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
The amendment filed 2/10/2026 has been entered. Applicant's amendments overcome the previous rejections under pre-AIA 35 U.S.C. 102. Claims 13-16 and 19 have been canceled. Claims 2-12, 17-18, and 20 remain pending.
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 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.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 2-12, 18, and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Somervell et al. (WO 2008091164 A1), hereafter Somervell, in view of O’Connor et al. (US 20040118403 A1), hereafter O’Connor.
Regarding claim 2, Somervell discloses a breathing assistance apparatus (abstract ln 1) comprising: a gases supply unit (blower unit 15; Fig. 1-3) configured to, in use, deliver a stream of pressurised gases (blower unit 15 supplies a pressurized flow of gases; pg. 10 ln 30-31), an outlet (Fig. 1-3, blower unit outlet 1) configured to supply, in use, the stream of pressurised gases to a supply path including a breathing tube and a patient interface (stream of pressurized gases from outlet 1 flows through supply path including breathing conduit 3 and patient interface 12; Fig. 1, pg. 11 ln 24-pg. 12 ln 6); and a control system in communication with the gases supply unit (control system 9 is part of blower unit 15; Fig. 1-3) and configured to control the gases supply unit to generate the stream of pressurized gases (control system 9 controls blower unit 15 to alter output parameters of the breathing circuit; pg. 11 ln 11-13, pg. 12 ln 20-32), the control system further configured to detect a type of the patient interface connected to the breathing tube (RFID tag 2 is used to provide a patient interface identification signal to the control system; pg. 16 ln 16-pg. 17 ln 2); wherein the control system is further configured to set a mode of operation to: a closed CPAP mode based on detecting a closed CPAP patient interface configured to seal against a face of a user, in use (control system 9 adjusts settings according to an identification profile based on the identified patient interface, pg. 16 ln 16-pg. 17 ln 2; patient interface includes closed patient interfaces such as nasal mask and full face mask, pg. 12 ln 12-13; output parameters are determined based on type of patient interface identified, pg. 4 ln 26-32); or an open CPAP mode based on detecting an open CPAP patient interface that does not seal against the face of the user, in use (control system 9 adjusts settings according to an identification profile based on the identified patient interface, pg. 16 ln 16-pg. 17 ln 2; patient interface includes open patient interfaces such as nasal cannula, pg. 12 ln 6-7; output parameters are determined based on type of patient interface identified, pg. 4 ln 26-32).
Somervell does not disclose wherein the control system is configured to measure an indication to determine the type of the patient interface connected to the breathing tube, the indication being one or more of a resistance to flow, a pressure fluctuation during an inspiration-expiration cycle, or a flow fluctuation during the inspiration- expiration cycle.
O’Connor teaches a CPAP apparatus wherein the control system is configured to measure an indication to determine the type of the patient interface connected to the breathing tube, the indication being one or more of a resistance to flow, a pressure fluctuation during an inspiration-expiration cycle, or a flow fluctuation during the inspiration-expiration cycle (processor characterizes mask based on flow sensor measurements, par. 0019; flow sensor 13 measures air flow characteristics of mask system 14, par. 0042; control system of the apparatus uses pneumatic impedance/resistance to flow data from flow sensor to characterize mask attached to the apparatus; par. 0059-0060, par. 0090-0092).
The only difference in the prior art and the claimed device is the substitution of how the type of patient interface is determined. The substituted components and their functions are well known in the art and one of ordinary skill in the art could have substituted Somevell’s RFID tag arrangement with the flow sensor arrangement taught by O’Connor and the results of the substitution would have been predictable. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Somervell such that an information parameter from a sensor is used to determine the type of patient interface as taught by O’Connor as the courts have held that simple substitution of one known element for another to obtain predictable results supports a conclusion of obviousness. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 3, the modified Somervell discloses the breathing assistance apparatus of Claim 2 (shown above), wherein said closed CPAP patient interface is one of a nasal mask, full face mask, nasal pillow mask, or nares sealing nasal cannula (patient interface includes closed patient interfaces such as nasal mask and full face mask, Somervell pg. 12 ln 12-13).
Regarding claim 4, the modified Somervell discloses the breathing assistance apparatus of Claim 2 (shown above), wherein said open CPAP patient interface is a non-sealing nasal cannula (patient interface includes open patient interfaces such as nasal cannula, Somervell pg. 12 ln 6-7).
Regarding claim 5, the modified Somervell discloses the breathing assistance apparatus of Claim 2 (shown above), further comprising a humidification unit (humidifier chamber 5; Somervell), wherein the control system (9; Somvervell) is configured to adjust a humidity of the stream of pressurised gases (control system adjusts power to a heater plate to alter the humidity of gas stream; Somervell pg. 12 ln 25-32).
Regarding claim 6, the modified Somervell discloses the breathing assistance apparatus of Claim 5 (shown above), wherein the humidification unit and the gases supply unit are integrated into one housing (blower unit 15 and humidifier chamber 5 form an integrated unit; Somervell pg. 11 ln 7-10).
Regarding claim 7, the modified Somervell discloses the breathing assistance apparatus of Claim 2 (shown above), wherein the control system (9; Somervell) is further configured to control a pressure provided by the gases supply unit in the closed CPAP mode (control system 9 alters the speed of the fan 20 in the blower unit 15 to alter the pressure or flow of the gas based on information from RFID tags; Somervell pg. 12 ln 25-32, pg. 13 ln 31-pg. 14 ln 6), and control a flow rate provided by the gases supply unit in the open CPAP mode (control system 9 alters the speed of the fan 20 in the blower unit 15 to alter the pressure or flow of the gas based on information from RFID tags; Somervell pg. 12 ln 25-32, pg. 13 ln 31-pg. 14 ln 6).
Regarding claim 8, the modified Somervell discloses the breathing assistance apparatus of Claim 2 (shown above), wherein the gases supply unit comprises a blower (gases supply unit is a blower unit 15; Somervell pg. 10 ln 28-34).
Regarding claim 9, the modified Somervell discloses the breathing assistance apparatus of Claim 8 (shown above), wherein the control system is further configured to operate the blower to provide a substantially fixed pressure in the closed CPAP mode (blower unit can be a CPAP blower unit which is known in the art to provide a fixed pressure/flow; Somervell pg. 10 ln 25-27).
Regarding claim 10, the modified Somervell discloses the breathing assistance apparatus of Claim 8 (shown above), wherein the control system is further configured to control a speed of the blower to provide a substantially fixed gases flow rate in the open CPAP mode (blower unit can be a CPAP blower unit which is known in the art to provide a fixed pressure/flow; Somervell pg. 10 ln 25-27).
Regarding claim 11, the modified Somervell discloses the breathing assistance apparatus of Claim 2 (shown above), further comprising the breathing tube (breathing conduit 3; Somervell) and/or the patient interface (patient interface 12; Somervell).
Regarding claim 12, the modified Somervell discloses the breathing assistance apparatus of Claim 2 (shown above), further comprising at least one sensor to measure at least one information parameter relating to the patient interface (flow sensor 13 measures air flow characteristics of mask system 14; O’Connor par. 0042), the control system configured to receive the at least one information parameter (processor characterizes mask based on flow sensor measurements; O’Connor par. 0019), said control system containing reference data (O’Connor par. 0059-0060) and configured to compare the at least one information parameter to the reference data to determine type of the patient interface connected to the breathing tube (control system of the apparatus uses data from flow sensor to characterize type of mask attached to the apparatus based on a comparison to reference data; O’Connor par. 0059-0060).
Regarding claim 18, the modified Somervell discloses the breathing assistance apparatus of Claim 2 (shown above), wherein the control system comprises conditional elements configured to restrict changes to the mode of operation of the control system (control system operates autonomously unless a manual override switch is operated by the user; Somervell pg. 16 ln 25-pg. 17 ln 6).
Regarding claim 20, the modified Somervell discloses the breathing assistance apparatus of Claim 2 (shown above), wherein the indication of the resistance to flow is a total flow rate through the supply path (impedance can be measured by an associated flow value at a controlled pressure; O’Connor par. 0096).
Claim 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Somervell in view of O’Connor as applied to claim 2 above, and further in view of Truschel et al. (US 20110197882 A1), hereafter Truschel.
Regarding claim 17, the modified Somervell discloses the breathing assistance apparatus of Claim 2 (shown above), wherein the control system is further configured to periodically check a behaviour of the breathing assistance apparatus (RFID tags are monitored at predetermined intervals of time; Somervell pg. 17 ln 21-24), wherein the control system is configured to reassess the type of the patient interface connected to the breathing tube (the type of patient interface attached to the apparatus is reassessed when the device is switched on; Somervell pg. 16 ln 25- pg. 17 ln 2).
Somervell does not disclose the reassessment occurs in response to an expected range of pressure and flow readings falling outside predetermined limits.
Truschel teaches a ventilator which reassesses operational settings in response to an expected range of pressure and flow readings falling outside predetermined limits (ventilator operation is adjusted when a leak is detected, par. 0084; one of ordinary skill in the art would understand that a leak would correspond to abnormal pressure/flow readings) for the purpose of compensating for a potential leak (par. 0084).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the apparatus of Somervell to reassess operational settings in response to an expected range of pressure and flow readings falling outside predetermined limits as taught by Truschel for the purpose of compensating for a potential leak (Truschel par. 0084).
Response to Arguments
Applicant's arguments filed 2/10/2026 have been fully considered but they are not persuasive.
Regarding claim 2, Applicant argues that O’Connor’s approach does not determine a type of patient interface. However, the flow sensor of O'Connor can distinguish flow characteristics of different mask systems. These flow characteristics can define a type of patient interface, such as a high flow resistance or low flow resistance mask. Further, an open and closed CPAP patient interface would have different flow characteristics. Therefore, an open and closed CPAP patient interface can be identified by their respective flow characteristics when measured by the flow sensor of O'Connor.
Applicant also argues neither Somervell or O’Connor teach setting a mode of operation based on the identification of the patient interface. However, Somervell discloses that the control system adjusts output parameters of the blower according to an identification profile based on the identified patient interface (as shown in the rejection above). An identification profile of output parameters can be understood as a mode of operation associated with an identified patient interface. Applicant further argues that neither Somervell or O’Connor teach a selection of modes between an open CPAP mode and a closed CPAP mode. However, Somervell accounts for the identification of patient interfaces including both open patient interfaces and closed patient interfaces. Detection of a patient interface which is closed will adjust output parameters to a setting appropriate for that closed patient interface, which can be understood as a closed CPAP mode.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.R./Examiner, Art Unit 3785 /BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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