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
This Office Action is in response to a preliminary amendment filed on 07/27/2022. As directed by the preliminary amendment, claims 5, 13, and 23-24 were canceled, claims 4, 6, 8-10, 12, and 17-22 were amended, and no new claims were added. Thus, claims 1-4, 6-12 and 14-22 are pending for this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 20-22 are dependent on claim 13 however claim 13 has been canceled, therefore the metes and bounds of claims 20-22 are not clear. For the purpose of examination, claims 20-22 are interpreted to be dependent on claim 14.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 6-7, 9, 14, 15-16, 18-20 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wang (US 2020/0238042).
Regarding claim 1, Wang discloses (Fig. 4) an anesthetic gas delivery system comprising:
a gas machine (“anesthetic machine”, paragraph [0052]) for supplying anesthetic gas to a patient (Abstract);
a scavenger control system (anesthesia machine exhaust emission control system 200) that controls a level of vacuum suction to evacuate waste anesthetic gas (via controller 230); and
a user interface (display 240) electronically coupled to the scavenger control system; (“electrically connected to the controller 230”, paragraph [0052]) wherein:
the scavenger control system is configured to adjust the level of vacuum suction to adjust an actual flow rate of the waste anesthetic gas through the scavenger control system based on a measured actual flow rate of the waste anesthetic gas external from the gas machine (compares measured flow rate compared to a preset range value to adjust an actual flow rate of the anesthetic gas, paragraph [0060]);
the scavenger control system further is configured to transmit actual flow rate information corresponding to the measured actual flow rate to the user interface (sends flow rate measured to display 240, paragraph [0060]); and
the user interface is configured to output the actual flow rate information to convey the actual flow rate information to an operator of the anesthetic gas delivery system (paragraph [0060]), wherein the user interface includes a scavenger flow rate control for receiving an input of a flow rate control command (receives command for a preset range value of flow rate, paragraphs [0058] and [0060]), and the scavenger control system adjusts the actual flow rate of the waste anesthetic gas in accordance with the flow rate control command (compares flow rate measured to preset value to determine if alarm or adjustment of flow rate should occur, paragraph [0060]).
Regarding claim 2, Wang discloses wherein the flow rate control command is a flow rate setpoint (preset range value of flow rate, paragraph [0060]), and the scavenger control system operates in accordance with closed-loop control to automatically adjust the actual flow rate of the waste anesthetic gas to achieve the flow rate setpoint (flow rate adjusted based on flow detector sensing flow value, paragraph [0060]).
Regarding claim 4, Wang discloses wherein the scavenger control system comprises: an air flow sensor (electronic flow detector 220) positioned external from the gas machine (gas machine is external to control system 200, within which sensor 220 is disposed, and thus the sensor is external to the gas machine) that measures the actual flow rate of the waste anesthetic gas through the scavenger control system (paragraph [0060]); a control valve (flow regulator 270, in the form of an electromagnetic proportional valve, paragraph [0060]) that is controllable to adjust the level of vacuum suction to adjust the actual flow rate of the waste anesthetic gas (paragraph [0060]); and electronic control circuitry (controller 230) that is configured to receive a measured actual flow rate from the sensor and to control the control valve to adjust the level of vacuum suction based on the actual flow rate measured by the sensor (adjusts vacuum level within scavenger control system by adjustably opening/closing based on flow value, paragraph [0060]); wherein the electronic control circuitry further is configured to transmit the actual flow rate information corresponding to the actual flow rate measured by the sensor to the user interface (via display, paragraph [0060]).
Regarding claim 6, Wang discloses wherein the user interface includes a scavenger flow rate control for receiving an input of a flow rate control command (processing component of display 240 that receives preset range value for flow rate, paragraphs [0058] and [0060]), and the electronic control circuitry controls the control valve to adjust the actual flow rate of the waste anesthetic gas in accordance with the flow rate control command (paragraph [0058] and [0060]).
Regarding claim 7, Wang discloses wherein the flow rate control command is a flow rate setpoint (“preset range value”, paragraphs [0058] and [0060]), and the scavenger control system operates in accordance with closed-loop control whereby the electronic control circuitry automatically controls the control valve to achieve the flow rate setpoint (paragraphs [0058] and [0060]).
Regarding claim 9, Wang discloses where the user interface includes a display for displaying the flow rate information (display 240 that displays flow rate information, paragraphs [0058] and [0060]).
Regarding claim 14, Wang discloses (Fig. 4) a method of delivering an anesthetic gas to a patient comprising the steps of:
supplying anesthetic gas to a patient with a gas machine (“anesthetic machine”, paragraph [0052]);
operating a scavenger control system (anesthesia machine exhaust emission control system 200) to control a level of vacuum suction to evacuate waste anesthetic gas comprising measuring a flow rate of the waste anesthetic gas through the scavenger control system external from the gas machine (compares measured flow rate compared to a preset range value to adjust an actual flow rate of the anesthetic gas, paragraph [0060]), and adjusting the flow rate of the waste anesthetic gas through the scavenger control system based on the measured flow rate (paragraph [0060]); and
transmitting flow rate information corresponding to the measured flow rate to a user interface (sends flow rate measured to display 240, paragraph [0060]); and,
wherein the user interface outputs the flow rate information to convey the flow rate information to an operator of the anesthetic gas delivery system (paragraph [0060]).
Regarding claim 15, Wang discloses the method further comprising receiving an input of a flow rate control command via the user interface (receives command for a preset range value of flow rate, paragraphs [0058] and [0060]), wherein the scavenger control system adjusts the flow rate of the waste anesthetic gas in accordance with the flow rate control command (paragraphs [0058] and [0060]).
Regarding claim 16, Wang discloses wherein the flow rate control command is a flow rate setpoint (preset range value of flow rate, paragraph [0060]), and the scavenger control system operates in accordance with closed-loop control to automatically adjust the actual flow rate of the waste anesthetic gas to achieve the flow rate setpoint (paragraph [0060]).
Regarding claim 18, Wang discloses wherein operating the scavenger control system includes controlling a proportional control valve (flow regulator 270, in the form of an electromagnetic proportional valve, paragraph [0060]) to adjust the flow rate of the waste anesthetic gas through the scavenger control system (paragraph [0060]).
Regarding claim 19, Wang discloses wherein user interface outputs the flow rate information by displaying the flow rate information on a display (display 240 that displays flow rate information, paragraphs [0058] and [0060]).
Regarding claim 20, Wang discloses wherein the scavenger control system automatically is actuated when the gas machine is initiated to provide gas flow to the patient (When the anesthesia machine is in a ventilation state, the controller 230 controls the switch 260 to open the connection pipeline 210, see paragraph [0052]).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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) 3, 12, 17 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2020/0238042) in view of Bellefeuille (US 2008/0190431).
Regarding claim 3, Wang discloses wherein the flow rate control command is a flow rate adjustment input to increase or decrease the actual flow rate of the waste anesthetic gas (increases or decreases flow rate in comparison to an inputted preset flow rate range value, paragraph [0060]), and but does not disclose the scavenger control system operates in accordance with open-loop control to adjust the actual flow rate in accordance with the flow rate adjustment input.
However, Bellefeuille teaches (Fig. 22) a scavenger control system (comprising valve 42, scavenger assembly 44, valve 46 and controller 24) that operates in accordance with open-loop control to adjust the actual flow rate in accordance with the flow rate adjustment input (open loop control because variable valve 42 is opened by a selectable amount to adjust rate that anesthetic passes through scavenger assembly 44, paragraph [0019]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the scavenger control system of Wang to operates in accordance with open-loop control to adjust the actual flow rate in accordance with the flow rate adjustment input, as taught by Bellefeuille, for the purpose of allowing for adjustable control of rate of flow of the anesthetic waste without requiring sensor control in case sensor is malfunctioning (paragraph [0019] Bellefeuille).
Regarding claim 12, Wang discloses anesthetic gas delivery, but does not disclose wherein the anesthetic gas delivery system is a nitrous oxide delivery system, the gas machine has a first inlet for receiving a supply of nitrous oxide and a second inlet for receiving a supply of oxygen, and the gas machine mixes the nitrous oxide and the oxygen to form a mixed anesthetic gas that is supplied to the patient.
However, Bellefeuille teaches (Fig. 1) the anesthetic gas delivery system is a nitrous oxide delivery system (nitrous oxide via nitrous oxide tank 12c, paragraph [0013]), the gas machine has a first inlet for receiving a supply of nitrous oxide (inlet having control valve 18c for receiving nitrous oxide) and a second inlet for receiving a supply of oxygen (inlet having control valve 18b for receiving oxygen), and the gas machine mixes the nitrous oxide and the oxygen to form a mixed anesthetic gas that is supplied to the patient (gas mixed via gas mixer 16, paragraph [0014]-[0015]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Wang to include wherein the anesthetic gas delivery system is a nitrous oxide delivery system, the gas machine has a first inlet for receiving a supply of nitrous oxide and a second inlet for receiving a supply of oxygen, and the gas machine mixes the nitrous oxide and the oxygen to form a mixed anesthetic gas that is supplied to the patient, as taught by Bellefeuille, for the purpose of providing a well-known and safe anesthetic to a user so that operation can be performed safely and optimally.
Regarding claim 17, Wang discloses wherein the flow rate control command is a flow rate adjustment input to increase or decrease the actual flow rate of the waste anesthetic gas (increases or decreases flow rate in comparison to an inputted preset flow rate range value, paragraph [0060]), and but does not disclose the scavenger control system operates in accordance with open-loop control to adjust the actual flow rate in accordance with the flow rate adjustment input.
However, Bellefeuille teaches (Fig. 22) a scavenger control system (comprising valve 42, scavenger assembly 44, valve 46 and controller 24) that operates in accordance with open-loop control to adjust the actual flow rate in accordance with the flow rate adjustment input (open loop control because variable valve 42 is opened by a selectable amount to adjust rate that anesthetic passes through scavenger assembly 44, paragraph [0019]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the scavenger control system of Wang to operates in accordance with open-loop control to adjust the actual flow rate in accordance with the flow rate adjustment input, as taught by Bellefeuille, for the purpose of allowing for adjustable control of rate of flow of the anesthetic waste without requiring sensor control in case sensor is malfunctioning (paragraph [0019] Bellefeuille).
Regarding claim 21, Wang does not disclose wherein the anesthetic gas is nitrous oxide, the method further comprising receiving a supply of nitrous oxide, receiving a supply of oxygen, and mixing the nitrous oxide and the oxygen to form a mixed anesthetic gas that is supplied to the patient.
However, Bellefeuille teaches (Fig. 1) a method of anesthesia delivery comprising an anesthetic in the form of nitrous oxide (nitrous oxide via nitrous oxide tank 12c, paragraph [0013]), and method includes receiving a supply of nitrous oxide (inlet having control valve 18c for receiving nitrous oxide) and receiving a supply of oxygen (inlet having control valve 18b for receiving oxygen), and mixing the nitrous oxide and the oxygen to form a mixed anesthetic gas that is supplied to the patient (gas mixed via gas mixer 16, paragraph [0014]-[0015]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Wang to include wherein the anesthetic gas is nitrous oxide, the method further comprising receiving a supply of nitrous oxide, receiving a supply of oxygen, and mixing the nitrous oxide and the oxygen to form a mixed anesthetic gas that is supplied to the patient, as taught by Bellefeuille, for the purpose of providing a well-known and safe anesthetic to a user so that operation can be performed safely and optimally.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2020/0238042) in view of Tornesel (US 2010/0095961)
Regarding claim 8, modified Wang discloses wherein the flow rate control command is a flow rate adjustment input to increase or decrease the actual flow rate (increase if less than minimum value, paragraph [0016] Wang), but does not disclose the scavenger control system operates in accordance with open-loop control whereby the electronic control circuitry controls the control valve in accordance with the flow rate adjustment input.
However, Tornesel teaches (Fig. 1-2) scavenger control system (comprising exhaust line 7, APL valve 17, haptic control 18, and control unit 25) that operates in accordance with open-loop control whereby the electronic control circuitry controls the control valve in accordance with the flow rate adjustment input (control valve 17 is controlled via open loop control because user directly adjusts valve 20 independent of output of the gas and flow rate adjustment input in the form of how much the haptic knob 20 is turned, see paragraph [0058]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Wang such that the scavenger control system operates in accordance with open-loop control whereby the electronic control circuitry controls the control valve in accordance with the flow rate adjustment input, as taught by Tornesel, for the purpose of allowing an operator to directly adjust operation of the control valve in case finer adjustment is required that is better suited to a patient (paragraph [0058] Tornesel).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2020/0238042) in view of Nashed (US 20100229861).
Regarding claim 10, Wang does not disclose the system further comprising a breathing apparatus in fluid communication with the gas machine and the scavenger control system; wherein the breathing apparatus comprises an inhalation line that transmits the anesthetic gas from the gas machine to the patient, a nasal mask that is worn by the patient to inhale at least a portion of the anesthetic gas, and an evacuation line that transmits the waste anesthetic gas from the nasal mask to the scavenger control system.
However, Nashed teaches (Fig. 1-4) a system comprising a breathing apparatus in fluid communication with the gas machine (gas mixing module 102) and the scavenger control system (AVS module 114); wherein the breathing apparatus comprises an inhalation line (inner sleeve 144 defining inhalation passage 146) that transmits the anesthetic gas from the gas machine to the patient (paragraph [0044]), a nasal mask (mask 10) that is worn by the patient to inhale at least a portion of the anesthetic gas, and an evacuation line (outer sleeve 142) that transmits the waste anesthetic gas from the nasal mask to the scavenger control system (paragraph [0064] and Fig. 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Wang to include a breathing apparatus in fluid communication with the gas machine and the scavenger control system; wherein the breathing apparatus comprises an inhalation line that transmits the anesthetic gas from the gas machine to the patient, a nasal mask that is worn by the patient to inhale at least a portion of the anesthetic gas, and an evacuation line that transmits the waste anesthetic gas from the nasal mask to the scavenger control system, as taught by Nashed, for the purpose of allowing a user to simultaneously receive breathing air while anesthetic gas is delivered and removed, thereby improving patient outcome.
Regarding claim 11, modified Wang discloses a bag tee (t-connector 140 Nashed) that is in fluid communication with the gas machine and the breathing apparatus (paragraph [0056] Nashed), and a reservoir bag (bag 176) that is fluid communication with the bag tee, wherein the anesthetic gas flows through the bag tee to fill up the reservoir bag (paragraph [0062] Nashed).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US 2020/0238042) in view of Bellefeuille (US 2008/0190431), and further in view of Ahearn (US 2009/0223567).
Regarding claim 22, modified Wang discloses wherein the scavenger control system automatically is actuated when the gas machine is initiated to provide the supply of oxygen to the patient (paragraph [0007] Bellefeuille), and but does not discloses further comprising turning off the nitrous oxide flow and scavenging excess nitrous oxide while the nitrous oxide flow is off.
However, Ahearn teaches (Fig. 1) a method of scavenging comprising the step of turning off the nitrous oxide flow and scavenging excess nitrous oxide while the nitrous oxide flow is off (paragraph [0015] and [0031]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of modified Wang to include the step of turning off the nitrous oxide flow and scavenging excess nitrous oxide while the nitrous oxide flow is off, as taught by Ahearn, for the purpose of improving safety of the device by preventing potential overdose of anesthetic (paragraph [0031] Ahearn).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Nelson (US 2020/0188624) discloses a system of medical scavenging having nitrous oxide.
Ahearn (US 2015/0075525) discloses a system of medical scavenging having nitrous oxide and a vacuum source.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R MOON whose telephone number is (571)272-2554. The examiner can normally be reached Monday-Thursday 7:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at 571-272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW R MOON/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785