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
Examiner acknowledges the reply filed on 10/10/2025 in which claims 1-3, 9, 11, and 18 have been amended. Currently, claims 1-21 are pending for examination in this application.
Response to Arguments
Applicant has resolved the objection to claim 8; however, an additional objection has been found.
The double patenting rejections have been withdrawn due to the amendments to the claims.
Applicant’s arguments with respect to claim(s) 1, 11, and 18 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.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11, line 7, “a first hose gas source” should be “the first host gas source”.
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.
Claim(s) 1-2, 6, 11-13, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1).
Regarding claim 1, Haberland discloses a portable ventilator (portable oxygen concentrating device 10; figure 1-3) comprising:
a portable gas connection port configured to connect to a portable gas source (see figure 3 and [0018-0019], port connecting valve 25 and “oxygen to patient” to product tank 24 which receives air from compressor 14);
at least one host gas port (see [0027], port at connector 34; figure 2-3. Examiner notes in figure 2 connector 34 is incorrectly labeled 14) configured to connect to a host gas source of a host (see [0027], stationary compressor 30 of stationary device 12; figure 2-3);
a ventilation drive configured to drive a ventilation gas alternately from the portable gas source and the host gas source ([0016] As shown in FIGS. 1 and 2, a dual mode oxygen generator 8 may be used to provide oxygen to a patient in either a portable or stationary mode. The dual mode oxygen generator 8 acts as a ventilation drive); and
wherein the portable ventilator is configured to:
removably connect to the host such that when the portable ventilator is connected to the host, the ventilation drive drives the ventilation gas from the host gas source received via the at least one host gas port to the patient ([0028] In an embodiment, upon connection of portable device 10 to stationary device 12, portable compressor 14 is shut off in favor of stationary compressor 30. While such shut off may be implemented manually, an automatic shut off is a useful approach. [0030] In an embodiment, portable compressor 14 may remain on when the two devices are connected, and work in conjunction with stationary compressor 30. In this embodiment, stationary compressor 30 may have a correspondingly reduced output capacity such that the two compressors together have an output capacity sufficient to meet the patient's need); and
upon disconnection from the host, switch to driving the ventilation gas from the portable gas source, wherein the portable ventilator acts on its own to drive the ventilation gas from the portable gas source to the patient ([0016] As shown in FIGS. 1 and 2, a dual mode oxygen generator 8 may be used to provide oxygen to a patient in either a portable or stationary mode; see figure 1. See [0018]-[0023] which discloses how the device 8 operates when in the portable mode).
Haberland does not explicitly disclose the switching being automatic. However, making the switching automatic involves only routine skill in the art (only need a simple mechanical/digital switching means). So it would have been obvious to make the switching automatic since portable ventilation is the only option available once the stationary source is disconnected and doing so would remove an extra step of having to manually change it. Broadly claiming switching as an automatic action rather than a manual one doesn't patentably distinguish from the prior art, see MEPE 2111.4.
Regarding claim 2, Haberland discloses the portable ventilator of claim 1, further comprising a portable gas source input valve configured to automatically open to allow the ventilation gas to flow from the portable gas source connected to the portable gas connection port when the portable ventilator is not connected to the host gas source ([0018] Portable device 10 includes a compressor 14 that compresses ambient air 15, and provides it to a valve 16 that controls flow into a pair of molecular sieves 18, 20. In an embodiment, ambient air 15 first passes through an air filter (not shown) to remove particulate matter prior to compression and oxygen concentration. In operation, valve 16 alternately provides the compressed air to the sieves, each of which includes a nitrogen binding material such as zeolite. As the compressed air passes through the zeolite, nitrogen is extracted, leaving an oxygen-enriched gas. See [0018]-[0023] which discloses how the device 8 operates when in the portable mode).
Regarding claim 6, Haberland discloses the portable ventilator of claim 1, but is silent as to further comprising a flow controller configured to control flow of the ventilation gas from both the host gas source and the portable gas source to the patient ([0019] oxygen-enriched air may be provided directly to a patient via valve 25, which may be, for example, a proportional valve, controllable to vary the output flow rate of the system; figure 3).
Regarding claim 11, Haberland discloses a patient ventilation system (dual mode oxygen generator 8; figure 1-2) comprising:
a first host connected to a first host gas source (see [0027], stationary device 12 and stationary compressor 30; figure 2-3);
a portable ventilator (portable oxygen concentrating device 10; figure 1-3) configured to removably connected to the first host ([0027] Connector 34 removably connects portable device 10 to stationary device 12; figure 2-3);
a portable gas source connected to the portable ventilator (see [0018-0019], product tank 24 receives air from compressor 14; figure 3);
wherein the portable ventilator comprises:
a portable gas connection port configured to connect to the portable gas source (see figure 3 and [0018-0019], port connecting valve 25 and “oxygen to patient” to product tank 24 which receives air from compressor 14);
at least one host gas port (see [0027], port at connector 34; figure 2-3. Examiner notes in figure 2 connector 34 is incorrectly labeled 14) configured to connect to a first host gas source of the first host (see [0027], stationary compressor 30 of stationary device 12; figure 2-3);
a ventilation drive configured to drive a ventilation gas alternatively from the first host gas source and the portable gas source to a patient ([0016] As shown in FIGS. 1 and 2, a dual mode oxygen generator 8 may be used to provide oxygen to a patient in either a portable or stationary mode. The dual mode oxygen generator 8 acts as a ventilation drive);
wherein the portable ventilator is configured to:
drive the ventilation gas from the first hot gas source when the portable ventilator is connected to the first host while the portable gas source is connected to the portable gas connection port ([0028] In an embodiment, upon connection of portable device 10 to stationary device 12, portable compressor 14 is shut off in favor of stationary compressor 30. While such shut off may be implemented manually, an automatic shut off is a useful approach. [0030] In an embodiment, portable compressor 14 may remain on when the two devices are connected, and work in conjunction with stationary compressor 30. In this embodiment, stationary compressor 30 may have a correspondingly reduced output capacity such that the two compressors together have an output capacity sufficient to meet the patient's need; see figure 2-3);
upon disconnection from the first host, switch to driving the ventilation gas from the portable gas source, wherein the portable ventilator acts on its own to drive the ventilation gas from the portable gas source to the patient when the portable ventilator is not connected to the first host or any additional host ([0016] As shown in FIGS. 1 and 2, a dual mode oxygen generator 8 may be used to provide oxygen to a patient in either a portable or stationary mode; see figure 1. See [0018]-[0023] which discloses how the device 8 operates when in the portable mode).
Haberland does not explicitly disclose the switching being automatic. However, making the switching automatic involves only routine skill in the art (only need a simple mechanical/digital switching means). So it would have been obvious to make the switching automatic since portable ventilation is the only option available once the stationary source is disconnected and doing so would remove an extra step of having to manually change it. Broadly claiming switching as an automatic action rather than a manual one doesn't patentably distinguish from the prior art, see MEPE 2111.4.
Regarding claim 12, Haberland discloses the patient ventilation system of claim 11, further comprising a portable gas source input valve in the ventilation drive and configured to automatically facilitate flow of the ventilation gas from the portable gas source when the portable ventilator is not connected to the first host gas source ([0018] Portable device 10 includes a compressor 14 that compresses ambient air 15, and provides it to a valve 16 that controls flow into a pair of molecular sieves 18, 20. In an embodiment, ambient air 15 first passes through an air filter (not shown) to remove particulate matter prior to compression and oxygen concentration. In operation, valve 16 alternately provides the compressed air to the sieves, each of which includes a nitrogen binding material such as zeolite. As the compressed air passes through the zeolite, nitrogen is extracted, leaving an oxygen-enriched gas. See [0018]-[0023] which discloses how the device 8 operates when in the portable mode).
Regarding claim 13, Haberland discloses the patient ventilation system of claim 12, further comprising a flow control valve configured to control the flow of the ventilation gas to the patient ([0019] oxygen-enriched air may be provided directly to a patient via valve 25, which may be, for example, a proportional valve, controllable to vary the output flow rate of the system).
Regarding claim 18, Haberland discloses a method of ventilator operation ([0016] dual mode oxygen generator 8; figure 1-3) comprising:
operating a ventilation drive ([0016] As shown in FIGS. 1 and 2, a dual mode oxygen generator 8 may be used to provide oxygen to a patient in either a portable or stationary mode. The dual mode oxygen generator 8 acts as a ventilation drive) of a portable ventilator (portable oxygen concentrating device 10; figure 1-3) to drive ventilation gas from a portable gas source through a patient interface to a patient (see figure 1&3 and [0018-0020], air from compressor 14 is driven to product tank 24 and delivered to patient breathing mask or nasal cannula), wherein the portable ventilator is not connected to any host ([0016] As shown in FIGS. 1 and 2, a dual mode oxygen generator 8 may be used to provide oxygen to a patient in either a portable or stationary mode; see figure 1. See [0018]-[0023] which discloses how the device 8 operates when in the portable mode) and the ventilation gas from the portable gas source is at a first pressure ([0025] a portable compressor with a capacity of 12-14 l/m is capable of producing about 1 l/m of enriched product gas using an air-side balance approach. Examiner notes that one of ordinary skill in the art that a gas flowing has a given pressure since flow rate is proportional to pressure);
upon connection of the portable ventilator to a host while the portable gas source remains connected to the portable ventilator ([0027] Connector 34 removably connects portable device 10 to stationary device 12. In an embodiment, connector 34 is a quick connect gas line that provides for pressurized air flow from stationary compressor 30 to the portable device 10; figure 2-3), operating the ventilation drive to drive the ventilation gas from a hot gas source (see [0027], stationary compressor 30 of stationary device 12; figure 2-3) through the patient interface to the patient ([0028] In an embodiment, upon connection of portable device 10 to stationary device 12, portable compressor 14 is shut off in favor of stationary compressor 30. While such shut off may be implemented manually, an automatic shut off is a useful approach. [0030] In an embodiment, portable compressor 14 may remain on when the two devices are connected, and work in conjunction with stationary compressor 30. In this embodiment, stationary compressor 30 may have a correspondingly reduced output capacity such that the two compressors together have an output capacity sufficient to meet the patient's need; see figure 2-3), wherein the ventilation gas from the host gas source is at a second pressure ([0025] in order to provide a 5 l/m output, the stationary compressor may have a capacity of 50-70 l/m. Examiner notes that one of ordinary skill in the art that a gas flowing has a given pressure since flow rate is proportional to pressure), wherein the second pressure is greater than the first pressure (see [0025], flow rate produced by stationary compressor is higher than flow rate produced by portable compressor and since flow rate is proportional to pressure, pressure of stationary compressor is greater than pressure produced by portable compressor);
upon disconnection of the portable ventilator from the host, switching back to driving the ventilation gas from the portable gas source, wherein the portable ventilator acts on its own to drive the ventilation gas from the portable gas source to the patient when the portable ventilator is not connected to the host ([0016] As shown in FIGS. 1 and 2, a dual mode oxygen generator 8 may be used to provide oxygen to a patient in either a portable or stationary mode; see figure 1. See [0018]-[0023] which discloses how the device 8 operates when in the portable mode).
Haberland does not explicitly disclose the switching being automatic. However, making the switching automatic involves only routine skill in the art (only need a simple mechanical/digital switching means). So it would have been obvious to make the switching automatic since portable ventilation is the only option available once the stationary source is disconnected and doing so would remove an extra step of having to manually change it. Broadly claiming switching as an automatic action rather than a manual one doesn't patentably distinguish from the prior art, see MEPE 2111.4.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) as applied to claim 2 above, and further in view of Tyomkin et al. (US 6675798 B1).
Regarding claim 3, Haberland discloses the portable ventilator of claim 2, but is silent as to wherein the portable gas source input valve is further configured to open when a delivery pressure of the ventilation gas from the host gas source via the at least one host gas port is lower than a delivery pressure of the ventilation gas from the portable gas source via the portable gas connection port.
However, Tyomkin teaches a system for automatically regulating oxygen flow to a patient (title) comprising a primary gas source (primary oxygen supply 101, Fig. 1) which may be a host gas source (col. 6 line 15-22) and a secondary gas source (auxiliary oxygen supply 2; Fig. 1) which may be portable (col. 6 line 15-22) wherein the secondary gas source (102) comprising a input valve (Connected to the other inlet port of selector valve 105 are auxiliary oxygen supply 102 and supply valve 104, Fig. 1, col. 5 line 14-16) configured to open when a delivery pressure of the ventilation gas from the host gas source (101) is lower than a delivery pressure of the ventilation gas from the portable gas source (102) (The auxiliary oxygen supply 102 is provided so that, should there be a failure of supply from the primary oxygen supply 101, a patient will continue to be supplied with oxygen. To give effect to continuous supply, relating to a flow failure from primary supply 101, auxiliary supply signal 117 is received by detector device 118, which, in turn, causes opening of selector valve 105 auxiliary supply port, to permit gas flow from auxiliary oxygen supply 102, col. 5 line 28-35. Failure is either a fall in flow rate below a predetermined rate or a total cessation of flow, col. 5 line 56-65). Examiner notes that if the flow rate of the primary oxygen supply falls or a total cessation of flow occurs, the delivery pressure also falls or completely goes to zero and therefore, the flow rate and delivery pressure of the auxiliary oxygen supply is higher than that of the primary oxygen supply at least in the situation where there is a total cessation of flow.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the valve of Haberland to be configured to open when a failure of supply from the host gas source resulting from a cessation of flow and therefore delivery pressure at the host gas source in order to facilitate an automatic and continued supply of oxygen to the patient via the portable gas source as taught by Tyomkin (col. 5 line 28-35 and line 56-65).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) as applied to claim 1 above, and further in view of McClain et al.( US 20080202508 A1).
Regarding claim 4, Haberland discloses the portable ventilator of claim 1, but is silent as to further comprising a host source connection valve in the ventilation drive configured to open when the portable ventilator is connected to the host to facilitate flow of the ventilation gas from the host gas source to the ventilation drive.
However, McClain teaches a host source connection valve ([0026]the PSA or VPSA system 64, 68 includes a PSA or VPSA sieve bed, valves; figure 2. Also see circle with X representing a valve in “STATIONARY” portion in figure 2) in the ventilation drive (oxygen concentrator system 10; figure 1-2) configured to open when the portable ventilator is connected to the host to facilitate flow of the ventilation gas from the host gas source to the ventilation drive ([0019] The station 18 also includes a stationary oxygen outlet 54, which is in operative communication with the stationary oxygen concentrator 42 and is configured to selectively provide a direct fluid supply. [0020] It is to be understood that in an embodiment, the stationary oxygen concentrator 42 receives control via the control inlet 50. As such, the station 18, including the stationary oxygen concentrator 42 and the stationary oxygen outlet 54, are operable when the portable system 14 is engaged with the station 18. [0023] when the portable system 14 is not engaged with the station 18, the stationary oxygen concentrator 42 is inoperable).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Haberland to implement a host source connection valve in the stationary device that is inoperable when the portable system is not engaged with the stationary system but is configured to be open when the portable device is engaged with the stationary device in order to selectively provide a direct fluid supply from the stationary device as taught by McClain [0023].
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) and McClain et al.( US 20080202508 A1) as applied to claim 4 above, and further in view of Duff et al. (US 6269811 B1).
Regarding claim 5, modified Haberland teaches the portable ventilator of claim 4, wherein the host source connection valve is configured to open when the portable ventilator connects to the host (McClain: see modification above), but is silent as to wherein the host source connection valve is a normally closed valve.
However, Duff teaches a pressure support system with a primary and secondary gas flow (title) comprising a host source connection valve (valve 50, Fig. 1) wherein the host source connection valve (50) is a normally closed valve configured to open when the pressure support system (30, Fig. 1) connects to the host (pressure generator 32; Fig. 1) (the valve is a normally closed valve that is actuated to cause it to move to an open position responsive to a signal from the control unit, and wherein the signal is output by the control unit responsive to a determination that the pressure generator is at least one of (1) actuated and (2) operating within normal parameters, claim 2, col. 9 line 9-15. Examiner notes that the pressure generator must be connected to the system in order to be one of (1) actuated and (2) operating within normal parameters).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the host source connection valve of modified Haberland to be a normally closed valve, as taught by Duff, as it would have been obvious substitution of one known element for another, using the normally closed valve taught by Duff in place of the valve of modified Haberland, and would provide predictable results, controlling the flow of gas to a patient (Duff col. 6, line 34-35).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) as applied to claim 6 above, and further in view of Boulanger (US 20190321576 A1).
Regarding claim 7, Haberland discloses the portable ventilator of claim 6, but is silent as to further comprising a pressure regulator in the ventilation drive that regulates a delivery pressure of the ventilation gas from the portable gas source to the flow controller wherein the delivery pressure of the ventilation gas from the portable gas source to the flow controller is less than a delivery pressure of the ventilation gas from the host gas source to the flow controller.
However, Boulanger teaches comprising a pressure regulator (third pressure regulator 31, Fig. 1) in the ventilation drive (gas mixer 1, Fig. 1-3) that regulates a delivery pressure of the ventilation gas from the portable gas source ([0058] First pressure regulator 11 is provided for reducing the pressure of the first gas, e.g. air, delivered by the first gas source, e.g. a medicinal air source 10a. The level of the desired lower pressure depends on the settings of the first pressure regulator 11. For instance, if the pressure of the first gas is of about 3.5 bars abs, the pressure level of the first pressure regulator 11 can be set to a lower pressure of 2.5 bars abs (of course, it could be higher or lower) so that the first gas exhibits said lower pressure downstream of the first pressure regulator 11, in first line 13. Third pressure regulator 31 provides the same function for third source 30a as established by [0058]-[0068]) to the flow controller (fourth proportional valve 61, Fig. 1; [0072]-[0073], [0075]-[0076], and [0083]), wherein the delivery pressure of the ventilation gas from the portable gas source (30a) to the flow controller (61) is less than a delivery pressure of the ventilation gas from the host gas source (20a) to the flow controller (61) (The level of the desired lower pressure depends on the settings of the first pressure regulator 11. For instance, if the pressure of the first gas is of about 3.5 bars abs, the pressure level of the first pressure regulator 11 can be set to a lower pressure of 2.5 bars abs (of course, it could be higher or lower) so that the first gas exhibits said lower pressure downstream of the first pressure regulator 11, in first line 13). Examiner notes that the pressure level set at the pressure regulators 11, 21, 31 are disclosed to vary and therefore, under routine optimization and experimentation it is expected that one may be higher or lower than the other even by + or _ 0.01 bars.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Haberland to include pressure regulators that regulate the delivery pressure from the portable gas source and the host gas source to the flow controller as taught by Boulanger in order to control the pressure sent to the patient ([0058-[0061]), additionally under routine optimization and experimentation it is possible for the delivery pressure of the ventilation gas from the portable gas source to be slightly less than a delivery pressure of the ventilation gas from the host gas source as the pressure level set by the pressure regulators are said to vary.
Claim(s) 8 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) as applied to claim 1 above, and further in view of Manigel et al. (US 20080264417 A1).
Regarding claim 8, Haberland discloses the portable ventilator of claim 1, further comprising a patient interface section connected to the ventilation drive (see figure 1-2, patient interface in the form of nasal cannula connected to portable oxygen concentrating device 10. Also see [0016] cannula) and configured to guide the ventilation gas from the ventilation drive to a patient connection (see figure 3, “O2 to patient”); and
wherein the ventilation drive is configured to drive the ventilation gas from either one of the host gas source ([0028-0029]; figure 2) and the portable gas source ([0018-0022]; figure 1) through the patient interface section to the patient ([0016]; figure 1-2).
Haberland is silent as to the patient interface section configured to receive expiratory gas from the patient connection, and expel the expiratory gas out of the portable ventilator.
However, Manigel teaches a patient interface section configured to receive expiratory gas from the patient connection ([0040] breathing tube 19; figure 3), and expel the expiratory gas out of the portable ventilator ([0041] The expiration gas enters the environment or an expiration gas discharge line 18 during expiration from the mobile respiration module 1 through the interface 8 and the outlet-side, expiratory flow sensor 9 in the stationary part 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patient interface of Haberland to implement a breathing line for expiration gas and a system for expelling expiration gas as taught by Manigel in order to efficiently expel expiratory gas.
Regarding claim 10, Haberland discloses the portable ventilator of claim 1, wherein the host is a first host and the host gas source is a first host gas source (see [0027], stationary compressor 30 of stationary device 12; figure 2-3), but is silent as to wherein the portable ventilator is configured to connect to each of the first host such that the ventilation drive drives ventilation gas from the first host gas source and a second host such that the ventilation drive drives the ventilation gas from a second host gas source, alternately one at a time.
However, Manigel teaches a portable ventilator system comprising a plurality of hosts (stationary part 2, Fig. 2, [0039] The mobile respiration module 1, which is always the same, can be connected to stationary parts 2 that have specifically different designs or configurations. Thus, the respiration module 1 may be connected to a stationary part 2 in an emergency department (ED), in the operating room (Perioperative Care, POC), in the intensive care unit (Critical Care, CC), or, for example, at the Nuclear Spin Tomograph (Nuclear Magnetic Resonance, NMR)) and the host gas source is a first host gas source (fresh gas feed 14, Fig. 2; [0037] and [0040] infrastructure of hospital), and wherein the portable ventilator is configured to connect to each of the first host such that the ventilation drive (1) drives ventilation gas from the first host gas source (fresh gas feed 14, Fig. 2; [0037] and [0040] infrastructure of hospital) and a second host (“second host” is any second host that supplies a second source of fresh gas feed 14 from infrastructure of the hospital or optionally corresponding portable storage devices as established by [0037]) such that the ventilation drive (1) drives the ventilation gas from a second host gas source (fresh gas feed 14, Fig. 2; [0037] and [0040] infrastructure of hospital or optionally corresponding portable storage devices), alternately one at a time ([0040] The fresh gas feed 14 is used to supply fresh gas, i.e., oxygen, air, laughing gas and/or anesthetic, into the respiration system. [0022] The stationary parts of the entire modular respiration system are available in various variants, which are adapted to the particular needs for transportation within the hospital, stationary intensive respiration or anesthesia. Together with the mobile respiration module, full-fledged medical workstations are obtained for transportation, intensive respiration or anesthesia).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Haberland to implement a plurality of variations of the stationary parts as hosts configured to be connected to the portable oxygen concentrating device such that ventilation gas can be provided alternatively from different hosts for different uses or in different locations as taught by Manigel [0022] and [0039].
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) as applied to claim 1 above, and further in view of Lampotang et al. (US 6131571 A) and Schreuder et al. (US 20110224475 A1).
Regarding claim 9, Haberland discloses the portable ventilator of claim 1, but is silent as to wherein the ventilation drive is configured to connect to each of a high pressure portable gas source and a low pressure gas source, and wherein the portable ventilator is configured to provide the ventilation gas from the low pressure gas source only when the high pressure portable gas source is not connected or is depleted.
Examiner notes that in Applicant’s specifications [0030] there is an admission that wall gas is an example of a portable ventilation gas source: “The portable ventilator 2 can attach to any of the various portable ventilation gas sources, such as oxygen tanks or wall gas”.
Lampotang establishes that a hospital supply system is a high pressure portable gas source (oxygen from source 274, which is nominally 50 psig for most hospital supply systems, Fig. 2, col. 18 line 23-24) and a O2 cylinder is a low pressure gas source (oxygen from cylinders 246, 248 at a nominal pressure of 40 to 45 psig, Fig. 6, col. 18 line 65-66)
Additionally, Schreuder teaches a portable anesthesia system (title) wherein a ventilation drive ([0029] anesthesia machine 102, Fig. 4) is configured to connect to each of a high pressure (Lampotang: 50 psig) portable gas source ([0038] a mobile anesthesia system is shown hooked up to a medical facility gas system via gas supply lines 428, Fig. 4. As evidenced by Applicant’s specifications [0030], the wall gas is a portable gas source) and a low pressure (Lampotang: 40-45 psig) gas source ([0029] portable gas system 108 can include cylinders of essential anesthetic gases, including oxygen; Fig. 4), and wherein the portable ventilator is configured to automatically switch to the ventilation gas from the low pressure gas source only when the high pressure portable gas source is not connected to the portable gas connection port ([0038] The mobile anesthesia system can include a switching mechanism (not shown) configured to switch between the portable gas system 108 and the medical facility gas system. The ability to switch between a fixed supply of anesthetic gases provided through the medical facility gas system and the portable gas system provides versatility with respect to the location where the patient undergoes anesthesia. For example, an anesthesiologist can administer anesthesia to a patient using a portable gas system 108 during patient transport, or when the patient is outside a treatment room. When the patient is taken into the treatment room, the mobile anesthesia system can then be hooked up to the medical facility gas system and switched off of the portable gas system. See figure 4, the portable gas connection port on 102 that receives lines 428).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Haberland to include a wall gas supply connected to the portable gas connection port and an oxygen cylinder, wherein the oxygen cylinder is only switched on when the wall gas supply is not connected as taught by Schreuder in order to provide versatility with respect to where the patient undergoes treatment [0038]. As evidenced by Lampotang, the hospital wall gas supply is a high pressure source and the O2 cylinder is a low pressure gas source. As evidenced by the Applicant’s specification, the wall gas supply is a portable ventilation gas source.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) as applied to claim 13 above, and further in view of Boulanger (US 20190321576 A1).
Regarding claim 14 ,Haberland discloses the patient ventilation system of claim 13, but is silent as to further comprising a pressure regulator in the ventilation drive that regulates a delivery pressure of the ventilation gas from the portable gas source to the flow control valve, wherein the delivery pressure of the ventilation gas from the portable gas source to the flow controller is less than a delivery pressure of the ventilation gas from the first host gas source.
However, Boulanger teaches comprising a pressure regulator (third pressure regulator 31, Fig. 1) in the ventilation drive (gas mixer 1, Fig. 1-3) that regulates a delivery pressure of the ventilation gas from the portable gas source ([0058] First pressure regulator 11 is provided for reducing the pressure of the first gas, e.g. air, delivered by the first gas source, e.g. a medicinal air source 10a. The level of the desired lower pressure depends on the settings of the first pressure regulator 11. For instance, if the pressure of the first gas is of about 3.5 bars abs, the pressure level of the first pressure regulator 11 can be set to a lower pressure of 2.5 bars abs (of course, it could be higher or lower) so that the first gas exhibits said lower pressure downstream of the first pressure regulator 11, in first line 13. Third pressure regulator 31 provides the same function for third source 30a as established by [0058]-[0068]) to the flow control valve (fourth proportional valve 61, Fig. 1; [0072]-[0073], [0075]-[0076], and [0083]), wherein the delivery pressure of the ventilation gas from the portable gas source (30a) is less than a delivery pressure of the ventilation gas from the host gas source (20a) (The level of the desired lower pressure depends on the settings of the first pressure regulator 11. For instance, if the pressure of the first gas is of about 3.5 bars abs, the pressure level of the first pressure regulator 11 can be set to a lower pressure of 2.5 bars abs (of course, it could be higher or lower) so that the first gas exhibits said lower pressure downstream of the first pressure regulator 11, in first line 13). Examiner notes that the pressure level set at the pressure regulators 11, 21, 31 are disclosed to vary and therefore, under routine optimization and experimentation it is expected that one may be higher or lower than the other even by + or _ 0.01 bars.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Haberland to include pressure regulators that regulate the delivery pressure from the portable gas source and the host gas source to the flow controller as taught by Boulanger in order to control the pressure sent to the patient ([0058-0061]), additionally under routine optimization and experimentation it is possible for the delivery pressure of the ventilation gas from the portable gas source to be slightly less than a delivery pressure of the ventilation gas from the host gas source as the pressure level set by the pressure regulators are said to vary.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) and Boulanger (US 20190321576 A1) as applied to claim 14 above, and further in view of Tyomkin et al. (US 6675798 B1).
Regarding claim 15, modified Haberland teaches the patient ventilation system of claim 14, but is silent as to wherein the portable gas source input valve is further configured to open when the delivery pressure of the ventilation gas from the first host gas source to the flow control valve is lower than the delivery pressure of the ventilation gas from the portable gas source.
However, Tyomkin teaches a system for automatically regulating oxygen flow to a patient (title) comprising a primary gas source (primary oxygen supply 101, Fig. 1) which may be a first host gas source (col. 6 line 15-22) and a secondary gas source (auxiliary oxygen supply 2; Fig. 1) which may be portable (col. 6 line 15-22) wherein the secondary gas source (102) comprising a input valve (Connected to the other inlet port of selector valve 105 are auxiliary oxygen supply 102 and supply valve 104, Fig. 1, col. 5 line 14-16) configured to open when a delivery pressure of the ventilation gas from the first host gas source (101) to the flow control valve (valve 108, Fig. 2; valve 108 directs the flow of gas, col. 5 line 23) is lower than a delivery pressure of the ventilation gas from the portable gas source (102) (The auxiliary oxygen supply 102 is provided so that, should there be a failure of supply from the primary oxygen supply 101, a patient will continue to be supplied with oxygen. To give effect to continuous supply, relating to a flow failure from primary supply 101, auxiliary supply signal 117 is received by detector device 118, which, in turn, causes opening of selector valve 105 auxiliary supply port, to permit gas flow from auxiliary oxygen supply 102, col. 5 line 28-35. Failure is either a fall in flow rate below a predetermined rate or a total cessation of flow, col. 5 line 56-65). Examiner notes that if the flow rate of the primary oxygen supply falls or a total cessation of flow occurs, the delivery pressure also falls or completely goes to zero and therefore, the flow rate and delivery pressure of the auxiliary oxygen supply is higher than that of the primary oxygen supply at least in the situation where there is a total cessation of flow.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the valve of Haberland to be configured to open when a failure of supply from the first host gas source resulting from a cessation of flow and therefore delivery pressure at the first host gas source in order to facilitate an automatic and continued supply of oxygen to the patient via the portable gas source as taught by Tyomkin (col. 5 line 28-35 and line 56-65).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) as applied to claim 11 above, and further in view of Schreuder et al. (US 20110224475 A1).
Regarding claim 16, Haberland discloses the patient ventilation system of claim 11, wherein the portable gas source is a 02 cylinder ([0019] Oxygen-enriched air passes through check valves 20, 22 to reach a product tank 24; see figure 3) but is silent as to wherein the first host gas source is a wall gas source.
However, Schreuder teaches a portable anesthesia system (title) wherein the portable gas source is a 02 cylinder ([0029] The portable gas system 108 can include cylinders of essential anesthetic gases, including oxygen, medical air, nitrous oxide, for example; figure 4) and wherein the first host gas source is a wall gas source ([0038] a mobile anesthesia system is shown hooked up to a medical facility gas system via gas supply lines 428).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the Haberland device to implement the first host gas source as gas supply lines hooked up to a medical facility gas system, as taught by Schreuder, as it would have been obvious substitution of one known element for another, using the gas supply lines taught by Schreuder in place of the compressor of Haberland, and would provide predictable results, allowing the switching of gas provided through the medical facility gas system or portable gas system (see Schreuder [0038]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) as applied to claim 11 above, and further in view of Manigel et al. (US 20080264417 A1).
Regarding claim 17, Haberland discloses the patient ventilation system of claim 11, wherein the portable ventilator further comprises a patient interface section connected to the ventilation drive (see figure 1-2, patient interface in the form of nasal cannula connected to portable oxygen concentrating device 10. Also see [0016] cannula) and configured to guide the ventilation gas from the ventilation drive to a patient connection (see figure 3, “O2 to patient”); and
wherein the ventilation drive is configured to drive the ventilation gas from either one of the host gas source ([0028-0029]; figure 2) and the portable gas source ([0018-0022]; figure 1) through the patient interface section to the patient ([0016]; figure 1-2).
Haberland is silent as to the patient interface section configured to receive expiratory gas from the patient connection, and expel the expiratory gas out of the portable ventilator.
However, Manigel teaches a patient interface section configured to receive expiratory gas from the patient connection ([0040] breathing tube 19; figure 3), and expel the expiratory gas out of the portable ventilator ([0041] The expiration gas enters the environment or an expiration gas discharge line 18 during expiration from the mobile respiration module 1 through the interface 8 and the outlet-side, expiratory flow sensor 9 in the stationary part 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the patient interface of Haberland to implement a breathing line for expiration gas and a system for expelling expiration gas as taught by Manigel in order to efficiently expel expiratory gas.
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) as applied to claim 18 above, and further in view of McClain et al.( US 20080202508 A1).
Regarding claim 19, Haberland discloses the method of claim 18, but is silent as to further comprising, upon connection of the portable ventilator to the host, opening a host source connection valve to facilitate flow of the ventilation gas from the host gas source to the ventilation dive and closing a portable gas source input valve to stop flow of the ventilation gas from the portable gas source through the ventilation drive.
Haberland teaches [0028] In an embodiment, upon connection of portable device 10 to stationary device 12, portable compressor 14 is shut off in favor of stationary compressor 30. While such shut off may be implemented manually, an automatic shut off is a useful approach. [0029] Automatic shutoff can be achieved in a number of ways. An electrical sensor (not shown) may be configured and arranged to sense the presence of the connector 34 and to provide a control signal to compressor 14. In an alternate approach, a pressure sensor, for example positioned in line with connector 34 in portable device 10, could be used to detect pressurized air from compressor 30 and to provide a control signal to turn off compressor 14.
However, McClain teaches upon connection of a portable ventilator to a host ([0020]), opening a host source connection valve ([0026] the PSA or VPSA system 64, 68 includes a PSA or VPSA sieve bed, valves; figure 2. Also see circle with X representing a valve in “STATIONARY” portion in figure 2) to facilitate flow of the ventilation gas from the host gas source to the ventilation dive in the ventilation drive (oxygen concentrator system 10; figure 1-2. Examiner notes the valve of stationary oxygen outlet 54 must be open for gas to flow to patient) and closing a portable gas source input valve ([0026] the PSA or VPSA system 64, 68 includes a PSA or VPSA sieve bed, valves; figure 2. Also see circle with X representing a valve in “MOBILE” portion in figure 2) to stop flow of the ventilation gas from the portable gas source through the ventilation drive ([0020] It is to be understood that in an embodiment, the stationary oxygen concentrator 42 receives control via the control inlet 50. As such, the station 18, including the stationary oxygen concentrator 42 and the stationary oxygen outlet 54, are operable when the portable system 14 is engaged with the station 18. [0023] As mentioned above, the portable oxygen concentrator 22 is inoperable during operation of the stationary oxygen concentrator 42 when the portable system 14 is engaged with the station 18. Examiner notes the valve of mobile oxygen outlet 34 must be closed “during operation of the stationary oxygen concentrator 42 when the portable system 14 is engaged with the station 18” to prevent flow of gas to patient).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Haberland to implement a host source connection valve in the stationary device that is closed/inoperable when the portable system is not engaged with the stationary system but is configured to be open when the portable device is engaged with the stationary device and a portable gas source input valve configured to open when the portable system is not connected to the stationary system but closed/inoperable when the portable system is engaged with the stationary system in order to selectively provide a direct fluid supply from the portable device or stationary device as taught by McClain [0023].
Additionally, one of ordinary skill in the art is capable of and would be motivated to actuating the host source connection valve to open and actuating the portable gas source input valve to be closed upon connection of the portable ventilator is connected to the host in order to allow gas to flow from the host gas source.
Regarding claim 20, modified Haberland teaches the method of claim 19, further comprising, upon disconnection of the portable ventilator from the host, closing the host source connection valve (see modification above, McClain: when the portable system 14 is not engaged with the station 18, the stationary oxygen concentrator 42 is inoperable) and opening the portable gas source input valve to facilitate flow of the ventilation gas from the portable gas source through the ventilation drive (see modification above, McClain: see [0013]. Examiner notes the valve of mobile oxygen outlet 34 must be open for gas to flow to patient when the portable system 14 is not engaged with the station 18).
Additionally, one of ordinary skill in the art at the time of the invention would find it obvious and would be capable of actuating the host source connection valve to close and actuating the portable gas source input valve to open upon disconnection of the portable ventilator from the host with the motivation to allow gas to flow from the portable gas source.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haberland et al. (US 20110232483 A1) as applied to claim 18 above, and further in view of Tyomkin et al. (US 6675798 B1).
Regarding claim 21, Haberland discloses the method of claim 18, but is silent as to further comprising, upon a pressure of the host gas source becoming less than the first pressure of the portable gas source, automatically operating the ventilation drive to drive the ventilation gas from the portable gas source through the patent interface to the patient.
However, Tyomkin teaches a system for automatically regulating oxygen flow to a patient (title) comprising a primary gas source (primary oxygen supply 101, Fig. 1) which may be a host gas source (col. 6 line 15-22) and a secondary gas source (auxiliary oxygen supply 2; Fig. 1) which may be portable (col. 6 line 15-22) wherein the secondary gas source (102) comprising a input valve (Connected to the other inlet port of selector valve 105 are auxiliary oxygen supply 102 and supply valve 104, Fig. 1, col. 5 line 14-16) configured to open when a delivery pressure of the ventilation gas from the host gas source (101) is lower than a delivery pressure of the ventilation gas from the portable gas source (102) (The auxiliary oxygen supply 102 is provided so that, should there be a failure of supply from the primary oxygen supply 101, a patient will continue to be supplied with oxygen. To give effect to continuous supply, relating to a flow failure from primary supply 101, auxiliary supply signal 117 is received by detector device 118, which, in turn, causes opening of selector valve 105 auxiliary supply port, to permit gas flow from auxiliary oxygen supply 102, col. 5 line 28-35. Failure is either a fall in flow rate below a predetermined rate or a total cessation of flow, col. 5 line 56-65). Examiner notes that if the flow rate of the primary oxygen supply falls or a total cessation of flow occurs, the delivery pressure also falls or completely goes to zero and therefore, the flow rate and delivery pressure of the auxiliary oxygen supply is higher than that of the primary oxygen supply at least in the situation where there is a total cessation of flow.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Haberland to implement automatic switching from the host gas source to the portable gas source when a failure of supply from the host gas source resulting from a cessation of flow and therefore delivery pressure at the host gas source in order to facilitate an automatic and continued supply of oxygen to the patient via the portable gas source as taught by Tyomkin (col. 5 line 28-35 and line 56-65).
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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/M.I.A./Examiner, Art Unit 3785
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785