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 1/5/2026. Per the amendment, claims 1, 95, 97-98, 100-102, and 11 are as amended; claims 2-94 and 112 are cancelled; claims 96, 99, 103-110, and 113 are as previously presented, and claims 114-121 are new. As such, claims 1, 95-111, and 113-121 are pending in the instant application.
All rejections pursuant to 35 U.S.C. 112(b) made in the Office Action mailed 9/24/2025 are withdrawn in light of the amendments.
Claim Objections
Claims 1, 97, 104, 106-107, 111, 113, and 115 are objected to because of the following informalities:
Claim 1, line 25: “of the humidifier” should read “of the respiratory or surgical humidifier” for consistency and clarity.
Claim 97, line 5: “to produce a heater plate” should read “to produce the heater plate” for consistency and clarity.
Claim 104, line 2: “the humidity profile” should read “the one or more humidity profiles” for consistency and clarity.
Claim 106, lines 3-4: “upon only one monitored variable, being” should read “upon only one monitored variable, where the only one monitored variable is” for clarity.
Claim 106 (line 4) and claim 110 (line 2): “the heater plate temperature sensor” should read “the heater plate sensor” for consistency and clarity.
Claim 107, lines 3-4: “the level of the power supply” should read “the level of power supplied” for clarity and consistency.
Claim 111, line 6: “the heater plate temperature signal” should read “the temperature signal” for consistency and clarity.
Claim 113, line 8: “to sense the temperature” should read “to sense a temperature” to establish antecedent basis.
Claim 113, line 12: “for the humidifier” should read “for the respiratory or surgical humidifier” for clarity and consistency.
Claim 115, lines 4-5: “a heater plate temperature setpoint” should read “the heater plate temperature setpoint” for consistency and clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 102-103 and 119-120 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 102 and 119 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as based on a disclosure which is not enabling. The disclosure does not enable one of ordinary skill in the art to practice the invention without an error signal (specification [00145], [00146], [00143]), a filtered signal (specification [00145] & [00146]), or an estimated water temperature (specification [00141]-[00143]), which are critical or essential to the practice of the invention but not included in the claim. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976). The specification recites two polynomial equations for two separate embodiments to calculate the rate signal:
Equation 1 (Pg. 28, line 20).
r
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, and
Equation 2 (Pg. 29, lines 5-10).
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.
Equation 1 requires an estimated water temperature error signal and a heater plate temperature error signal to calculate a rate signal ([00143]), and Equation 2 requires a heater plate temperature error signal and a filter signal to calculate a rate signal ([00145]). As stated above, claims 102 and 119 omit essential subject matter in which the rate signal, using Equation 1 and/or Equation 2 above, cannot be calculated. Therefore, it is not clear how to make or use the invention because one having ordinary skill in the art would not know what equation, or calculation method, to use to get the claimed result of a rate signal.
Further, scope of claims 102 and 119 are large as the specification discloses a polynomial function “could be any of a number of suitable quadratic, cubic or other functions. Any other suitable function may be employed, such as an exponential function” ([00145]). Due to this broad scope, one having ordinary skill in the art would not be able to make or use the invention in its entire scope without undue experimentation because no explanation or guidance has been disclosed as to how to determine what design, and/or equation, to use. Applicant may argue that one in the art would know how to make and use the invention; however, this would not be persuasive because the disclosure fails to include a function to calculate a rate signal without undue experimentation due to the broad nature of the claims.
As to the level of one of ordinary skill in the art, one could not make or use the invention with the provided disclosure. Due to the lack of any explanation on determining what type of mathematical function to use to calculate a rate signal (i.e., a quadratic function, a cubic function, a polynomial function, an exponential function, etc.), one could not make or use the invention without undue experimentation.
As noted above Applicant has provided no way to determine what type of function to use to calculate a rate signal, or the required inputs to calculate the rate signal as disclosed in claims 102 and 119, and therefore the amount of direction provided is insufficient to constitute an enabling disclosure.
Due to the failure of Applicant to adequately describe the invention one would have to experiment unduly to reach the claimed result of the required inputs to calculate a rate signal and a function to do so, and thus the invention is not enabled.
Regarding claims 103 and 120, the breadth of the claims are large as the claims simply discloses a rate signal being filtered by an asymmetric filter, but claim limitations and specification do not explain what the asymmetric filter is, what the asymmetric filter does, or what is means to filter a rate signal with an asymmetric filter. Further the specification recites “Under this modified control strategy the modified low pass filtered estimated water temperature TH2O_est' behaves as an asymmetric filter” ([00147]). It is unclear if the rate signal of claims 103 and 120 must be filtered by an asymmetric filter, or if the rate signal may be filtered by something that behaves as an asymmetric filter, as recited in the specification. Due to this broad scope, one having ordinary skill in the art would not be able to make or use the invention in its entire scope without undue experimentation because no explanation or guidance has been disclosed as to how to determine what signal filter to use. Applicant may argue that one in the art would know how to make and use the invention; however, this would not be persuasive because the disclosure fails to include the purpose and behavior of the asymmetric filter individually, as well as the purpose and behavior of the rate signal filtered by an asymmetric filter, without undue experimentation due to the broad nature of the claims.
As to the level of one of ordinary skill in the art, one could not make or use the invention with the provided disclosure. Due to the lack of any explanation on determining what the asymmetric filter is and what the asymmetric filter does, one could not make or use the invention without undue experimentation.
As noted above Applicant has provided no way to determine what the asymmetric filter does, especially in relation to a rate signal being filtered by said asymmetric filter, and therefore the amount of direction provided is insufficient to constitute an enabling disclosure.
Due to the failure of Applicant to adequately describe the invention one would have to experiment unduly to reach the claimed result of a rate signal filtered by an asymmetric filter and thus the invention is not enabled.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 113-118 and 121 are rejected under 35 U.S.C. 103 as being unpatentable over Thudor & McPhee (US 20020112725 A1), in view of Smith et al. (US 9802022 B2).
Regarding claim 113, Thudor & McPhee discloses a respiratory or surgical humidifier (respiratory humidification system; Fig. 1) for delivering gases at a desired level of humidity and/or a desired temperature ([0012]) comprising:
a housing (body 2; Fig. 2) configured to receive a humidifier chamber (3; Fig. 1);
a heating assembly (heater plate 20; Fig. 2) located at least partially within the housing (heater plate 20 located at least partially within body 2; Fig. 2), the heating assembly (heater plate 20; Fig. 2) including:
a heater plate (heater plate 20; Fig. 2) configured to transfer heat to the humidifier chamber when the humidifier chamber is received by the housing ([0060], lines 9-11, where heater plate 110 is the same as heater plate 20; [0057], lines 8-10);
a heater plate sensor (temperature transducer 8; Fig. 1) configured to sense a temperature of the heater plate ([0057], last sentence of paragraph) and provide a temperature signal ([0057], last sentence of paragraph, where the electric control circuitry includes controller 100, the temperature transducer 8 communicates with controller 100, and it is inherent a transducer would generate a signal to communicate with a controller); and
a heater (electric heating element; [0057], line 3) configured to heat the heater plate ([0057], lines 3-5); and
a power controller (100; Fig. 3) configured to:
determine a heater plate temperature setpoint required for the humidifier to deliver gases at a desired level of humidity ([0063], lines 1-4) based at least in part on a level of power supplied to the heater ([0060], last sentence of paragraph) and the temperature signal ([0057], last sentence of paragraph, where the electric control circuitry includes controller 100, the temperature transducer 8 communicates with controller 100, and it is inherent a transducer would generate a signal to communicate with a controller, hence the temperature transducer 8 would generate a temperature signal to communicate with the controller 100); and
control the level of power supplied to the heater based on the heater plate temperature setpoint ([0060], lines 12-16) and the temperature signal ([0057], lines 25-28).
Thudor & McPhee does not explicitly disclose wherein a rate of change of the heater plate temperature setpoint is variably controlled in dependence at least in part upon a difference between the heater plate temperature setpoint and the temperature signal.
However, Smith et al. teaches the calculation of a duty ratio based on, at least in part, a temperature difference (Td) between a temperature reading of a humidifier that has been sensed by a temperature sensor (Col. 24, lines 53-57; Col. 24, lines 60-61).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Thudor & McPhee with Smith et al. such that a rate of change, in relation to a change in duty cycle, of the heater plate temperature setpoint ([0061], lines 1-9) is variably controlled in dependence at least in part upon a difference between the heater plate temperature setpoint and the temperature signal (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee) to ensure a desired humidity of the gas delivered to the patient is achieved (Smith et al.: Col. 22, lines 50-54) and to guarantee the heating plate is operating at a safe temperature (Col. 22, lines 63-65).
Regarding claim 114, Thudor & McPhee as modified teaches the invention as set forth in claim 113, wherein the power controller (100; Fig. 3) includes a heater plate temperature setpoint controller (an algorithm of controller 100, see [0063], lines 1-4) that produces a heater plate temperature setpoint value ([0063], lines 1-4) based at least in part upon the heater power supply level ([0060], last sentence of paragraph) and a rate signal (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee; EXAMINER NOTE: [0035] of Applicant’s specification recites “the rate signal can be based at least in part on the temperature signal and the heater plate temperature setpoint value”, hence a signal including the temperature signal and the heater plate temperature setpoint value reads on what Applicant has defined as the rate signal).
Regarding claim 115, Thudor & McPhee as modified teaches the invention as set forth in claim 114, wherein the heater plate temperature setpoint controller (an algorithm of controller 100) develops a target temperature (required heater plate temperature, [0063], line 3) based on a target temperature value associated with a heater power level of the one or more humidity profiles ([0060], last sentence of paragraph; [0063], lines 1-4, where a target temperature for a desired level of humidity is based on the level of power supplied to the heater) and modifies the target temperature (required heater plate temperature, [0063], line 3) based at least in part on the rate signal to produce a heater plate temperature setpoint (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee; EXAMINER NOTE: [0035] of Applicant’s specification recites “the rate signal can be based at least in part on the temperature signal and the heater plate temperature setpoint value”, hence a signal including the temperature signal and the heater plate temperature setpoint value reads on what Applicant has defined as the rate signal).
Regarding claim 116, Thudor & McPhee as modified teaches the invention as set forth in claim 115, wherein the heater plate temperature setpoint controller (an algorithm of controller 100, see [0063], lines 1-4) determines a difference between a prior heater plate temperature setpoint and a target heater plate temperature setpoint (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee) and integrates said difference to produce a new heater plate temperature setpoint value (required heater plate temperature, [0063], line 3; see claim 115 above).
Regarding claim 117, Thudor & McPhee as modified teaches the invention as set forth in claim 115, wherein the heater plate temperature setpoint controller (an algorithm of controller 100, see [0063], lines 1-4) determines the difference between a prior heater plate temperature setpoint and a target heater plate temperature setpoint (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee), but fails to teach this determination to produce a difference signal and combines proportional and integral components of the difference signal to produce a new heater plate temperature setpoint.
However, Smith et al. teaches one or more controllers (40 and/or 44) with a simplified proportional-integral control function to calculate a temperature difference (Col. 24, lines 58-62) that is combined with proportional components and integral components (proportional factor Pf, integral factor If; Col. 24, line 51; Col. 25, lines 49-51; Col. 24, lines 62-67) to produce a new duty ratio or the humidifier, where a duty ratio is directly related to a change in temperature and a change in temperature of the humidifier is caused by a change in temperature to the heater plate.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Thudor & McPhee by Smith et al. such that the heater plate temperature setpoint controller (an algorithm of controller 100, see [0063], lines 1-4) determines the difference between a prior heater plate temperature setpoint and a target heater plate temperature setpoint (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee) to produce a difference signal (Smith et al.: Col. 24, lines 58-62, where the temperature difference is communicated to a controller via a signal to use the temperature difference for further calculation) and combines proportional and integral components of the difference signal to produce a new heater plate temperature setpoint (required heater plate temperature, [0063], line 3; Smith et al.: proportional factor Pf, integral factor If; Col. 24, line 51; Col. 25, lines 49-51; Col. 24, lines 62-67) to more accurately control the humidifier via use of such control parameters (Smith et al.: Col. 3, lines 30-32).
Regarding claim 118, Thudor & McPhee as modified teaches the invention as set forth in claim 116, wherein the rate signal (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee; EXAMINER NOTE: [0035] of Applicant’s specification recites “the rate signal can be based at least in part on the temperature signal and the heater plate temperature setpoint value”, hence a signal including the temperature signal and the heater plate temperature setpoint value reads on what Applicant has defined as the rate signal) reduces an integral input with increasing difference between the temperature signal and the heater plate temperature setpoint value (Smith et al.: Col. 24, lines 62-67, where the integral factor is zero if the measured temperature is not close to the setpoint temperature value).
Regarding claim 121, Thudor & McPhee as modified teaches the invention as set forth in claim 113, wherein the power controller (100; Fig. 3) is configured to control the level of the power supply to the heater plate without additional sensor input in a gas flow path ([0059], lines 1-4; [0059], lines 7-8).
Claims 1, 95-101, 105-107, and 109 are rejected under 35 U.S.C. 103 as being unpatentable over Thudor & McPhee (US 20020112725 A1) in view of Smith et al. (US 9802022 B2) as applied to claim 113 above, and further in view of Harrington et al. (US 10518061 B2).
Regarding claim 1, Thudor & McPhee as modified teaches a respiratory or surgical humidifier (respiratory humidification system; Fig. 1) for delivering gases at a desired level of humidity and/or a desired temperature ([0012]) comprising:
a housing (body 2; Fig. 2) configured to receive a humidifier chamber (3; Fig. 1);
a heating assembly (heater plate 20; Fig. 2) located at least partially within the housing (heater plate 20 located at least partially within body 2; Fig. 2), the heating assembly (heater plate 20; Fig. 2) including:
a heater plate (heater plate 20; Fig. 2) configured to transfer heat to the humidifier chamber when the humidifier chamber is received by the housing ([0060], lines 9-11, where heater plate 110 is the same as heater plate 20; [0057], lines 8-10);
a heater plate sensor (temperature transducer 8; Fig. 1) configured to sense a temperature of the heater plate and output a temperature signal ([0057], last sentence of paragraph, where it is inherent the temperature transducer 8 outputs a temperature signal to communicate with the electronic control circuitry); and
a heater (electric heating element; [0057], line 3) configured to heat the heater plate ([0057], lines 3-5); and
a power controller (100; Fig. 3) configured to:
determine a heater plate temperature setpoint required for the respiratory or surgical humidifier to deliver gases at a desired level of humidity ([0063], lines 1-4) based at least in part on a level of power supplied to the heater ([0060], last sentence of paragraph) and the temperature signal ([0057], last sentence of paragraph, where the electric control circuitry includes controller 100, the temperature transducer 8 communicates with controller 100, and it is inherent a transducer would generate a signal to communicate with a controller, hence the temperature transducer 8 would generate a temperature signal to communicate with the controller 100), wherein a rate of change of the heater plate temperature setpoint (change in duty cycle of heater plate 20, where a change in duty cycle over a period of time is directly related to a change in temperature of a period of time; [0061], lines 1-9) is variably controlled in dependence at least in part upon a difference between the heater plate temperature setpoint and the temperature signal (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee): and
control the level of power supplied to the heater based on the heater plate temperature setpoint ([0060], lines 12-16), the temperature signal ([0057], lines 25-28), and one or more humidity profiles ([0060], lines 14-16) defining heater plate temperature and the heater power supply level combinations associated with a desired humidity value ([0060], lines 8-12, where heater plate temperature and heater power supply level in combination define a desired humidity).
Thudor & McPhee as modified fails to teach, wherein the heater plate temperature and the heater power supply level combinations form a curve associated with a constant humidity value over a desired operating range of the humidifier.
However, Harrington et al. teaches a condensation onset condition is dependent on, and can be represented by a curve associated with the combination of, a temperature of a heating element to provide heat to a humidification chamber and a power output of a heating element (4171) to heat the heating element providing heat to the humidification chamber (Col. 54, lines 46-53; Fig. 29).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Thudor & McPhee with Harrington et al. such that the heater plate temperature and the heater power supply level combinations ([0060], lines 8-12, where heater plate temperature and heater power supply level in combination define a desired humidity) form a curve associated with a constant humidity value over a desired operating range of the humidifier (Harrington et al.: Col. 54, lines 46-53; Fig. 29) to monitor and ensure the gases delivered to a patient are within a desired operating range of humidity (Col. 55, lines 61-67; Col. 56, lines 1-3).
Regarding claim 95, Thudor & McPhee as modified teaches the invention as set forth in claim 1, wherein the rate of change of the heater plate temperature setpoint (change in duty cycle of heater plate 20, where a change in duty cycle over a period of time is directly related to a change in temperature of a period of time; [0061], lines 1-9) is controlled in dependence upon a current heater plate temperature setpoint and the temperature signal (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee).
Regarding claim 96, Thudor & McPhee as modified teaches the invention as set forth in claim 1, wherein the power controller (100; Fig. 3) includes a heater plate temperature setpoint controller (an algorithm of controller 100, see [0063], lines 1-4) that produces a heater plate temperature setpoint value ([0063], lines 1-4) based at least in part upon the heater power supply level ([0060], last sentence of paragraph) and a rate signal (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee; EXAMINER NOTE: [0035] of Applicant’s specification recites “the rate signal can be based at least in part on the temperature signal and the heater plate temperature setpoint value”, hence a signal including the temperature signal and the heater plate temperature setpoint value reads on what Applicant has defined as the rate signal).
Regarding claim 97, Thudor & McPhee as modified teaches the invention as set forth in claim 96, wherein the heater plate temperature setpoint controller (an algorithm of controller 100) develops a target temperature (required heater plate temperature, [0063], line 3) based on a target temperature value associated with a heater power level of the one or more humidity profiles ([0060], last sentence of paragraph; [0063], lines 1-4, where a target temperature for a desired level of humidity is based on the level of power supplied to the heater) and modifies the target temperature (required heater plate temperature, [0063], line 3) based at least in part on the rate signal to produce a heater plate temperature setpoint (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee; EXAMINER NOTE: [0035] of Applicant’s specification recites “the rate signal can be based at least in part on the temperature signal and the heater plate temperature setpoint value”, hence a signal including the temperature signal and the heater plate temperature setpoint value reads on what Applicant has defined as the rate signal).
Regarding claim 98, Thudor & McPhee as modified teaches the invention as set forth in claim 97, wherein the heater plate temperature setpoint controller (an algorithm of controller 100, see [0063], lines 1-4) determines a difference between a prior heater plate temperature setpoint and a target heater plate temperature setpoint (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee) and integrates said difference to produce a new heater plate temperature setpoint value (required heater plate temperature, [0063], line 3; see claim 97 above).
Regarding claim 99, Thudor & McPhee as modified teaches the invention as set forth in claim 97, wherein the heater plate temperature setpoint controller (an algorithm of controller 100, see [0063], lines 1-4) determines the difference between a prior heater plate temperature setpoint and a target heater plate temperature setpoint (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee), but fails to teach this determination to produce a difference signal and combines proportional and integral components of the difference signal to produce a new heater plate temperature setpoint.
However, Smith et al. teaches one or more controllers (40 and/or 44) with a simplified proportional-integral control function to calculate a temperature difference (Col. 24, lines 58-62) that is combined with proportional components and integral components (proportional factor Pf, integral factor If; Col. 24, line 51; Col. 25, lines 49-51; Col. 24, lines 62-67) to produce a new duty ratio or the humidifier, where a duty ratio is directly related to a change in temperature and a change in temperature of the humidifier is caused by a change in temperature to the heater plate.
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Thudor & McPhee by Smith et al. such that the heater plate temperature setpoint controller (an algorithm of controller 100, see [0063], lines 1-4) determines the difference between a prior heater plate temperature setpoint and a target heater plate temperature setpoint (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee) to produce a difference signal (Smith et al.: Col. 24, lines 58-62, where the temperature difference is communicated to a controller via a signal to use the temperature difference for further calculation) and combines proportional and integral components of the difference signal to produce a new heater plate temperature setpoint (required heater plate temperature, [0063], line 3; Smith et al.: proportional factor Pf, integral factor If; Col. 24, line 51; Col. 25, lines 49-51; Col. 24, lines 62-67) to more accurately control the humidifier via use of such control parameters (Smith et al.: Col. 3, lines 30-32).
Regarding claim 100, Thudor & McPhee as modified teaches the invention as set forth in claim 98, wherein the rate signal (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee; EXAMINER NOTE: [0035] of Applicant’s specification recites “the rate signal can be based at least in part on the temperature signal and the heater plate temperature setpoint value”, hence a signal including the temperature signal and the heater plate temperature setpoint value reads on what Applicant has defined as the rate signal) reduces an integral input with increasing difference between the temperature signal and the heater plate temperature setpoint value (Smith et al.: Col. 24, lines 62-67, where the integral factor is zero if the measured temperature is not close to the setpoint temperature value).
Regarding claim 101, Thudor & McPhee as modified teaches the invention as set forth in claim 99, wherein the rate signal (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee; EXAMINER NOTE: [0035] of Applicant’s specification recites “the rate signal can be based at least in part on the temperature signal and the heater plate temperature setpoint value”, hence a signal including the temperature signal and the heater plate temperature setpoint value reads on what Applicant has defined as the rate signal) reduces an integral input with increasing difference between the temperature signal and the heater plate temperature setpoint value (Smith et al.: Col. 24, lines 62-67, where the integral factor is zero if the measured temperature is not close to the setpoint temperature value).
Regarding claim 105, Thudor & McPhee as modified teaches the invention as set forth in claim 1, further comprising an ambient temperature sensor ([0023], lines 1-2), wherein the one or more humidity profiles are modified based on an ambient temperature received from the ambient temperature sensor ([0023], lines 3-7).
Regarding claim 106, Thudor & McPhee as modified teaches the invention as set forth in claim 1, wherein the power controller (100; Fig. 3) controls the level of power supplied to the heater in dependence upon only one monitored variable ([0015]-[0017], where humidification means to deliver said gases to said patient is the electric heating element, see claim 1), being a temperature signal received from the heater plate temperature sensor ([0057], last sentence of paragraph, where the electric control circuitry includes controller 100, the temperature transducer 8 communicates with controller 100, and it is inherent a transducer would generate a signal to communicate with a controller, hence the temperature transducer 8 would generate a temperature signal to communicate with the controller 100).
Regarding claim 107, Thudor & McPhee as modified teaches the invention as set forth in claim 1, wherein the power controller (100; Fig. 3) is configured to control the level of the power supply to the heater plate without additional sensor input in a gas flow path ([0059], lines 1-4; [0059], lines 7-8).
Regarding claim 109, Thudor & McPhee as modified teaches the invention as set forth in claim 1, wherein the power controller (100; Fig. 3) is configured to control the level of power supplied to the heater plate without additional sensors in: the humidifier chamber ([0059], lines 1-4, where a means of controlling at least the heater plate is based on a level of power supplied to the heater and the controller 100 is capable of controlling a level of power supplied to the heater, see claim 1 above), a gases outlet of the humidifier chamber, and/or a breathing circuit connected to the gases outlet of the humidifier chamber.
Claim 104 is rejected under 35 U.S.C. 103 as being unpatentable over Thudor & McPhee (US 20020112725 A1) in view of Smith et al. (US 9802022 B2) in view of Harrington et al. (US 10518061 B2) as applied above, and further in view of Gradon et al. (US 7051733 B2).
Regarding claim 104, Thudor & McPhee as modified teaches the invention as set forth in claim 1, but fails to teach wherein the humidity profile is selected from one of a number of profiles for different constant humidity values.
However, Gradon et al. teaches a memory, data storage means, or memory device to look up required power values of at a number of desired humidity levels stored therein (Col. 7, lines 60-64), where the power value applied to a heater plate adjusts the temperature of the heater plate to achieve the desired humidity level (Col. 4, lines 7-11).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Thudor & McPhee with Gradon et al. such that the humidity profile ([0060], lines 14-16) is selected from one of a number of profiles for different constant humidity values (Gradon et al.: Col. 7, lines 60-64; Col. 4, lines 7-11) to ensure the desired humidity level is achieved to meet a patient’s physiological humidity needs (Gradon et al.: Col. 8, lines 8-10; Col. 12, lines 26-27).
Claim 108 is rejected under 35 U.S.C. 103 as being unpatentable over Thudor & McPhee (US 20020112725 A1) in view of Smith et al. (US 9802022 B2) in view of Harrington et al. (US 10518061 B2) as applied to claims 1, 95-101, 105-107, and 109 above, and further in view of Weinstein et al. (US 20070137646 A1).
Regarding claim 108, Thudor & McPhee as modified teaches the invention as set forth in claim 1, but fails to teach wherein the power controller (100; Fig. 3) is configured to control the level of power supplied to the heater plate without requiring use of a flow rate of the gases.
However, Weinstein et al. teaches a controller (1500) maybe be operated without having gas flow rate information by adjusting the gas temperature ([0112], lines 17-19), where the controller (1500) controls the temperature of a heater device (1510) based on the power supplied to the heater device (1510; [0105], lines 1-6).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Thudor & McPhee with Weinstein et al. such that the power controller (100; Fig. 3) is configured to control the level of power supplied to the heater plate (see claim 1 above) without requiring use of a flow rate of the gases ([0112], lines 17-19) to simplify and streamline the control of the power level supplied to the heater plate.
Claim 110 is rejected under 35 U.S.C. 103 as being unpatentable over Thudor & McPhee (US 20020112725 A1) in view of Smith et al. (US 9802022 B2) in view of Harrington et al. (US 10518061 B2) as applied to claims 1, 95-101, 105-107, and 109 above, and further in view of Fridberg & Dubinsky (US 20120248636 A1).
Regarding claim 110, Thudor & McPhee as modified teaches the invention as set forth in claim 1, but is silent to the heater plate temperature sensor (temperature transducer 8; Fig. 1) being a negative temperature coefficient thermistor, a positive temperature coefficient thermistor, a thermocouple, or an infrared sensor.
However, Fridberg & Dubinsky teaches a temperature sensor (42) is in thermal communication with a hot plate (32) and provides plate temperature signals (44) corresponding to the temperature of the hot plate (32), where the temperature sensor (42) is a thermocouple ([0029], lines 20-23).
Therefore, it would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Thudor & McPhee with Fridberg & Dubinsky such that the heater plate temperature sensor (temperature transducer 8; Fig. 1) is a negative temperature coefficient thermistor, a positive temperature coefficient thermistor, a thermocouple (Fridberg & Dubinsky: [0029], lines 20-23), or an infrared sensor to accurately measure the temperature of the heater plate even when there is a fast change in temperature of the heater plate.
Claim 111 is rejected under 35 U.S.C. 103 as being unpatentable over Thudor & McPhee (US 20020112725 A1) in view of Smith et al. (US 9802022 B2) in view of Harrington et al. (US 10518061 B2) as applied to claims 1, 95-101, 105-107, and 109 above, and further in view of Crone et al. (CA 3051967 C).
Regarding claim 111, Thudor & McPhee as modified teaches the invention as set forth in claim 1, wherein the rate of change of the heater plate temperature setpoint (change in duty cycle of heater plate 20, where a change in duty cycle over a period of time is directly related to a change in temperature of a period of time; [0061], lines 1-9) is controlled in dependence upon a rate signal which is based on the current heater plate temperature setpoint and the temperature signal (Smith et al.: Col. 24, lines 53-57; Col. 24, lines 60-61; where the temperature signal is a temperature signal generated by temperature transducer 8 of Thudor & McPhee; EXAMINER NOTE: [0035] of Applicant’s specification recites “the rate signal can be based at least in part on the temperature signal and the heater plate temperature setpoint value”, hence a signal including the temperature signal and the heater plate temperature setpoint value reads on what Applicant has defined as the rate signal; claim 1 above, where a rate of change of the heater plate temperature setpoint is variably controlled in dependence at least in part upon a difference between the heater plate temperature setpoint and the temperature signal).
Thudor & McPhee as modified is does not explicitly teach the rate of change of the heater plate temperature setpoint is controlled in dependence upon a rate signal which is based on the current heater plate temperature setpoint and both the temperature signal and an estimated temperature of a fluid within the humidifier chamber when in use, wherein the estimated temperature is obtained by using the heater plate temperature signal when the low pass filtered signal is greater than the heater plate temperature and using the low pass filtered signal when the low pass filtered signal is less than the heater plate temperature.
However, Crone et al. teaches a controller capable of controlling and adjusting a flow rate of a humidifier system, where a signal indicative of an actual flow rate in a humidifier chamber is measured by a flow probe and filtered through a low pass filter to produce a low pass output signal (Pg. 10, lines 14-17), said low pass output signal is subtracted from a user defined flow rate signal and passed into a first Proportional-Integral-Derivative (P.I.D.) filter and a second P.I.D. filter (Pg. 10, lines 18-19; Pg. 10, lines 28-29), where the controller uses an output of the first P.I.D. filter or the second P.I.D. filter to adjust an output of a fan to match the actual flow rate to the user defined flow rate (Pg. 10, lines 29-31), where the first P.I.D. filter is used if a large deviation from the set flow rate is determined, and the second P.I.D. filter is used if a small deviation from the set flow rate is determined (Pg. 32, line 32; Pg. 33, lines 1-4). Crone et al. further teaches, if a large deviation from the set flow rate, or a step change in the flow rate, is determined, coarse control parameters will be used to restore the flow rate to the flow rate defined by the user (Pg. 34, lines 9-12) and adjust an output of a fan to match the flow rate defined by the user (Pg. 9, lines 22-25); however, if a small deviation from the set flow rate is determined, or the flow rate is changing slowly, fine control parameters are used to adjust the flow rate using the actual flow rate (Pg. 9, lines 19-21, where the user defined flow rate and the actual flow rate are substantially equal) and adjust the output of the fan to match the actual flow rate (Pg. 9, lines 19-20, where the user defined flow rate and the actual flow rate are substantially equal).
Therefore, a person of ordinary skill in the art, before the effective filing date of the claimed invention, would have recognized applying the known technique of controlling and adjusting a characteristic (e.g. flow rate) of a humidified gas within a humidifier chamber, as taught by Crone et al., with the use of a current heater plate temperature setpoint, a temperature signal measured by a temperature sensor, and an estimated temperature of a fluid within the humidifier in place of a current user defined flow rate, an actual flow rate measured by a flow probe, and an estimated flow rate within a humidifier chamber would have yielded predictable results of the control and adjustment of the temperature of a humidified gas within a humidifier chamber, resulting in an improved humidification system with temperature control to ensure a desired humidity is achieved before the humidified gas is delivered to a patient for treatment (see MPEP §2143 Section I).
Response to Arguments
Regarding the rejection of claims 102 and 103 under 35 U.S.C. § 112(a), Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive.
In regard to claim 102, Applicant states the Office Action (mailed 09/24/2025) insists Applicant simply imports limitations to the claims based on an example of a calculation (Equation 1 and Equation 2) that could be used; however, there is nothing in the specification that states said equations are the only equations, or are required, to obtain a rate signal. The Examiner acknowledges that Equation 1 and Equation 2 provided in Applicant’s specification are not required, and instead are mere examples of equations that could be used to produce the rate signal. However, Applicant’s specification does require an error signal to produce the rate signal (see [00139], [00141], [00142], and [00145]). Additionally, Applicant’s specification requires either a filtered signal (see [00141] and [00145]) and/or a estimated water temperature (see [00141] and [00143]) is required to produce the rate signal. Hence, an error signal, a filtered signal and/or an estimated water temperature are critical or essential to the practice of the invention, and are not included in claim 102. Therefore, the disclosure does not enable a person of ordinary skill in the art to obtain the claimed rate signal without undue experimentation.
Applicant further states the claim (claim 102) provides explicit and specific guidance to a person of skill in the art for generating a polynomial equation to implement the claimed invention and that any number of equations could be developed without undue experimentation, and that the Office Action (mailed 9/24/2025) fails to show that an equation, or polynomial equation, to implement the claimed invention would not work without an error signal, and simply stating an example equation as an error statement is insufficient to require the Applicant to incorporate limitations into its claims (see pgs. 8-9 of Remarks filed 01/05/2026). The Examiner respectfully disagrees that claim 102 provides explicit and specific guidance to a person of skill in the art for generating a polynomial equation to implement the claimed invention without undue experimentation as [00145] of Applicant’s specification discloses both a filtered signal and an error signal are required to produce the rate signal, wherein neither a filtered signal nor an error signal are recited in claim 102. Additionally, the “polynomial function” disclosed in Applicant’s specification is simply employed at a block in a rate control diagram (see Fig. 11 and [00145]), where the polynomial function “could be any of a number of suitable quadratic, cubic, or other function,” including an exponential function (see [00145]). However, exponential functions are not polynomial function; therefore, it is best understood by the examiner, that any suitable function may be employed to produce the rate signal. Hence, a person of ordinary skill in the art could not make or use the invention without undue experimentation to at least determine the type of mathematical function to use to produce the rate signal (see MPEP 2146.06).
In regard to claim 103, Applicant argues an asymmetric filter is a well known technique; therefore, further disclosure is not required to perform the claimed invention without undue experimentation as a person of skill would readily understand that “an asymmetric filter simply indicates that the time responses for increasing and decreasing are different” (see pg 9 of Remarks filed 01/05/2026). The Examiner notes, while a person of ordinary skill in the art may know what an asymmetric filter is, it would not be readily understood that the use of the asymmetric filter specifically indicates that the time responses for increasing and decreasing are different. Additionally, Applicant’s specification discloses an output signal is filtered by a filter, that may be an asymmetric filter, to produce the rate signal (see [00145]), and that a modified low pass filter behaves as an asymmetric filter (see [00147]), but is not an asymmetric filter itself. Hence, it is unclear if the rate signal of claim 103 must be filtered by an asymmetric filter, or if the rate signal is filtered by something that acts as an asymmetric filter. Therefore, a person of ordinary skill in the art would not be able to make or use the invention in its entire scope without undue experimentation.
Regarding the rejection of claims 1 and 113 under 35 U.S.C. § 103, Applicant's arguments filed 01/05/2026 have been fully considered but they are not persuasive.
Applicant argues the prior art, specifically Smith, fails to teach “wherein a rate of change of the heater plate temperature setpoint is variably controlled in dependence at least in part on a difference between the heater plate temperature setpoint and the temperature signal” (see pg. 11 of Remarks filed 01/05/2026). The Examiner acknowledges that controllers taught by Smith are utilized to ensure the combined duty cycle of a duty ratio assigned to a humidifier and a duty ratio assigned to a heated tube does not exceed 100% (Smith col. 24, lines 21-24), this is not the sole function of the controllers. Smith teaches the controllers vary the heating elements between “on” and “off” according to timings provided by the duty ratios for the main purpose of power management (Smith col. 24, lines 26-30); however, it is well-understood by one of ordinary skill in the art that this would consequently vary the temperature of the heating element as well. The controllers taught by Smith control a duty ratio of a heating element of a humidifier, where a duty ratio is a rate of change between the “on” time of the heating element and the total cycle time (e.g., “on” time and “off” time combined) of the heating element.
Applicant further argues Smith fails to teach a rate of change of a heater plate temperature setpoint being variably controlled. 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). Smith further teaches that the duty ratios rely on the input of a temperature setpoint for the humidifier that may be set by an algorithm (Smith col. 24, lines 38-40), where Thudor teaches a controller that executes a supervisory algorithm to control the heater plate and the heater plate temperature setpoint (see Thudor [0061]). Hence Thudor in combination with Smith does teach a rate of change of a heater plate temperature setpoint being variably controlled.
Applicant argues the teachings of Smith are not applicable to a heat temperature setpoint as Smith does not teach a rate of change of the heater plate temperature setpoint being variably controlled in dependence at least in part on a difference, where the “difference” must be equivalent to signal 224 disclose by Applicant, where said signal is multiplied with an error signal (see pgs. 12-13 of Remarks filed on 01/05/2026). However, the controllers taught by Smith do variably control the duty ratio of the heating element based of a difference (see Smith col. 24, lines 53-61), and therefore, in combination with Thudor, teach a variably controlling a heater plate temperature setpoint in dependence at least in part on a difference (also see 103 rejection of claims 1 and 113 above). Furthermore, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a difference between a heater plate temperature setpoint and a temperature signal is multiplied with an error signal) is not recited in the rejected claim. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Tatkov et al. (US 20110120462 A1): Regarding controlling a humidifier chamber temperature with a P.I.D. controller.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ABIGAYLE DALE/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785