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 .
Priority
Acknowledgment is made of applicant’s claim for priority to Application No. (PCT/CN2018/092937) filed on the June 26, 2018.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 09, 2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on April 09, 2025. As directed by the amendment: claims 1, 4, and 18 have been amended, no claims have been canceled, and claim 20 have been added. Thus, claims 1-8, 10-11, 16-20 are presently pending in the application and claims 9, 12-15 are still withdrawn from consideration.
Response to Arguments
Applicant argues on page 7 of the remarks that 112(b) on claim 1 should be removed. Applicant has amended the claim and previous 112(b) rejection has hereby been withdrawn.
Applicant argues on page 7-8 of the remarks that the 102-rejection of Jamison et al. made on Claims 1, 7-8, 10-11, and 19 is improper. However, Applicant amended the claim to add new limitation “the oxygen supply apparatus provides the oxygen at a flow rate greater than or equal to 15 liters per minute, wherein the flow rate provides an extended asphyxia time window for performing intubation on the patient before anaesthesia,” that was not previously considered. Applicant has amended the claims and a new 103 rejection stated below addresses the new limitation of the claim. Furthermore, Applicant is arguing that Jamison does not teach providing approximately 100% oxygen to the patient, however, that limitation was amended out of the claims.
Applicant argues on page 9 of the remarks that the 103-rejections of Jamieson made on claims 2-6 and 16-18 are improper. Applicant’s arguments with respect to these claim(s) have been considered but are moot because the new ground of rejection is given.
New claim 20 have been entered and rejected below.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1, 7-8, 10-11, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamison (US 20100175695 A1) in view of Lei (US 20170203070 A1).
Regarding Claim 1, Jamison discloses an anesthesia machine (anesthesia system 100; Fig. 1; para. 0018, 0024-0025), comprising a gas source interface (110; Fig. 2; para. 0018-0021, 0024, 0026, 0029, 0031), and an oxygen supply apparatus (270; Fig. 2; para. 0029-30, 0032-34) and an anesthesia breathing apparatus (anesthesia machine 112; Fig. 1-2; para. 0018-0021, 0027-0028, 0031) that are respectively connected to the gas source interface (Fig. 2);
wherein the gas source interface is connected to an oxygen gas source (air supply 218; Fig. 2; para. 0025, 0031), to receive oxygen therefrom (Fig. 2), and the oxygen supply apparatus (270) comprises only one gas path for receiving an oxygen-containing gas (270) on has one path (coming from 218) from the gas source interface and provides the received oxygen-containing gas (auxiliary output 122; Fig. 2; para. 0025) to a patient (patient 119; Fig. 2; para. 0019-0020, 0024-0025);
the oxygen-containing gas is the oxygen received from the oxygen gas source (Fig. 2; para. 0020-0226)
Jamison does not disclose that the oxygen supply apparatus provides the oxygen at a flow rate greater than or equal to 15 liters per minute, wherein the flow rate provides an extended asphyxia time window for performing intubation on the patient before anaesthesia.
However, Lei teaches the oxygen supply apparatus (not shown, but through gas supplying tubing 104 Fig. 1-2; para. 0046) provides the oxygen at a flow rate greater than or equal to 15 liters per minute (para. 0046, Examiner notes: that the flow rate can be up to 50 liters per minute) wherein the flow rate provides an extended asphyxia time window for performing intubation on the patient before anaesthesia (para. 0046).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the oxygen supply apparatus of Jamison to include the oxygen supply apparatus provides the oxygen at a flow rate greater than or equal to 15 liters per minute, wherein the flow rate provides an extended asphyxia time window for performing intubation on the patient before anaesthesia as taught by Lei for the purpose of preoxygenation during general anesthesia and emergency endotracheal intubation. It will increase the patient's comfort and decrease the incidents of hypoxemia. It also can be used as a rescue measure to decrease the chance for intubation or reintubation (para. 0046).
Regarding Claim 7, Modified Jamison discloses the anesthesia machine (anesthesia system 100; Fig. 1; para. 0018, 0024-0025) of claim 1, wherein the gas source interface (110; Fig. 2; para. 0018-0021, 0024, 0026, 0029, 0031) comprises an oxygen input interface (220; Fig. 2) for providing oxygen and an equilibrium gas input interface (N2O supply 210, or 214, gas so-urce 110; Fig. 2; para. 0025-0029: Examiner notes: the equilibrium gas is air and laughing gas (N2O)) for providing equilibrium gas (para. 0025-0029).
Regarding Claim 8, Modified Jamison discloses the anesthesia machine of claim 7, wherein the oxygen supply apparatus (270; Fig. 1; para.0029-0030) comprises a flow regulation module for regulating the flow rate of the oxygen-containing gas, (para. 0022-0023) (para. 0049; Examiner notes: flow control valve 272 (equivalent to flow and concentration adjustment modules) for adjusting the flow and concentration).
Regarding Claim 10, Modified Jamison discloses the anesthesia machine (anesthesia system 100; Fig. 1; para. 0018, 0024-0025) of claim 1, wherein the anesthesia breathing apparatus (anesthesia machine 112; Fig. 1-2; para. 0018-0021, 0027-0028, 0031) comprises an anesthetic delivery module (fig. 2; para 0026), a breathing control module (ventilator 238; Fig. 2; para 0027-0028), and a breathing circuit (main breathing system 118: respiration loop 240, inhalation limb 242 and an exhalation limb 244; Fig. 2; para. 0019—0020, 0023,0026-0027); the anesthetic delivery module is connected to the gas source interface(gas source 110, Fig. 1-2; para. 0018-0021) and the breathing circuit (Fig 2; 112 is connected to the gas source 110 and the breathing circuit in 118), and delivers an anesthetic (common output 116; Fig. 2; para. 0026-0028) into the breathing circuit; and the breathing control module is connected to the gas source interface and the breathing circuit (Fig 2), and provides breathing support to the patient (patient 119; Fig. 2; para. 0019-0020, 0024-0025) through the breathing circuit (0027-0028).
Regarding Claim 11, Modified Jamison discloses the anesthesia machine(anesthesia system 100; Fig. 1; para. 0018, 0024-0025) of claim 10, wherein the anesthetic delivery module comprises a gas mixer (location 236; Fig. 2; para. 0026) and an anesthetic evaporator(vaporizers 234; Fig. 2; para. 0026, 0044-0045) the gas mixer is connected to the gas source interface (gas source 110, Fig. 1-2; para. 0018-0021) and the anesthetic evaporator (Fig. 2), and the oxygen and the equilibrium gas (228, 230, 232; Fig. 2; para 0026) are mixed (in the location 236) and then outputted to the anesthetic evaporator(0026); and the anesthetic is mixed with the gas provided by the gas mixer and then outputted to the breathing circuit (main breathing system 118: respiration loop 240, inhalation limb 242 and an exhalation limb 244; Fig. 2; para. 0019—0020, 0023,0026-0027) by the anesthetic evaporator (para. 0026).
Regarding Claim 19, Modified Jamison discloses the anesthesia machine of claim 1, wherein the oxygen supply apparatus (270; Fig. 2; para. 0029-30, 0032-34) is integrated inside a housing of the anesthesia machine (anesthesia system 100; Fig. 2; para. 0018, 0024-0025).
Claim(s) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamison and Lei, as applied to claim 1, in view of Shawn et al. (CN 103809619 A), hereafter as Shawn.
Regarding Claim 2, Modified Jamison discloses the anesthesia machine (anesthesia system 100; Fig. 1; para. 0018, 0024-0025) of claim 1, oxygen supply apparatus (270; Fig. 2; para. 0029-30, 0032-34) .
Modified Jamison does not discloses further comprising a mode regulation apparatus, which responds to a received operation instruction to control the oxygen supply apparatus to switch between at least two working modes.
However, Shawn teaches further comprising a mode regulation apparatus (knob; para. 0027), which responds to a received operation instruction to control the oxygen supply apparatus (breathing system 21; Fig. 2; para. 0040) to switch between at least two working modes (para. 0027; Examiner notes: to working modes are manual mode and electronic mode).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Modified Jamison to include the mode regulation apparatus that switches between two modes as taught by Shawn for the purpose of mechanical back-up control if something happens in the electronic control mode (para. 0027).
Regarding Claim 4, Modified Jamison discloses the anesthesia machine of claim 1, oxygen supply apparatus (270; Fig. 2; para. 0029-30, 0032-34) or the anesthesia breathing apparatus (anesthesia machine 112; Fig. 1-2; para. 0018-0021, 0027-0028, 0031)
Modified Jamison does not disclose further comprising a working information transmission apparatus and a display, wherein the working information transmission apparatus acquires working information of the oxygen supply apparatus and/or the anesthesia breathing apparatus and transmits the working information to display, and the working information of the oxygen supply apparatus and the anesthesia breathing apparatus are displayed on the display.
Shawn teaches further comprising a working information transmission apparatus (microprocessor; para. 0033) and a display (electronic display device 120; 220; Fig. 1-2; para. 0038-0040), wherein the working information transmission apparatus acquires working information of the oxygen supply apparatus and/or the anesthesia breathing apparatus (anesthesia delivery system 300; Fig. 3; para. 0043) and transmits the working information (para. 0033, 0035, 0038-0040; Fig. 1-3) to display, and the working information of the oxygen supply apparatus and the anesthesia breathing apparatus are displayed on the display (para. 0038, 0040; Examiner notes: the working transmission apparatus is the microprocessor that is part of control system that is the puts out the working transmission information to be displayed on the touch screen of 120/220 and which can be provide information about the flow quantity and/or anaesthetic transmission process to the operator information).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Jamison to include further comprising a working information transmission apparatus and a display, wherein the working information transmission apparatus acquires working information of the oxygen supply apparatus and/or the anesthesia breathing apparatus and transmits the working information to display, and the working information of the oxygen supply apparatus and the anesthesia breathing apparatus are displayed on the display as taught by Shawn for the purpose of measuring data to display associated with a patient, information, and/or information and one or more associated anaesthetic transmission associated with the gas flow (para. 0057).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamison, Lei, and Shawn, as applied to claim 2, in view of Wallin et al. (US 20150250976 A1), hereafter as Wallin.
Regarding Claim 3, Modified Jamison discloses the anesthesia machine of claim 2,
Modified Jamison does not disclose further comprising a setup monitoring apparatus, which generates alarm prompt information when a setup value of flow rate and/or oxygen concentration of the oxygen-containing gas inputted by a user is monitored to be not within a range corresponding to a current working mode.
Wallin teaches further comprising a setup monitoring apparatus(control unit 60; Fig. 6; para. 0016 and 0105), which generates alarm prompt information (second code segment 222; Fig. 7; para. 0105; Examiner Notes: this segment triggers an alarm) when a setup value (Examiner is interpreting a setup value as a threshold) of flow rate of the oxygen-containing gas (para. 0105) inputted by a user (para. 0063) is monitored to be not within a range corresponding to a current working mode (para. 0105: Examiner notes: Wallin teaches that when the oxygen is below a certain threshold it with trigger an alarm then changing into a “safety” mode).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Modified Jamison to include a setup monitoring apparatus(control unit 60; Fig. 6; para. 0016 and 0105), which generates alarm prompt information (second code segment 222; Fig. 7; para. 0105; Examiner Notes: this segment triggers an alarm) when a setup value (Examiner is interpreting a setup value as a threshold) of flow rate of the oxygen-containing gas (para. 0105) inputted by a user is monitored to be not within a range corresponding to a current working mode (para. 0105) as taught by Wallin for the purpose of mitigating or avoiding hypoxia of the patient (para. 0103).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamison and Lei, as applied to claim 1, in view of Obenchain (US 20140152468 A1).
Regarding Claim 5, Modified Jamison discloses the anesthesia machine of claim 1,
oxygen supply apparatus (270; Fig. 2; para. 0029-30, 0032-34) and/or the anesthesia breathing apparatus.
Modified Jamison does not disclose further comprising a fault self-checking apparatus, which monitors fault information of the oxygen supply apparatus and/or the anesthesia breathing apparatus.
However, Obenchain teaches further comprising a fault self-checking apparatus (communication/flow monitor module 268; Fig. 27A; para. 0120, 174) which monitors fault information of the oxygen supply apparatus (communication/flow/oxygen monitor module 414; Fig. 26; para. 0174) (para. 0120).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Jamison to include a fault self-checking apparatus (communication/flow monitor module 268; Fig. 27A; para. 0120, 174) which monitors fault information of the oxygen supply apparatus (communication/flow/oxygen monitor module 414; Fig. 26; para. 0174) (para. 0120) as taught by Obenchain for the purpose of detection of such malfunctions as obstructions or kinks in the pressurized gas system (para. 0063).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamison and Lei, as applied to claim 1, in view of Ratto et al. (US 20120017904 A1), hereafter as Ratto.
Regarding Claim 6, Modified Jamison discloses the anesthesia machine of claim 1, oxygen supply apparatus (270; Fig. 2; para. 0029-30, 0032-34).
Jamison does not disclose further comprising a temperature regulation apparatus and/or a humidity regulation apparatus, wherein the temperature regulation apparatus regulates a temperature of the oxygen-containing gas outputted by the oxygen supply apparatus, and/or the humidity regulation apparatus regulates a humidity of the oxygen-containing gas outputted by the oxygen supply apparatus.
However, Ratto teaches a temperature regulation apparatus (temperature sensor 118, heater 110 and cooler 111 processor 124; Fig. 1; para. 0020—0021, 0024) and (humidity sensor 122, processor 124; Fig 1; para. 0020 and 0024), wherein the temperature regulation apparatus regulates a temperature of the oxygen-containing gas (oxygen intake 117; Fig. 1; para. 0023) outputted by the oxygen supply apparatus (Oxygen supply system 114; Fig. 1; para. 0020-0022), and/or the humidity regulation apparatus regulates a humidity of the oxygen-containing gas outputted by the oxygen supply apparatus(para. 0026).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Jamison to include a temperature regulation apparatus (temperature sensor 118, heater 110 and cooler 111 processor 124; Fig. 1; para. 0020—0021, 0024) and (humidity sensor 122, processor 124; Fig 1; para. 0020 and 0024), wherein the temperature regulation apparatus regulates a temperature of the oxygen-containing gas (oxygen intake 117; Fig. 1; para. 0023) outputted by the oxygen supply apparatus (Oxygen supply system 114; Fig. 1; para. 0020-0022), and/or the humidity regulation apparatus regulates a humidity of the oxygen-containing gas outputted by the oxygen supply apparatus(para. 0026) as taught by Ratto for the purpose of controlling the temperature and relative humidity of the supplied respiratory gas (para. 0007) and gas may be heated and humidified to closely match the temperature and humidity of gases within a healthy respiratory tract (para. 0008).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamison, Lei, and Shawn, as applied to claims 2, in view of Taktov et al. (US 20150128942 A1), hereafter as Taktov.
Regarding Claim 16, Modified Jamison discloses the anesthesia machine of claim 2, wherein the at least two working modes comprises a low-flow mode and a high-flow mode (para. 0040-0041); that the oxygen supply apparatus (270; Fig. 2; para. 0029-30, 0032-34) is controlled to provide the oxygen-containing gas to the patient at a flow rate less than 15 liters per minute in the low-flow mode (para. 0040).
Modified Jamison does not specifically disclose provide the oxygen-containing gas to the patient at a flow rate greater than 15 liters per minute in the high-flow mode.
However, Taktov teaches a high flow rate above 25 liter per minute (para. 0083).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Jamison to high flow mode as taught by Taktov because it is known in the art that the apparatus is controlled to keep flow rate and higher while they are asleep (para. 0079) to improve CO.sub.2 washout and also to lower the chance of obstructive events during sleep and higher flow rate may be uncomfortable for the patient when they are awake (para. 0078).
It would have been obvious to one having ordinary skill in the art at the effective filing date the invention to modify Jamison to include high flow mode to be greater than 15 LPM because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Regarding Claim 17, Modified Jamison discloses the anesthesia machine of claim 16,
Modified Jamison does not specifically disclose wherein the oxygen supply apparatus is controlled to work in the high-flow mode before anesthesia and to work in the low-flow mode after a surgery.
However, Taktov teaches oxygen supply apparatus is controlled to work in the high-flow mode when they are sleep and to work in the low-flow mode when a person is awake.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Jamison to include an oxygen supply apparatus to be controlled to work in the high-flow mode before anesthesia and when falling asleep and to work in the low-flow mode after a surgery when the person is awake as taught by Taktov because it is known in the art that the apparatus is controlled to keep flow rate lower while the patient is awake, and higher while they are asleep (para. 0079) to improve CO.sub.2 washout and also to lower the chance of obstructive events during sleep and higher flow rate may be uncomfortable for the patient when they are awake (para. 0078).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamison, Lei, and Shawn, as applied to claims 2, in view of Barnes et al. (WO 2018033863 A1), hereafter as Barnes.
Regarding Claim 18, Modified Jamison discloses the anesthesia machine of claim 2, wherein the at least two working modes.
Jamison does not specifically disclose a child mode and an adult mode; the oxygen supply apparatus is controlled to provide the oxygen-containing gas to the patient at a flow rate within a range of 15-20 liters per minute in the child mode, and to provide the oxygen-containing gas to the patient at a flow rate within a range of 15-100 liters per minute in the adult mode.
However, Barnes teaches for children they have low flow rate of 1-50 liters per minute and adults could range from 30-100 liters per minute(pg. 24; line 8-12).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Jamison to include an oxygen supply apparatus to a flow rate within a range of 15-20 liters per minute in the child mode, and to provide the oxygen-containing gas to the patient at a flow rate within a range of 15-100 liters per minute in the adult mode as taught by Barnes because it is known in the art that the apparatus is controlled to keep flow rate lower while the patient is a child, and higher while they are adult (pg. 24; line 8-12).
Modified Jamison does not teach the specific ranges as claimed. However, it would have been obvious to one having ordinary skill in the art at the effective filing date the invention to modify Jamison to include the range of a child to be between 15-20 and for an adult to be between 15-100 liters per minute because where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. MPEP 2144.05(I).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jamison and Lei, as applied to claims 1, in view of Payton et al. (US 20180126110 A1), hereafter as Payton.
Regrading Claim 20, Modified Jamison discloses the anesthesia machine of claim 1, and the oxygen supply apparatus (270; Fig. 2; para. 0029-30, 0032-34).
Modified Jamison does not specifically disclose that oxygen supply apparatus is capable of extending the asphyxia time window to up to 17 minutes.
However, Payton teaches oxygen supply apparatus (flow source 102; Fig. 1; para. 0262) is capable of extending the asphyxia time window (para. 0272).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Jamison to include oxygen supply apparatus is capable of extending the asphyxia time window as taught by Payton for the purpose of properly oxygenate the patient and maintain an acceptable blood oxygen saturation level (para. 0273) and being able to properly intubate the patient without causing apneic.
Modified Jamison does not specifically teach that the window is extended for 17 minutes.
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 extend the window to up to 17 minutes. Applicant has not disclosed that 17 minutes provides criticality as evidenced by the Applicant' s specification which recites an exemplary arrangement indicating that the “average” time reached is 17 minutes (para. 0047). Since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). One of ordinary skill in the art, furthermore, would have expected Jamison and Lei in view of Payton’s system to be able to extend the asphyxia time window as the high flow therapy is used to provide a flow at a constant flow rate to deliver the “dose” oxygen required (patient oxygen requirement) to avoid hypoxia.
Therefore, it would have been prima facie obvious to modify the device taught by Jamison and Lei in view of Payton to incorporate the duration of 17 minutes to obtain the invention as specified in claim 20, because such a modification is considered to be well within the skill level of the ordinary artisan in order to achieve the desired duration for avoiding hypoxia, and thus fails to patentably distinguish over the prior art.
Conclusion
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/MAAP AHMED ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785