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 action is responsive to the amendment filed 11/11/2025. The previous claim objections and 112 rejections have been withdrawn in response to amendment. Claim 11 has been added thus claims 1-11 are pending.
Claim 9 is objected to because of the following informalities: “the manual valve” should read ---the one or more valves---. Appropriate correction is required.
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 1, 3, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Khwaja (WO 2021/189138 A1) in view of Chang (US 2019/0275273 A1).
Regarding claim 1, Khwaja discloses an intelligent distribution module (abstract, #100 fig 3-4, #102 fig 7), to be attached to a ventilator (#51 fig 3-7), the intelligent distribution module comprising one or more air inlet tubes (connections between ventilator and port 1 in fig 7), one or more air outlet tubes (connections between port 1 and the patient fig 7-8, including separation to ports 2 and 3 shown in fig 8), each of the one or more air outlet tubes is equipped with one or more air flow sensors (par 0024, #140a/b fig 8 par 0088 discloses 140 as pressure sensors further disclosing the use of other sensors such as flow sensors), one or more valves (#160a/b fig 7, par 0090 discloses one way valves); and a control system (#130 fig 7, par 0083), including a HMI human interface central unit (#105 fig 7 “user interface”, par 0085).
Khwaja does not expressly disclose the outlet tube being equipped with one or more antibacterial filters or a pressurized breathable air tank which accumulates air received from the ventilator. Khwaja discloses the use of filters for filtering viruses and other contaminants in the expiratory branch of the device (Fig. 7, viral filters 170a and 170b).
Chang teaches a ventilator system with a pressurized breathable air tank which accumulates air received from the ventilator (#19 fig 3, par 0271) and a bacterial filter (#13 fig 3, par 0259) in the inspiratory branch/outlet tube.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the filters in the inspiratory branch/the “outlet tubes” as taught by Chang on the device of Khwaja to deliver bacteria free air to a user. It would have further been obvious to use a pressure tank as taught by Chang on the module of Khwaja as doing so allows the system for oxygen to be mixed with the air supplied by the ventilator.
Regarding claim 3, modified Khwaja discloses the module of claim 1. Chang further discloses one or more pressure sensors in the pressurized breathable air tank (#21 fig 3, par 0275).
Regarding claim 8, modified Khwaja discloses the module of claim 1. Khwaja further discloses each of the one or more air outlet tube comprises a pressure sensor (par 0086 pressure regulator may include pressure sensors, par 0022).
Regarding claim 9, modified Khwaja discloses the module of claim 8. Khwaja does not disclose the pressure sensor is located after the valve.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to place the pressure sensor downstream of the valve as a simple rearrangement of part (MPEP 2144.04.VI.C) as doing so will not affect the intended function of the valves/sensor. Further the rearrangement may improve the pressure reading as the pressure sensor can accurately read the pressure being delivered to the patient including the pressure drop caused by the valve.
Regarding claim 10, modified Khwaja discloses the module of claim 1. Larson further teaches each of the one or more air outlet tube comprises one or more check or one-way valves (par 0090).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over modified Khwaja as applied to claim 1 above, and further in view of Jonson (US 2003/0078512 A1).
Regarding claim 2, modified Khwaja discloses the module of claim 1. Khwaja further discloses the control system comprises an HMI screen (#105 fig 7, 9, par 0085), which can manage one, two or three air outlet tubes simultaneously (see fig 3-8 showing 2 outlet tubes, par 0083 “independently monitoring and/or controlling certain parameters of the fluid in different breathing circuits, such as … the inspiratory branches”).
Khwaja is silent to an analog-digital converter module.
Jonson teaches a ventilation apparatus utilizing an analog-digital converter (par 0059 “The flow measured by the inspiratory flow sensor is subjected to analogue/digital conversion in the computer and compared to the intended flow at every instant”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate an analog-digital converter as taught by Jonson on the module of modified Khwaja so that the controller of Khwaja can utilize/monitor the measurements from the sensors.
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over modified Khwaja as applied to claim 1 above, and further in view of Friberg (US 2005/0000519 A1).
Regarding claim 4, modified Khwaja discloses the module of claim 1. Khwaja does not expressly disclose the one or more air flow sensors are proximal and / or bidirectional.
Friberg teaches a ventilation system that utilizes a proximal airflow sensor (par 0017, 0027, #23 fig 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize a proximal flow sensor as taught by Friberg on the module of modified Khwaja as doing so allows for the system to monitor the breathing efforts of the patient (Friberg par 0017).
Regarding claim 5, modified Khwaja discloses the module of claim 1. Khwaja does not expressly disclose the one or more valves allow passage of airflow from 0% to 100%.
Friberg teaches a ventilation system utilizing a proportional valve (claim 16) thus disclosing a valve allowing passage of airflow from 0% flow to 100% flow.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize proportional valves as taught by Friberg on the module of Khwaja as doing so allows for the flow delivered in each outlet/inspiratory branch to be adjusted individually in infinite increments allowed for by a proportional valve.
Regarding claim 6, modified Khwaja discloses the module of claim 1. Khwaja does not expressly disclose the one or more valves are electrically actuated valves.
Friberg teaches a ventilation system utilizing electrically actuated valves (par 0006 “electrical valve controls”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize electric valves as taught by Friberg on the module of Khwaja as doing so allows for the valves to be controlled directly by the computer system.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over modified Khwaja as applied to claim 1 above, and further in view of Fuhrman (US 2009/0050151 A1).
Regarding claim 7, modified Khwaja discloses the module of claim 1. Khwaja discloses the use of a humidifier (#55 fig 7).
However, Khwaja is silent to the humidifier being in one, two or three outlet tubes of the intelligent distribution module, located between the or each antibacterial filter and an air inlet pathway to the patient.
Fuhrman teaches a ventilation system with humidifiers located in individual outlet tubes/ inspiratory branches (#99 fig 4, par 0029).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize humidifiers in the outlet tubes as taught by Fuhrman instead of one humidifier of Khwaja as having a humidifier for each outlet tube allows for the humidity of the breathing gas to be adjusted for the individual user. It would have further been obvious to locate the humidifier between the filter and the patients air inlet as having the filter downstream of the humidifier prevent the humidity from being filtered out or damaging the filter with moisture.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over modified Khwaja as applied to claim 1 above, and further in view of Larson (US 2013/0306062 A1).
Regarding claim 11, modified Khwaja discloses the module of claim 1. Khwaja is silent to the valves being manual valves.
Larson discloses a similar ventilation device (abstract) utilizing one or more manual valves in outlet tubes (#190 and 195 fig 1, par 0023 “manual valves 190, 195 located at or near each of the one or more dispensers”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize manual valves as taught by Larson on module of Khwaja as doing so allows for a user to operate the valves individually/directly avoiding issues present with non-manual valves such as loss of power to the valves.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. While Khwaja and Chang continue to be used in the 35 USC 103 rejection, the application of these reference has changed in response to the applicant’s amendments (see rejection of claim 1 above).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Boussignac US 5,964,220 discloses a multi patient system with a reservoir/pressurized breathable air tank (4) fed by the ventilator
Lemer US 6,474,334 B1 discloses a multi-patient ventilation system
Naghavi WO 2007/137302 A2 discloses a multi-patient ventilation system , see fig 18
Delangre WO 2015/179915 A1 discloses a ventilation system utilizing an anti-bacterial filter
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 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
/TIMOTHY A STANIS/Primary Examiner, Art Unit 3785