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 .
Information Disclosure Statement
The information disclosure statement (IDS) filed on 12/28/2022 has been considered by the examiner.
Election/Restrictions
Applicant's election with traverse of invention 1 for claims 1-7 in the reply filed on 12/26/2025 is acknowledged. The traversal is on the ground(s) that the restriction has not been properly established for groupings of inventions I and II, I and III, and II and III. Although applicant’s argument does hold weight based on the way the restriction was written, however typographical errors were made and the arguments are not found persuasive as examiner’s groupings of the inventions are correct. These errors are corrected below to properly establish the restriction.
Regarding inventions II and I, as being related as a product and process of use, the product of invention II as claimed can be used in a materially different process such as one that does not involve the use of a pneumatically controlled valve arranged between a bag and a scavenging circuit.
Regarding Inventions II and III, as being related by product and process of use, the product of invention II as claimed can be used in a materially different process such as one that involves an on-off electronic valve rather than a three-way port. Applicant argues that substantial overlap exists between the two inventions. Examiner respectfully disagrees as the product that is used can have a substantially different method of control of the electronic valve, such as one that involves an on/off switch. The use of a three-port and two-way valve is not described in invention II.
Regarding inventions I and III, as being related by combination and subcombination, the subcombination has separate utility such as it does not involve the adjustment of a pilot pressure based on a comparison of a patient airways pressure to a target PEEP. The combination as claimed does not require the particulars of the subcombination as claimed as invention I does not require the use of a three-way two-port valve.
The requirement is still deemed proper and is therefore made FINAL.
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 1, 2, 6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Dahlstrom et al. US2010/0252046, in view of Oddo et al. 2021/0001075
Regarding claim 1, Dahlstrom teaches a method for operating a ventilation system in a manual ventilation mode (0002), comprising: activating an electronically-controlled valve (electronically controlled expiratory valve 40, 0045) and a valve (“Manual ventilation valve 48 is actuated to an open position in order to allow gas flow in the manual ventilation line 46”) to provide a pilot pressure to the valve (0049 states that “Between the bag and the junction 90 is provided a manual ventilation valve 48 for selecting manual ventilation. The junction 90 connects the manual ventilation bag 50 to the expiration branch 36 with the expiratory valve 40 and to the breathing circle via a selection valve 80 and the common inspiration and expiration line 14. Thus, the expiratory valve 40 controls the pressure provided by the manual bag 50 to the breathing gas flow in the circle system 7.”) to deliver a target positive end expiratory pressure (PEEP) from a gas control unit (Supply valves 86a and 86b) during expiration (0059 states that “During mechanical ventilation, a PEEP may be maintained by means of the expiratory valve 40.”);
adjusting the pilot pressure based on a comparison of a patient airways pressure to the target PEEP (0059 states that “If the pressure during manual ventilation exceeds a predetermined pressure value, the valve is opened and relieves the pressure in a precise and controlled manner.”).
Dahlstrom fails to explicitly teach manual ventilation valve 48 as being pneumatically controlled. However, Oddo teaches an analogous ventilator that does teach the control of a Peep through the use of pneumatics (0023 states “Thus, the valve 502 can be a check valve. As such, the cracking pressure of the check valve (e.g., valve 502) is higher than the pressure of the input gas IG and, therefore, the check valve (e.g., valve 502) can only be opened using the pneumatic actuator (e.g., an air cylinder or pressure actuator) For this reason, the valve 502 is downstream of the pneumatic actuator 514.”). 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 48 of Dahlstrom to be controlled through the use of pneumatics as this allows for PEEP to be controlled based on the breathing cycle of a user, while further allowing for the use of lower pressure gas sources (0023).
Regarding claim 2, Dahlstrom teaches the method of claim 1, wherein activating the electronically-controlled valve includes energizing an electromagnet to control a position of a solenoid of the electronically-controlled valve (0074 states that “The expiratory valve 40 comprises a solenoid 500 driving a push rod 501 connected to an expiratory valve membrane 502. The solenoid comprises for instance a permanent magnet 507 and a coil 508.”).
Regarding claim 6, Dahlstrom teaches the method of claim 1, wherein the pilot pressure is controlled by adjusting a pilot gas flow from the gas control unit (0048 states “In this way the O2 and air sources provide driving gas, during mechanical ventilation, to the bag driving the breathing gas inside the bag and which driving gas pressure is adjusted by, means of controlling, the expiratory valve 40”).
Regarding claim 8, Dahlstrom teaches a ventilation system, comprising: a pneumatically-controlled valve (Manual ventilation valve 48) arranged in a path of pilot gas flow between a bag (bag 50) and a scavenging circuit of the ventilation system (Scavenging system 42), the pneumatically-controlled valve adjusted based on a pilot pressure directed thereto by an electronically-controlled valve (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.”) to provide a positive end expiratory pressure (PEEP) to a patient during manual ventilation of the patient (0059 states that “During mechanical ventilation, a PEEP may be maintained by means of the expiratory valve 40.”);
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over modified Dahlstrom in view of Bromster et al. 2004/0144385
Regarding claim 3, modified Dahlstrom teaches the method of claim 1, but fails to teach 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. Bromster teaches an analogous ventilatory system that does teach, wherein activating a valve (Filling valve 96) includes retracting a solenoid (Valve stem 154) away from a diaphragm (Figure 3a 164) of the 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 a pressure from a bag and/or breathing system of the ventilation system 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 modified 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, modified 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 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 modified 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).
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over modified Dahlstrom in view of Haggblom et al. 2016/0354568
Regarding claim 5, modified 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 modified 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).
Regarding claim 7, modified Dahlstrom teaches the method of claim 6, but fails to teach wherein adjusting the pilot pressure includes adjusting a position of a valve of the gas control unit 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. Haggblom does teach an analogous ventilatory system that does teach wherein adjusting the pilot pressure includes adjusting a position of a valve of the gas control unit (0032 discusses the closing of control valve 34 to stop inspiration delivery and activate expiration valve 37) 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 (0037 states that “The fresh gas flow and inspiration flow continues the manual bag filling until the bag pressure achieves the desired expiration pressure such as the target PEEP.”), and wherein the pilot pressure is adjusted for each breath of a patient (0037 describes the process of adjusting the valve (0037 discusses the use of the adjustment system taking place at each detected inspiration and 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 modified Dahlstrom with the teachings of Haggblom and include wherein adjusting the pilot pressure includes adjusting a position of a valve of the gas control unit 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 as this allows for the maintaining of a desired predetermined pressure (0037).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kollmeyer et al. 20080196720
Di Capua et al 8631790
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785