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 § 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.
Claim 33 recites the limitation "the positive end expiratory pressure valve of the expiratory member" in line 2. There is insufficient antecedent basis for this limitation in the claim.
For examining purposes, the limitation is to be taken as “a positive end expiratory valve of the expiratory member”, an additional valve to the “further end expiratory pressure valve of the inspiratory member”.
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.
Claims 1, 3, 15, 17, 22, 24-25, 29, 31, 36, 38-39, 44-45, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (US 20170095631 A1).
Regarding claim 1, Fukunaga teaches a positive pressure breathing circuit for ventilating a patient (FIG. 3a-1 The Resuscitation device is operatively connected to a patient airway device to provide gases to and/or exhaust gases from a patient as set forth in the abstract, [0018]-[0020], and [0029]; positive pressure set forth in [0004] and [0094]), the breathing circuit including: an inspiratory member (FIG. 3a-1 Inspiratory conduit 2a as set forth in [0021]) with a gas passageway (FIG. 3a-1 Inside of the inspiratory conduit 2a of the multilumen breathing conduit 2 denoted by the dotted arrows as shown in the figure) including a proximal portion (“A” shown in the annotated figure below) that is connectable to a patient interface for supplying a breathing gas (FIG. 3a-1 Continuously inflowing O2 provided in inlet 5 at low flow foes through the inspiratory tube 2a and inflows directly to the patient’s airway via a mask/patient airway device 1 as set forth in [0019]), and a distal portion (“B” shown in the annotated figure below) that is connectable to a source of a pressurized first gas (FIG. 3a-1 Pump/bag 8 and the air inlet and valve 9 as set forth in [0031] and [0033]; connected to the distal portion “B” of the inspiratory conduit through various elements of the breathing circuit);
a pressure regulation device configured to regulate pressure in the inspiratory member (FIG. 3a-1 Pressure limiting valve 6 as set forth in [0018] and [0031]-[0032]); and
an expiratory member configured to vent exhaled gases from the patient interface (FIG. 3a-1 Expiratory tube 2b where exhaled gases are vented out as set forth in [0019]); wherein the inspiratory member is further connectable to a source of a pressurized second gas (FIG. 3a-1 O2 inlet 5 where oxygen gas is provided to the patient via conduit 2, where the O2 gas is continuously flowing, indicating it is a pressurized gas, as set forth in [0018]-[0019]) and the breathing circuit includes a first non-return valve (FIG. 3a-1 Non-rebreathing valve 4 as set forth in [0018]) that is arranged proximally to the second gas entering the inspiratory member (FIG. 3a-1 Non-rebreathing valve 4 is proximally located to the O2 inlet 5 as shown in the figure), and the first non-return valve is configured to inhibit the exhaled gases from entering the inspiratory member (FIG. 3a-1 Non-rebreathing valve 4 opens and the patient’s exhaled gases are released out of the system as set forth in [0034]; At the expiratory phase, the NRV 4 causes release of exhaled gases from the system, when a multilumen conduit and valve are used, initially, during the expiratory phase the coaxial valve 4 inspiratory valve closes the pathway to inspiratory conduit 2a and releases expiratory gases out of the system via expiratory conduit 2b and the expiratory path in coaxial calve 4 as set forth in [0093]), and the inspiratory member is configured so that a volume of the second gas can enter and be stored in the inspiratory member whilst the first gas can be supplied to the inspiratory member (FIG. 4 Demonstrates that at the location of the oxygen delivery inlet and proximal end of the tube sores the low flow inflowing oxygen in the tube and part of the bag, instead of diluting or releasing O2 out of the system as set forth in [0069]).
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The embodiment of Fukunaga referenced above, FIG. 3a-1, fails to explicitly disclose, wherein specifically the proximal portion of the inspiratory member is further connectable to a source of a pressurized second gas.
However, the embodiment of FIG. 3b-3 of Fukunaga shows the source of a pressured second gas is connected to the proximal end of the inspiratory member (FIG. 3b-3 O2 inlet 5 is located proximally, near mask1, as shown in the figure).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fukunaga shown in FIG. 3a-1 to incorporate the teaching of the embodiment of and include, wherein the source of a pressured second gas is connected to the proximal end of the inspiratory member (FIG. 3b-3 O2 inlet 5 is located proximally, near mask1, as shown in the figure). Doing so would reduce the dilution of incoming O2 (As set forth in [0030]). It would also be readily understood by one of ordinary skill in the art that with the non-rebreathing valve being located in closer proximity to the patient interface/mask, the less rebreathing of exhaled gas due to it quickly being released out of the system.
Regarding claim 3, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the gas passageway of the inspiratory member receives both the first and second gases during patient inhalation and exhalation (FIG. 3a-1 At inspiration , incoming O2 from O2 inlet 5 will go directly to the inspiratory conduit 2a while the bag’s content, which has an enriched O2 concentration from mixing O2 with air from inlet 9, will also be forced through inspiratory conduit 2a to the patient as set forth in [0094]; at expiration the coaxial valve 4 closes the pathway to inspiratory conduit 2a as set forth in[0093], storing gas as set forth in [0069]).
Regarding claim 15, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the expiratory member has a second non-return device (FIG. 3a-1 PEEP valve 7 as set forth in [0018]; if multi-lumen conduit is used then the coaxial valve can include inspiratory and expiratory valves connecting to the breathing conduit such as a PEEP valve as set forth in [0042], such as PEEP 7) that can regulate the pressure at which gases are vented from the expiratory member (The function of a PEEP valve understood by one of ordinary skill in the art is to maintain positive pressure in the airways at the end of exhalation, which would in turn regulate the pressure at which gases are vented from the expiratory member during exhalation).
Regarding claim 17, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Fukunaga as modified further discloses the breathing circuit, wherein the second non-return device is a positive end expiratory pressure valve (FIG. 3a-1 PEEP valve 7 as set forth in [0018]).
Regarding claim 22, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the pressure regulation device includes a pressure relief valve configured to control the pressure of the first gas supplied to the inspiratory member (FIG. 3a-1 Pressure limiting valve 6 as set forth in [0018] and [0031]-[0032]; located downstream from the FIG. 3a-1 Pump/bag 8 and the air inlet and valve 9 to regulate the pressure of the first gas in the inspiratory member).
Regarding claim 24, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the pressure regulation device includes a further positive end expiratory pressure valve (FIG. 3a-1 PEEP valve 7 as set forth in [0018])
Fukunaga as modified fails to explicitly disclose that the positive end expiratory pressure valve is directly on the distal portion of the inspiratory member.
However, the PEEP valve of Fukunaga is still on the same gas passageway as the inspiratory member and therefore, the location of the PEEP valve of Fukunaga would perform the identical function specified in the claim in substantially the same way, and produce substantially the same results as the corresponding element disclosed in the specification where the PEEP valve is directly on the distal portion of the inspiratory member. See in Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000) and Odetics Inc. v. Storage Tech. Corp., 185 F.3d 1259, 1267, 51 USPQ2d 1225, 1229-30 (Fed. Cir. 1999); Lockheed Aircraft Corp. v. United States, 193 USPQ 449, 461 (Ct. Cl. 1977), see also MPEP § 2183. The concepts of equivalents as set forth in Graver Tank & Mfg. Co. v. Linde Air Products, 339 U.S. 605, 85 USPQ 328 (1950) are relevant to any "equivalents" determination. Both the location of the PEEP valve of Fukunaga and the element claimed by Applicant are configured to control the pressure of gas in the inspiratory member. Additionally, A person of ordinary skill in the art would have recognized the interchangeability of the element location as shown in the prior art for the corresponding element disclosed in the specification. Both would result in the same completion of the same function, controlling the gas pressure in the breathing apparatus. See in Caterpillar Inc. v. Deere & Co., 224 F.3d 1374, 56 USPQ2d 1305 (Fed. Cir. 2000); Al-Site Corp. v. VSI Int’ l, Inc., 174 F.3d 1308, 1316, 50 USPQ2d 1161, 1165 (Fed. Cir. 1999).
Therefore, it would have been prima facie obvious to modify Fukunaga as modified to obtain the invention as specified in claim 24, because such a modification is considered to be well within the skill level of the ordinary artisan since they are equivalents and thus fails to patentably distinguish over the prior art of Fukunaga as modified.
Regarding claim 25, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 24 above.
Fukunaga as modified further discloses the breathing circuit, wherein the further positive end expiratory pressure valve (FIG. 3a-1 PEEP valve 7 as set forth in [0018]) is configured to vent the pressurized first gas from the inspiratory member during patient expiration (The function of a PEEP valve understood by one of ordinary skill in the art is to maintain positive pressure in the airways at the end of exhalation, which is done by creating resistance to the airflow being vented during exhalation; in the case of Fukunaga, the first gas, air, is mixed with the O2 from inlet 5 and the mixed gas is delivered into the patient’s airway as set forth in [0035], indicating that air would be present at the PEEP valve and would in turn be vented during expiration).
Regarding claim 29, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 24 above.
Fukunaga as modified further discloses the breathing circuit, wherein the distal portion of the inspiratory member (“B” shown in the annotated figure below) has a first gas inlet (“C” shown in the annotated figure below) adjacent to the further positive end expiratory pressure valve of the inspiratory member (Shares the same gas passageway as conduit 2a), in which the first gas inlet is connectable to a source of the pressurized first gas (FIG. 3a-1 Pump/bag 8 and the air inlet and valve 9 as set forth in [0031] and [0033]; connected at ‘C’ to the distal portion “B” of the inspiratory conduit through the valves of the breathing circuit).
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Regarding claim 31, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 24 above.
Fukunaga as modified further discloses the breathing circuit, wherein the positive end expiratory valve of the expiratory member is operable to vent exhaled gases at a higher pressure than the pressure at which the first gas is vented from the inspiratory member during patient inhalation (The function of a PEEP valve understood by one of ordinary skill in the art is to maintain positive pressure in the airways at the end of exhalation, which would indicate that valve would have to vent exhaled gas at a higher pressure than the pressure of the inhaled gas from the inspiratory member during patient inhalation in order to prevent alveolar collapse).
Regarding claim 36, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the first non-return valve is located on the proximal portion of the inspiratory member (Fukunaga as modified in claim 1 discloses that a first non-return valve (FIG. 3a-1 Non-rebreathing valve 4 as set forth in [0018]) is arranged proximally to the second gas entering the inspiratory member (FIG. 3a-1 Non-rebreathing valve 4 is proximally located to the O2 inlet 5 as shown in the figure), and that, as in the embodiment of Fukunaga shown in FIG. 3a-1, is to incorporate the teaching of the embodiment of FIG. 3b-3 and include, wherein the source of a pressured second gas is connected to the proximal end of the inspiratory member (FIG. 3b-3 O2 inlet 5 is located proximally, near mask1, as shown in the figure, indicating the first non-return valve is located on the proximal portion of the inspiratory member.
Regarding claim 38, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the first non-return valve is located on the proximal portion of the inspiratory member and is arranged adjacent to the patient interface (Fukunaga as modified in claim 1 discloses that a first non-return valve (FIG. 3a-1 Non-rebreathing valve 4 as set forth in [0018]) is arranged proximally to the second gas entering the inspiratory member (FIG. 3a-1 Non-rebreathing valve 4 is proximally located to the O2 inlet 5 as shown in the figure), and that, as in the embodiment of Fukunaga shown in FIG. 3a-1, is to incorporate the teaching of the embodiment of FIG. 3b-3 and include, wherein the source of a pressured second gas is connected to the proximal end of the inspiratory member (FIG. 3b-3 O2 inlet 5 is located proximally, near mask1, as shown in the figure, indicating the first non-return valve is located on the proximal portion of the inspiratory member, near the mask).
Regarding claim 39, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the proximal portion of the inspiratory member has a second gas inlet (The opening of O2 inlet 5) upstream of the first non-return valve, at which the second gas inlet is connectable to the source of the second gas (FIG. 3a-1 Non-rebreathing valve 4 is proximally located to the O2 inlet 5 as shown in the figure), and that, as in the embodiment of Fukunaga shown in FIG. 3a-1, is to incorporate the teaching of the embodiment of FIG. 3b-3 and include, wherein the source of a pressured second gas is connected to the proximal end of the inspiratory member (FIG. 3b-3 O2 inlet 5 is located proximally, near mask1, as shown in the figure, indicating the first non-return valve is located on the proximal portion of the inspiratory member
Regarding claim 44, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the first gas is pressurized air (FIG. 3a-1 and 4 Air coming from inlet 9 as set forth in [0019]).
Regarding claim 45, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the first gas is continuously supplied to the inspiratory member (Shown by FIG. 4 the air from inlet 9 is continuously supplied to the device, during both the inspiratory and expiratory phases).
Regarding claim 49, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the second gas is pressurized oxygen gas (Set forth in [0019]).
Claims 5 and 47 are rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (US 20170095631 A1) as applied to claim 1, in view of Burchell (US 20160339202 A1).
Regarding claim 5, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified fails to explicitly disclose the breathing, wherein the inspiratory member is sized to store a volume of the second gas that is supplied to the inspiratory member at a constant flow rate.
However, Burchell teaches wherein the inspiratory member is sized to store a volume of the second gas that is supplied to the inspiratory member at a constant flow rate (Burchell: FIG. 1 Oxygen is supplied to the patient valve housing 34 at a relatively low rate continuously both during inspiratory and expiratory phases of the flow as set forth in [0017]).
Fukunaga and Burchell are both considered to be analogous to the claimed invention because they are in the same field of breathing circuits proving supplementary oxygen to a user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fukunaga to incorporate the teaching of Burchell and include wherein the inspiratory member is sized to store a volume of the second gas that is supplied to the inspiratory member at a constant flow rate (Burchell: FIG. 1 Oxygen is supplied to the patient valve housing 34 at a relatively low rate continuously both during inspiratory and expiratory phases of the flow as set forth in [0017]). Doing so would enable the device to provide a volume of oxygen in the tubing that is delivered to the patient during a subsequent inspiratory phase (Burchell: As set forth in [0004]).
Regarding claim 47, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified fails to explicitly disclose the breathing circuit, wherein the second gas supplied to the inspiratory member at a constant flow rate.
However, Burchell teaches wherein the second gas supplied to the inspiratory member at a constant flow rate (Burchell: FIG. 1 Oxygen is supplied to the patient valve housing 34 at a relatively low rate continuously both during inspiratory and expiratory phases of the flow as set forth in [0017]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fukunaga to incorporate the teaching of Burchell and include wherein the second gas supplied to the inspiratory member at a constant flow rate (Burchell: FIG. 1 Oxygen is supplied to the patient valve housing 34 at a relatively low rate continuously both during inspiratory and expiratory phases of the flow as set forth in [0017]). Doing so would enable the device to provide a volume of oxygen in the tubing that is delivered to the patient during a subsequent inspiratory phase (Burchell: As set forth in [0004]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (US 20170095631 A1) as applied to claim 1, in view of Figley (US 20190091425 A1).
Regarding claim 8, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the inspiratory member includes a tube defining the gas passageway (FIG. 3a-1 Inside of inspiratory conduit 2a).
Fukunaga as modified fails to explicitly disclose wherein the inspiratory member tube includes a length ranging from about 0.5 m to 2.5 m, or a length ranging from about 0.75 to 2.0 m for receiving the first and second gases.
However, Figley teaches, wherein the inspiratory member includes a tube defining the gas passageway, the tube including a length ranging from about 0.5 m to 2.5 m, or a length ranging from about 0.75 to 2.0 m for receiving the first and second gases (Figley: The reservoir tube is 1.76 meters as set forth in [0148]).
Fukunaga and Figley are both considered to be analogous to the claimed invention because they are in the same field of breathing circuits proving supplementary oxygen to a user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the length of the inspiratory member of Fukunaga to incorporate the teaching of Figley and include wherein the tube includes a length ranging from about 0.5 m to 2.5 m, or a length ranging from about 0.75 to 2.0 m for receiving the first and second gases (Figley: The reservoir tube is 1.76 meters as set forth in [0148]). Doing so would contribute to a length to cross-section aspect ratio that effectively shuttles gas along the length of the reservoir without undue mixing of the gas in the longitudinal flow direction (Figley: As set forth in [0117]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (US 20170095631 A1) as applied to claim 1, in view of Diehl (WO 2015110098 A1).
Regarding claim 10, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified fails to explicitly disclose the breathing circuit, wherein the inspiratory member has an internal volume ranging from about 400 ml to 600 ml for adult patients.
However, Diehl teaches wherein the inspiratory member has an internal volume ranging from about 400 ml to 600 ml (FIG. 1 The tubing and tubing volumes of the patient tubing 23 and the tubing and tubing present within the baseline device 110 are tuned to deliver a tidal volume of up to 600 ml with up to 100% oxygen concentration per inspiratory cycle as set forth on page 5 paragraph 9 of the machine translation; it would be readily understood by one skilled in the art that this would apply to an adult patient).
Fukunaga and Diehl are both considered to be analogous to the claimed invention because they are in the same field of breathing circuits proving supplementary oxygen to a user. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inspiratory member of Fukunaga to incorporate the teaching of Diehl and include wherein the tube includes an internal volume ranging from about 400 ml to 600 ml (FIG. 1 The tubing and tubing volumes of the patient tubing 23 and the tubing and tubing present within the baseline device 110 are tuned to deliver a tidal volume of up to 600 ml with up to 100% oxygen concentration per inspiratory cycle as set forth on page 5 paragraph 9 of the machine translation; it would be readily understood by one skilled in the art that this would apply to an adult patient). Doing so would ensure the inspiratory member ideally has an internal volume that allows the pressurized oxygen gas that is stored in the inspiratory member to be up to 100% inhaled by the patient in a single inhalation.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (US 20170095631 A1) as applied to claim 15, in view of Tero (US 20140066801 A1).
Regarding claim 16, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Fukunaga as modified is silent as to whether the second non-return device inhibits exhaled gases from re-entering the patient interface via the expiratory member.
However, Tero teaches a non-return device that inhibits exhaled gases from re-entering the patient interface via the expiratory member (Tero: FIG. 15 A PEEP valve 730 may be inserted in discharge portion 723 of expiratory tube in order to regulate pressure and to prevent excessive buildup of back pressure as set forth in [0079]).
Fukunaga and Tero are both considered to be analogous to the claimed invention because they are in the same field of breathing circuits for providing breathable gas to a patient comprised of an exhalation member containing a PEEP valve. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fukunaga to incorporate the teaching of Tero and include wherein a non-return device inhibits exhaled gases from re-entering the patient interface via the expiratory member (Tero: FIG. 15 A PEEP valve 730 may be inserted in discharge portion 723 of expiratory tube in order to regulate pressure and to prevent excessive buildup of back pressure as set forth in [0079]). Doing so provides a known teaching as to one of the functions of a PEEP valve in a breathing circuit (Tero: As set forth in [0079]).
Claims 18-19 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (US 20170095631 A1) as applied to claims 17 and 24, in view of Doshi (US 20090194109 A1).
Regarding claim 18, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Fukunaga as modified is silent as to whether the positive end expiratory valve of the expiratory member is a passive valve.
However, Doshi teaches the positive end expiratory valve of the expiratory member is a passive valve (Doshi: The passive EPAP airflow resistor may also include a PEEP or threshold valve as set forth in [0027]).
Fukunaga and Doshi are both considered to be analogous to the claimed invention because they are in the same field of breathing circuits for providing breathable gas to a patient comprised of an exhalation member containing a PEEP valve. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fukunaga to incorporate the teaching of Doshi and include wherein the positive end expiratory valve of the expiratory member is a passive valve (Doshi: The passive EPAP airflow resistor may also include a PEEP or threshold valve as set forth in [0027]). Doing so provides a known teaching as to one of the aspects of a PEEP valve, and would maintain a constant and controlled resistance in the expiratory member (Doshi: As set forth in [0027]).
Regarding claim 19, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Fukunaga as modified is silent as to whether the positive end expiratory valve has a fixed operating pressure.
However, Doshi teaches wherein the positive end expiratory valve has a fixed operating pressure (Doshi: The passive EPAP airflow resistor may also include a PEEP valve where the passive airflow resistor may have a non-zero threshold pressure for opening during expiration so that the airflow resistor is closed during expiration when the pressure across the airflow resistor is below the threshold pressure for opening, and the airflow resistor opens during expiration when the pressure across the airflow resistor exceeds the threshold pressure for opening during expiration as set forth in [0027]; the threshold being the fixed operating pressure).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fukunaga to incorporate the teaching of Doshi and include wherein the positive end expiratory valve has a fixed operating pressure (Doshi: The passive EPAP airflow resistor may also include a PEEP valve where the passive airflow resistor may have a non-zero threshold pressure for opening during expiration so that the airflow resistor is closed during expiration when the pressure across the airflow resistor is below the threshold pressure for opening, and the airflow resistor opens during expiration when the pressure across the airflow resistor exceeds the threshold pressure for opening during expiration as set forth in [0027]; the threshold being the fixed operating pressure). Doing so provides a known teaching as to one of the aspects of a PEEP valve, and would maintain a constant and controlled resistance in the expiratory member (Doshi: As set forth in [0027]).
Regarding claim 27, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 24 above.
Fukunaga as modified is silent as to whether the further positive end expiratory valve of the expiratory member is a passive valve.
However, Doshi teaches wherein the positive end expiratory valve of the expiratory member is a passive valve (Doshi: The passive EPAP airflow resistor may also include a PEEP or threshold valve as set forth in [0027]).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fukunaga to incorporate the teaching of Doshi and include wherein the positive end expiratory valve of the expiratory member is a passive valve (Doshi: The passive EPAP airflow resistor may also include a PEEP or threshold valve as set forth in [0027]). Doing so provides a known teaching as to one of the aspects of a PEEP valve, and would maintain a constant and controlled resistance in the expiratory member (Doshi: As set forth in [0027]).
Regarding claim 28, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 27 above.
Fukunaga as modified is silent as to whether the further positive end expiratory valve has a fixed operating pressure
However, Doshi teaches wherein the positive end expiratory valve has a fixed operating pressure (Doshi: The passive EPAP airflow resistor may also include a PEEP valve where the passive airflow resistor may have a non-zero threshold pressure for opening during expiration so that the airflow resistor is closed during expiration when the pressure across the airflow resistor is below the threshold pressure for opening, and the airflow resistor opens during expiration when the pressure across the airflow resistor exceeds the threshold pressure for opening during expiration as set forth in [0027]; the threshold being the fixed operating pressure).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fukunaga to incorporate the teaching of Doshi and include wherein the positive end expiratory valve has a fixed operating pressure (Doshi: The passive EPAP airflow resistor may also include a PEEP valve where the passive airflow resistor may have a non-zero threshold pressure for opening during expiration so that the airflow resistor is closed during expiration when the pressure across the airflow resistor is below the threshold pressure for opening, and the airflow resistor opens during expiration when the pressure across the airflow resistor exceeds the threshold pressure for opening during expiration as set forth in [0027]; the threshold being the fixed operating pressure). Doing so provides a known teaching as to one of the aspects of a PEEP valve, and would maintain a constant and controlled resistance in the expiratory member (Doshi: As set forth in [0027]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (US 20170095631 A1) as applied to claim 1, in view of Van Beurden (US 20060266359 A1).
Regarding claim 22, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified further discloses the breathing circuit, wherein the pressure regulation device includes a pressure relief valve (FIG. 3a-1 Pressure limiting valve 6 as set forth in [0018] and [0031]-[0032]).
Fukunaga as modified is silent as to whether the valve is configured to vent the first gas from the breathing circuit.
However, Van Beurden teaches where a valve is configured to vent a gas from the breathing circuit (Van Beurden: The pressure relief valve may be used as both an over pressure control valve or as an overpressure control valve, and comprises a magnetic seating that is associated with an outlet vent formed on a breathing assistance apparatus, and a magnetic cover capable of covering the seating and the outlet vent to allow gases to exit the outlet vent as set forth in the Abstract).
Fukunaga and Van Beurden are both considered to be analogous to the claimed invention because they are in the same field of breathing circuits for providing breathable gas to a patient comprised of pressure relief valves. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fukunaga to incorporate the teaching of Van Beurden and include wherein the valve is configured to vent a gas from the breathing circuit (Van Beurden: The pressure relief valve may be used as both an over pressure control valve or as an overpressure control valve, and comprises a magnetic seating that is associated with an outlet vent formed on a breathing assistance apparatus, and a magnetic cover capable of covering the seating and the outlet vent to allow gases to exit the outlet vent as set forth in the Abstract). Doing so would reduce the gases pressure in the breathing assistance apparatus, preventing possible barotraumas to the patient (Van Beurden: As set forth in the Abstract).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (US 20170095631 A1) as applied to claim 24, in view of Erceg (US 4245633 A).
Regarding claim 22, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified fails to explicitly disclose, wherein the inspiratory member is configured so that the stored second gas is inhibited from being discharged from the inspiratory member with the first gas via the further positive end expiratory pressure valve.
However, Ecreg teaches wherein the inspiratory member and valves are configured so that the stored second gas is inhibited from being discharged from the inspiratory member with the first gas via the further positive end expiratory pressure valve (Ecreg: FIG. 1 The PEEP circuit 2 also includes expiratory conduit means or an expiratory conduit 22, which transfers gas flow from the extension conduit 6 back to the respirator conduit 21, and reverse flow resisting means or a unidirectional PEEP providing valve 24, which is disposed between the conduit 6 and the expiratory conduit 22 as set forth in column 4 lines 16-22; the configuration precludes reverse flow of gas in said inspiratory means upstream of said first valve means when a patient exhales and prevents gas flow other than said reverse flow of gas from passing through said expiratory conduit means as set forth in claims 1 and 4).
Fukunaga and Ecreg are both considered to be analogous to the claimed invention because they are in the same field of breathing circuits for providing breathable gas to a patient comprised of pressure relief valves. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the configuration Fukunaga to incorporate the teaching of Ecreg and include wherein the inspiratory member and valves are configured so that the stored second gas is inhibited from being discharged from the inspiratory member with the first gas via the further positive end expiratory pressure valve (Ecreg: FIG. 1 The PEEP circuit 2 also includes expiratory conduit means or an expiratory conduit 22, which transfers gas flow from the extension conduit 6 back to the respirator conduit 21, and reverse flow resisting means or a unidirectional PEEP providing valve 24, which is disposed between the conduit 6 and the expiratory conduit 22 as set forth in column 4 lines 16-22; the configuration precludes reverse flow of gas in said inspiratory means upstream of said first valve means when a patient exhales and prevents gas flow other than said reverse flow of gas from passing through said expiratory conduit means as set forth in claims 1 and 4). Doing so would preclude reverse flow of gas in said inspiratory means upstream of said f valve means when a patient exhales and prevents gas flow other than said reverse flow of gas from passing through said expiratory conduit means (Ecreg: As set forth in claims 1 and 4).
Fukunaga as modified by Ecreg does not explicitly disclose, wherein the specific configuration is that the inspiratory member is sufficiently long so that the stored second gas is inhibited from being discharged from the inspiratory member with the first gas via the further positive end expiratory pressure valve.
However, before the effective filing date of the invention, it would have been obvious to one of ordinary skill in the art to make the specific configuration so that the inspiratory member is sufficiently long so that the stored second gas is inhibited from being discharged from the inspiratory member with the first gas via the further positive end expiratory pressure valve in the device of Fukunaga as modified by Ecreg, because Applicant has not disclosed that specifically inhibiting the stored gas from being discharged from the inspiratory member with the first gas via the further positive end expiratory pressure valve by the inspiratory member being sufficiently long provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected the configuration of modified Fukunaga, and Applicant' s configuration, to perform equally well because both configurations perform the same function of inhibiting stored second gas from being discharged from the inspiratory member via the further positive end expiratory pressure valve.
Therefore, it would have been prima facie obvious to further modify Fukunaga as modified by Ecreg to obtain the invention as specified in claim 30, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the function of inhibiting stored second gas from being discharged from the inspiratory member via the further positive end expiratory pressure valve.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (US 20170095631 A1) as applied to claim 24, in view of Henkin (US 5398675 A).
Regarding claim 33, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 24 above.
Fukunaga as modified fails to explicitly disclose the breathing circuit, wherein there is an additional positive end expiratory pressure valve of the expiratory member.
However, Henkin teaches multiple positive end expiratory pressure valves of the breathing circuit (Henkin: A PEEP valve 460 is connected in the patient overflow path, where PEEP Valve 460 supplements a PEEP Valve 470, the purpose of the PEEP Valve 470 is to establish a positive end expiratory pressure against which the patient breaths as set forth in column 15 line 6 – column 16 line 11).
Fukunaga and Henkin are both considered to be analogous to the claimed invention because they are in the same field of gas delivery systems using PEEP valve control for pressure within the breathing circuit. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the expiratory member configuration of Fukunaga to incorporate the teaching of Henkin and include where there are multiple positive end expiratory pressure valves of the breathing circuit (Henkin: A PEEP valve 460 is connected in the patient overflow path, where PEEP Valve 460 supplements a PEEP Valve 470, the purpose of the PEEP Valve 470 is to establish a positive end expiratory pressure against which the patient breaths as set forth in column 15 line 6 – column 16 line 11). Doing so would provide an improved control over pressure regulation within the breathing circuit.
Fukunaga as modified by Henkin fails to explicitly disclose the breathing circuit, wherein a positive end expiratory pressure valve of the expiratory member has a higher pressure setting than a pressure setting of the further positive end expiratory pressure valve of the inspiratory member.
However, for user safety, it would be understood by one of ordinary skill in the art that it would be essential for a breathing circuit with two PEEP valves that the PEEP valve of the expiratory pathway be set at a higher pressure than the pressure setting of the further positive end expiratory pressure valve of the inspiratory member. Doing so would ensure a positive pressure is maintained at the end of exhalation in order to prevent alveolar collapse.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Fukunaga (US 20170095631 A1) as applied to claim 1, in view of Landis (US 9427547 B2).
Regarding claim 46, Fukunaga as modified discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Fukunaga as modified is silent as to whether the first gas is supplied at a rate that is greater than or equal to peak inspiratory flow rate of a patient.
However, Landis teaches a first gas supplied at a rate that is greater than or equal to peak inspiratory flow rate of a patient (Landis: FIG. 17 If the patient is inhaling gas at a faster rate than the rate of gas that high flow therapy device 2000 is delivering to the patient, in addition to breathing in the supplied gas, the patient also inhales ambient air the microprocessor 2060 of high flow therapy device 2000 is able to adjust various flow parameters, such as increasing the flow rate, to minimize or eliminate the entrainment of ambient air as set forth in column 16 lines 7-20).
Fukunaga and Landis are both considered to be analogous to the claimed invention because they are in the same field of systems for delivering pressurized respiratory gas to an airway of a patient. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fukunaga to incorporate the teaching of Landis and include a first gas supplied at a rate that is greater than or equal to peak inspiratory flow rate of a patient (Landis: FIG. 17 If the patient is inhaling gas at a faster rate than the rate of gas that high flow therapy device 2000 is delivering to the patient, in addition to breathing in the supplied gas, the patient also inhales ambient air the microprocessor 2060 of high flow therapy device 2000 is able to adjust various flow parameters, such as increasing the flow rate, to minimize or eliminate the entrainment of ambient air as set forth in column 16 lines 7-20). Doing so would minimize or eliminate the entrainment of ambient air (Landis: As set forth in column 16 lines 7-20)
Conclusion
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/KEIRA EILEEN CALLISON/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785