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 § 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 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, 2, 5, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. (US PGPub 2014/0305431) in view of Broborg (US PGPub 2010/0307490), further in view of Glenn et al. (US PGPub 2016/0256656) and further in view Wallen (US 6035851).
Regarding claim 1, Holley teaches a system for artificial ventilation (see paragraphs 26 and 149 and fig. 22, the conduit can be used in in a ventilator) comprising: a convertible ventilator circuit (see fig. 23 and paragraph 149, circuit can be used in different types of respiratory settings)
said convertible ventilator circuit connected for use with one of a manual ventilator or a mechanical ventilator (see paragraph 149, the device can be used in a ventilator that provides a volume of controlled ventilation, so a mechanical ventilator),
a patient manifold (Fig. 22 and 23, manifold 101) comprising at least one non- return valve (Fig. 23, valve 2390; see paragraph 125) located at a junction between an inspiratory limb connection and an expiratory limb connection of the patient manifold (see fig. 23, the valve 2390 is located at a junction between inspiratory limb 102 and expiratory limb 104) and operable on both of the limb connections to alternate fluid flow along one of the limb connections (see Figs. 23 and 24 and paragraph 125 showing that the inspiratory limb is blocked during exhale and the expiratory limb is blocked during inhale) wherein during inspiration, the at least one non-return valve is configured to prevent fluid flow through the expiration limb connection from reaching a patient (see Figs. 23 and 24 and paragraph 125 showing the expiratory limb is blocked during inhale, the pressure pushing the valve down during inspiration to allow flow through limb 102) and during expiration, the at least one non-return valve is configured to prevent fluid flow through the inspiration limb connection from reaching the patient (see Figs. 23 and 24 and paragraph 125 showing the inspiration limb is blocked during exhale).
Holley does not explicitly teach wherein the convertible ventilator circuit is configured to convert between manual ventilation use and mechanical ventilation use.
However, Broborg teaches an analogous ventilator circuit (see fig. 1 and abstract) wherein the wherein the convertible ventilator circuit is configured to convert between manual ventilation use and mechanical ventilation use (see paragraphs 13 and 16, the circuit system can be switched between being driven by mechanical ventilation and manual bag).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to use the manifold of Holley in either a manual or mechanical ventilator because Broborg teaches that an apparatus that connects a source of air to a patient interface can be used in either manual ventilation or mechanical ventilation.
Holley does not teach the manifold comprising one or more sensor ports and a data acquisition unit comprising one or more sensors configured to interface with the one or more sensor ports of the patient manifold; wherein the data acquisition unit is configured to receive electronic data associated with transmission of respiratory gases through the convertible ventilator circuit.
However, Glenn teaches an analogous ventilator circuit (abstract and fig. 1) comprising a manifold (Fig. 2) wherein the manifold comprises one or more sensor ports (see Fig. 2, sensor port 216; see paragraph 20) and a data acquisition unit (Fig. 2, sensor assembly 210; see paragraph 20) comprising one or more sensors configured to interface with the one or more sensor ports of the patient manifold (see fig. 2 and paragraphs 20-21, the sensor assembly mates to the manifold via the port 216 and has oxygen sensor 222) wherein the data acquisition unit is configured to receive electronic data associated with transmission of respiratory gases through the ventilator circuit (see paragraphs 20-21, the oxygen sensor assembly measures the concentration of oxygen in a sample of air being delivered to the patient).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the circuit of Holley to have sensor port to which a data acquisiton unit interfaces with to receive data about the respiratory gases through the citcuit, as taught by Glenn, for the purpose of detecting the amount of oxygen in the delivered air to confirm an appropriate oxygen percentage is maintained. Further, making the sensor removable allows it to be easily cleaned (see paragraphs 2-3 of Glenn).
Holley does not teach the circuit comprising at least one inspiratory filter and at least one expiratory filter.
However, Wallen teaches an analogous patient circuit for a ventilator (abstract and fig. 1) wherein the circuit comprises at least one inspiratory filter (Fig. 1, 16; see col. 2, lines 41-42) and at least one expiratory filter (Fig. 1, 22; see col. 2, lines 47-49).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the circuit of Holley to have at least one inspiratory filter and at least one expiratory filter, as taught by Wallen, for the purpose of reducing the risk of a spread of infection between patients, reduce the risk of exposing patients to bacteria in the inspiratory air, and prevent the escape of bacteria from the circuit to the ambient air (see col. 1, lines 15-19 of Wallen). Holley further teaches that filters may be used in the apparatus (see paragraph 4).
Regarding claim 2, Holley further teaches the patient one or more non-return valves are configured to direct or pause inspiratory gases to the convertible ventilator circuit and direct or pause expiratory gases from the convertible ventilator circuit (see figs. 23 and 24 and paragraph 125, the valve directs the inspiratory as shown by arrow “IF” and the expiratory gas shown by arrows “EF”).
Regarding claim 5, Holley, as modified, further teaches a data processing unit (see Glenn fig. 1, controller 110) configured to process the electronic data received by the data acquisition unit (see Glenn paragraph 18, the processor 116 records and processes the data from the sensor); store the electronic data received by the data acquisition unit (see Glenn paragraph 18, the controller has a memory); and electronically transmit the electronic data received by the data acquisition unit to a neighboring device (see Glenn paragraphs 18 and 37, the data is sent to a monitor to be displayed).
Regarding claim 8, Holley, as modified, further teaches wherein the neighboring device comprises a bedside monitor (see Glenn fig. 1 and paragraph 17, the display is a monitor that is on the ventilator system which is placed next to the user’s bed).
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. (US PGPub 2014/0305431) in view of Broborg (US PGPub 2010/0307490), further in view of Glenn et al. (US PGPub 2016/0256656) and further in view Wallen (US 6035851) as applied to claim 1 above, and further in view of Hess et al. (US PGPub 2019/0209044).
Regarding claim 3, Holley teaches all previous elements of the claim as stated above. Holley does not teach wherein the data acquisition unit comprises one or more additional sensors that interface with one or more sensor ports of an airway adjunct in physical contact with a patient.
However, Hess teaches an analogous ventilation circuit (see abstract and Fig. 2) wherein the wherein the data acquisition unit (Fig. 5, 16) comprises one or more additional sensors (Fig. 5, sensing tubes 62, 34) that interface with one or more sensor ports of an airway adjunct in physical contact with a patient (see Fig. 2 and 3; tubes interfacing with ports on airway adjunct 74; see paragraphs 98 and 104).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the data acquisition unit of Holley to comprise sensors to interface with sensor ports of an airway adjunct contacting the patient, as taught by Hess, for the purpose of measuring parameters at the patient interface for respiration feedback to improve operation.
Regarding claim 4, Holley, as modified, further teaches wherein the one or more additional sensors comprise at least one of: a flow sensor; a pressure sensor; a temperature sensor; or a partial pressure gas sensor for carbon dioxide (see Hess paragraph 98, the parameters measured may include all of these).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. (US PGPub 2014/0305431) in view of Broborg (US PGPub 2010/0307490), further in view of Glenn et al. (US PGPub 2016/0256656) and further in view Wallen (US 6035851) as applied to claim 5 above, and further in view of Benoit et al. (US PGPub 2022/0023558).
Regarding claim 6, Holley teaches all previous elements of the claim as stated above. Holley does not teach wherein the data processing unit is housed in a single housing with the data acquisition unit.
However, Benoit teaches an analogous respiratory device comprising a data processing unit (see abstract and Fig. 2) wherein the data processing unit is housed in a single housing with the data acquisition unit (see paragraph 24, all components housed in a self-contained, single device).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the data processing unit of Holley to be housed in a single housing with the data acquisition unit, as taught by Benoit, for the purpose of using the system for” ready-to-use at moment’s notice” situations such as in military usage (see paragraph 24 of Benoit).
Regarding claim 7, Holley teaches all previous elements of the claim as stated above. Holley, as modified, does not explicitly teach wherein the data processing unit is housed in a housing of the neighboring device.
However, Benoit teaches an analogous respiratory device comprising a data processing unit (see abstract and Fig. 2) wherein the data processing unit (Fig. 2, 24) is housed in a housing of the neighboring device (see Fig. 2 and paragraph 54, the processor may be integrated into an existing monitor).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the data processing unit of Holley to be housed in a housing of a neighboring device, as taught by Benoit, for the purpose of using a configuration suitable for users who regularly monitor multiple devices (see paragraph 25 of Benoit).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. (US PGPub 2014/0305431) in view of Broborg (US PGPub 2010/0307490), further in view of Glenn et al. (US PGPub 2016/0256656) and further in view Wallen (US 6035851) as applied to claim 5 above, and further in view of Freeman et al. (US PGPub 2012/0302910).
Regarding claim 9, Holley teaches all previous elements of the claim as stated above. Holley does not teach a manual ventilator compatible with the convertible ventilator circuit, said manual ventilator comprising one or more settings configured to control one or more characteristics of manual ventilation
However, Freeman teaches an analogous ventilation system (se abstract and fig. 1) comprising a manual ventilator (Fig. 2, 212) comprising one or more settings configured to control one or more characteristics of manual ventilation (see fig. 3, steps 308 and 310; see paragraphs 126-129 and Fig; the manual ventilator has a set protocol, or settings, that should be following, the settings are used to guide the user to control the characteristics of the ventilation).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the system of Holley to comprise a manual ventilator comprising one or more settings configured to control one or more characteristics of manual ventilation, as taught by Freeman, for the purpose of guiding the user for proper ventilation. As modified, the manual ventilator is compatible with the convertible ventilator circuit as Holley, as modified, teaches the convertible ventilator circuit can be used with a manual ventilator known in the art.
Regarding claim 10, Holley, as modified, further teaches wherein the characteristics of manual ventilation comprise at least one of tidal volume or positive end-expiratory pressure (see paragraph 13 of Freeman).
Claims 11 and 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. (US PGPub 2014/0305431) in view of Broborg (US PGPub 2010/0307490), further in view of Glenn et al. (US PGPub 2016/0256656) and further in view Wallen (US 6035851) and further in view of Tham et al. (US PGPub 2015/0165142).
Regarding claim 11, Holley teaches a system for artificial ventilation (see paragraphs 26 and 149 and fig. 22, the conduit can be used in in a ventilator) comprising: a convertible ventilator circuit (see fig. 23 and paragraph 149, circuit can be used in different types of respiratory settings)
Wherein the convertible ventilator circuit comprises at least one inspiratory tube segment (Fig. 23, segment 102) and at least one expiratory tube segment (Fig. 23, segment 104), both the at least one inspiratory tube segment and at least one expiratory tube segment being in fluid communication with at least one non-return valve (see figs. 23 and 24, the segments communicate with valve 2390) located at a junction between the tube segment and the expiratory tube segment of the patient manifold (see fig. 23, the valve 2390 is located at a junction between inspiratory limb 102 and expiratory limb 104), the non-return valve being operable on both of the tube segments (see Figs. 23 and 24 and paragraph 125 showing that the inspiratory limb is blocked during exhale and the expiratory limb is blocked during inhale) wherein during inspiration, the at least one non-return valve is configured to prevent fluid flow through the expiratory tube segment from reaching a patient (see Figs. 23 and 24 and paragraph 125 showing the expiratory limb is blocked during inhale, the pressure pushing the valve down during inspiration to allow flow through limb 102) and during expiration, the at least one non-return valve is configured to prevent fluid flow through the inspiratory tube segment from reaching the patient (see Figs. 23 and 24 and paragraph 125 showing the inspiration limb is blocked during exhale).
Holley does not explicitly teach wherein the convertible ventilator circuit is configured to convert between manual ventilation use and mechanical ventilation use.
However, Broborg teaches an analogous ventilator circuit (see fig. 1 and abstract) wherein the wherein the convertible ventilator circuit is configured to convert between manual ventilation use and mechanical ventilation use (see paragraphs 13 and 16, the circuit system can be switched between being driven by mechanical ventilation and manual bag);
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to use the manifold of Holley in either a manual or mechanical ventilator because Broborg teaches that an apparatus that connects a source of air to a patient interface can be used in either manual ventilation or mechanical ventilation.
Holley does not teach the manifold comprising one or more sensor ports and a data acquisition unit comprising one or more sensors configured to interface with the one or more sensor ports of the patient manifold; wherein the data acquisition unit is configured to receive electronic data associated with transmission of respiratory gases through the convertible ventilator circuit.
However, Glenn teaches an analogous ventilator circuit (abstract and fig. 1) comprising a manifold (Fig. 2) wherein the manifold comprises one or more sensor ports (see Fig. 2, sensor port 216; see paragraph 20) and a data acquisition unit (Fig. 2, sensor assembly 210; see paragraph 20) comprising one or more sensors configured to interface with the one or more sensor ports of the patient manifold (see fig. 2 and paragraphs 20-21, the sensor assembly mates to the manifold via the port 216 and has oxygen sensor 222) wherein the data acquisition unit is configured to receive electronic data associated with transmission of respiratory gases through the ventilator circuit (see paragraphs 20-21, the oxygen sensor assembly measures the concentration of oxygen in a sample of air being delivered to the patient).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the circuit of Holley to have sensor port to which a data acquisiton unit interfaces with to receive data about the respiratory gases through the citcuit, as taught by Glenn, for the purpose of detecting the amount of oxygen in the delivered air to confirm an appropriate oxygen percentage is maintained. Further, making the sensor removable allows it to be easily cleaned (see paragraphs 2-3 of Glenn).
Holley does not teach the circuit comprising at least one inspiratory filter and at least one expiratory filter.
However, Wallen teaches an analogous patient circuit for a ventilator (abstract and fig. 1) wherein the circuit comprises at least one inspiratory filter (Fig. 1, 16; see col. 2, lines 41-42) and at least one expiratory filter (Fig. 1, 22; see col. 2, lines 47-49).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the circuit of Holley to have at least one inspiratory filter and at least one expiratory filter, as taught by Wallen, for the purpose of reducing the risk of a spread of infection between patients, reduce the risk of exposing patients to bacteria in the inspiratory air, and prevent the escape of bacteria from the circuit to the ambient air (see col. 1, lines 15-19 of Wallen). Holley further teaches that filters may be used in the apparatus (see paragraph 4).
Holley further does not teach wherein the data acquisition unit receives electronic data from one or more identification chips of the artificial ventilation system.
However, Tham teaches an analogous ventilation system (see abstract) wherein the data acquisition unit (Fig. 5, controller 300; see paragraph 16) receives electronic data from one or more identification chips of the artificial ventilation system (see paragraph 16 and Fig. 5, the RFID data is sent to the controller).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify cartridge of the modified Broborg to comprise a identification chips within the circuit that communicate with the data acquisition unit, as taught by Graboi, for the purpose of automating the integrity check of the breathing system and alerting the user if a vital component is absent or not fully connected (see paragraph 5 of Tham).
Regarding claim 14, Holley teaches that the circuit can be used with a ventilator (see paragraph 149), but does not explicitly teach a mechanical ventilator compatible with the convertible ventilator circuit, said mechanical ventilator comprising an inspiratory port configured to communicatively couple to the at least one inspiratory tube segment of the convertible ventilator circuit and an expiratory port configured to communicatively couple to the at least one expiratory tube segment of the convertible ventilator circuit.
However, Broborg teaches an analogous ventilator circuit (abstract and paragraph 48) with a mechanical ventilator compatible with the convertible ventilator circuit (see Fig. 1 and paragraph 48 of Broborg, a mechanical ventilator may be used to drive the circuit; Fig 1A shows an example mechanical ventilator), said mechanical ventilator comprising an inspiratory port configured to communicatively couple to the at least one inspiratory tube segment of the convertible ventilator circuit (see paragraph 56, the ‘inlet 308 should hence be regarded as connected to the inspiratory portion of a ventilator”; the connection inherently having a port, a port being an opening) and an expiratory port configured to communicatively couple to the at least one expiratory tube segment of the convertible ventilator circuit (see paragraph 58 “the outlet 318 is typically connected to the expiratory portion of the ventilator”; the connection inherently having a port, a port being an opening).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the system of Holley to have a mechanical ventilator with inspiratory and expiratory ports to supply and receive air, as taught by Broborg, for the purpose of using it in a known respiratory system for supplying air.
Regarding claim 15, Holley, as modified, further teaches wherein the data acquisition unit is configured to electronically detect the manual ventilator when communicatively coupled to at least one of the at least one inspiratory tube segment or the at least one expiratory tube segment of the convertible ventilator circuit (see Glenn paragraph 36, the unit detects when it is connected to the ventilator and, as modified, the manual ventilator ports).
Regarding claim 16, Holley, as modified, further teaches comprising one or more airway adjuncts compatible with the convertible ventilator circuit, wherein the one or more airway adjuncts comprise at least one of a face mask or an endotracheal tube (see fig. 1 and paragraph 87, the apparatus is used to deliver air and is connected to an interface such as a face mask ), wherein the data acquisition unit is configured to electronically detect the one or more airway adjuncts when communicatively coupled to a patient port of the convertible ventilator circuit (see Tham Fig. 2 and paragraph 16; Tham teaches an RFID tag to detect connection between the patient interface and the circuit; as modified, Broborg would have tags here to detect connection).
Regarding claim 17, Holley, as modified by Tham, further teaches wherein the one or more airway adjuncts comprise one or more identification chips comprising stored parameters (see Fig. 2 of Tham, each airway adjunct has a chip for identification; see paragraph 21), wherein the stored parameters comprise at least one of airway adjunct size and shape (see Tham paragraph 21; the RFID for the endotracheal tube, for example, includes data on device type and its properties, these indicating size and shape of the adjunct).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. (US PGPub 2014/0305431) in view of Broborg (US PGPub 2010/0307490), further in view of Glenn et al. (US PGPub 2016/0256656) and further in view Wallen (US 6035851) and further in view of Tham et al. (US PGPub 2015/0165142) as applied to claim 11 above, and further in view of Williams (US 8,973,580).
Regarding claim 12, Holley teaches all previous elements of the claim as stated above. Holley does not teach a manual ventilator compatible with the convertible ventilator circuit, said manual ventilator comprising an inspiratory port configured to communicatively couple to the at least one inspiratory tube segment of the convertible ventilator circuit and an expiratory port configured to communicatively couple to the at least one expiratory tube segment of the convertible ventilator circuit.
However, Williams teaches an analogous ventilation system (see abstract) comprising a manual ventilator (Fig. 1, 10), said manual ventilator comprising an inspiratory port (Fig. 1, port at the end of segment 10N) configured to communicatively couple to an inspiratory tube segment (see col. 54, lines 31-38, the inspiratory intersection 10N is operative for connecting the circuit, the inspiratory intersection guiding inspiratory gas to the circuit to be delivered to the patient) and an expiratory port (Fig. 1, port at end of segment 10E) configured to communicatively couple to an expiratory tube segment (see col. 54, lines 31-38, the expiratory intersection 10E is operative for connecting the circuit, expiratory gas being guided to this section).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the ventilator system of Holley to comprise a manual ventilator configured to connect to the circuit via an inspiratory port and expiratory port, as taught by Williams, for the purpose of using a compact, portable ventilation device for manual ventilation (See col. 2, lines 40-41 of Williams). As modified, the manual ventilator inspiratory port would be compatible with the convertible ventilator circuit, the inspiratory port configured to couple to the at least one inspiratory tube segment of the convertible ventilator circuit, and the expiratory port configured to couple to the at least one expiratory tube segment of the convertible ventilator circuit (see Williams col. 54, lines 31-38 and Broborg paragraph 48; Holley, as modified by Broborg, teaches a circuit that can be driven by a manual resuscitation bag, Williams teaches a manual resuscitation bag that can be connected to a ventilation circuit, as modified, the two are compatible and the inspiratory port connects to the inspiratory segment and the expiratory port connects to the expiratory segment).
Regarding claim 13, Holley, as modified, further teaches wherein the data acquisition unit is configured to electronically detect the manual ventilator when communicatively coupled to at least one of the at least one inspiratory tube segment or the at least one expiratory tube segment of the convertible ventilator circuit (see Tham Fig. 2 and paragraph 16; Tham teaches an RFID tag to detect connection at the inspiratory port and expiratory port to the circuit; as modified, these would detect connection between the inspiratory and expiratory segments of the convertible ventilator circuit of Holley and the manual ventilator ports).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. (US PGPub 2014/0305431) in view of Broborg (US PGPub 2010/0307490), further in view of Glenn et al. (US PGPub 2016/0256656) and further in view Wallen (US 6035851) and further in view of Tham et al. (US PGPub 2015/0165142) as applied to claim 16 above, and further in view of Goebel (US PGPub 2009/0120439).
Regarding claim 18, Holley teaches all previous elements of the claim as stated above. Holley does not teach wherein the one or more airway adjuncts comprise one or more cuff pressure tubes configured to monitor cuff pressure and compatible with the data acquisition unit.
However, Goebel an analogous ventilation system (see abstract) wherein the one or more airway adjuncts (fig. 1A, endotracheal tubes 1) comprise one or more cuff pressure tubes configured to monitor cuff pressure (Fig. 1A, 1a, 1b; see paragraph 35) and compatible with the data acquisition unit (see Fig. 1A, connection to data acquisition unit 2).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the airway adjunct of Holley to comprise one or more cuff pressure tubes configured to monitor cuff pressure and compatible with the data acquisition unit, as taught by Goebel, for the purpose of controlling operation to have the appropriate endotracheal tube balloon pressure.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Holley et al. (US PGPub 2014/0305431) in view of Broborg (US PGPub 2010/0307490), further in view of Glenn et al. (US PGPub 2016/0256656) and further in view Wallen (US 6035851) and further in view of Tham et al. (US PGPub 2015/0165142) as applied to claim 11 above, further in view of Baldwin et al. (US PGPub 2008/0027372) and further in view of Barker (US PGPub 2015/0359990).
Regarding claim 19, Holley teaches all previous elements of the claim as stated above. Holley does not teach a cap configured to cover and seal a patient port of the convertible ventilator circuit.
However, Baldwin teaches an analogous ventilation system (abstract) comprising a cap (Fig. 3, 140) configured to cover and seal a patient port of the convertible ventilator circuit (see paragraph 30-31).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify Holley to have a cap configured to cover and seal a patient port of the convertible ventilator circuit, as taught by Baldwin, for the purpose of sealing an unused patient port.
Holley further does not teach wherein the data acquisition unit is configured to electronically detect the cap when communicatively coupled to the patient port of the convertible ventilator circuit
However, Barker teaches an analogous respiratory circuit (abstract) comprising a cap (Fig. 9, 41), wherein the data acquisition unit is configured to electronically detect the cap when communicatively coupled to the patient port of the convertible ventilator circuit (see Figs. 17 and 21; see paragraph 147, the presence of the cap is detected with RFID).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the cap of the modified Holley to be able to be electronically detected by the data acquisition unit, as taught by Barker, for the purpose of detected if it is properly in place.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable Holley et al. (US PGPub 2014/0305431) in view of Broborg (US PGPub 2010/0307490), further in view of Glenn et al. (US PGPub 2016/0256656) and further in view Wallen (US 6035851) and further in view of Tham et al. (US PGPub 2015/0165142) as applied to claim 16 above, and further in view of Goebel (US PGPub 2009/0120439).
Regarding claim 20, Holley teaches all previous elements of the claim as stated above. Holley does not teach a heat-moisture exchanger compatible with the convertible ventilator circuit and comprising one or more identification chips comprising stored parameter, wherein the stored parameters comprise at least one of heat-moisture exchanger size, shape, manufacturing lot number, or previously recorded data indicating use on a prior patient
However, Doudkine teaches an analogous respiratory circuit (abstract) comprising a heat-moisture exchanger compatible with circuit (see paragraph 292, HME connected to the circuit) and comprising one or more identification chips (see paragraph 292, contact assembly has electrical connectors for identification) comprising stored parameter, wherein the stored parameters comprise at least one of heat-moisture exchanger size, shape, manufacturing lot number (see paragraph 292, type and presence of HME detected).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the system of Holley to comprise an HME with an identification chip, as taught by Doudkine, for the purpose of heating and moisturizing the air as is known in the art. It would have further been obvious to one skilled in the art to provide an HME that would be compatible with the convertible ventilation circuit in order to make the HME useable.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over unpatentable Holley et al. (US PGPub 2014/0305431) in view of Broborg (US PGPub 2010/0307490), further in view of Glenn et al. (US PGPub 2016/0256656) and further in view Wallen (US 6035851) and further in view of Tham et al. (US PGPub 2015/0165142) and further in view of Goebel (US PGPub 2009/0120439) as applied to claim 20 above, and further in view of Lang (US 5383447).
Regarding claim 21, Holley teaches all previous elements of the claim as stated above. Holley does not teach wherein the heat-moisture exchanger comprises at least one of one or more pressure sensors or one or more temperature sensors compatible with the data acquisition unit.
However, Lang teaches a heat-moisture exchanger (Fig. 1 and abstract) comprising one or more temperature sensors (Fig. 2, 13 and 14; see col. 2, line 69 - col. 3, line 4) compatible with the data acquisition unit (see col. 3, lines 1-3, the sensors communicate with a controller).
Therefore, it would have been obvious to one skilled in the art, before the time of the effective filing date of the invention, to modify the modified Holley to have an HME with temperature sensors, as taught by Lang, for the purpose of controlling the desired temperature within the circuit.
Regarding claim 22, Holley, as modified, further teaches wherein the at least one of the one or more temperature sensors comprise ports emerging from a side of the heat-moisture exchanger (see figs. 1 and 2, the sensors 13 and 14 comprise port 15 emerging from the side of the HME to communicate with the controller).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 11 have been considered but are not persuasive.
Regarding Failure Mode #1: Applicant speculates that inspiratory flow conditions of Holley would case membrane 2390 to open during inspiration. However, Holley specifically teaches that during inspiration membrane 2390 is maintained in a cover position against apertures of vent 318 due to pressure in the inspiratory channel 102 and/or the resilient memory of the membrane. Holley further teaches that membrane deflection occurs when pressure on the expiratory side of the membrane overcomes the treatment pressure on the inspiratory side. Thus, Holley considers the pressure forces acting on membrane 2390 and teaches that the membrane remains closed during inspiration and opens when expiratory pressure exceeds the inspiratory treatment pressure.
Regarding Failure Mode #2: Applicant’s argument is not found persuasive because the modification in question is not relied upon by the rejection. Examiner maintains that membrane 2390 remains in a cover position during inspiration and deflects during expiration when expiratory pressure overcomes inspiratory treatment pressure.
As for the missing element argument, one of ordinary skill in the art would understand membrane 2390 is involved in isolating inspiratory limb 102 from the patient. Holley states that closure of the inspiratory valve during expiration permits pressure to build at an expiratory channel side of the membrane – the flexible membrane deflects/expands to permit flow out through the vent. The deflection of the flexible membrane into the inspiratory channel also prevents communication though the junction between inspiratory limb 102 and the patient manifold.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDY SCOTT LEE whose telephone number is (571)270-7410. The examiner can normally be reached 8:00am-5:00pm, M-Th, alternating Fridays.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alford Kindred can be reached at (571)272-4037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
BRANDY SCOTT LEE
Supervisory Patent Examiner
Art Unit 3785
/BRANDY S LEE/
Supervisory Patent Examiner, Art Unit 3785
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