DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is in response to the amendment filed on 10/06/2025. As directed by the amendment, claims 40-41 has been cancelled and claims 42-43 have been added. As such, claims 21-37, 39, and 42-43 are pending in the instant application.
Response to Arguments
Applicant's arguments filed 10/06/2025 have been fully considered but they are not persuasive. Applicant states that Bowman fails to show a direct coupling between a ventilator and a humidifier and that Bowman (merely) show that the base 404 (which contains the water reservoir 406, a part of the humidifier subsystem) can be separated from the body 402 (which contains inter alia, the ventilator and the humidifier (= heating element) 600, which also is a part of the humidifier subsystem). In contrast, applicant points to Fig. 1b of their drawings and states the humidifier 11 can be directly coupled to ventilator 1 and can be decoupled in one piece from the ventilator when the humidifier is not needed. The examiner respectfully disagrees. Bowman teaches a humidifier (humidifier 600 and base 404, see Fig. 12) comprising a heating element (CFV 602, see Fig. 12) and a water container (reservoir 406, see Fig. 12) and a ventilator (body 402, blower 430, fan 431 and motor 433, see Fig. 12). Bowman teaches the base 404 to be separable from the body 402 to provide access to the water reservoir 406 as seen in [0084] and teaches the separation of base 404 from the body 402 for the removal of humidifier 600 for maintenance as seen in [0087]. Furthermore, base 404 and body 402 comprises of a connection interface as seen on the top of base 404 and bottom of body 402 in Figs. 8-10. Not to mention, base 404 includes an opening 424 which allows placement for humidifier 600 as seen in Fig. 9 and [0087]. Therefore, base 404 is capable of housing humidifier 600 and is directly coupled to body 402 (of the ventilator).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The term “control unit” in claim 21 is taken to invoke 112(f). The specification, page 10, lines 8-11, cites “controller which, among other duties, can modulate or otherwise control a speed of the motor, for example in order to generate a variable flow rate at a constant pressure. In one embodiment, the controller can contain a microprocessor-based motor controller.” For examination purposes, as best understood, the “control unit” corresponds to a microprocessor.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 21-25, 28 and 36-41 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Bowman (US 20150165146 A1).
Regarding claim 21, Bowman teaches a ventilator system (PAP apparatus 400, see Fig. 12 and [0083]), wherein the ventilator system comprises (i) a ventilator (body 402, blower 430, fan 431 and motor 433, see Fig. 12) comprising a respiratory gas unit (blower assembly 430, see Fig. 12 and [0089]) as well as (ii) a humidifier (humidifier 600 and base 404, see Fig. 12) comprising a heating element (CFV 602, see Fig. 12) and a water container (reservoir 406, see Fig. 12) (“…the humidifier 600 may include a CFV 602 that vaporizes water 435 drawn from the reservoir 406 and emits the vapor into a humidification chamber 456 formed by the humidifier housing 446.” See [0096]) and being configured for direct coupling to the ventilator (body 402 is directly coupled to base 404 as seen in Figs. 7 and 12, wherein the body 402 contains the blower assembly 430 and the base 404 contains the reservoir of the humidifier as seen in Fig. 12. Furthermore, Bowman teaches the base 404 to be separable from the body 402 to provide access to the water reservoir 406 as seen in [0084] and teaches the separation of base 404 from the body 402 for the removal of humidifier 600 for maintenance as seen in [0087]. As such, the base 404 is removable and directly connected/coupled to body 402), the ventilator system further comprising:
- at least one sensor (temperature and humidity sensor 458, see Fig. 12 and [0096]) which detects one or more parameters of the respiratory gas (“The sensor 458 may provide a signal representative of the temperature and/or humidity level of ambient air at system startup. By providing the sensor 458 within the humidification chamber 456, the sensor may be used to monitor temperature and humidity during operation as well.” See [0096]),
- at least one control unit (PAP controller 437 and humidity controller 630, see Fig. 12 and [0099] and [0100]) for predefining a heating power of the heating element at least partially on the basis of the one or more parameters of the respiratory gas (Fig. 16 shows measuring parameters 636 to modulate power to humidifier to achieve target humidity level 642 and [0116]. Bowman further teaches the CFV to be modulated based on parameters such as intentional leak, unintentional leak and more as seen in [0081]), the one or more parameters of the respiratory gas being selected from one or more of: pressure of respiratory gas stream; volume of respiratory gas stream; intentional leakage; unintentional leakage; respiratory frequency; inspiratory tidal volume; expiratory volume; I:E ratio; start and end of inspiration; start and end of expiration; peak flow during inspiration; peak flow during expiration (“…the power interval start time (also referred to herein as a power interval delay time) and duration, as well as how electrical power to the CFV will be modulated, may be determined based on one or more of: a pressure of the pressurized gas; total hose flow (which may include flow attributable to each of: intentional leak; unintentional leak; and breath cycle flow); a breath rate of the user; inspiratory tidal volume; expiratory volume; I:E ratio; inspiratory and expiratory flow dynamics (e.g., shape and amplitude of the flow curves)…” see [0081]).
Regarding claim 22, Bowman teaches the ventilator system of claim 21, and further teaches wherein the one or more parameters of the respiratory gas comprise an intentional leakage (“…as well as how electrical power to the CFV will be modulated, may be determined based on one or more of: a pressure of the pressurized gas; total hose flow (which may include flow attributable to each of: intentional leak; unintentional leak; and breath cycle flow) …” see [0081] and Figs. 18-19).
Regarding claim 23, Bowman teaches the ventilator system of claim 21, and further teaches wherein the one or more parameters of the respiratory gas comprise an unintentional leakage (“…as well as how electrical power to the CFV will be modulated, may be determined based on one or more of: a pressure of the pressurized gas; total hose flow (which may include flow attributable to each of: intentional leak; unintentional leak; and breath cycle flow) …” see [0081] and Figs. 18-19).
Regarding claim 24, Bowman teaches the ventilator system of claim 21, and further teaches wherein the control unit determines a leakage flow of the respiratory gas and controls the heating power of the humidifier according to the leakage flow of the respiratory gas, the leakage flow being an intentional leakage flow and/or an unintentional leakage flow (“…as well as how electrical power to the CFV will be modulated, may be determined based on one or more of: a pressure of the pressurized gas; total hose flow (which may include flow attributable to each of: intentional leak; unintentional leak; and breath cycle flow) …” see [0081] and Figs. 18-19; the electrical power to the CFV will be determined on parameters such as intentional leak and unintentional leak as seen in [0081] and the controller computes simulations including parameters such as intentional leak and unintentional leak as seen in [0169] and [0172]-[0173] and Fig. 22A).
Regarding claim 25, Bowman teaches the ventilator system of claim 21, and further teaches wherein the heating power of the humidifier is controlled on the basis of an average overall flow in such a way that a drying out of mucous membranes of a patient is reduced in the event of high leakage and at the same time a situation where water droplets condense out in a breathing hose in the event of low leakage is prevented (“…humidification of the flow of pressurized gas (to produce a flow of pressurized gas with added humidity) may be precisely controlled during individual breath cycles to ensure a constant (or near constant) level of humidity is provided to the user during inspiration (over the entire treatment period), even when parameters such as breath rate, breath flow, leak magnitude (intentional or unintentional), tidal volume, and/or pressure changes.” See [0065]; it is the examiner’s position the PAP apparatus 400 taught by Bowman will reduce drying out of the mucous membranes of a patient in event of high leakage and prevent water droplets in the event of low leakage by calculating the humidification parameters after the flow parameters which include leak magnitude (see [0135] and Fig. 18 and 19).
Regarding claim 28, Bowman teaches the ventilator system of claim 21, and further teaches wherein the humidifier, upon connection to the ventilator, is coupled to electronics of the ventilator and is controlled via the ventilator (PCB 434 contains PAP controller 437 and humidification controller 630 as seen in [0090] in which the PAP controller 437 and humidity controller 630 are in communication (see [0100]) and is controlled using control interface 410 (see [0106]). Furthermore, Fig. 10 shows the removal of humidifier 600 from the housing for maintenance (see [0087]) and when correctly installed the humidifier 600 makes an electrical connection with housing 403 (see [0099]).
Regarding claim 36, Bowman teaches a method for predefining the heating power of a heating element (CFV 602, see Fig. 12 and [0096]) in a ventilator system according to claim 21 (PAP apparatus 400, see Fig. 12 and [0083]), wherein at least one parameter of a respiratory gas is detected by a sensor (“The sensor 458 may provide a signal representative of the temperature and/or humidity level of ambient air at system startup. By providing the sensor 458 within the humidification chamber 456, the sensor may be used to monitor temperature and humidity during operation as well.” See [0096]), and wherein the predefining of the heating power is done at least partially on the basis of the at least one parameter of the respiratory gas (Fig. 18 shows a method for calculating flow dynamics using parameters and Fig. 19 shows a method for humidification in accordance with the flow dynamics from Fig. 18 (see [0032] and [0033]), the at least one parameter of the respiratory gas being selected from one or more of: pressure of respiratory gas stream; volume of respiratory gas stream; intentional leakage; unintentional leakage; respiratory frequency; inspiratory tidal volume; expiratory volume; I:E ratio; start and end of inspiration; start and end of expiration; peak flow during inspiration; peak flow during expiration (“The exemplary computer model allows for manual input of pertinent system and breath parameters including: hose volume (e.g., hose length and diameter); user interface (mask dead space) volume; intentional leak; PAP pressure; user breath rate; I/E ratio; tidal volume; inspiratory and expiratory flow dynamics/patterns; unintentional leak; ambient humidity and temperature; and target humidity and temperature, among others.” See [0127] and Fig. 18).
Regarding claim 37, Bowman teaches a method of claim 36, and further teaches wherein the one or more parameters of the respiratory gas comprise an intentional leakage or an unintentional leakage (“…as well as how electrical power to the CFV will be modulated, may be determined based on one or more of: a pressure of the pressurized gas; total hose flow (which may include flow attributable to each of: intentional leak; unintentional leak; and breath cycle flow) …” see [0081] and Figs. 18-19).
Regarding claim 39, Bowman teaches a method of claim 36, and further teaches wherein the control unit determines a leakage flow of the respiratory gas and controls the heating power of the humidifier according to the leakage flow of the respiratory gas, the leakage flow being an intentional leakage flow and/or an unintentional leakage flow (“…as well as how electrical power to the CFV will be modulated, may be determined based on one or more of: a pressure of the pressurized gas; total hose flow (which may include flow attributable to each of: intentional leak; unintentional leak; and breath cycle flow) …” see [0081] and Figs. 18-19; the electrical power to the CFV will be determined on parameters such as intentional leak and unintentional leak as seen in [0081] and the controller computes simulations including parameters such as intentional leak and unintentional leak as seen in [0169] and [0172]-[0173] and Fig. 22A).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 26 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Bowman (US 20150165146 A1) as applied to claim 21 above.
Regarding claim 26, Bowman teaches the ventilator system of claim 21, and further teaches wherein the heating power is modified on the basis of required power at certain flows (Fig. 18 shows a method for calculating flow dynamics using parameters and Fig. 19 shows a method for humidification in accordance with the flow dynamics from Fig. 18 (see [0032] and [0033]) but it is unclear whether the modification of heating power is based on the average overall flow.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the ventilator taught by Bowman modify the heating power based on the average overall flow. A practitioner in the art would recognized it would have been beneficial to have numerous data points instead of a singular one to improve accuracy of the ventilator.
Claim 27 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Bowman (US 20150165146 A1) in view of Hunt (US 20160067443 A1).
Regarding claim 27, Bowman teaches the ventilator system of claim 21, but does not teach wherein the ventilator additionally comprises hose heating, the hose heating being controlled according to flow or a leakage.
However, Hunt teaches wherein the ventilator additionally comprises hose heating (heated conduit 116, see Fig. 3), the hose heating being controlled according to flow or a leakage (“The present invention provides a means of controlling at least the heater plate and preferably also the conduit heater element without the need for any sensors, either in the humidifier chamber or positioned in the conduit. This is achieved by estimating the rate of flow of gases through the humidifier using parameters already available to the controller.” See [0105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by Bowman to include a heated conduit to be controlled by the controller as taught by Hunt to overcome the issue of condensation within the conduit (see [0011]).
Claims 29-32 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Bowman (US 20150165146 A1) in view of Novkov (US 20190344038 A1).
Regarding claim 29, Bowman teaches the ventilator system of claim 21, but does not teach wherein the control unit provides a function of a temperature increase in the humidifier, such that a desired humidification or a desired heating power is achieved more quickly by a higher heating power in a first, shorter-lasting phase than in a second, longer phase.
However, Novkov teaches wherein the control unit provides a function of a temperature increase in the humidifier, such that a desired humidification or a desired heating power is achieved more quickly by a higher heating power in a first, shorter-lasting phase than in a second, longer phase (“In aspects, the heating element 308 may heat quickly, e.g., in one minute or less, and may be controlled by humidifier 300 and/or ventilator 100 to rapidly achieve a desired temperature of the breathing gases within heating tube 319. As such, ventilator 100 and/or humidifier 300 require very little start up time for humidifying the breathing gas.” See [0053]; it is the examiner’s position the control unit will have a ramp module to quickly increase the temperature in the humidifier for the first phase, and can lower the heat during a second phase).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by Bowman to teach a module which will allow the humidifier to rapidly heat up as taught by Novkov to have a short start up time for humidifying the breathing gas for users (see [0053]).
Regarding claim 30, Bowman in view of Novkov teaches the ventilator system of claim 29, and Bowman further teaches wherein the control unit is configured to take account of a temperature in a water container and/or an ambient temperature when controlling the heating power at least in the first phase (“This may be accomplished using the temperature and humidity sensor, e.g., sensor 458. The user may set a desired target humidity level, e.g., via interaction with the control interface 410. Based upon the relative humidity of the ambient air and its temperature and pressure, and upon the user-selected target humidity level of the flow of pressurized gas, the apparatus (e.g., PAP controller 437 or humidification controller 630) may determine how much water vapor should be added (per unit volume of gas) by the humidifier 600.” See [0106]) and, for this purpose, elements are arranged for detecting a water temperature in the humidifier, in order to transmit an actual temperature to the control unit (Bowman teaches a humidifier 600 provided with a temperature and humidity sensor 458 (see [0096]). Furthermore, the temperature and humidity sensor 458 can measure the relative humidity of the ambient air and its temperature as seen in [0106]. Therefore, temperature and humidity sensor 458 can detect a water temperature in the humidifier).
Regarding claim 31, Bowman in view of Novkov teaches the ventilator system of claim 29, and Bowman further teaches wherein the control unit comprises predefined different power curves that can be called up or adjusted (“A substantial number of breathing scenarios that might be encountered during typical PAP operation were investigated using the computer model simulation, and corresponding values for power interval delay and duration were iteratively determined for each scenario. These values, could, in one embodiment, be stored, e.g., as a lookup table, within (or otherwise accessible by) the PAP apparatus (e.g., apparatus 70, 100, and 400). Based upon actual sensor measurements and system inputs (e.g., flow, pressure, etc.), the PAP apparatus could then identify the simulation scenario within the lookup table that most closely matches the actual breath cycle and then select the power interval delay and duration values associated with that lookup table entry.” See [00126]).
Regarding claim 32, Bowman in view of Novkov teaches the ventilator system ventilator of claim 29, and Bowman further teaches wherein the control unit additionally is capable of adjustably delaying a start of a respiration function (“the controller (e.g., controller 437 or 630) may automatically select or calculate a power interval start time or delay (e.g., a period of time measured from an indexing event after which power will be provided to the CFV) and power interval duration at 647.” See [0121]).
Claims 33-34 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Bowman (US 20150165146 A1) in view of Novkov (US 20190344038 A1), as applied to claim 29 above, and further in view of McRae (US 20030033055 A1).
Regarding claim 33, Bowman in view of Novkov teaches the ventilator system ventilator of claim 29, but does not teach wherein a predefining of different heat stages by the control unit is realized by power regulation, wherein current and voltage at the heating element are detected by a cyclical measurement.
However, McRae teaches wherein a predefining of different heat stages by the control unit is realized by power regulation (“Under a power control scheme, a certain amount of power is supplied to the heater arrangement and the power is monitored and adjusted to maintain the heater arrangement at a desired temperature.” See [0034]), wherein current and voltage at the heating element are detected by a cyclical measurement (“…the controller can be programmed to control delivery of a pulse of power (e.g., duty cycle of 25% to 100% using a fixed pulse and pulse width of 1 to 10 msec) to the heater, measure the voltage drop across the heater, calculate the temperature dependent resistance of the heater and control the on/off supply of energy to the heater arrangement to maintain a target resistance value of the heater arrangement. In a preferred arrangement, the on time of the duty cycle is 2 to 4 milliseconds and the off time is varied between 2 and 16 milliseconds.” See [0034])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by Bowman in view of Novkov to use pulse width modulation to control the heater and to measure the current and voltage at the heating element as taught by McRae to maintain the heater arrangement at a desired temperature base on parameters (see [0034]).
Regarding claim 34, modified Bowman teaches the ventilator system ventilator of claim 33, and McRae further teaches wherein power is readjusted by pulse width modulation, so that a constant power output is permitted even when a resistance of the heating element changes (“…the controller can be programmed to control delivery of a pulse of power (e.g., duty cycle of 25% to 100% using a fixed pulse and pulse width of 1 to 10 msec) to the heater, measure the voltage drop across the heater, calculate the temperature dependent resistance of the heater and control the on/off supply of energy to the heater arrangement to maintain a target resistance value of the heater arrangement.” See [0034]).
Claims 35 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Bowman (US 20150165146 A1) in view of Vos (US 20140216459 A1), McRae (US 20030033055 A1) and Feldhahn (US 20160213869 A1).
Regarding claim 35, Bowman teaches the ventilator system ventilator of claim 21, but does not teach wherein the heating element has a temperature-dependent resistance characteristic curve, and the heating element has an actual resistance value calculated from a measured current and voltage at the heating element, the actual resistance value being configured to be compared with threshold values in order to identify an empty water container, and the control unit being configured to switch off the heating power if a threshold value is exceeded.
However, Vos teaches wherein the heating element has a temperature-dependent resistance characteristic curve (“For example, if the heater element 906 is made of resistive film of a material whose resistance increases with temperature, the electric circuit can measure the heater plate temperature by measuring the resistance of the heating element.” See [0160]), and the control unit being configured to switch off the heating power if a threshold value is exceeded (“…a controller configured to control the power supply to prevent overheating of the heating plate and the heated tube.” See [0023]; “If the sensed temperature is above the predetermined range (S310: Yes), the algorithm proceeds to S314 shuts off power to the heated tube.” See [0088]; it is the examiner’s position if the water container is empty, the temperature of the heated element would be above the temperature of a heated element in a container filled with water).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by Bowman to have a heating element be made of a material whose resistance increases with temperature as taught and be switched off once a threshold value is exceeded as taught by Vos which will allow an easy measurement of the heating element and to prevent overheating (see [0023] and [0160]).
Bowman in view of Vos teaches wherein the heating element has a temperature-dependent resistance characteristic curve and the control unit being configured to switch off the heating power if a threshold value is exceeded but does not teach the heating element has an actual resistance value calculated from a measured current and voltage at the heating element, the actual resistance value being configured to be compared with threshold values in order to identify an empty water container.
However, McRae teaches the heating element has an actual resistance value calculated from a measured current and voltage at the heating element (“…the resistance of the heater is calculated by measuring the voltage across a shunt resistor (not shown) in series with the heater 710 (to thereby determine current flowing to the heater), and measuring the voltage drop across the heater (to thereby determine resistance based on the measured voltage and current flowing through the shunt resistor).” See [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by Bowman in view of Vos to calculate the actual resistance value of a heating element using a measured current and voltage at the heating element as taught by McRae to aid in maintaining the heater at a temperature that corresponds to the resistance target (see [0052]).
The modified Bowman teaches wherein the heating element has a temperature-dependent resistance characteristic curve, and the heating element has an actual resistance value calculated from a measured current and voltage at the heating element, and the control unit being configured to switch off the heating power if a threshold value is exceeded but does not teach the actual resistance value being configured to be compared with threshold values in order to identify an empty water container,
However, Feldhahn teaches the actual resistance value being compared with threshold values in order to identify an empty water container (“The control unit (19) registers current or resistance or voltage changes in the region of the heating element of the humidifier. The resistance of the heating element increases with a falling water level. This is detected by the control unit. The control unit then displays a symbol for a low water level in the region of the display or outputs a corresponding text message.” See [0068]; it is the examiner’s opinion the control unit can identity when there is an empty water container due to the changes in the resistance of the heating element).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator taught by modified Bowman to have the control unit detect the resistance changes of the heating element to identify the water level as taught by Feldhahn to give a warning to the user (see [0020]).
Claim(s) 21 and 42-43 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Mayer (US 7096864 B1) in view of Tatkov (US 20110120462 A1).
Regarding claim 21, Mayer teaches a ventilator system (CPAP-unit 1 and humidifying apparatus 2, see Figs. 1-3), wherein the ventilator system comprises (i) a ventilator (CPAP-unit 1, see Fig. 1-2) comprising a respiratory gas unit (Mayer teaches CPAP-unit 1 to convey respiratory gas and therefore is a respiratory gas unit as seen in Col. 6, lines 51-62) and as well as (ii) a humidifier (humidifying apparatus 2, see Figs. 1-3) comprising a heating element (heating device 214, see Fig. 3) and a water container (liquid storage container 17/cup portion 202, see Figs. 1 and 3) and being configured for direct coupling to the ventilator (Mayer teaches the connecting device 9 of CPAP-unit 1 to be of complementary configuration to the connecting device 21 on the humidifying apparatus 2 such that the two connecting devices 9 and 21 can be joined as seen in Figs. 1 and 2 and Col. 11, line 62 to Col. 12, line 4. Mayer further teaches front end face 4 of CPAP-unit 1 to be slightly curved to help center the humidifying apparatus 2 when connecting as seen in Fig. 1 and Col. 11, lines 22-29), the ventilator system further comprising:
- at least one sensor which detects one or more parameters of the respiratory gas (Mayer teaches a pressure transducer arranged on a control board and integrated into the CPAP-unit as seen in Col 9, lines 24-37 and Col. 17, lines 45-48, wherein the pressure transducer is to detect a pressure of the gas).
- at least one control unit (Mayer teaches a control board as seen in Col. 17, lines 45-48)
but does not teach - at least one control unit for predefining a heating power of the heating element at least partially on the basis of the one or more parameters of the respiratory gas,
the one or more parameters of the respiratory gas being selected from one or more of: pressure of respiratory gas stream; volume of respiratory gas stream; intentional leakage; unintentional leakage; respiratory frequency; inspiratory tidal volume; expiratory volume; I:E ratio; start and end of inspiration; start and end of expiration; peak flow during inspiration; peak flow during expiration.
However, Tatkov teaches - at least one sensor which detects one or more parameters of the respiratory gas (Tatkov teaches a pressure sensor in the incoming gas path to the humidification chamber as seen in [0086]),
- at least one control unit (control system 8, blower controller 8a and humidifier controller 8b, see Fig. 2a and [0056]) for predefining a heating power of the heating element at least partially on the basis of the one or more parameters of the respiratory gas (Tatkov teaches controller 8 to adjust the power output of the heater plate to match the measured chamber exit temperature with the “ideal” temperature from the memory of the controller as seen in [0086]. Tatkov further teaches refining the accuracy if the pressure level can be known using a pressure sensor as seen in [0086]. As such, controller 8 uses pressure measurements from a pressure sensor to aid in adjusting the power output of the heater plate),
the one or more parameters of the respiratory gas being selected from one or more of: pressure of respiratory gas stream; volume of respiratory gas stream; intentional leakage; unintentional leakage; respiratory frequency; inspiratory tidal volume; expiratory volume; I:E ratio; start and end of inspiration; start and end of expiration; peak flow during inspiration; peak flow during expiration (Tatkov teaches using pressure of the respiratory gas stream measured by the pressure sensor to aid in refining the accuracy for adjusting the power output of the heater plate as seen in [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the ventilator system taught by Mayer to include the controller as taught by Tatkov to aid in adjusting the power output of the heater plate to refine the accuracy of the power output (see [0086]).
Regarding claim 42, Mayer in view of Tatkov teaches the ventilator system of claim 21, and Mayer further teaches wherein an apparatus construction of the humidifier is adapted to a contour of the ventilator (Mayer teaches front end face 4 of CPAP-unit 1 to be slightly curved to help center the humidifying apparatus 2 when connecting as seen in Fig. 1 and Col. 11, lines 22-29, as such the apparatus construction of humidifying apparatus 2 is inwardly curved as seen in Fig. 1 to adapt to a contour of the CPAP-unit 1) and the humidifier can be connected and disconnected from the ventilator as one unit (humidifying apparatus 2 can be connected and disconnected from CPAP-unit 1 as one unit as seen in Figs. 1 and 2 and Col. 11, line 62 to Col. 12, line 4).
Regarding claim 43, Mayer in view of Tatkov teaches the ventilator system of claim 21, and Mayer further teaches wherein the humidifier comprises a housing bottom part with heating element (Tatkov teaches a housing bottom part including heating device 214 and the bottom region 215 of the trough element 201 as seen in Fig. 3 and (31)), a housing top part (Tatkov teaches a housing top part which includes a portion of cup portion 202 as seen in Fig. 3), and a multifunctional middle part, with a sealing support in relation to the housing bottom part and the housing top part (Tatkov teaches a multifunctional middle part that includes sealing structure 206 which comprises of first sealing ring 207 and second sealing ring 208 to sealingly couple trough element 201 and cup portion 202 as seen in Fig. 3 and Col. 12, line 66 to Col. 13, line 9. Furthermore, the middle part includes separating element 209 and separating wall 205 in which separating wall 205 separates cup portion 202 from trough element 201 as seen in Fig. 3 and Col. 12, line 66 to Col. 13, line 9).
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.
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/TINA ZHANG/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785