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 .
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) filed 1/28/26. Claims 19, 27, and 34 have been amended. Claims 1-18 are canceled. Claims 19-38 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/28/26 has been entered.
Claim Objections
Claims 19, 27, and 34 are objected to because of the following informalities: Examiner suggests using consistent language throughout the claims by amending as follows: “…drug library program settings are provided in a drug library installed on the infusion pump….” Appropriate correction is required.
Claims 19, 27, and 34 are objected to because of the following informalities: change “the determination” to “a determination.” Appropriate correction is required.
Claims 20-25 are objected to because of the following informalities: it is unclear which “the error message” is being referred to – the “an error message” in claim 19, or the “an error message” in claim 20. Appropriate correction is required.
Claims 28-33 are objected to because of the following informalities: it is unclear which “the error message” is being referred to – the “an error message” in claim 27, or the “an error message” in claim 28. Appropriate correction is required.
Claims 35-38 are objected to because of the following informalities: it is unclear which “the error message” is being referred to – the “an error message” in claim 34, or the “an error message” in claim 35. Appropriate correction is required.
Claim 20, 28, and 35 are objected to because of the following informalities: change “a screen” to “the screen.” Appropriate correction is required.
Claims 22 and 23 are objected to because of the following informalities: it is unclear which “the suggested action” is being referred to – the “a suggested action” in claim 19, or the “a suggested action” in claim 21. Appropriate correction is required.
Claims 30 and 31 are objected to because of the following informalities: it is unclear which “the suggested action” is being referred to – the “a suggested action” in claim 27, or the “a suggested action” in claim 29. Appropriate correction is required.
Claims 36 and 37 are objected to because of the following informalities: it is unclear which “the suggested action” is being referred to – the “a suggested action” in claim 34, or the “a suggested action” in claim 36. Appropriate correction is required.
Claims 19, 27, and 34 are objected to because of the following informalities: it is unclear whether or not the “generating…” and “displaying..” steps of the claims are required to be performed since the determining that the settings are inconsistent appears to be an optional limitation in the “determining…” step. 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 (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 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.
Claim(s) 19-21, 24, 25, 27-29, 32-35, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wehba et al. (US 2007/0233521 A1) in view of Matsiev et al. (US 2010/0305499 A1), and further in view of Russell (US 2006/0116639 A1).
(A) Referring to claim 19, Wehba discloses A method of electronically preventing execution of an auto-programming request locally at an infusion pump, the method comprising (para. 103 of Wehba; the infusion pump 3130, 3230 will automatically reject the medical device specific delivery information, and will prevent the infusion pump 3130, 3230 from being programmed):
receiving, by the infusion pump from a remote computing device, the auto-programming request comprising IV drug container information, infusion pump information, and infusion program settings (Fig. 1, para. 86, 90, and 91 of Wehba; The POC computer 3224 or the POC client 3126 sends or transmits the medical device specific identification information, such as the pump ID, the caregiver specific identification information, such as the nurse's ID, the order ID obtained or retrieved from one of the drug container specific identification information or from the associated medication order stored in the memory associated with the POC computer 3224 and/or the POC client 3126, and the medical device specific delivery information, such as the pump settings for the order, to the MMU computer 3108, 3208. The MMU computer transmits the medical device specific delivery information, such as the pump settings, to the infusion pump 3130, 3230. The infusion pump 3130, 3230 includes a medical device memory for storing the medical device specific delivery information for use in programming the infusion pump 3130, 3230 to deliver the medication 3100, 3200 to the patient 3104, 3204);
comparing, by the infusion pump, the infusion program settings with drug library program settings, wherein the drug library program settings are provided in a drug library stored at the infusion pump (para. 134 and 160 Wehba; Advantageously in a tenth process step 3920, the pump 3130, 3230 checks the entered program settings against the permissible settings specified in the drug library of the pump 3130, 3230 and alerts the nurse of any impermissible settings. The nurse 3132, 3232 can then adjust the pump program settings in an optional step 3922 or override the alert in the case of soft limit violations. Any adjusted pump program settings are also checked against the drug library, and eventually the final program settings are viewed on the pump display screen 88 and confirmed by the nurse 3132, 3232 in process step 3924. Then the nurse 3132, 3232 is presented with a start button on the screen 88 to start the infusion in accordance with the final confirmed programmed pump settings.), wherein the infusion pump performs a drug name, concentration, dosing units, or drug ID comparison against a drug list in the drug library installed on the infusion pump for a selected clinical care area (para. 11 of Wehba; The MMU translates the simple infusion rate of the delivery order into delivery programming code or information suitable for automatically programming the designated pump and further checks the delivery order and delivery programming code against a variety of drug library parameters (including but not limited to hard and/or soft limits for drug delivery rates, dose, volume, duration, route and site of administration), patient-specific safety factors, and clinical decision support rules including drug compatibility and drug-drug interactions. The MMU can be configured by the user at the MMU console or client workstation to monitor the status of the pump and the infusion (including alarms, event logs, and pump user interface inputs), generate reports, and control the distribution of drug library and operating software code updates to one or more pumps. A drug library editor (DLE) deployed as a part of the MMU, its console, or on a separate computer (DLE client workstation), enables the user to import, export and edit whole drug libraries and individual drug library values to control and customize a drug library according to hospital preferences.);
determining, by the infusion pump, whether the infusion program settings are consistent or inconsistent with the drug library program settings based on the comparing (para. 134 of Wehba; the POC system learns of any program adjustments made at the pump 3130, 3230. This embodiment advantageously has fewer steps yet allows for program adjustments. Any adjustments made will also be subject to the safety limits of the drug library of the pump and will give the caregiver immediate alarm feedback if the adjusted pump program settings are not within such limits.);
generating, by the infusion pump, an error message based on the determining that the infusion program settings are inconsistent with the drug library program settings (para. 134 of Wehba; Any adjustments made will also be subject to the safety limits of the drug library of the pump and will give the caregiver immediate alarm feedback if the adjusted pump program settings are not within such limits.).
Wehba does not expressly disclose rejecting, by the infusion pump, the auto-programming request based on the determination that the infusion program settings cause a concurrency violation for concurrent delivery of two different medications from two different source containers upstream of the infusion pump to a single line downstream of the infusion pump; and displaying, by the infusion pump, a screen, wherein the screen comprises the error message and a suggested action.
Matsiev discloses rejecting, by the infusion pump, the auto-programming request based on the determination that the infusion program settings cause a concurrency violation for concurrent delivery of two different medications from two different source containers upstream of the infusion pump to a single line downstream of the infusion pump (para. 138 & 141-145 of Matsiev; the systems and device may be used to help control IV pumps to ensure that the correct drug sequence is delivered. For example, when two or more drugs are attached to one multi-channel pump, or two or more single channel pumps, the sensor system can be used for controlling a programmed sequence of infusions by signaling to the pump(s) when each infusion is complete to allow the pump to initiate delivery of the next medication. For example, when two or more drugs are infused simultaneously from one multi-channel pump or two or more single channel pumps, the sensor system can be used to control the relative proportions of the drugs being administered by measuring the signature of the drug combination and sending signals to the pumps adjusting the administration rate of one or more drugs, thereby adjusting the relative proportions of the drugs administered. This would eliminate delivery errors associated with line connection errors in multi-channel pumps by verifying the drug in each channel, and may be particularly useful for preventing errors arising from crossing IV fluid lines. The system can control an IV pump or pumps to stop or reduce flow in the event of a detected adverse drug event (ADE). When a drug error is detected, a signal can be sent to an IV pump to stop, suspend or reduce the flow to avoid patient harm.).
Russell discloses displaying, by the infusion pump, a screen, wherein the screen comprises the error message and a suggested action (para. 37, 30, 34, 42, and 18 of Russell; The monitoring system 10 may also include a drug library database stored in the data storage unit 16 having ranges of acceptable values for various operating parameters of the infusion pump 24 and/or dosages of the medication. The drug library database would be accessible by the processor 14. Additionally, the drug library database may include various data sets of acceptable operating parameters linked to the particular medication being delivered. For example, data sets for NICU, CCU, General Surgery, and others. In this embodiment, the processor compares the operating parameter values for the particular medication to the medication database range of acceptable values. If the entered value for the operating parameter is within the range of accepted values and/or the dosage of the medication is within accepted values, the processor will permit the parameter to be entered into the infusion pump and the infusion started. If not, an alert is provided to the operator. The nurse is then prompted to correct the discrepancy by entering the correct data. In the event the nurse determines that the discrepancy cannot be corrected but that the discrepancy is minor and will not affect the accuracy or safety of the delivery of the medication, the nurse may override the alert. The monitoring system 10, of which the pump 24 forms a part in this embodiment, monitors the infusion process in a real-time manner, providing alerts on the display 18 and allowing intervention by nurses if necessary.)
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify Wehba to the include the aforementioned features of Matsiev and Russell. The motivation for doing so would have been to avoid patient harm (para. 145 of Matsiev) and to correct the discrepancy (para. 37 of Russell).
(B) Referring to claims 20 and 21, Wehba does not expressly disclose further comprising: generating, by the infusion pump, an error message based on the determining that the infusion program settings cause the concurrency violation; and displaying the error message on a screen of the infusion pump and further comprising determining a suggested action to resolve the error message.
Matsiev discloses generating, by the infusion pump, an error message based on the determining that the infusion program settings cause the concurrency violation; and displaying the error message on a screen of the infusion pump (para. 219, 144, 145 of Matsiev) and determining a suggested action to resolve the error message (para. 218-222, 278, and 279 Matsiev).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Matsiev within Wehba. The motivation for doing so would have been to avoid patient harm (para. 145 of Matsiev).
(C) Referring to claim 24, Wehba discloses wherein the error message describes a cause of an error with the auto-programming request (para. 77 of Wehba).
(D) Referring to claim 25, Wehba discloses further comprising automatically rejecting, by the infusion pump, the auto-programming request when no input is received by the infusion pump for a predetermined time after the error message is displayed (para. 70, 152, 120, 121, and 149 of Wehba).
(F) Claim 27 differs from claim 19 by reciting “An infusion pump comprising: a memory storing computer-executable instructions; and one or more processors in communication with the memory and programmed by the computer-executable instructions to:” (see para. 75, 153 and 154 of Wehba).
The remainder of claim 27 repeats substantially the same limitations as claim 19, and is therefore rejected for the same reasons given above.
(G) Claim 34 differs from claim 19 by reciting “A non-transitory computer-readable storage medium having computer- executable program instructions stored thereon that, when executed by a processor of an infusion pump, cause the processor to perform a process comprising:” (see para. 75, 153 and 154 of Wehba).
The remainder of claim 34 repeats substantially the same limitations as claim 19, and is therefore rejected for the same reasons given above.
(H) Claims 28, 29, 32, 33, 35, and 38 repeat substantially the same limitations as claims 20, 21, 24, and 25, and are therefore rejected for the same reasons given above.
Claim(s) 22, 23, 30, 31, 36, and 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wehba et al. (US 2007/0233521 A1) in view of Matsiev et al. (US 2010/0305499 A1), in view of Russell (US 2006/0116639 A1), and further in view of Kopp et al. (US 2011/0133946 A1).
(A) Referring to claims 22 and 30, Wehba, Matsiev, and Russell do not expressly disclose wherein the screen comprises a header portion, a middle portion, and a bottom portion, wherein the middle portion includes the error message and wherein the bottom portion includes selectable options responsive to the suggested action.
Kopp discloses wherein the screen comprises a header portion, a middle portion, and a bottom portion, wherein the middle portion includes the error message and wherein the bottom portion includes selectable options responsive to the suggested action (see Figures 4 & 6A-6D and para. 31-33 of Kopp).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Kopp within Wehba, Matsiev, and Russell. The motivation for doing so would have been to display a possible solution for correcting the error that the user can follow (para. 4 of Kopp).
(B) Referring to claim 31 and similar claims 23 & 37, Wehba, Matsiev, and Russell do not expressly disclose wherein the one or more processors are further programmed by the computer-executable instructions to receive a response to the error message, wherein the response comprises the suggested action.
Kopp discloses wherein the one or more processors are further programmed by the computer-executable instructions to receive a response to the error message, wherein the response comprises the suggested action (see Figures 4 & 6A-6D and para. 31-33 of Kopp).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Kopp within Wehba, Matsiev, and Russell. The motivation for doing so would have been to correct the error (para. 4 of Kopp).
(C) Referring to claim 36, Wehba does not expressly disclose wherein the process further comprises determining a suggested action to resolve the error message, wherein the screen comprises a header portion, a middle portion, and a bottom portion, wherein the middle portion includes the error message, and wherein the bottom portion includes selectable options responsive to the suggested action.
Matsiev discloses wherein the process further comprises determining a suggested action to resolve the error message (para. 218-222, 278, and 279 Matsiev).
Matsiev and Russell do not disclose wherein the screen comprises a header portion, a middle portion, and a bottom portion, wherein the middle portion includes the error message, and wherein the bottom portion includes selectable options responsive to the suggested action. However, these limitations are taught by Kopp (see Figures 4 & 6A-6D and para. 31-33 of Kopp).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned features of Matsiev and Kopp within Wehba and Russell. The motivation for doing so would have been to provide guidance (para. 278 of Matsiev) and to display a possible solution for correcting the error that the user can follow (para. 4 of Kopp).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wehba et al. (US 2007/0233521 A1) in view of Matsiev et al. (US 2010/0305499 A1), in view of Russell (US 2006/0116639 A1), and further in view of MacKenzie et al. (US 2015/0365512 A1).
(A) Referring to claim 26, Wehba, Matsiev, and Russell do not disclose wherein the predetermined time is within a range of 15-35 seconds.
MacKenzie discloses wherein the predetermined time is within a range of 15-35 seconds (para. 28, 35, and 25 of MacKenzie).
Before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the aforementioned feature of MacKenzie within Wehba, Matsiev, and Russell. The motivation for doing so would have been to utilize time limit durations (para. 25 of MacKenzie).
Response to Arguments
Applicant’s arguments with respect to claim(s) 19, 27, and 34 have been considered but are moot because 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.
Applicant's additional arguments filed 1/28/26 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed hereinbelow in the order in which they appear in the response filed 1/28/26.
Applicant's arguments that the cited references fail to teach or suggest elements of amended claims 19, 27, and 34 fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. See 103 rejection above which points to portions of Wehba, Matsiev, and new reference Russell that teach the limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches drug component admixture library for a drug infusion delivery system (US 2011/0320049 A1) and intravenous medication harm index system (US 2005/0224083 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENA NAJARIAN whose telephone number is (571)272-7072. The examiner can normally be reached Monday - Friday 9:30 am-6 pm.
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687