DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8, 10, and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Speldrich (WO 2009073410 A1).
Regarding claim 1, Speldrich discloses gas valve system (FIG. 1-2 Airflow sensor apparatus as set forth in the Abstract) adapted for controlling the flow of a gas for a user (MEMS based flow sensors, such as the airflow sensor apparatus of Speldrich, are used in flow rate control mechanisms in flow systems as a means for controlling the amount of fluid, gaseous or liquid, traveling through the system as set forth in [002]-[003]), the gas valve system comprising: a housing (FIG. 1-2 Housing 110 as set forth in [0019] and [0021]), at least one sensor (FIG. 2 Flow sensor die 190 as set forth in [0021]), one or more electronic components for controlling the gas flow (The velocity pressure can be sensed electronically utilizing the flow sensor as set forth in [0012], MEMS based flow sensors, such as the one of Speldrich, can be utilized for measuring such flow rates of fluids introduced intravenously to medical patients and thereby control the flow rate of such fluids, in such applications, flow control is an inherent aspect of proper operation, which can be achieved in part by utilizing the flow sensors to measure the flow rate of fluid within the flow system as set forth in [003]), and a manifold (FIG. 1-2 Airflow sensor apparatus 100 as set forth in [0019] and [0021]) comprising one or more channels for guiding the gas between an input and an output of the gas valve system (FIG. 2 Taps 141 , 142, 143, 144, 146, 147, 148 and 149, pilot tube 130, and bypass channel 170, and flow channel 125 as set forth in [0019]-[0023]; inlet 155 and outlet 165 of the flow channel 125 as set forth in [0021]) and to which the at least one sensor and the one or more electronic components can be directly coupled (FIG. 2 The fluid flows through flow channel 125, and then through the taps into pilot tube 130, and to the bypass channel 170 where the sensor die 190 is located as set forth in [0021]-[0023]; The velocity pressure can be sensed electronically utilizing the flow sensor as set forth in [0012], MEMS based flow sensors, such as the one of Speldrich, can be utilized for measuring such flow rates of fluids introduced intravenously to medical patients and thereby control the flow rate of such fluids, in such applications, flow control is an inherent aspect of proper operation, which can be achieved in part by utilizing the flow sensors to measure the flow rate of fluid within the flow system as set forth in [003]).
Regarding claim 2, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Speldrich further discloses the gas valve system, wherein the at least one sensor comprises at least a first sensor and at least a second sensor. (FIG. 3 is similar to FIG. 2 except downstream taps are oriented opposite the flow direction, and FIG. 4 is a cross-sectional view of airflow sensor 200 of FIG. 3; the sensor 200 includes an upstream sensing element 191 and a downstream sensing element 192 as set forth in [0024]).
Regarding claim 3, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Speldrich further discloses the gas valve system, wherein one or more of the channels in the manifold comprise one or more local channel diameter reductions (FIG. 2 Taps 141 , 142, 143, 144, 146, 147, 148 and 149).
Regarding claim 4, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Speldrich further discloses the gas valve system, wherein the local channel diameter reduction is provided by local protrusions of the channel wall into the channel (Shown in FIG. 2).
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Regarding claim 5, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 4 above.
Speldrich further discloses the gas valve system, wherein the channel comprises openings in the channel wall before and after the local channel diameter reduction (FIG. 2 The openings of Taps 141, 142, 143, 144, 146, 147, 148 and 149, as well as the inlet 155 and outlet 165 of the flow channel 125, as well as the upstream port 150 and downstream port 160 of the bypass channel 170 as set forth in [0029]), to which a flow sensor can be coupled for measuring the flow of the gas in a bypass channel (FIG. 2 Bypass-sensing channel 170, where the sensor die 190 is located as set forth in [0021]-[0023]).
Regarding claim 6, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 5 above.
Speldrich further discloses the gas valve system, wherein the openings in the channel wall have an axial direction perpendicular to the overall longitudinal direction of the gas channel (As shown in the annotated figure below).
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Regarding claim 7, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 6 above.
Speldrich further discloses the gas valve system, wherein the openings in the channel wall have an axial direction non-perpendicular to the overall longitudinal direction of the gas channel (As shown in the annotated figure below).
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Regarding claim 8, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Speldrich further discloses the gas valve system, wherein the manifold is made of a single piece or a combination of pieces comprising the channels (FIG. 1-2 Airflow sensor apparatus 100 as set forth in [0019] and [0021], comprising taps 141 , 142, 143, 144, 146, 147, 148 and 149, pilot tube 130, and bypass channel 170 as set forth in [0019]-[0023]).
Regarding claim 10, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Speldrich further discloses the gas valve system, wherein, wherein the manifold comprises alignment features for aligning one of the one or more sensors in the manifold (FIG. 2 Flow sensor die 190 is disposed in a bypass-sensing channel 170 on a substrate 117 as set forth in [0021], the disposal of the sensor die 190 in the bypass channel aligning it in the manifold so it can measure the flow rate as set forth in [0023]).
Regarding claim 12, Speldrich discloses a manifold (FIG. 1-2 Airflow sensor apparatus 100 as set forth in [0019] and [0021]) for use in a gas valve system (FIG. 1-2 Airflow sensor apparatus as set forth in the Abstract), the manifold comprising one or more channels for guiding a gas between an input and an output of the gas valve system (FIG. 2 Taps 141 , 142, 143, 144, 146, 147, 148 and 149, pilot tube 130, and bypass channel 170, and flow channel 125 as set forth in [0019]-[0023]; inlet 155 and outlet 165 of the flow channel 125 as set forth in [0021]) and to which at least one sensor and one or more electronic and/or mechanical components can be directly coupled (FIG. 2 The fluid flows through flow channel 125, and then through the taps into pilot tube 130, and to the bypass channel 170 where the sensor die 190 is located as set forth in [0021]-[0023]; The velocity pressure can be sensed electronically utilizing the flow sensor as set forth in [0012], MEMS based flow sensors, such as the one of Speldrich, can be utilized for measuring such flow rates of fluids introduced intravenously to medical patients and thereby control the flow rate of such fluids, in such applications, flow control is an inherent aspect of proper operation, which can be achieved in part by utilizing the flow sensors to measure the flow rate of fluid within the flow system as set forth in [003]).
Regarding claim 13, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 12 above.
Speldrich further discloses the gas valve system, wherein the one or more channels in the manifold comprise one or more local channel diameter reductions (FIG. 2 Taps 141 , 142, 143, 144, 146, 147, 148 and 149).
Regarding claim 14, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 13 above.
Speldrich further discloses the gas valve system, wherein the local channel diameter reduction is provided by local protrusions of the channel wall into the channel (Shown in FIG. 2).
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Regarding claim 15, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 14 above.
Speldrich further discloses the gas valve system, wherein the channel comprises openings in the channel wall before and after the local channel diameter reduction (FIG. 2 The openings of Taps 141, 142, 143, 144, 146, 147, 148 and 149, as well as the inlet 155 and outlet 165 of the flow channel 125, as well as the upstream port 150 and downstream port 160 of the bypass channel 170 as set forth in [0029]), to which a flow sensor can be coupled for measuring the flow of the gas in a bypass channel (FIG. 2 Bypass-sensing channel 170, where the sensor die 190 is located as set forth in [0021]-[0023]).
Regarding claim 16, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 15 above.
Speldrich further discloses the gas valve system, wherein, wherein the openings in the channel wall have an axial direction perpendicular to the overall longitudinal direction of the gas channel (As shown in the annotated figure below).
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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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Speldrich (WO 2009073410 A1) as applied to claim 1, in view of Weikert (US 20190336718 A1).
Regarding claim 8, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Speldrich is silent as to the material of the manifold and fails to explicitly disclose the gas valve system according to claim 1, wherein the manifold is made of any of a plastic or a metal.
However, Weikert teaches wherein a valve apparatus is made of any of a plastic or a metal (Weikert: FIG. 1-2 Housing 102 and conduits 136, 144 of valve apparatus 100 may be composed of any now known or later developed material used for respiratory or medical valves such as, for example, a plastic or a metal).
Speldrich and Weikert are both considered to be analogous to the claimed invention because they are in the same field of respiratory valve apparatuses for the control of delivered gases. 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 manifold of Speldrich to incorporate the teaching of Weikert and include wherein a valve apparatus is made of any of a plastic or a metal (Weikert: FIG. 1-2 Housing 102 and conduits 136, 144 of valve apparatus 100 may be composed of any now known or later developed material used for respiratory or medical valves such as, for example, a plastic or a metal). Doing so would provide a material for medical valves that is known in the art
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Speldrich (WO 2009073410 A1) as applied to claim 1, in view of White (US 20160193438 A1).
Regarding claim 11, Speldrich discloses the claimed invention substantially as claimed as set forth for claim 1 above.
Speldrich fails to explicitly disclose, the gas valve system comprising: a local controller for controlling the flow of gas supplied to the user, and a remotely positioned controller in communication with the local controller, the remote controller being configured for remotely obtaining information regarding the flow of gas supplied to a user from the local controller and being configured for adjusting the local controller for adjusting the flow of the gas supplied to the user.
However, White teaches a gas valve system comprising: a local controller for controlling the flow of gas supplied to the user (White: FIG. 1 User interface 14 and control system 13 can comprise comprising levers, dials, buttons, touch screens, or other means of adjusting the flow rate as set forth in [0852]), and a remotely positioned controller in communication with the local controller, the remote controller being configured for remotely obtaining information regarding the flow of gas supplied to a user from the local controller and being configured for adjusting the local controller for adjusting the flow of the gas supplied to the user (White: FIG. 1 The blower 11 may be controlled remotely using a remote user interface, the blower 11 may being a pressurized gas container used with a valve as set forth in [0852]).
Speldrich and White are both considered to be analogous to the claimed invention because they are in the same field of monitoring and administering a gas at a flow rate to 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 the system of Speldrich to incorporate the teaching of White and include a local controller for controlling the flow of gas supplied to the user (White: FIG. 1 User interface 14 and control system 13 can comprise comprising levers, dials, buttons, touch screens, or other means of adjusting the flow rate as set forth in [0852]), and a remotely positioned controller in communication with the local controller, the remote controller being configured for remotely obtaining information regarding the flow of gas supplied to a user from the local controller and being configured for adjusting the local controller for adjusting the flow of the gas supplied to the user (White: FIG. 1 The blower 11 may be controlled remotely using a remote user interface, the blower 11 may being a pressurized gas container used with a valve as set forth in [0852]). Doing so would enable the device to adjust the flow rate of gases passing through the respiratory therapy system, by a controller and user interface of the device or by a remoter user interface (White: As set forth in [0852]).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Speldrich (WO 2009073410 A1) in view of Kirby (US 7798143 B1).
Regarding claim 17, Speldrich discloses a gas valve system adapted for controlling the flow of a gas for a user, the gas valve system comprising at least one sensor for measuring the output flow and or pressure of the gas supplied by the gas valve system (FIG. 2 The fluid flows through flow channel 125, and then through the taps into pilot tube 130, and to the bypass channel 170 where the sensor die 190 is located as set forth in [0021]-[0023]; The velocity pressure can be sensed electronically utilizing the flow sensor as set forth in [0012], MEMS based flow sensors, such as the one of Speldrich, can be utilized for measuring such flow rates of fluids introduced intravenously to medical patients and thereby control the flow rate of such fluids, in such applications, flow control is an inherent aspect of proper operation, which can be achieved in part by utilizing the flow sensors to measure the flow rate of fluid within the flow system as set forth in [003]).
Speldrich fails to explicitly disclose that the sensor is used so as to determine the amount of gas delivered during a predetermined period.
However, Kirby teaches a flow sensor is used so as to determine the amount of gas delivered during a predetermined period (FIG. 1. Processor 34 includes a treatment measurement module 38 that measures an amount of treatment received by the patient from patient treatment system 10; The treatment measurement module 38 may measure the amount of treatment in terms of a usage parameter such as, an amount of breathable gas delivered by gas delivery system 12 as determined by flow sensor 26, an amount of breathable gas received by the patient as determined by a flow sensor and the treatment measurement module 38 measures the amount of treatment received by the patient while simultaneously monitoring the passage of time as set forth in column 5 lines 7-31).
Speldrich and Kirby are both considered to be analogous to the claimed invention because they are in the same field of delivering a pressurized flow of breathable gas to 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 the system of Speldrich’s controlling means and methods to incorporate the teaching of Kirby and include wherein the flow sensor is used so as to determine the amount of gas delivered during a predetermined period (FIG. 1. Processor 34, associated with memory 46 as set forth in column 8 lines 1-12, includes a treatment measurement module 38 that measures an amount of treatment received by the patient from patient treatment system 10; The treatment measurement module 38 may measure the amount of treatment in terms of a usage parameter such as, an amount of breathable gas delivered by gas delivery system 12 as determined by flow sensor 26, an amount of breathable gas received by the patient as determined by a flow sensor and the treatment measurement module 38 measures the amount of treatment received by the patient while simultaneously monitoring the passage of time as set forth in column 5 lines 7-31).
Doing so would allow for improved monitoring of the patient by enabling the device to determine the amount of gas delivered (Kirby: As set forth in column 5 lines 7-31).
Regarding claim 18, Speldrich as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Speldrich as modified by Kirby further teaches, wherein the gas valve system comprises a memory for storing the amount of gas delivered during a predetermined period (FIG. 1 There is a memory 46 associated with processor 34 for storing data regarding the operation of the gas delivery such as measured values of gas flow and volume as set forth in column 8 lines 1-12) and wherein the gas valve system is adapted for determining the amount of gas delivered during a predetermined period for an identified user (FIG. 1. Processor 34 includes a treatment measurement module 38 that measures an amount of treatment received by the patient from patient treatment system 10; The treatment measurement module 38 may measure the amount of treatment in terms of a usage parameter such as, an amount of breathable gas delivered by gas delivery system 12 as determined by flow sensor 26, an amount of breathable gas received by the patient as determined by a flow sensor and the treatment measurement module 38 measures the amount of treatment received by the patient while simultaneously monitoring the passage of time as set forth in column 5 lines 7-31).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Speldrich (WO 2009073410 A1) in view of Kirby (US 7798143 B1) as applied to claim 17, in further view of Biondi (US 6158432 A).
Regarding claim 19, Speldrich as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Speldrich as modified fails to explicitly disclose the gas valve system, wherein the gas valve system comprises a processor for identifying when a patient does not follow a predetermined gas therapy.
However, Biondi teaches wherein the gas valve system comprises a processor for identifying when a patient does not follow a predetermined gas therapy (Biondi: FIG. 5 If any step in the therapy provided to the user is not completed, the clinician is alerted via the panel 36 to the cause of the error and the process is terminated as set forth in column 7 lines 7-13).
Speldrich and Biondi are both considered to be analogous to the claimed invention because they are in the same field of delivering and monitoring a pressurized flow of breathable gas to 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 the system of Speldrich’s controlling means and methods to incorporate the teaching of Biondi and include wherein the gas valve system comprises a processor for identifying when a patient does not follow a predetermined gas therapy (Biondi: FIG. 5 If any step in the therapy provided to the user is not completed, the clinician is alerted via the panel 36 to the cause of the error and the process is terminated as set forth in column 7 lines 7-13). Doing so would ensure the user is being provided proper therapy (Biondi: As set forth in column 7 lines 7-13).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Speldrich (WO 2009073410 A1) in view of Kirby (US 7798143 B1) as applied to claim 17, in further view of Shelly (US 20190099571 A1).
Regarding claim 20, Speldrich as modified discloses the claimed invention substantially as claimed as set forth for claim 17 above.
Speldrich as modified fails to explicitly disclose the gas valve system, wherein the gas valve system is furthermore configured for detecting a breathing type.
However, Shelly teaches, wherein the gas valve system is furthermore configured for detecting a breathing type (Shelly: FIG. 1 Processing unit 24 is structured to receive output of one or more sensors structured to gather data indicative of disordered breathing events of patient via a flow sensor 22, the disordered breathing events including, without limitation, obstructive apneas, obstructive and central hypopneas, effort related arousals, non-obstructive apneas, etc. as set forth in [0029])
Speldrich and Shelly are both considered to be analogous to the claimed invention because they are in the same field of delivering and monitoring a pressurized flow of breathable gas to 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 the system of Speldrich’s controlling means and methods to incorporate the teaching of Shelly and include wherein the gas valve system is furthermore configured for detecting a breathing type (Shelly: FIG. 1 Processing unit 24 is structured to receive output of one or more sensors structured to gather data indicative of disordered breathing events of patient via a flow sensor 22, the disordered breathing events including, without limitation, obstructive apneas, obstructive and central hypopneas, effort related arousals, non-obstructive apneas, etc. as set forth in [0029]). Doing so would allow for detailed monitoring as to the state of the user, as well as enable the processing unit to output a response to detecting a disorder breathing event (Shelly: As set forth in [0029]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEIRA EILEEN CALLISON whose telephone number is (571)272-0745. The examiner can normally be reached Monday-Friday 7:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEIRA EILEEN CALLISON/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785