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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dahlstrom et al 2010/0252046
Regarding claim 1, Dahlstrom teaches a method for operating a ventilation system comprising: activating a first valve (manual ventilation valve 48) to provide a pilot pressure to a second valve (Expiratory valve 40, 0049 states “the expiratory valve 40 controls the pressure provided by the manual bag 50 to the breathing gas flow in the circle system 7.”) activating the second valve (0043 states “, the manual ventilation valve 48 is actuated to an open position in order to allow gas flow in the manual ventilation line 46 to and from the manual ventilation bag 50, and the manual ventilation control unit 64 is activated to control the expiratory valve 40.”) to permit a diaphragm of the second valve (Expiratory valve membrane 602, figure 8) to establish fluidic communication between a manual circuit of the ventilation system and a scavenging circuit of the ventilation system when a pressure of the manual circuit exceeds the pilot pressure (0045 states “When functionally operated as an APL valve during manual ventilation, the expiratory valve 40 implements an electronically controlled pressure relief valve for venting the anesthesia patient breathing circuit when the pressure within the circuit reaches a predetermined level, such that the patient is not subjected to an excessive pressure.” Evacuation line 36 in figure 2 leads to a scavenging system, communication between the manual circuit of bag 50 and the scavenging circuit occur through expiration valve 40), and to block the fluidic communication when the pressure of the manual circuit is less than or equal to the pilot pressure (0051 states “the electronic expiratory valve 40 to open or close at pre-defined pressure levels and thereby limit the pressure in the breathing circuit, according to a first set of predetermined control rules during mechanical ventilation mode,”), thereby delivering a target positive end expiratory pressure (PEEP) from a gas control unit during expiration (0059 states “During mechanical ventilation, a PEEP may be maintained by means of the expiratory valve 40.’); and adjusting the pilot pressure based on a comparison of a patient airways pressure to the target PEEP (0041 states the control rules implement pressure control functions of the patient pressure. During expiration, a positive end expiratory pressure (PEEP) may be adjusted by the expiratory valve 40 at the end of the expiratory breathing phase, before the next inspiration phase starts. The expiratory valve 40 is usually closed during inspiration and controls the expiratory pressure level, and expiratory flow, during expiration.”).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 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 2, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Dahlstrom in view of Lindsay et al. WO 8605992
Regarding claim 2, Dahlstrom teaches the method of claim 1, wherein the second valve is a pneumatically controlled pressure relief valve (PRV) (0083 and 0084 discuss pneumatic operation of valve 40), but fails to teach wherein activating the first valve includes energizing an electromagnet to control a position of a solenoid of the first valve wherein the first valve is an electronically-controlled valve. Lindsay teaches an analogous gas flow system that does teach wherein activating the first valve includes energizing an electromagnet to control a position of a solenoid of the first valve (page 17 states “the pneumatic signal may conveniently be supplied automatically upon switching of the solenoid valve 19 into the condition wherein mechanical ventilation can occur. The valve 16 further comprises a biasing spring 81 arranged to urge the closure member 77 into its first condition when actuating pressure is removed from the diaphragm 80. In this way, in the event of a power or gas supply failure, the valve 16 is returned to the condition wherein the ventilator bag rather than the mechanical ventilator is connected to the patient, and this is important from the safety point of view. The shaft 78 of the valve 16 is provided at one end with a magnet 82 arranged to operate a Hall Effect switch associated with an end cap 83 whereby the microprocessor may monitor the condition of the switching valve.”) wherein the valve is an electronically-controlled three-port, two-way (Figure 11 depicts a three port two way valve with inlet port 79) valve (page 7 states “In a preferred such embodiment, the switching valve is operated by gas pressure under the control of an electrically operable solenoid valve so that both the electricity and gas supplies must be provided to switch the valve to the mechanical ventilation mode.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the first valve 48 of Dahlstrom with the teachings of Lindsay and include wherein activating the first valve includes energizing an electromagnet to control a position of a solenoid of the first valve wherein the first valve is an electronically-controlled valve as to allow for switching between a manual and mechanical ventilator mode (page 7).
Regarding claim 6, Dahlstrom teaches the method of claim 1, wherein adjusting the first valve, adjusting the second valve, and adjusting the pilot pressure are performed during a manual ventilation mode (0043 states “In the manual ventilation mode, the manual ventilation valve 48 is actuated to an open position in order to allow gas flow in the manual ventilation line 46 to and from the manual ventilation bag 50, and the manual ventilation control unit 64 is activated to control the expiratory valve 40.”), wherein during the manual ventilation mode, the pilot pressure is provided to the second valve via a first port of the first valve (the pilot pressure provided from bag 50 is provided to valve 40 from a first port of valve 48), but fails to teach during a mechanical ventilation mode, deactivating the first valve to direct a pilot gas flow to a mechanical ventilation circuit via a second port of the first valve. Lindsay does teach during a mechanical ventilation mode, deactivating the first valve to direct a pilot gas flow to a mechanical ventilation circuit via a second port of the first valve (Figure 11 depicts ports 75 and 76 for connection to the mechanical ventilator circuit and the manual bag circuit, the deactivation would allow for a switching that directs the flow within the mechanical ventilation circuit). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dahlstrom with the teachings of Lindsay and include during a mechanical ventilation mode, deactivating the first valve to direct a pilot gas flow to a mechanical ventilation circuit via a second port of the first valve as this allows for a switching between manual and mechanical ventilation mode (page 7).
Regarding claim 7, Dahlstrom in view of Lindsay teaches the method of claim 6, wherein the pilot pressure is controlled by adjusting a pilot gas flow from the gas control unit (ventilation control system 56 of Dahlstrom) and wherein adjusting the pilot pressure includes adjusting a position of a third valve of the gas control unit (Valves 30 and 32 of Dahlstrom) at a beginning of each expiration cycle to increase the pilot pressure when the patient airways pressure is less than the target PEEP or to decrease the pilot pressure when the patient airways pressure is greater than the target PEEP, and wherein the pilot pressure is adjusted for each breath of a patient (0023 states “provide for a substantially maintenance free expiratory valve operating unit arranged for regulating PEEP during mechanical ventilation and providing an adjustable pressure limit during manual ventilation both during normal and emergency operation”).
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Dahlstrom in view of Bromster et al. 2004/0144385
Regarding claim 3, Dahlstrom teaches the method of claim 1, wherein the pressure of the manual circuit is a pressure from a bag and/or breathing system of the ventilation system (Bag 50, figure 2), but fails to teach wherein activating the second valve includes retracting a solenoid away from a diaphragm of the second valve, and wherein the pilot pressure is communicated to a first face of the diaphragm and a pressure of the manual circuit is communicated to a second face of the diaphragm, the second face opposite of the first face. Bromster teaches an analogous ventilatory system that does teach, wherein activating the second valve (Filling valve 96) includes retracting a solenoid (Valve stem 154) away from the diaphragm (Figure 3a 164) of the second valve, and wherein a pilot pressure is communicated to a first face of the diaphragm (Communicated to left side of the diaphragm through inlet port 124) and the pressure of the manual circuit is communicated to a second face of the diaphragm (pressure cavity 160) the second face opposite of the first face (Figure 3a). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify valve 40 of Dahlstrom with the teachings of Bromster and include wherein activating the pneumatically-controlled valve includes retracting a solenoid away from a diaphragm of the pneumatically-controlled valve, and wherein the pilot pressure is communicated to a first face of the diaphragm and a pressure from a bag and/or breathing system of the ventilation system is communicated to a second face of the diaphragm, the second face opposite of the first face as this would allow for a process of compression and filling of the manual bag (0046).
Regarding claim 4, Dahlstrom in view of Bromster teaches the method of claim 3, wherein when the pressure from the bag and/or breathing system is less than or equal to the pilot pressure, a gas flow from the bag to the scavenging circuit is blocked, and wherein when the pressure from the bag and/or breathing system is greater than the pilot pressure, the diaphragm is displaced and the gas flow from the bag is enabled (The abstract states that “The manual bag filling valve includes a valve assembly that is movable between an open position and a closed position based on the difference in the forces created by the pressures of the manual bag and the inhalation gas.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Dahlstrom with the teachings of Bromster and include wherein when the pressure from the bag and/or breathing system is less than or equal to the pilot pressure, a gas flow from the bag is blocked, and wherein when the pressure from the bag and/or breathing system is greater than the pilot pressure, the diaphragm is displaced and the gas flow from the bag is enabled as this allows for movement of the valve to be controlled by a comparison between the inhalation gas and the pressure contained within the manual bag (0010).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Dahlstrom in view of Bromster et al. 2016/0354568
Regarding claim 5, Dahlstrom teaches the method of claim 1, but fails to teach wherein the pilot pressure is set to a target maximum pressure of a bag of the ventilation system during an inspiration cycle of the ventilation system and set to the target PEEP during an expiration cycle of the ventilation system. Haggblom discloses an analogous ventilator system that does teach wherein the pilot pressure is set to a target maximum pressure of a bag of the ventilation system during an inspiration cycle of the ventilation system (0049 states that “At an inspiration phase 216 the bag pressing is more aggressive and the dot line 212 of the maximum pressure limit is achieved at point 217.”) and set to the target PEEP during an expiration cycle of the ventilation system (0048 states that “During the expiration the control unit 21 guides to deliver further gas to the breathing circuit to reach the desired expiration pressure and regulates the expiration valve 37 to maintain that throughout the expiration.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Dahlstrom with the teachings of Haggblom and include wherein the pilot pressure is set to a target maximum pressure of a bag of the ventilation system during an inspiration cycle of the ventilation system and set to the target PEEP during an expiration cycle of the ventilation system as this leads to a protection for sustained lung pressure and gives the user an adjustable desired expiration pressure (0050).
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.
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.
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
