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 preliminary amendment filed on 06/11/2026. As directed by the amendment, claims 1-79 were canceled, claims 80, 82-85, 88-90, 93, and 97-104 were amended, and no claims were newly added. Thus, claims 80-104 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 85-88 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 85 line 4, the term “patient breathing conduit” is unclear as to if the term is the same or different than “a patient breathing conduit” of claim 80 line 5-6.
Any remaining claims are rejected as being dependent upon a rejected base claim.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 80-88, 92-99, and 103-104 are rejected under 35 U.S.C. 103 as being unpatentable over O’Donnell et al. (US 2008/0310994; hereinafter “O’Donnell”) in view of Peake et al. (US 2020/0360636; hereinafter “Peake”).
Regarding claim 80, O’Donnell discloses a breathing assistance apparatus (Fig. 1; title “Breathing Assistance Apparatus”) comprising:
a flow generator configured to generate a flow of gases (gas supply generator 4, such as a blower, fan, or compressor [0069]),
a humidifier configured to be pneumatically connected to the flow generator and to humidify the flow of gases (humidification chamber 5),
wherein the breathing assistance apparatus is configured to be connected to a patient breathing conduit that conveys the flow of gases (delivery conduit 3 and elbow conduit 12),
wherein the breathing assistance apparatus is configured to operate in at least one therapy mode ([0016] “treatment session”; [0098] “After a patient 1 has completed their treatment (for example, each morning)”) and at least one non-therapy mode (Disinfection modes/methods [0098]; claim 1 first disinfection conduit), wherein when operating in the at least one therapy mode therapy is being provided to a user (therapy mode is the treatment session above, which is therapy being provided to the user), and when operating in the at least one non-therapy mode, no therapy is being provided to the user ([0098] disinfection of conduit 3 using dry heat is carried out when patient 1 is not using the system 100; and in disinfection conduit 14 mode of use [0080]),
wherein the breathing assistance apparatus is configured to collect and store data (controller 200; [0074] receives inputs of data from sensors or other points in the system 100), the data comprising therapy data collected during operation in the at least one therapy mode or breathing assistance apparatus data ([0075] controller 200 receives data from sensors in the system when controlling blower unit 4),
wherein after a predetermined time operating in the at least one non-therapy mode, the breathing assistance apparatus is configured to:
receive a software package, receive therapy parameters, or update parameters of the breathing assistance apparatus (Temperature sensor 24 in elbow conduit 12 continuously monitors [0094]; and specifically can be after the time of “non-therapy”, or disinfection, [0088] “After a preset or predetermined period of time, the temperature inside the elbow conduit 12 is again measured by the temperature sensor 24”).
O’Donnell is silent as to transmit the collected and stored data to an external device (see O’Donnell sensor 24 communicates via controller 200, but [0073] controller 200 is contained within the housing 10). However, Peake teaches transmit the collected and stored data to an external device (see Peake RPT device 4000 with electrical components 4200; see Fig. 4C [0091-0096] central controller 4230 communicates to remote external device 4286). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller and sensors of O’Donnell with the addition of communication of data from the controller and sensors to an external device as taught by Peake so as to provide more personalized therapy and targeted care with external data processing (see Peake [0104]).
Regarding claim 81, modified O’Donnell discloses the at least one therapy mode comprises: a continuous positive airway pressure (CPAP) mode ([0005] Assisting patient’s breathing using CPAP; [0018] problem to solve in the invention is specifically for disinfecting CPAP devices; [0074] oxygen therapy).
Regarding claim 82, modified O’Donnell discloses the breathing assistance apparatus is configured to automatically operate in the at least one non-therapy mode after completion of the at least one therapy mode ([0098] “the device may automatically activate the conduit disinfecting control sequence after a certain predetermined time period has elapsed after completion of treatment”).
Regarding claim 83, modified O’Donnell discloses the breathing assistance apparatus is configured to enter the at least one non-therapy mode after receiving an end of therapy command ([0098] disinfection is carried out when patient 1 is not using the system 100 [using = treatment]), wherein the end of therapy command is generated: by detection that a patient interface has been removed from the user ([0098] “After a patient 1 has completed their treatment (for example, each morning) the patient 1 removes the patient interface 2”) or by detection that the patient interface has been removed from the user for a predetermined amount of time ([0098] “Removal of the patient interface 2 triggers the start of this predetermined time period”).
Regarding claim 84, modified O’Donnell discloses the breathing assistance apparatus is operating in the at least one non-therapy mode, the flow generator is activated and is generating the flow of gases and is providing the flow of gases at a predetermined flow rate ([0084] controller 200 sets blower unit 4 to a level of 1-50 litres per minutes in order to dry/disinfect the conduit 12; Also, in [0099] blower unit 4 is used to supply heated gas through conduit 3).
Regarding claim 85, modified O’Donnell discloses the at least one non- therapy mode comprises a drying mode configured to dry the conduit and to evaporate remaining condensate in one or more of the breathing assistance apparatus, patient breathing conduit or patient interface ([0098] To disinfect conduit 3 and patient interface 2, dry heat is forced through the conduit 3 to heat and dry the conduit 3; conduit 3 has heated wire 7), and wherein when the breathing assistance apparatus is operating in the drying mode at least one of the following occurs:
a heater of the conduit is controlled while the flow generator provides gases at a predetermined flow rate ([0099] “the controller 200 powers the plate 25 to maintain heat to the humidifying chamber 5, and the blower unit 4 supplies gases through the chamber 5, via the gases supply outlet 11 and the patient outlet 8. it can be seen that a supply of heated dry gases pass through the chamber 5 to the conduit 3”; to about 40-75 degrees C), or
the heater of the conduit is controlled to a predetermined temperature at an end of the conduit ([0099] power to the heater wires 7 throughout the conduit 3; to about 40-75 degrees C).
Regarding claim 86, modified O’Donnell discloses the predetermined temperature is greater than 45 degrees Celsius ([0099] temperature about 40-75 degrees C).
Regarding claim 87, modified O’Donnell discloses the drying mode is configured to be operated for about 20 minutes to about 120 minutes, or about 90 minutes ([0099] the heating sequence continues between 30-120 minutes).
Regarding claim 88, modified O’Donnell discloses the drying mode comprises controlling the flow generator to provide a predetermined flow generator output (see O’Donnell [0098] to disinfect conduit 3, heated air is forced through the conduit, forcing air via blower 4; activating the control sequence or algorithm pre-loaded into the controller 200 starts forcing the heated air), wherein the drying mode further comprises controlling the flow generator to provide a predetermined flow rate, wherein the predetermined flow rate is about 5 litres/minute to about 20 litres/minute ([0030] “Preferably said controller provides a flow of gases through said disinfection conduit at a flow rate of approximately 10 litres per minute”).
Regarding claim 92, modified O’Donnell discloses the non-therapy mode is a disinfection mode ([0094] “The breathing circuit 100 is provided with a first disinfection conduit 14 to allow in particular for disinfection of the elbow conduit 12”).
Regarding claim 93, modified O’Donnell discloses in the disinfection mode, the breathing assistance apparatus is configured to be connected to a disinfection conduit (disinfection conduit 14).
Regarding claim 94, modified O’Donnell discloses in the disinfection mode a heater of the disinfection conduit is controlled so that the flow of gases in the disinfection conduit reaches a predetermined temperature ([0081] blower unit 4 circulates gasses through disinfection conduit 14 heated by heater 19), wherein the predetermined temperature is about 60 degrees Celsius to about 90 degrees Celsius ([0081] the heated gases in the disinfection conduit 14 are heated to a temperature between 60-90 degrees C).
Regarding claim 95, modified O’Donnell discloses the disinfection conduit comprises a temperature sensor (temperature sensor 24).
Regarding claim 96, modified O’Donnell discloses the disinfection mode comprises controlling the flow generator to provide a predetermined flow rate, wherein the predetermined flow rate is about 10 litres/minute to about 20 litres/minute (Claim 4 “said controller provides a flow of gases through said disinfection conduit at a flow rate of approximately 10 litres per minute”).
Regarding claim 97, modified O’Donnell discloses the therapy data comprises data relating to the user or therapy provided to the user (controller 200; [0074] receives inputs of data from sensors or other points in the system 100), wherein the therapy data comprises one or more of: a flow rate of the gases provided to the user ([0075] blower 4 has variable speed controlled by controller 200, where data from sensors located in the system 100 relate to the variable speed for calculating flow rate through the whole system), usage data of the breathing assistance apparatus (temperature sensor 24 measures whether or not the apparatus has been disinfected to a high enough temperature).
Regarding claim 98, modified O’Donnell discloses the breathing assistance apparatus comprises one or more sensors configured to determine the therapy data (see O’Donnell controller 200; [0074] receives inputs of data from sensors or other points in the system 100), wherein the breathing assistance apparatus is configured to receive a sensor output from the one or more sensors (see O’Donnell temperature sensor 24), wherein the therapy data is based on the sensor output from one or more sensors (see O’Donnell [0094] temperature sensor 24 is continuously monitored to validate each disinfection cycle; displays information to user). O’Donnell is silent as to wherein when the breathing assistance apparatus is operating in the at least one non-therapy mode the user is presented with one or more questions, and provides answers to these questions via at least one user interface, and wherein the questions or answers to the questions form part of the therapy data.
However, Peake teaches the breathing assistance apparatus is operating in the at least one non-therapy mode the user is presented with one or more questions (see Peake [0113] Questions provided on the output devices 4290 [such as a display], and may only receive inputs during setup, which would mean non-therapy is occurring), and provides answers to these questions via at least one user interface (see Peake [0113] user answers questions using input devices 4220), and wherein the questions or answers to the questions form part of the therapy data (see Peake Claim 1 questions are asked, where the answers from the user are used as inputs to the apparatus, and “settings for the respiratory pressure therapy system determined based on the transmitted answers; and adjust, based on the received settings, control settings of the respiratory pressure therapy system”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus display and controller of O’Donnell with the question and answer system for the user as taught by Peake so as to adjust the therapy system according to direct user input of how the therapy is being performed, and increase the information used to properly treat the patient.
Regarding claim 99, modified O’Donnell discloses the therapy data comprises data from at least one historic therapy mode ([0100] controller 200 is pre-loaded with flow and pressure characteristics for a range of users; and [0107] “comparing the flow and temperature characteristics as measured, with pre-loaded parameters indicative of a particular cycle”).
Regarding claim 103, modified O’Donnell discloses after receiving the software package, the breathing assistance apparatus applies the software package to the breathing assistance apparatus ([0073] Controller 200 executes computer software commands stored in memory; when the memory receives these software commands, the controller 200 executes them), wherein after receiving the therapy parameters, the breathing assistance apparatus updates the therapy parameters of the breathing assistance apparatus ([0094] temperature of the conduit 12 is continuously monitored by temperature sensor 24 so each cycle can be validated within the apparatus).
Regarding claim 104, modified O’Donnell discloses an breathing assistance apparatus controlled by an updatable software package (see O’Donnell [0073]), but is silent as to the breathing assistance apparatus only receives the software package or the therapy parameters if the software package or therapy parameters are an update to a current software package or a current therapy parameter. However, Peake teaches the breathing assistance apparatus only receives the software package if the software package are an update to a current software package (see Peake [0136] The models (can be considered software the apparatus is operating under) may be updated with new data as new data (e.g., data including demographic feedback, subjective feedback, and/or changes to compliance standards) become available. If there is no new data, the update would not be necessarily made). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller with software package of O’Donnell with the controller with software packages that are updated when available as taught by Peake so as to update the apparatus needs as the patient requires them, and as this would have been an obvious substitution for one known type of software system in a controller for another and would yield predictable results, i.e. control the apparatus.
Claims 89-91 are rejected under 35 U.S.C. 103 as being unpatentable over O’Donnell in view of Peake as applied to claim 80 above, and further in view of Payton et al. (US 2008/0190427; hereinafter “Payton”).
Regarding claim 89, modified O’Donnell is silent as to the non-therapy mode is a warm up mode, wherein the breathing assistance apparatus operates in the warm up mode when the breathing assistance apparatus is powered on. However, Payton teaches the non-therapy mode is a warm up mode (see Payton [0077-0081] Warm up mode), wherein the breathing assistance apparatus operates in the warm up mode when the breathing assistance apparatus is powered on (see Payton [0077-78] On start-up of therapy, blower 15 slowly supplies warmed air through heated conduit 3 until the controller informs the user to wear the interface, meaning therapy is not supplied until the conduit is warmed). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the non-therapy mode of O’Donnell with the warm up mode as taught by Payton so as to supply the patient with optimal temperature of gas as soon as possible once therapy starts (see Payton [0078]).
Regarding claim 90, modified O’Donnell discloses the warm up mode comprises controlling a heater (see Payton heater plate 7 of humidification chamber 5) of the conduit to control a temperature at an end of the conduit to a desired temperature (see Payton [0078] “the temperature of the gases at the chamber outlet are measured by a sensor this is the temperature that is to be controlled to the set temperature value”; the chamber outlet is the start of conduit 3), wherein the desired temperature at the end of the conduit is a predetermined temperature (see Payton [0078] when the gas temperature in the chamber outlet reaches the set temperature, the patient can now wear the interface), wherein the one or more therapy parameters are: a therapy chamber outlet temperature or a therapy temperature at the end of the conduit (see Payton [0078] temperature of the gas is taken at the chamber outlet, which is the same as the inlet end to the conduit).
Regarding claim 91, modified O’Donnell discloses the warm up mode comprises one or more of: controlling a heater of the humidifier to a predetermined temperature (see Payton [0078] heater plate 7 of humidification chamber 5 is heated until the gas temperature output is controlled to the set temperature value).
Claims 100-101 are rejected under 35 U.S.C. 103 as being unpatentable over O’Donnell in view of Peake as applied to claim 80 above, and further in view of Schwaibold (US 2022/0084671).
Regarding claim 100, modified O’Donnell is silent as to the data is transmitted to the external device even if the breathing assistance apparatus has not operated in at least one therapy mode. However, Schwaibold teaches the data is transmitted to the external device even if the breathing assistance apparatus has not operated in at least one therapy mode (see Schwaibold ventilator 1 communicates with server 7; [0046] data transfer between ventilator 1 and server 7 can be a live transfer, for example a transfer every 1-60 minutes. If the data is transferred periodically every 1-60 minutes, the therapy mode provided is not a factor in the transfer). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus controller of modified O’Donnell with the breathing assistance apparatus transferring data to a device as taught by Schwaibold so as to communicate the data regarding the patient in order to personalize treatment.
Regarding claim 101, modified O’Donnell discloses a remote device (see modified O’Donnell including Peake remote external device 4286), but is silent as to the data is transmitted to the device after a predetermined period of time has elapsed since a last transmission of data to the device, wherein the device is one or more of: a server a local device, or a remote device.
However, Schwaibold teaches the data is transmitted to the device after a predetermined period of time has elapsed since a last transmission of data to the device (see Schwaibold ventilator 1 communicates with server 7; [0046] data transfer between ventilator 1 and server 7 can be a live transfer, for example a transfer every 1-60 minutes),
wherein the device is one or more of: a server (see Schwaibold server 7), or a remote device (see Schwaibold server 7 connects to a computer [0065]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller communication between the sensors and external device of modified O’Donnell with the ability to communicate data from the device to a server/remote device periodically as taught by Schwaibold so as to consistently update the apparatus as to the patient’s condition and as this would have been an obvious substitution for one known type of communication system for an apparatus controller for another and would yield predictable results, i.e. collect data from the apparatus use.
Claim 102 is rejected under 35 U.S.C. 103 as being unpatentable over O’Donnell in view of Peake as applied to claim 80 above, and further in view of Feldhahn et al. (US 2016/0213869; hereinafter “Feldhahn”).
Regarding claim 102, modified O’Donnell is silent as to the user is presented with a visual indicator and/or an audio indicator while the data is being transmitted to the external device, or wherein the user is presented with a visual indicator and/or an audio indicator if the user attempts to power off the breathing assistance apparatus when the data is being transmitted to the external device. However, Feldhahn teaches the user is presented with a visual indicator and/or an audio indicator while the data is being transmitted to the external device (see Feldhahn Breathing apparatus with control unit 19; where [0030] the storage of data or remote transmission of data is visualized by means of flashing). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller of O’Donnell with the controller ability to emit a visual indicator when the controller is transmitting data as taught by Feldhahn so as to indicate to the user when data is transferred, and ensure the full process of transmission is completed prior to shutting off the apparatus.
Response to Arguments
Applicant's arguments filed 06/11/2026 have been fully considered but they are not persuasive.
Applicant' s arguments, see pages 8-9 of the remarks, with respect to the rejection(s) of claim(s) 80-88, 92-97, 99, and 103 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection in view of the amended claim language is made in view of O’Donnell in view of Peake under 35 USC 103.
Applicant argues, see page 10 of the remarks, in regards to the rejection of claims 100-101 that “Schwaibold does not teach a non-therapy mode and does not teach transmitting, receiving or updating anything after a predetermined time operating in a non- therapy mode”. However, Examiner disagrees because claim limitations in 100-101 do not operate in the non-therapy mode. Schwaibold teaches periodic transfer of data regardless of device operation, thus meeting the limitations of claims 100-101, see rejections above. Thus, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GWYNNETH L HOWELL whose telephone number is (703)756-4742. The examiner can normally be reached 8:30-4:30 M-F.
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/GWYNNETH L HOWELL/Examiner, Art Unit 3785
/RACHEL T SIPPEL/Primary Examiner, Art Unit 3785
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