Conclusion
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This action is responsive to the amendment filed 01/14/2026. Claims 24 and 26-43 remain pending.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 24, 26-29, 31, 35, 40 and 42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McGroary (US 2011/0308518 A1) in view of Alexander (CN 101541367 A) and Tobia (US 2005/0284469 A1).
Regarding claim 24, McGroary discloses a respiratory humidification system (abstract), comprising: a flow generator that is configured to deliver a flow of breathing gas (#52 fig 2, par 0027), the flow generator comprising a ventilator (#50 fig 2-7 par 0027 discloses a pressure support or CPAP system thus disclosing a ventilator); a separate humidifier (#70 fig 2, 4, par 0033-0035 disclose humidifier as an accessory that can be coupled to the ventilator thus disclosing separate, further #104 fig 8 discloses the ventilator can be operated without the humidifier further disclosing the humidifier accessory to be separate) that is configured to receive the flow of breathing gas from the flow generator and output a humidified flow of breathing gas (par 0034 discloses the humidifier coupled to the CPAP thus it is seen as disclosed that the humidifier is used to humidify the flow produced by the flow generator); and a communication connection between the humidifier and the flow generator , wherein the communication connection is configured to permit electronic communication between the humidifier and the flow generator (see arrow between humidifier 70 and controller 64 in fig 2, par 0034 discloses controller of ventilator/cpap controlling the humidifier thus disclosing electronic communication), wherein the communication connection is configured to allow control signals to be transmitted between the flow generator and the humidifier of the system to permit the flow generator to control the humidifier (par 0034); wherein the communication connection is configured such that the ventilator is configured to set or confirm one or more operating parameters of the humidifier (par 0036 user interface of ventilator used to adjust and/or set operating parameters of the humidifier).
McGroary is silent to the humidifier comprising a humidifier unit and a heater plate configured to heat a liquid in a humidity chamber, and wherein the humidifier provides power to a breathing tube including a heater wire and wherein the flow generator informs the humidifier to shut off power to the heater plate and/or the heater wire when the flow of breathing gas is interrupted or stopped.
Alexander teaches a respiratory system involving a flow generator and a humidifier (abstract). Alexander further teaches a humidifier that uses of a heater plate configured to heat a liquid in a humidity chamber (par 0005 teaches a heating plate under a humidity chamber and par 00131 discloses a heater plate floating inside the humidity chamber, fig 4A and 7) and a heating wire inside a breathing tube (see fig 1A-1C, 5, abstract par 00142), wherein the flow generator informs the humidifier to shut off power to the heater plate and/or the heater wire when the flow of breathing gas is interrupted or stopped (par 00217 discloses a signal of no air-flow causing the power to the heating pipe to be cut off, par 0075 discloses the heater controller may be incorporated in the humidifier, see also par 00140 disclosing the heater controller 21 supplying power to the heater components).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize heating wires and heater plates as taught by Alexander on the system of McGroary as the two are common humidifier components. It would have further been obvious to have the flow generator inform the humidifier to shut off power when flow is interrupted as doing so can prevent the breathing tube from overheating (Alexander par 00217).
McGroary is further silent to the operating parameter comprising at least a type of ventilator utilized. However, McGroary does disclose the operating parameters including information on the type of therapy and setup (par 0037) therefore suggesting that the humidifier may be informed on the ventilator it is connected to by way of the therapy to be delivered and the setup/connection.
Tobia teaches a ventilator (#24 fig 2) and a separate nebulizer (#18 fig 2) with a communication connection (#28 fig 2, par 0029), wherein the communication connection allows for the nebulizer to be controlled by operating parameters including a type of ventilator utilized (par 0011 discloses the ventilator controlling the nebulizer based on parameters such as breath control type of the ventilator thus disclosing a parameter of a type of ventilator utilized, see also par 0033).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have one of the parameters of the device of McGroary include a type of ventilator, as utilizing such parameters can help ensure the humidifier and ventilator provide “optimal delivery” to the patient (Tobia: par 0033).
Regarding claim 26, modified McGroary discloses the system of claim 25. McGroary further discloses the one or more operating parameters are further configured to: include one or more operating modes of the humidifier; be related to an operating mode of the ventilator; comprise a temperature of the flow of breathing gas; or comprise a humidity of the flow of breathing gas (par 0040 discloses humidity level as an operating parameter).
Regarding claim 27, modified McGroary discloses the system of claim 24. McGroary further discloses a user interface (#66 fig 2, 5-7, par 0033), the user interface configured to display ventilator operating data and information (par 0033 “ displays and/or outputs information and data to the user”), the user interface further configured to permit a user to interact with the ventilator by entering data or information, or setting or confirming various operating settings or operating modes of the ventilator via the user interface (par 0033, 0036), wherein the user interface comprises a touch screen user interface (par 0035 “touch pad”).
Regarding claim 28, modified McGroary discloses the system of claim 27. McGroary further discloses wherein the user interface of the ventilator is configured to replace the user interface of the humidifier (par 0006-0007 discloses the interface of the ventilator being used to control the humidifier as well so that the user interface of the humidifier is not needed and essentially replaced) or provide an alternative interface to the user interface of the humidifier.
McGroary does not expressly disclose the humidifier comprises a user interface. However, McGroary does disclose that it is common in the art for both the ventilator and the humidifier to have user interfaces (fig 1, par 0004).
It would have been obvious to an artisan at the time of invention to continue to utilize humidifiers with user interfaces so that known and already manufactured humidifiers can be integrated for use in the system of McGroary thus reducing the cost by requiring manufacturing of a ventilator with an interface that can control the humidifier and not requiring manufacturing of a new humidifier attachment.
Regarding claim 29, modified McGroary discloses the system of claim 27. McGroary further discloses the user interface of the ventilator includes a menu that displays available operating parameter(s) or operating mode(s) of the humidifier (#82 fig 6-7, par 0039-0040).
Regarding claim 31, modified McGroary discloses the system of claim 27. McGroary further discloses the ventilator is configured to allow the user to set or confirm operating parameters or operating modes of the humidifier utilizing the user interface (par 0036).
Regarding claim 35, modified McGroary discloses the system of claim 24. McGroary further discloses the system is operative according to a control routine for operating the humidifier with the ventilator, wherein the control routine is configured to establish communication between the humidifier and the ventilator (Step 100 fig 8, par 0043).
Regarding claim 40, modified McGroary discloses the system of claim 24. McGroary further discloses one or both of: a breathing circuit (#56 fig 2) that is configured to receive the humidified flow of breathing gas from the humidifier; or a patient interface (#58 fig 2) that is configured to receive the humidified flow of breathing gas from the breathing circuit and deliver the humidified flow of breathing gas to a patient.
Regarding claim 42, modified McGroary discloses the system of claim 24. McGroary further discloses the flow generator and the humidifier are integrated with one another (see fig 4 showing the ventilator and humidifier integrated together).
Claim 30 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over modified McGroary as applied to claim 27 above, and further in view of Brooker (US 20020026940 A1).
Regarding claim 30, modified McGroary discloses the system of claim 27. McGroary is silent to the user interface of the ventilator is configured to display a prompt to direct the user to set an operating parameter or an operating mode of the humidifier.
Brooker teaches a similar ventilator/pulmonary system (abstract) wherein a user interface of the ventilator is configured to display a prompt to direct the user to set an operating parameter or an operating mode (par 0101 “once in the setup mode, the software will prompt the user to enter the values for the parameters”).
It would have been obvious to an artisan at the time of invention to include input prompts as taught by Brooker onto the system of McGroary as doing so ensures that the user properly assigns operating parameters after setup rather than automatically using previously set parameters for a different patient.
Claims 32-34, 36-39 and 43 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over modified McGroary as applied to claims 24 and 25 above, and further in view of Makinson (US 2004/0016430).
Regarding claim 32, modified McGroary discloses the system of claim 24. McGroary is silent to the communication connection is configured to transmit data between the ventilator and humidifier, the data including any one or more of: an on/off power state of a component of the system; a current operational status of a component of the system; current sensor data; or parameter set-points.
Makinson teaches a similar respiratory humidification system (abstract) with a flow generator (#21 fig 2) and a humidifier (#6 fig 2) with a communication connection that allows control signals to be transmitted between the flow generator and the humidifier (par 0033-0034) wherein the communication connection is configured to transmit data between the ventilator and humidifier, the data including any one or more of: an on/off power state of a component of the system; a current operational status of a component of the system; current sensor data (par 0034 discloses the controller receives sensor data); or parameter set-points.
It would have been obvious to an artisan at the time of invention to have the communication connection allow for data to be transmitted between the humidifier and the ventilator as taught by Makinson in addition to control signals of the system of McGroary. Transmitting data allows for better control of the humidifier as feedback from sensor data allows for better control of the delivered flow than the operating settings alone (Makinson par 0047).
Regarding claim 33, modified McGroary discloses the system of claim 24. McGroary is silent to the communication connection is configured to transmit data between the ventilator and humidifier, wherein the data comprises data relating to the humidifier that is configured to be transmitted to the ventilator over the communication connection, wherein the data includes information relating to a status or operation of the humidifier.
Makinson teaches a similar respiratory humidification system (abstract)with a flow generator (#21 fig 2) and a humidifier (#6 fig 2) with a communication connection that allows control signals to be transmitted between the flow generator and the humidifier (par 0033-0034) wherein the communication connection is configured to transmit data between the ventilator and humidifier, wherein the data comprises data relating to the humidifier that is configured to be transmitted to the ventilator over the communication connection, wherein the data includes information relating to a status or operation of the humidifier (par 0034 e.g. heater plate temperature sensor, 0038-0040 humidity data).
It would have been obvious to an artisan at the time of invention to have the communication connection allow for data to be transmitted between the humidifier and the ventilator as taught by Makinson in addition to control signals of the system of McGroary. Transmitting data allows for better control of the humidifier as feedback from sensor data allows for better control of the delivered flow than the operating settings alone (Makinson par 0047).
Regarding claim modified 34, modified McGroary discloses the system of claim 33. Makinson further teaches the information relating to the status or operation of the humidifier comprises one or more of temperature information (par 0034 “heater plate temp sensor”), error status, or alarm conditions.
Regarding claim 36, modified McGroary discloses the system of claim 24. McGroary is silent to the humidifier is configured to transmit information or data relating to the humidifier to the ventilator.
Makinson teaches a similar respiratory humidification system (abstract)with a flow generator (#21 fig 2) and a humidifier (#6 fig 2) with a communication connection that allows control signals to be transmitted between the flow generator and the humidifier (par 0033-0034) wherein the humidifier is configured to transmit information or data relating to the humidifier to the ventilator (par 0034 e.g., heater plate temperature sensor, 0038-0040 humidity data).
It would have been obvious to an artisan at the time of invention to have the communication connection allow for data to be transmitted between the humidifier and the ventilator as taught by Makinson in addition to control signals of the system of McGroary. Transmitting data allows for better control of the humidifier as feedback from sensor data allows for better control of the delivered flow than the operating settings alone (Makinson par 0047).
Regarding claim 37, modified McGroary discloses the system of claim 36. Makinson further teaches the humidifier data comprises any one or more of: temperature information (par 0034 e.g., heater plate temperature sensor); humidity information (par 0034 humidity sensors); humidifier chamber volume information.
Regarding claim 38, modified McGroary discloses the system of claim 24. McGroary further discloses a breathing circuit (#56/58 fig 2) that is configured to receive the humidified flow of breathing gas from the humidifier.
McGroary is silent to the humidifier is configured to transmit information or data relating to the breathing circuit to the ventilator.
Makinson teaches a similar respiratory humidification system (abstract)with a flow generator (#21 fig 2), a humidifier (#6 fig 2), a communication connection that allows control signals to be transmitted between the flow generator and the humidifier (par 0033-0034) and a breathing circuit (#3/2 fig 1) that is configured to receive the humidified flow of breathing gas from the humidifier, and wherein the humidifier is configured to transmit information or data relating to the breathing circuit to the ventilator (sensors 11 and 12 on breathing circuit, see par 0034, and par 0042-0044 regarding compliance of the circuit/interface).
It would have been obvious to an artisan at the time of invention to have the communication connection allow for data relating to the breathing circuit to be transmitted between the humidifier and the ventilator as taught by Makinson in addition to control signals of the system of McGroary. Transmitting data allows for better control of the humidifier and ventilator as feedback from sensor data allows for better control of the delivered flow than the operating settings alone (Makinson par 0047).
Regarding claim 39, modified McGroary discloses the system of claim 38. Makinson further teaches the data relating to the breathing circuit comprises one or more of: compliance information (par 0042-0044); leak rate information; dead space information; an actual tidal volume.
Regarding claim 43, modified McGroary discloses the system of claim 24. McGroary is silent to the flow generator is configured to communicate with a central monitoring system or an electronic patient data recordation system, wherein the flow generator is configured to communicate the one or more operating parameters or an operating mode of the humidifier to the central monitoring system or electronic patient data recordation system.
Makinson teaches a similar respiratory humidification system (abstract)with a flow generator (#21 fig 2), a humidifier (#6 fig 2), a communication connection that allows control signals to be transmitted between the flow generator and the humidifier (par 0033-0034) wherein the flow generator is configured to communicate with a central monitoring system or an electronic patient data recordation system, wherein the flow generator is configured to communicate the one or more operating parameters or an operating mode of the humidifier to the central monitoring system or electronic patient data recordation system (par 0038 analysis and reporting software, par 0049-0051 compliance reporting software).
It would have been obvious to an artisan at the time of invention to incorporate the data recordation system of Makinson onto the system of McGroary as doing so allows for a clinician to review the data and better advise a patient on settings to employ for effective results (Makinson par 0053).
Claim 41 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over modified McGroary as applied to claim 24 above, and further in view of Lewis (US 20080142019 A1).
Regarding claim 41, modified McGroary discloses the system of claim 24. McGroary does not expressly disclose the communication connection comprises a wired connection.
Lewis teaches a ventilator system (abstract) that uses a wired connection for electronic communication between components (par 0112 heating element in electrical communication with microprocessor via wire).
It would have been obvious to an artisan at the time of invention to utilize a wired connection as taught by Lewis for the communication connection of McGroary as a wired connection provides a secure communication preventing disconnection as can be common with wireless connections.
Response to Arguments
Applicant's arguments filed 01/14/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim 24’s limitation of “the operating parameter comprising at least a type of ventilator utilized” are not persuasive. Applicant asserts that Tobia’s disclosure of “breath control type of the ventilator, e.g. pressure or volume” amounts to an operating parameter of the ventilator rather than a ventilator type (see pg 6-7 of response filed 01/14/2026). However, it remains seen that the disclosure supports identifying if the ventilator is a pressure control type of ventilator or a volume control type of ventilator, thus disclosing identifying a type of ventilator. Further relied upon par 0011 and 0033 disclose information such as “information obtained during checkout of the ventilator” and “inspiratory volume of the ventilator” which is further seen to disclose a type of ventilator as this information is dependent on the type of ventilator. It is unclear how applicant intends the term “type of ventilator” to be limiting i.e. to brand of ventilator, to invasive or noninvasive ventilators, the specification fails to provide a definition/clarification on how “type of ventilator” should be read to exclude the disclosure of Tobias. Applicant’s arguments are not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cortez WO 2009/011907 A1 discloses a heater coupled to a ventilator to control operation of the heater
Klasek CN 101541367 A discloses integrated control of a humidifier and flow generator
Heine US 8,800,970 B2 discloses cutting of power to a heater when insufficient gas flow is recognized see col 10 ln 15-20
Gradon US 6,349,722 B1 discloses a humidifier with a heater plate and a heating wire wherein the power supplied to the heating elements is dependent on/proportional to the gas flow
Tobia US 2005/0284469 A1 discloses integrated control of a ventilator and a nebulizer
Somervell US 2011/0088693 A1 discloses a breathing circuit with controls for a humidifier and ventilator
Payton US 2008/0028850 A1 a breathing circuit with controls for a humidifier and ventilator
Meier US 2009/0159079 A1 discloses a respiratory system, controlling a humidifier based on sensor data
Andrew WO 2009/145646 A1 a breathing circuit with controls for a humidifier and ventilator
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KIRA B DAHER whose telephone number is (571)270-0190. The examiner can normally be reached M-F 8am-5pm.
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/KIRA B DAHER/Examiner, Art Unit 3785
/BRADLEY H PHILIPS/Primary Examiner, Art Unit 3799