DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. This office action is responsive to the preliminary amendment filed on 02/22/2023. As directed by the amendment: claims 2, 4-5, 8, 10, 13, 16, 18-19, and 21 have been amended, claims 7, 9, 20, 23, and 25-27 have been cancelled, and no claims have been added. Thus, claims 1-6,8,10-19,21-22 and 24 are presently pending in this application.
Election/Restrictions
3. Claims 12-19, 21-22, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/23/2026.
Claim Rejections - 35 USC § 102
4. 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.
5. 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.
(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.
6. Claim(s) 1-2, 8, and 10-11 is/are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Kokko (US 2015/0164412).
Regarding claim 1, Kokko discloses an anesthesia control method, comprising:
establishing communication ([0032] states that infusion pumps 9 can be controlled by a central monitor 10) connection between an anesthesia machine (fig. 1, central anesthesia controller 10 which allows the clinician to set parameters for the anesthesia machine 8, see [0018]) and an infusion device (fig. 1, infusion pump 9);
controlling, through the anesthesia machine ([0026] states that anesthesia machine 8 ventilates the patient), ventilation of a patient according to anesthesia machine control information which is inputted by a user ([0026] states that the anesthesia machine 8 can be controlled by the central monitor 10 which the physician inputs controls);
sending, through the anesthesia machine, a corresponding infusion device control instruction to the infusion device according to infusion device control information which is inputted by the user ([0026] states that IV pumps 9 are controlled by a central monitor 10 and the clinician interacts with the central monitor 10 to enter controls); and
through the infusion device, receiving the corresponding infusion device control instruction from the anesthesia machine ([0032] states the clinician can enter infusion pump controls remotely by a central monitor 10) and controlling medication administration to the patient according to the corresponding infusion device control instruction ([0032] states that the infusion pump 9 can be controlled by setting infusion rate or bolus amount which is the control instruction).
Regarding claim 2, the method of Kokko reads on the limitations of claim 1 and further reads on wherein the anesthesia machine control information comprises: anesthesia machine control information which is inputted by hand ([0026] states the clinician interacts with central monitor 10 to control the anesthesia machine 8); or the infusion device control information comprises infusion device control information which is inputted by hand ([0026] states the clinician interacts with central monitor 10 to control the IV pumps 9).
Regarding claim 8, the method of Kokko reads on the limitations of claim 1 and further reads on wherein the infusion device comprises a first injection pump and a second injection pump (fig. 1, IV pumps 9); and the anesthesia control method further comprises: wherein the infusion device comprises a first injection pump (fig. 1, IV pump 9); and the anesthesia control method further comprises: through the first injection pump (fig. 1, IV pump 9 communicates with central monitor 10), acquiring a working state of the second injection pump ([0032] states that IV pumps 9 communicate delivered anesthetic amount 20 to central monitor 10) when the first injection pump is in a no-output state or a standby state ([0025] states anesthesia amount 20 can be delivered in any combination of drugs and/or gases, where drugs not being delivered through a first pump is a no-output or standby state), and before injection, updating information of the patient in the first injection pump at least based on the acquired working state ([0032] anesthetic amount 20) of the second injection pump (fig. 2, sensitivity calculation module 37 calculates a drug sensitivity index (DSI) based on patient response to a defined anesthesia, [0025] states that this is found by determining the amount of anesthesia 20 delivered); or
through the first injection pump (fig. 1, IV pump 9 communicates with central monitor 10), acquiring a working state of the anesthesia machine ([0025] states the anesthetic amount 20 is controlled by the central monitor by the clinician, where the delivery of anesthesia 20 by the anesthesia machine 8 would be a working state) when the first injection pump is in a no-output state or a standby state ([0025] states that anesthetic amount 20 includes any combination of delivered gases and drugs, and is set by the clinician, where the anesthesia machine 8 can deliver gases while no drugs are being delivered by the IV pumps 9), and before injection, updating information of the patient in the first injection pump (fig. 2, sensitivity calculation module 37 calculates a drug sensitivity index (DSI) based on patient response to a defined anesthesia, [0025] states that this is found by determining the amount of anesthesia 20 delivered. Meaning if no anesthesia is delivered by IV pumps 9, the DSI is calculated based on the anesthesia machine 8 gases prior to injection) at least based on the acquired working state of the anesthesia machine ([0017] states a drug sensitivity index (DSI) is a model created by comparing patient response to a defined anesthesia, see fig. 2, 37 where the DSI is calculated which is dependent on the anesthesia amounts 20 including the anesthesia delivered from gases).
Regarding claim 10, the method of Kokko reads on the limitations of claim 8 and further reads on wherein the anesthesia control method further comprises: through the anesthesia machine, acquiring a working state of the infusion device ([0032] states that the anesthetic amount 20 information of the infusion pumps 9 is transferred to a central processor) when the anesthesia machine is in a no-output state or a standby state, and before ventilation ([0025] states anesthetic is administered as any combination of gases and/or drugs, where the IV pumps can deliver a drug while no gas is delivered), updating information of the patient in the anesthesia machine at least based on the acquired working state of the infusion device (fig. 2, sensitivity calculation module 37 calculates a drug sensitivity index (DSI) based on patient response to a defined anesthesia, [0025] states that this is found by determining the amount of anesthesia 20 delivered).
Regarding claim 11, the method of Kokko reads on the limitations of claim 1 and further reads on wherein the anesthesia control method further comprises: displaying, on a same interface of the anesthesia machine (fig. 1, central monitor 10 includes user interface/display 4), an anesthesia machine setting area for receiving the anesthesia machine control information which is inputted by the user and an infusion device setting area for receiving the infusion device control information which is inputted by the user ([0054] states that user interface 4 acts as a user input device, and [0026] states that the clinician interacts with central monitor 10 to control the dosing of each of the anesthesia machine 8 and IV pumps 9).
Claim Rejections - 35 USC § 103
7. 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.
8. Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kokko as applied to claim 1 above, and further in view of Beck et al. (US 2022/0293262).
Regarding claim 3, the method of Kokko reads on the limitations of claim 1, and further discloses that the IV pumps (fig. 1, 9) can be controlled by a central monitor remotely ([0032]), but does not expressly state that the communication connection is wireless communication connection.
However, Beck teaches of a method for connecting a medical device and a mobile, companion device ([0404]) that connects by establishing a wireless connection.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the method of Kokko with the wireless connection as taught by Beck to facilitate the remote operation of the IV pumps by the central monitor (Kokko [0032]).
Regarding claim 4, the method of Kokko reads the method of Kokko reads on the limitations of claim 1, and further discloses that the IV pumps (fig. 1, 9) can be controlled by a central monitor remotely ([0032]), but does not expressly state that the communication connection is wireless communication connection; and the anesthesia control method further comprises: through the anesthesia machine, indicating that, the wireless communication connection with the infusion device is established, after establishing the wireless communication connection between the anesthesia machine and the infusion device; or through the infusion device, indicating that, the wireless communication connection with the anesthesia machine is established, after establishing the wireless communication connection between the anesthesia machine and the infusion device.
However, Beck teaches of a method for connecting a medical device and a mobile, companion device ([0404]) that connects by establishing a wireless connection and presents a notification on one or both devices to allows a wireless communication link ([0404]) to ensure credentialed users are controlling the device ([0406]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the method of Kokko with the wireless connection and notification as taught by Beck to facilitate the remote operation of the IV pumps by the central monitor (Kokko [0032]), and ensure that proper users are accessing the mobile device (Beck [0406]).
The modified method of Kokko reads on the communication connection is wireless communication connection (Beck [0404] states that the devices establish a wireless connection); and the anesthesia control method further comprises:
through the anesthesia machine, indicating that, the wireless communication connection with the infusion device is established, after establishing the wireless communication connection (Beck [0404] states the notification occurs after detection of the respective device to send a notification where the detection is considered a wireless communication connection) between the anesthesia machine and the infusion device (Beck [0404] states that the medical device and/or the mobile device may present a notification to a user requesting authorization for connection); or
through the infusion device, indicating that, the wireless communication connection with the anesthesia machine is established (Beck [0404] states that the medical device and/or the mobile device may present a notification to a user requesting authorization for connection), after establishing the wireless communication connection between the anesthesia machine and the infusion device (Beck [0404] states the notification occurs after detection of the respective device to send a notification where the detection is considered a wireless communication connection).
9. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kokko as applied to claim 1 above, and further in view of Mann et al. (US 2002/0107476).
Regarding claim 5, the method of Kokko reads on the limitations of claim 1, but does not disclose wherein the anesthesia control method further comprises: through the infusion device, indicating that the corresponding infusion device control instruction is received, after receiving the corresponding infusion device control instruction.
However, Mann teaches of an infusion system that uses a remote controller, receiver, and indication device ([0009]), where the indication device indicates when a command has been received and when the infusion device is being utilized ([0009]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the method of Kokko with the indication device and associated indication step as taught by Mann to allow the use of the infusion device while it is not in view (Mann [0009]).
The modified method of Kokko reads on through the infusion device (Mann [0009] the indication device is provided on the external infusion device), indicating that the corresponding infusion device control instruction is received, after receiving the corresponding infusion device control instruction (Mann [0009] states that the indication device provides an indication when a command has been received).
10. Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kokko as applied to claim 1 above, and further in view of Mann and Matsiev et al. (US 2010/0305499).
Regarding claim 6, the method of Kokko reads on the limitations of claim 1 and further discloses that the IV pumps (fig. 1, 9) can be controlled by a central monitor remotely ([0032]), but does not expressly state that the communication connection is wireless communication connection. Kokko also discloses that patient demographic information can be obtained from a database to advise the recommended anesthesia amount ([0042]), but does not expressly state the step of: through the anesthesia machine, determining whether information of the patient in the anesthesia machine is consistent with information of the patient in the infusion device, before sending the corresponding infusion device control instruction to the infusion device; if not, disconnecting the wireless communication connection, refusing to send the corresponding infusion device control instruction or sending an alarm massage.
However, Beck teaches of a method for connecting a medical device and a mobile, companion device ([0404]) that connects by establishing a wireless connection.
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the method of Kokko with the wireless connection as taught by Beck to facilitate the remote operation of the IV pumps by the central monitor (Kokko [0032]).
Further, Matsiev teaches of a method for controlling an IV pump that consists of interrogating electronic medical records of specific patients to detect any wrong drugs or dangerous drugs for the patient ([0145]).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to provide the method of Kokko with the electronic medical record interrogation step as taught by Matsiev to control drug combinations associated when multiple drugs are infused (Matsiev [0144]).
The modified method of Kokko reads on wherein the communication connection is wireless communication connection (Beck [0404] states that the devices establish a wireless connection) and the anesthesia control method further comprises: through the anesthesia machine, determining whether information of the patient in the anesthesia machine is consistent with information of the patient in the infusion device (Matsiev [0145] states that the electronic medical records can be interrogated to detect potential wrong drug errors due to drug and dose detected in the IV pump), before sending the corresponding infusion device control instruction to the infusion device (Matsiev [0145] the IV pump is controlled based on the wrong drug error); if not, refusing to send the corresponding infusion device control instruction (Matsiev [0145] states that when a drug error is detected a signal can be sent to stop the IV pump) or sending an alarm massage (Matsiev [0145] states that when a drug error is detected, a warning signal can also be transmitted to a healthcare worker).
Conclusion
11. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ledford et al. (US 2018/0126067) discloses an embedded server system for an infusion pump that allows the infusion machine to transmit and receive control commands). Steinhauer et al. (US 2013/0104889) discloses a ventilator that communicates with other medical devices and can connect to a network. Linden (US 5,626,151) discloses a life support system that includes a display monitor that communicates with a ventilator and infusion pumps.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS Z CHANG whose telephone number is (571)272-0432. The examiner can normally be reached Monday-Friday 9:00 am-5:00 pm.
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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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/THOMAS Z CHANG/Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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