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.
Response to Amendment
This office action is responsive to the amendment filed on April 24, 2026. As directed by the amendment: no claims have been amended, claims 1-23 have been canceled, and claims 24-44 have been added. Claims 24-31, 33-34, and 39-44 are presently pending in the application and claims 32 and 35-38 are withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the applicant has amended the claims and the new 103 rejection stated below addresses the new limitation of the claims.
The new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
New claims 24-31, 33-34, and 39-44 have been entered and rejected below.
Claim Objections
Claim 24 objected to because of the following informalities:
Regrading Claim 24, line 5, “first oxygen-containing gas” should read as “an oxygen-containing gas”.
Regarding Claim 24, line 6, “the received oxygen-containing gas” should read as “the oxygen-containing gas”.
Appropriate correction is required.
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) 24, 27, 30-31, 33, 42 and 44 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Payton et al. (WO 2016133406 A1), hereafter as Payton.
Regarding Claim 24, Payton discloses an anesthesia machine (Fig. 1), comprising a gas source interface (“A” in Annotated Fig. A below), an oxygen supply apparatus (Fig. 1; 102) and an anesthesia breathing apparatus (Fig. 1; 124) that are respectively connected to the gas source interface (Examiner notes: the anesthesia apparatus is connected indirectly to the gas source interface);
wherein the gas source interface (“A” in Annotated Fig. A below) is connected to an oxygen gas source (Fig. 1; 124, 128; para. 0168) to receive oxygen therefrom, and the oxygen supply apparatus comprises only one gas path for receiving first oxygen-containing gas from the gas source interface (Examiner notes: the tube 128 direct oxygen to “A” in Figure A below) and provides the received oxygen- containing gas to a patient (Fig. 1; para. 0168-0169);
the oxygen-containing gas is medical-grade received from the oxygen gas source has an oxygen concentration level within a range of 90%-100% (para. 0008, 0109-0115, 0161, 0173, 0289);
and the oxygen supply apparatus provides the medical-grade oxygen at a flow rate greater than or equal to 15 liters per minute (para. 0110, 0289), wherein the flow rate provides an extended asphyxia time window for performing intubation on the patient before anesthesia
PNG
media_image1.png
360
509
media_image1.png
Greyscale
[AltContent: textbox (Figure A: Adapted Figure 1 from Payton)](Examiner notes: this limitation is functional; para. 0112) .
Regarding Claim 27, Payton discloses anesthesia machine of claim 24, further comprising a working information transmission apparatus and a display (Fig. 1; 110; para. 0167), wherein the working information transmission apparatus acquires working information of the oxygen supply apparatus and transmits the working information to the display (para. 0167), and the working information of the oxygen supply apparatus and the anesthesia breathing apparatus are displayed on the display (para. 0167, 0206, 0222). Regarding Claim 30, Payton discloses the anesthesia machine (Fig. 1) of claim 24, wherein the gas source interface “A” in Annotated Fig. A below) comprises an oxygen input interface (Fig. 1; 126, 128) for providing oxygen and an equilibrium gas input interface (Fig. 1; 130, 132) for providing equilibrium gas (para. 0168).
Regarding Claim 31, Payton discloses the anesthesia machine of claim 30, wherein the oxygen supply apparatus (Fig. 1; 102) comprises a flow regulation module (Fig. 1; 108 controls 102) for regulating the flow rate of the oxygen-containing gas, (para. 0167-0168).
Regarding Claim 33, Payton discloses the anesthesia machine (Fig. 1) of claim 24, wherein the anesthesia breathing apparatus (Fig. 1; 124; 130) comprises an anesthetic delivery module (Fig. 1; through 130), a breathing control module (Fig. 1; 108), and a breathing circuit (Fig. 1; 114, 112, 116, 118); the anesthetic delivery module is connected to the gas source interface(“A” in Figure A above) and the breathing circuit (Examiner notes: delivery module is connected to both) and delivers an anesthetic (para. 0168-0169) into the breathing circuit; and the breathing control module is connected to the gas source interface and the breathing circuit (para. 0168), and provides breathing support to the patient (para. 0109-0113) through the breathing circuit (para. 0168).
Regarding Claim 42, Modified Payton discloses the anesthesia machine of claim 24, wherein the oxygen supply apparatus (Fig. 1; 102) is integrated inside a housing of the anesthesia machine (Fig. 1).
Regarding Claim 44, Payton discloses the anesthesia machine of claim 24, wherein the flow rate of the oxygen provided by the oxygen supply apparatus (Fig. 1; 102, 108) to the patient the is greater than or equal to 40 liters per minute (para. 0109-0113).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Payton, as applied to claim 24, in view of Shawn et al. (CN 103809619 A), hereafter as Shawn.
Regarding Claim 25, Payton discloses the anesthesia machine (Fig. 1) of claim 24, oxygen supply apparatus (Fig. 1; 105) .
Modified Payton does not disclose 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 Payton 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).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Payton and Shawn, as applied to claim 25, in view of Wallin et al. (US 20150250976 A1), hereafter as Wallin.
Regarding Claim 26, Modified Payton discloses the anesthesia machine of claim 25, teaches alarms (par. 0181).
Modified Payton 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 Payton 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) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Payton, as applied to claim 24, in view of Obenchain (US 20140152468 A1).
Regarding Claim 28, Payton discloses the anesthesia machine of claim 24,
oxygen supply apparatus (Fig. 1; 102) and/or the anesthesia breathing apparatus (Fig. 1; 124).
Payton 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 Payton 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) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Payton as applied to claim 24, in view of Ratto et al. (US 20120017904 A1), hereafter as Ratto.
Regarding Claim 29, Modified Payton discloses the anesthesia machine of claim 24, oxygen supply apparatus (Fig. 1; 102).
Payton 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 Payton 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) 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Payton, as applied to claim 33, in view of Jamison (US 20100175695 A1).
Regarding Claim 34, Payton discloses the anesthesia machine(Fig. 1) of claim 33,
Payton does not specifically disclose wherein the anesthetic delivery module comprises a gas mixer and an anesthetic evaporator; the gas mixer is connected to the gas source interface and the anesthetic evaporator, and the oxygen and the equilibrium gas are mixed and then outputted to the anesthetic evaporator; and the anesthetic is mixed with the gas provided by the gas mixer and then outputted to the breathing circuit by the anesthetic evaporator.
Jamison teaches 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. 0026-0027).
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 Payton specifically include the anesthetic delivery module comprises a gas mixer and an anesthetic evaporator; the gas mixer is connected to the gas source interface and the anesthetic evaporator, and the oxygen and the equilibrium gas are mixed and then outputted to the anesthetic evaporator; and the anesthetic is mixed with the gas provided by the gas mixer and then outputted to the breathing circuit by the anesthetic evaporator as taught by Jamison for the purpose of providing the breathable gases and anesthetic agent to a patient (para. 0019).
Claim(s) 39-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Payton and Shawn, as applied to claim25, in view of Taktov et al. (US 20150128942 A1), hereafter as Taktov.
Regarding Claim 39, Modified Payton discloses the anesthesia machine of claim 25, wherein the at least two working modes comprises a low-flow mode and a high-flow mode (breathing system 21; Fig. 2; para. 0040; Shawn); that the oxygen supply apparatus (Fig 1; 102; Payton) is controlled to provide the oxygen-containing gas to the patient at a flow rate greater than 15 liters per minute in the high-flow mode. (0109-0115; Payton).
Modified Payton does not specifically disclose provide the oxygen-containing gas to the patient at a flow rate lower than 15 liters per minute in the low-flow mode.
However, Taktov teaches a low flow rate that can be in the range of 0-60 liters per minute (para. 0080-0085).
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 Payton to low 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 s1leep 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 Payton to include low flow mode to be less than 15 LPM because where the general conditions of a claim 39 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 40, Modified Payton discloses the anesthesia machine of claim 39,
Modified Payton 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 Payton 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) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Payton and Shawn, as applied to claim 25, in view of Barnes et al. (WO 2018033863 A1), hereafter as Barnes.
Regarding Claim 41, Modified Payton discloses the anesthesia machine of claim 25, wherein the at least two working modes.
Payton 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 Modified Payton 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 Payton 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 the Modified Payton 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 41 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) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Payton, as applied to claim 24.
Regrading Claim 43, Payton discloses the anesthesia machine of claim 24, and the oxygen supply apparatus (Fig. 1; 102) is capable of extending the asphyxia time window (para. 0173).
Payton does not specifically disclose that oxygen supply apparatus is capable of extending the asphyxia time window to up to 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 Payton 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 Payton to incorporate the duration of 17 minutes to obtain the invention as specified in claim 43, 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAAP A ELLABIB whose telephone number is (571)272-5879. The examiner can normally be reached 8-5.
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, KENDRA CARTER can be reached on (571) 272-9034. 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.
/MAAP AHMED ELLABIB/Examiner, Art Unit 3785
/KENDRA D CARTER/Supervisory Patent Examiner, Art Unit 3785
Prosecution Insights