The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/30/23 is in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDS is being considered by the Examiner.
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16, 18, 20-24 and 28-30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gargano et al. (US 5,814,015) (“Gargano”).
(claims 16 and 30): Gargano discloses an infusion pump system and method comprising: an infusion pump having an infusion pump user interface (display 26 and data entry knobs 30, 32, 36, and 40; figure 1) and associated infusion pump infusion state and infusion pump user interface state (the function states include set-up (infusion pump user interface state) and run (infusion pump infusion state): see claim 12); a controller coupled with the infusion pump (the pc (remote processor) can provide remote control (controller and controller interface are part of the remote processor) of the infusion pump system; column 6, lines 66-67; column 7, lines 1-2), wherein said controller is configured to bidirectionally communicate with the infusion pump (an RS-232 interface provides bidirectional communication between a PC (processor) and the infusion pump CPU board; column 6, lines 64-67; column 7, lines 2-5); determine a current infusion state of the infusion pump and a current infusion pump user interface state (the pc (remote processor) can provide remote control or monitoring (current infusion state) of the infusion pump system; column 6, lines 66-67; column 7, lines 1-2); accept a command to change the infusion state of the infusion pump (commands are provided in the first set-up screen 204 and second set-up screen 206, figure 14); determine if the command to change the infusion state of the infusion pump is consistent with the current infusion state of the infusion pump and consistent with the current infusion pump user interface state (the system will determine if the command is consistent and will generate warnings e.g. pump limit warning 494, if command is inconsistent; figure 14); execute the command to change the infusion state of the infusion pump if the command to change the infusion state of the infusion pump is able to be successfully executed based on the command, the current infusion state of the infusion pump and the current infusion pump user interface state (the system will only advance to the run screen 472 if the command can be successfully executed, figures 14-15).
Regarding claim 18: Gargano further discloses wherein said controller is further configured to translate the command into an infusion specific command associated with a particular type of infusion pump (the controller communicates via an RS-232 interface (translates the command) with different infusion pumps which can include a syringe pump, a peristaltic pump or a volumetric cassette pump; column 5, lines 29-36).
Regarding claim 20: Gargano further discloses wherein said infusion pump is configured to display said command on said infusion pump user interface (drug delivery parameters (pump rate and pump time commands) are provided on the pre-Bolus display screen (user interface); column 17, lines 12-14).
Regarding claim 21: Gargano further discloses wherein said controller is further configured to accept a confirmation input button request from said infusion pump ("START" is highlighted on the pre-Bolus screen (confirmation input button request); column 17, lines 18-19).
Regarding claim 22: Gargano further discloses wherein said controller is further configured to send a simulated button press command to said infusion pump to initiate infusion (pressing the data entry button when "START" is highlighted on the pre-Bolus screen starts the infusion pump, and further, the infusion pump is processor (controller) driven (receives a simulated button press command to start the pump); column 17. lines 18-19; column 1, line 40).
Regarding claim 23: Gargano further discloses wherein said controller is further configured to obtain input from said infusion pump user interface from a user to enable manual control takeover of the infusion pump (Bolus amount and duration can be changed (manual takeover) from the Bolus screen (user interface); column 17. lines 23-24, column 2 lines 50-52).
Regarding claim 24: Gargano further discloses wherein said controller is further configured to log infusion status to a log file (each pump maintains a history log (log file) indicating what states were transitioned between; column 18, lines 66-67).
Regarding claim 28: Gargano further discloses wherein said controller further configured to log infusion status to a log file occurs at a conclusion of a duration of the infusion (each pump maintains a history log indicating what states were transitioned between (log of infusion status during and at the conclusion of an infusion; column 18, lines 66-67), wherein the duration is a predefined value (a drug library can be installed in the pump which programs the controller with default Bolus duration; column 11, lines 50-61).
Regarding claim 29: Gargano further discloses wherein said command is configured to be generated from an external server remote to said controller (bidirectional serial communications allow the pump to be controlled (receive commands) from an external device; column 20, lines 23-25).
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 of this title, 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 factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 17, 19 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Gargano in view of Martinez et al. (US 2006/0229551) (“Martinez”).
Regarding claim 17: Gargano discloses the infusion pump automation system as substantially claimed but Gargano does not directly disclose wherein said controller is further configured to associate the infusion pump with a medication, a dose and a patient. Martinez, in the analogous art, discloses wherein a controller is further configured to associate an infusion pump (the controller provides pumping parameters to the infusion pump; paragraph [0017]) with a medication, a dose and a patient (controller receives drug (medication) and dose information for a patient; paragraph [0017]). 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 infusion pump automation system of Gargano, to include wherein said controller is further configured to associate the infusion pump with a medication, a dose and a patient, as taught by Martinez, because this would have provided an infusion pump automation system that would reduce the likelihood of patient medication errors (Martinez; paragraph [0011]).
Regarding claim 19: Gargano discloses the infusion pump automation system as substantially claimed but Gargano does not directly disclose wherein said command to change the infusion state of the infusion pump comprises a medication, a dose and a patient. Martinez further teaches wherein a command to change the infusion state of an infusion pump (programming parameters are automatically populated for the infusion pump when the pump is in a zero infusion state prior to pumping at a non-zero infusion state; paragraph [0055]) comprises a medication, a dose and a patient (controller receives drug (medication) and dose information for a patient; paragraph [0017]. 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 infusion pump automation system of Gargano, to include wherein said command to change the infusion state of the infusion pump comprises a medication, a dose and a patient, as taught by Martinez, because this would have provided an infusion pump automation system that would reduce the likelihood of patient medication errors (Martinez; paragraph [0011]),
Regarding claim 25: Gargano discloses the infusion pump automation system as substantially claimed but Gargano does not directly disclose wherein said controller is further configured to authenticate a user before said execute of said command. Martinez teaches wherein a controller is further configured to authenticate a user before execution of a command (infusion can begin when the controller receives the scanned clinician ID and recognizes the clinician (authenticates a user); paragraph [0050]). 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 infusion pump automation system of Gargano to include wherein said controller is further configured to authenticate a user before said execute of said command as taught by Martinez, because this would have provided an infusion pump automation system that would reduce the likelihood of patient medication errors due to unauthorized personnel making changes to an infusion regimen.
Regarding claim 26: Gargano and Martinez, in combination, disclose the infusion pump automation system as substantially claimed but this combination does not directly disclose wherein said controller is further configured to associate the infusion pump with at least two pump channels. However, Martinez teaches wherein said controller is further configured to associate the infusion pump with at least two pump channels (pumping channels 22 and 56; figure 2; paragraph [0044]). 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 infusion pump automation system of Gargano, to include at least two pump channels, as taught by Martinez, because this would have provided an infusion pump automation system that would reduce the likelihood of patient medication errors (Martinez; paragraph [0011]).
Regarding claim 27: Gargano and Martinez, in combination, disclose the infusion pump automation system as substantially claimed but this combination does not directly disclose wherein said controller is further configured to verify the medication on each of the at least two pump channels. Martinez teaches wherein a controller is further configured to verily the medication on each of at least two pump channels (the controller sends a channel select signal to identity which pumping channel 22 or 56 of the system the identified medication is on; figure 2; paragraph [0044]). 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 infusion pump automation system of Gargano, to include wherein said controller is further configured to verify the medication on each of the at least two pump channels, as taught by Martinez, because this would have provided an infusion pump automation system that would reduce the likelihood of patient medication errors (Martinez; paragraph [0011]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/ Primary Examiner, Art Unit 3783
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