] setting. The base setting and step change for each reading were empirically derived and tested in an altitude chamber. In one embodiment, the adjusted setting for motor rate for a particular respiratory inlet covering/filter system configuration took the following form: Adjusted Setting=Base+(Full scale reading-Pr)*(Step Change))
The arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
The following section is in reference to Claim 12:
In response to the Applicant’s argument that Bilger does not teach the claimed arrangement of the motor speed detector as described in Claim 12, it is noted that Bilger does disclose all of the limitations of the claim language (Paragraphs 0065-0070). The arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. If the Applicant intended a narrower interpretation of the claim, amending the language to incorporate limitations from the Specification could help overcome the prior art of record.
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, 3, and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Zwolinksy (US 20180221691 A1) in view of Fabian (US 20180078798 A1).
Regarding Claim 1, Zwolinksy discloses: A blower/filtration unit for a powered air purifying respirator (PAPR) (Paragraph 0068, Referring first to FIG. 1, there is shown a Powered Air Purified Respirator (hereinafter PAPR) 7, of a type generally known in which filter(s) 10 are fixed to the PAPR 7 so as to filter air as it is drawn into the PAPR), (Paragraph 0077, Each filter, as shown in FIG. 5a attached to a blower unit, is removably connectable to a port of the blower unit in order to easily enable filters to be replaced, either due to operational like having expired or because different filter characteristics are required) comprising:
a motor (Paragraph 0068, The PAPR contains a motor 6 that drives an impellor in a volute 2 so as to suck air into the unit and deliver to a headtop/mask 9 via a delivery tube or hose 8) configured to operate according to a motor control algorithm (Paragraph 0016, Advantageously, a closed loop system is used to alter the motor speed based on the flow rate measurement to adjust the flow rate to reach or maintain the target value);
and a motor controller that executes the motor control algorithm (Paragraph 0070, A motor drive and speed control 4 is also provided as the closed loop part of the system that controls the motor speed to reach or maintain a targeted air flow),
wherein the motor control algorithm determines a motor speed required to maintain an airflow rate based on signals (Paragraph 0003, the air delivery control system can use a closed loop flow measurement system maintain a given flow rate to the user irrespective of changes in conditions such as changes in the filter resistance or resistance of different headtop's or mask's worn by the user; changes in ambient ar pressure resulting from, for example, variations in altitude and the like. Similarly, an active system can use the closed loop flow rate control to automatically compensate for the effects of breathing that constantly vary the load on the breathing air delivery fan assembly).
Zwolinksy discloses multiple pressure sensors (Figure 6, Paragraph 0069, a high pressure sensing point 1a and a low-pressure sensing point 1b, that connect to a pressure differential sensor which sends a signal to a signal conditioning block 3. The pressure differential sensor may be composed of two pressure sensors 1c, 1b whose readings are then used to obtain a pressure difference) positioned at various locations along the system (Paragraph 0073, It will, of course, be recognized that the pressure differential sensor may be used in other parts of the system, for example either side of the filter, in the fan assembly or in the headtop. Two completely separate pressure sensors could also be used instead of a single pressure differential sensor). However, Zwolinksy does not explicitly disclose positioning the sensors at the inlet and outlet of the unit.
Fabian does disclose:
a first pressure sensor positioned at an inlet of the blower/filtration unit; a second pressure sensor positioned at an outlet of the blower/filtration unit (Paragraph 0061, For any of the above aspects, preferably the one or more sensors include one or more pressure sensors. For any of the above aspects, preferably the pressure sensors include a first sensor positioned to the outside of the inlet filter and inlet fan and a second sensor positioned to the inside of the inlet filter and inlet fan. For any of the above aspects, preferably the pressure sensors include a pressure sensor in the enclosed space).
and wherein the motor control algorithm determines a motor speed (Paragraphs 0023-0024, The controller may be configured to control the inlet fan such that sufficient pressure is generated to cause airflow into the enclosed space such that pressure acting outwards from the enclosed space causes the outlet valve to open or to remain open. Preferably the controller is configured to control one or more of: a power level of the inlet fan, and a power level applied to the closure of the outlet valve) required to maintain an airflow rate based on signals from the first and second pressure sensors (Paragraph 0031, Preferably the controller is configured to […] receive sensed parameters from the one or more sensors; control the controllable inlet blower and/or the controllable outlet valve in accordance with the updated local control data and sensed parameters received from the one or more sensors).
It would have been obvious to one skilled in the art before the effective filing date to position the sensors taught by Zwolinksy at the inlet and outlet of the blower/filtration unit in order to determine the pressure differential across the unit, as taught by Fabian (Paragraph 0221, data from the mask sensors can be used to monitor filter condition. The sensors provide information on the filter resistance to airflow. For example, sensors positioned outside and inside the filter provide a pressure difference across the filter. Together with information on the fan power or flow rate, this allows a resistance of the filter to be determined. This resistance can be monitored over time). Moreover, incorporating the sensor parameters and control features taught by Fabian into the motor control algorithm disclosed by Zwolinksy would provide an art-recognized means for additional measurement and assessment of flow rate in the overall system.
Regarding Claim 3, Zwolinksy in view of Fabian discloses all of the limitations of Claim 1. Fabian further discloses: a temperature sensor (Paragraph 0068, For any of the above aspects, the respiratory mask may include one or more physiological sensors. Preferably the physiological sensors comprise one or more of: temperature sensors; a body temperature sensor; an air temperature sensor positioned to sense temperature of exhaled air; an air pressure sensor)
Regarding Claim 6, Zwolinksy in view of Fabian discloses all of the limitations of Claim 1. Fabian further discloses: further comprising a communication component capable of sending and receiving sensor signals to a second device (Paragraph 0082, Preferably the device electronic system is configured to transmit the stored data to a user host device through one or more of the communications modules), (Paragraph 0274, At a secondary control level, the app may be used to control mask functions over a wireless link. User input may be received by the app. The app may issue control instructions and/or instructions to alter or update control data or parameters to the on-board controller. At a third control level, the remote computer may issue instructions to the app or directly to the mask. These may be control instructions and/or instructions to alter or update control data or parameters. When the app receives instructions from the remote computer it will issue its own instructions to the on-board controller).
Claims 4, 11, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Zwolinksy (US 20180221691 A1) in view of Fabian (US 20180078798 A1), further in view of Shissler (US 20060283450 A1).
Regarding Claim 4, Zwolinksy in view of Fabian discloses all of the limitations of Claim 3. Fabian discloses air density and temperature affecting the maximum flow rate (Paragraph 0269, The specific maximum flow rate is dependent on filter cleanliness, breathing capacity of the user, air density and temperature, speed of travel of the user, humidity, state of precipitation and accuracy of seal fit/continuity. However, for practical applications the maximum flow rate is expected to be in the range 50 litres per minute to 400 litres per minute. The fans may produce a flow rate of 0.4 m/s each), but does not disclose correcting a calculated motor speed based on an air density compensation.
Shissler does disclose: wherein the motor control algorithm corrects a calculated motor speed based on an air density compensation (Paragraph 0035, Monitoring the volumetric flow rate of the breathable gas enables the processing module to determine the total volume of breathable gas delivered by gas delivery system 12, and adjust the operation of pressure generator 14 and/or control valve 20 based on the specific parameters of the breathable gas and the ambient conditions. For example, processing module 32 may reduce the speed of motor 44 based on a determination of an elevated atmospheric pressure (or an elevated air density). Reducing the speed of motor 44 reduces the noise created by gas delivery system 12 and reduces the power used by gas delivery system 12, and reduces wear and tear on various components of blower 38 (e.g., impeller 40, motor 44, and drive shaft 46), among other things),
and wherein the air density compensation is calculated in part based on a temperature sensor signal (Paragraph 0030, The density correction factor is a function of the ambient conditions surrounding and within gas delivery system 12 such as ambient pressure, ambient temperature, and/or ambient air density) from the temperature sensor (Paragraph 0034, This enables processor module 32 to implement equation (5) to determine the current atmospheric pressure from the measurements of pressure sensor 21, tachometer 48, and a temperature sensor).
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of air density compensation as disclosed by Shissler with the system and control algorithms disclosed by Zwolinksy in view of Fabian, so as to provide an additional variable to better monitor air delivery to a patient. Accounting for changes in air density also serves to minimize unnecessary wear on the blower/filtration unit (Shissler, Paragraph 0035, Reducing the speed of motor 44 reduces the noise created by gas delivery system 12 and reduces the power used by gas delivery system 12, and reduces wear and tear on various components of blower 38 (e.g., impeller 40, motor 44, and drive shaft 46), among other things).
Regarding Claim 11, Zwolinksy in view of Fabian discloses all of the limitations of Claim 1. Zwolinksy discloses the controller further comprises a memory (Paragraph 0024, Each electronic storage means may be a wired storage medium which requires a direct connection with the reader for the reader to read data therefrom or may be a wireless medium such as an RFID chip. Each electronic storage means may store a simple ID tag which links to data stored in a central database or may store the full set of data relative to the component or user with which it is associated. In that case, the electronic storage means preferably has a write capability by means of which the controller is able to write information back to the storage means to enable an update of the data relating to the device with which it is associated. For example, the storage means may take the form of or at least include a flash memory device).
Zwolinksy does not disclose a motor speed detector, but would have been obvious to incorporate one into the system, as Zwolinksy and Fabian both describe adjusting the motor speed based on specific parameters.
Shissler explicitly discloses: a motor speed detector (Paragraph 0027, The operating speed of motor 44 is measured by a tachometer 48 that is in operative communication with processor module 32. U.S. Pat. No. 6,622,724 to Truitt et al., the contents of which are incorporated herein by reference, describes with greater particularity a blower and impeller that may be implemented as blower 38 and impeller 40, in one embodiment of the invention) and the controller further comprises a memory for storing motor speed data (Paragraph 0025, the processor module 32 optionally includes a memory 36 associated with gas delivery system 12 that stores the programming necessary to perform any of a plurality of modes of ventilation, depending on which mode of ventilation is selected by the caregiver or patient using control interface 34. Memory 36 is also capable of storing data regarding the operation of the patient treatment system 10, input commands, alarm thresholds, as well as any other information pertinent to the operation of the patient treatment system, such as measured values of patient flow, volume, pressure, device usage, operating temperatures, and motor speed)
It would have been obvious to one skilled in the art before the effective filing date to incorporate the motor speed detector as disclosed by Shissler with the system and control algorithms disclosed by Zwolinksy in view of Fabian, so as to provide an additional variable to better monitor air delivery to a patient (Shissler, Paragraph 0035, Reducing the speed of motor 44 reduces the noise created by gas delivery system 12 and reduces the power used by gas delivery system 12, and reduces wear and tear on various components of blower 38 (e.g., impeller 40, motor 44, and drive shaft 46), among other things).
Regarding Claim 15, Zwolinksy in view of Fabian discloses all of the limitations of Claim 1. Fabian discloses air density and temperature affecting the maximum flow rate (Paragraph 0269, The specific maximum flow rate is dependent on filter cleanliness, breathing capacity of the user, air density and temperature, speed of travel of the user, humidity, state of precipitation and accuracy of seal fit/continuity. However, for practical applications the maximum flow rate is expected to be in the range 50 litres per minute to 400 litres per minute. The fans may produce a flow rate of 0.4 m/s each), but does not disclose correcting a calculated motor speed based on an air density compensation.
Shissler does disclose: the motor control algorithm corrects a calculated motor speed based on air density compensation (Paragraph 0035, processing module 32 may reduce the speed of motor 44 based on a determination of an elevated atmospheric pressure (or an elevated air density). Reducing the speed of motor 44 reduces the noise created by gas delivery system 12 and reduces the power used by gas delivery system 12, and reduces wear and tear on various components of blower 38 (e.g., impeller 40, motor 44, and drive shaft 46), among other things), (Paragraph 0040, the measured atmospheric pressure, the atmospheric air density, and/or the density correction factor can be used by the processor 32 in a feedback loop to control various aspects of the patient treatment system 10. For example, the processor 32 can be used to control operation (e.g., speed and output) of the pressure generator 14)
and wherein the air density compensation is calculated (Paragraphs 0030-0031, The density correction factor is a function of the ambient conditions surrounding and within gas delivery system 12 such as ambient pressure, ambient temperature, and/or ambient air density. In order to determine the density correction factor according to one of the relationships expressed in equations (2) or (3), the processor module 32 first calculates either a measured absolute pressure (Eqn. 2) or a measured air density (Eqn. 3)) in part based on pressure measured by the first, second or other pressure sensors (Paragraph 0034, This enables processor module 32 to implement equation (5) to determine the current atmospheric pressure from the measurements of pressure sensor 21, tachometer 48, and a temperature sensor)
It would have been obvious to one skilled in the art before the effective filing date to incorporate the teachings of air density compensation as disclosed by Shissler with the system and control algorithms disclosed by Zwolinksy in view of Fabian, so as to provide an additional variable to better monitor air delivery to a patient. Accounting for changes in air density also serves to minimize unnecessary wear on the blower/filtration unit (Shissler, Paragraph 0035, Reducing the speed of motor 44 reduces the noise created by gas delivery system 12 and reduces the power used by gas delivery system 12, and reduces wear and tear on various components of blower 38 (e.g., impeller 40, motor 44, and drive shaft 46), among other things).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Zwolinksy (US 20180221691 A1) in view of Fabian (US 20180078798 A1), further in view of Bilger (US 20090266361 A1).
Regarding Claim 8, Zwolinksy in view of Fabian discloses all of the limitations of Claim 6. Zwolinksy discloses motor control means (Paragraph 0070, A motor drive and speed control 4 is also provided as the closed loop part of the system that controls the motor speed to reach or maintain a targeted air flow), but does not explicitly disclose a motor control value for correction.
Bilger does disclose: wherein the second device provides a motor control value for a correction to the motor control function (Figure 10A, Paragraph 0053, The software uses the pressure reading (Pr) to normalize the RPM [Rotation per Minute] setting. The base setting and step change for each reading were empirically derived and tested in an altitude chamber. In one embodiment, the adjusted setting for motor rate for a particular respiratory inlet covering/filter system configuration took the following form: Adjusted Setting=Base+(Full scale reading-Pr)*(Step Change)).
It would have been obvious to one skilled in the art before the effective filing date to modify the control algorithm disclosed by Zwolinksy in view of Fabian to incorporate an empirically derived and tested function to provide step-wise adjustments in motor speed as taught by Bilger.
Regarding Claim 9, Zwolinksy in view Fabian and Bilger discloses all of the limitations of Claim 8. Bilger further discloses: and wherein the motor control value is a location of the blower/filtration unit, an ambient temperature, an ambient pressure, or a humidity (Paragraph 0054, The upper and lower alarm limits from motor RPM were also adjusted according to the measured air pressure by a corresponding amount. The upper and lower alarm limits (for example, .+-.50) thus floated with the RPM set point. In several embodiments, the upper and lower alarm limits change but the span or difference between the limits remained the same. The above methodology assisted in ensuring that the mass flow of air within system 10 was generally the same at any altitude from 500 feet below sea level to, for example, 10,000 ft. Compensation for a wider range of altitudes/ambient pressures can be made with use of a suitable pressure sensor).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Zwolinksy (US 20180221691 A1) in view of Fabian (US 20180078798 A1), in view of Shissler (US 20060283450 A1), further in view of Bilger (US 20090266361 A1)
Regarding Claim 12, Zwolinksy in view of Fabian and Shissler discloses all of the limitations of Claim 11. Shissler discloses: wherein the motor speed detector detects the motor speed (Paragraph 0027, The operating speed of motor 44 is measured by a tachometer 48 that is in operative communication with processor module 32. U.S. Pat. No. 6,622,724 to Truitt et al., the contents of which are incorporated herein by reference, describes with greater particularity a blower and impeller that may be implemented as blower 38 and impeller 40, in one embodiment of the invention) and storing motor speed (Paragraph 0025, Memory 36 is also capable of storing data regarding the operation of the patient treatment system 10, input commands, alarm thresholds, as well as any other information pertinent to the operation of the patient treatment system, such as measured values of patient flow, volume, pressure, device usage, operating temperatures, and motor speed), but does not explicitly disclose detection at a predetermined time interval
Bilger does disclose: wherein the motor speed detector detects the motor speed at a predetermined time interval (Paragraph 0065, If after a certain period of time (for example, thirty seconds), the target RPM value of motor 140 is not within the limits calculated at calibration, a flow alarm can be generated) to generate a reference motor speed that is stored by the controller to create a stored reference motor speed (Paragraph 0068, After the motor stabilization period, the software compared the measured RPM reading to the set point target value. If adjustment was needed, the PWM [Pulse Width Modulation] was incremented or decremented. This process was repeated after the second, third and fourth minute of operation. The software stored the final PWM value into memory. If, for example, the actual RPM value rose above the set point value plus the alarm band (for example, +50) as described above, a flow alarm was generate), wherein the stored reference motor speed is replaced each time the motor speed is detected (Paragraph 0069, system 10 calibrated the motor speed to the actual flow resistance of the closed system each time motor 140 was started. At this point, the speed of motor 140 was set by motor controller 210)
It would have been obvious to one skilled in the art before the effective filing date to modify the motor control disclosed by Zwolinksy in view of Fabian and Shissler to incorporate a software that enables automatic recalibration and continuous assessment of motor speed to meet a target value that accommodates the specific needs of the user.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MISHAL HUSSAIN whose telephone number is (703)756-1206. The examiner can normally be reached M-F, 8:30am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy S. Lee can be reached at (571) 270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MISHAL HUSSAIN/
Examiner
Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights