Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Prosecution History Summary
Claims 1, 12-13, and 25 are amended.
Claims 1-25 are pending.
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 pre-AIA 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 –
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
Claims 1-25 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Wilkes et al. (U.S. Publication No. 2004/0078231).
As per claim 1, Wilkes teaches a system comprising:
-an infusion pump (Wilkes: para. 142; infusion pump); and
-a pump controller located at the infusion pump, and in operational control over the infusion pump (Wilkes: para. 142; Infusion system),
-wherein the pump controller includes a memory configured to store a drug library (Wilkes: para. 233; para. 302; Setting of system parameters of infusion system, which includes setting the following: tolerances, defaults, databases, defining functions, etc.. Infusion pump can include a database having a table of medications having associated flow rate tolerances.);
-wherein the pump controller is configured to:
-receive the drug library and store the drug library in the memory (Wilkes: figure 8, figure 11, para. 180; para. 140; para. 233; para. 302; Infusion system residing in processor controlled infusion pumps holds the system parameters of the infusion system. System parameters include tolerances regarding medication, flow rates, time, duration, etc.);
-receive authentication information via the infusion pump or the pump controller for a first user (Wilkes: para. 178; para. 207-209; para. 222; para. 358; The infusion system receiving patient identifier information to determine authorization.);
-determine, based on the received authentication information, that the first user is authorized to access the infusion pump (Wilkes: para. 207-209; para. 222; The infusion system recognizes the clinician as having authority to initiate treatment.);
-after determining the first user is authorized to access the infusion pump, enable the infusion pump for use by the first user (Wilkes: para. 207-209; para. 222; After determining the clinician is authorized, allowing administration of the treatment.);
-receive medication identification information for a medication to be administered by the infusion pump to a patient associated with the infusion pump (Wilkes: para. 174-175; para. 209; para. 224; Enter an order for medication into the system and generating operating parameters for the infusion pump. Authorizing the clinician to modify portions of the order.), the medication identification information received by the pump controller from a patient information received from a patient information server remote from the pump controller after a user scans, using a scanner, a scannable identifier associated with the medication (Wilkes: para. 209; Scanning medication label, patient wristband, clinician badge with a two-way communication to download operating parameters of the medical device.);
-access the drug library and compare the medication identification information received from the patient information server to data in the drug library to determine if an entry for the medication identification information is in the drug library stored in the memory of the pump (Wilkes: para. 142; para. 169; para. 302; Ensure the right infusion is being administered.);
-automatically select, from the drug library, the medication and a drug library entry for the medication and populate dose parameters in the infusion pump for the medication, from the drug library, when the medication identification information received from the patient information server is in the drug library (Wilkes: para. 249; Predefined infusion flow rates can be selected.);
-generate an alert when the medication identification information is not in the drug library (Wilkes: para. 142; Provide an alert if the administration parameters do not match.);
-receive, at the pump controller, user input to begin an infusion of the medication to be administered by the infusion pump (Wilkes: para. 142; para. 209-210; Clinician can confirm or modify the settings for the infusion.);
-administer, responsive to the user input, the medication to the patient using the infusion pump (Wilkes: para. 270; Administer the medication.); and
-send, to the patient information server, remote from the pump system, after the medication has been started to be administered to the patient, a report of the infusion of the medication, including a patient identification and an order identification (Wilkes: para. 195; Generate reports indicating infusion history, pump history, etc.).
As claim 2, the pump of claim 1 is as described. Wilkes further teaches wherein the pump system is further configured to: determine the first user is authorized to treat the patient associated with the infusion pump (Wilkes: para. 208-209; para. 222).
As claim 3, the pump of claim 1 is as described. Wilkes further teaches wherein the pump system is further configured to:
-receive an adjustment to the infusion pump (Wilkes: para. 208-209; Clinician can modify prescription orders if they are authorized.); and
-operate in accordance with the adjustment to the infusion pump (Wilkes: para. 208-209; para. 211).
As claim 4, the pump of claim 1 is as described. Wilkes further teaches wherein the pump system is further configured to:
-determine that the infusion pump is currently experiencing an error condition (Wilkes: para. 140; Determine alerts to the infusion system based on definable alerts and alarms.); and
-send a notification that the infusion pump is currently experiencing the error condition (Wilkes: para. 140),
-wherein after the notification is sent, a display screen of a different device displays an indication that the infusion pump is experiencing the error condition (Wilkes: para. 143; Inform the clinicians of the infusion alerts on a computing device.).
As claim 5, the pump of claim 4 is as described. Wilkes further teaches wherein the pump system is further configured to:
-receive a corrective action to address the error condition (Wilkes: para. 146; para. 219; Correct the alarm condition.);
-log the corrective action in an electronic data record (Wilkes: para. 195); and
-cause the infusion pump to operate in accordance with the corrective action (Wilkes: para. 208-209; para. 211).
As claim 6, the pump of claim 4 is as described. Wilkes further teaches wherein the pump system is further configured to:
-determine an amount of time has elapsed after sending the notification (Wilkes: para. 141; Provide escalation of alarms after a predetermined period of time is calculated.); and
-activate an alarm indicating the error condition (Wilkes: para. 141).
As claim 7, the pump of claim 4 is as described. Wilkes further teaches wherein the pump system is further configured to: determine that the infusion pump is currently experiencing the error condition while administering an infusion to a patient (Wilkes: para. 140; Determine alerts to the infusion system based on definable alerts and alarms.).
As claim 8, the pump of claim 1 is as described. Wilkes further teaches wherein the pump system is further configured to:
-determine whether the pump system is associated with a patient (Wilkes: para. 143; para. 146; para. 150; Providing on the digital assistant status of infusions assigned to patients.); and
-display, on a display screen associated with the pump controller, a user interface based on a patient association status (Wilkes: para. 150-152; Status of infusion can be viewed on an electronic computing device.).
As claim 9, the system of claim 8 is as described. Wilkes further teaches wherein the pump system is further configured to:
-display, on the display screen, a patient order selection user interface as the user interface when the pump system is associated with the patient (Wilkes: para. 92; para. 281; Ability to create a new order based on existing orders.); and
-display, on the display screen, an identify patient user interface as the user interface when the pump system is not associated with the patient (Wilkes: para. 410).
As claim 10, the system of claim 1 is as described. Wilkes further wherein the pump system is further configured to:
-receive a biometric information of a patient associated with the pump system (Wilkes: para. 178; para. 319; Infusion system identifies patients using biometric information.); and
-display, on a display screen associated with the pump controller, a user interface that includes an indication of the biometric information (Wilkes: para. 319-321; Verify the biometric information to authorize the system and provide authorized displays.).
As claim 11, the pump of claim 1 is as described. Wilkes further teaches wherein the pump system is further configured to: adjust an operation of the infusion pump based on a type of a medication to be administered by the infusion pump or a type of alarm generated by the pump system (Wilkes: para. 155; para. 208).
As claim 12, the pump of claim 1 is as described. Wilkes further teaches wherein the pump system is further configured to: log activity on the pump system (Wilkes: para. 106).
Claims 13-24 recite substantially similar limitations as those already addressed in claims 1-12, and, as such, are rejected for similar reasons as given above.
Claim 25 recite substantially similar limitations as those already addressed in claim 1, and, as such, are rejected for similar reasons as given above.
Response to Arguments
Applicant's arguments filed for claims 1-25 under 35 U.S.C. 102 have been fully considered but they are not persuasive.
Applicant argues that Wilkes does not disclose or suggest the amended features. Examiner disagrees and provides support within the art regarding the amended features. Applicant argues that cited portions of Wilkes do not disclose a drug library, or a pump controller receiving medication identification information from a server, or a controller at the infusion pump that selects a drug library entry and automatically populates dose parameters from the drug library. Wilkes teaches infusion pump in their memory including a database of table of medications with associated flow rate tolerances (i.e. drug library; para. 302). Wilkes teaches a patient care system using a communications system to convey to the infusion system the operating protocol of the infusion pump (i.e. a pump controller receiving medication identification information from a server; para. 132-133). Wilkes teaches the infusion system with setting parameters including a way to select from a drop down menu dosage for a specific medication (i.e. a controller at the infusion pump that selects a drug library entry and automatically populates dose parameters from the drug library; para. 249).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mohapatra et al. – WO 2006/060572 – Teaches a system for pharmaceutical management for medication administration based on instructions in a memory.
Suzuki et al. – U.S. Publication No. 2005/0240441 – Teaches a hospital information system for providing an injection treatment.
Holland et al. – U.S. Publication No. 2006/0089855 – Teaches a medication management unit downloading a medication order and having a drug library.
Schlotterbeck et al. – U.S. Publication No. 2004/0128162 – Teaches a system for confirming medication administration device has been programmed with the correct administration parameters.
THIS ACTION IS MADE FINAL. 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 SHEETAL R. PAULSON whose telephone number is (571)270-1368. The examiner can normally be reached M-F 8am-5pm.
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/SHEETAL R PAULSON/Primary Examiner, Art Unit 3686