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 .
This communication is in response to the amendment received on 01/29/2026. Claims 1, 3, 6-8, 10, 12-15 and 17-20 remain pending in this application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 6-8, 10, 12-15 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-19 of U.S. Patent No. 10,881,783 (hereinafter 783’ patent). Although the claims at issue are not identical, they are not patentably distinct from each other because both clam limitations of this application and the 783’ patent recites:
“receiving infusion pump history data from a plurality of infusion pumps over a network interface circuit, the infusion pump history data comprising:
current application: reprogram event indicating that a dose rate parameter was inputted to an infusion pump which was outside of a prestored limit, the dose rate parameter was then returned to within the prestored limit, and infusion was then started on the pump at the dose rate parameter within the prestored limit; and an override event indicating that a second dose rate parameter was inputted to the infusion pump which was outside of a second prestored limit and that a second infusion was started on the infusion pump at the dose rate parameter outside of the second prestored limit;
783’ patent: an indication that a user inputted to an infusion pump a parameter which was outside of a prestored limit, an indication that a user was notified that the parameter was outside the prestored limit; an indication that the infusion pump parameter was returned to within the prestored limit, and an indication that the user started infusion on the pump at the parameter within the prestored limit;
current application: generating display data for presentation on a display to a second user, the display data indicating, for a drug, a number of infusion events that occurred for the drug, a number of override events that occurred for the drug, a percentage of override events that occurred for the drug, a number of reprogram events that occurred for the drug, and a percentage of reprogram events that occurred for the drug,
783’ patent: generating display data for presentation on a display to a second user, the display data indicating a number of the events that occurred for a drug;
current application: receiving a change from the server computer to a data set comprising hard limits and soft limits for pump programming parameters; downloading the changed data set to the infusion pump to program the infusion pump with the changed data set based on the received change; and administering the drug to the patient pursuant to parameters entered by a clinician into the infusion pump and using the changed data set
783’ patent: after generating the display data, receiving a change from the second user to a data set comprising hard limits and soft limits for pump programming parameters; downloading the changed data set to the infusion pump to program the infusion pump with the changed data set based on the received change; and administering a medicament to a patient pursuant to parameters entered by a clinician into the infusion pump and using the changed data set.”.
Therefore, both the current application and the 783’ patent are directed to “receiving infusion pump history data…comprising: user input parameters and change of the parameters, generating a display data for presentation for the user a number of infusion events…, receiving a change data set…, downloading the changed data set to the infusion pump to program the infusion pump…, and administering a medicament to a patient pursuant the parameters entered by a clinician into the infusion pump and using the changed data set”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 6-8, 10, 12-15 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
MPEP section 2105 states that “If the broadest reasonable interpretation of the claimed invention as a whole encompasses a human being, then a rejection under 35 U.S.C. 101 must be made indicating that the claimed invention is directed to nonstatutory subject matter. Furthermore, the claimed invention must be examined with regard to all issues pertinent to patentability, and any applicable rejections under 35 U.S.C. 102, 103, or 112 must also be made.”
In particular, claims 1, 8 and 15 have been amended to recite “receive a user selection of a drug name for the drug…, after generating the display data, receive a change from the second user to a data set”, and the claimed second user correspond to a human being and therefore the claimed invention is directed to nonstatutory subject matter.
Claims 3, 6-7, 10, 12-14 and 17-20 inherit the deficiencies of claims 1, 8 and 15 through dependency and are therefore also rejected.
Claims 1, 3, 6-8, 10, 12-15 and 17-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1, 3, 6-7 are drawn to a system which is within the four statutory categories (i.e. machine). Claims 8, 10, 12-15, and 17-20 are drawn to a method which is within the four statutory categories (i.e. process).
Step 2A, Prong 1:
Claims 1 and 8 have been amended to recite:
“a network interface circuit configured to provide communications over a network; and
a processing circuit configured to:
receive infusion pump history data from a plurality of infusion pumps over the network interface circuit, the infusion pump history data comprising a reprogram event indicating that a dose rate parameter was inputted to an infusion pump which was outside of a prestored limit, the dose rate parameter was then returned to within the prestored limit, and infusion was then started on the pump at the dose rate parameter within the prestored limit, the infusion pump history data further comprising an override event indicating that a second dose rate parameter was inputted to the infusion pump which was outside of a second prestored limit and that a second infusion was started on the infusion pump at the dose rate parameter outside of the second prestored limit;
store a plurality of the reprogram events and the override events in a memory;
generate display data for presentation on a display to a second user, the display data indicating, for a drug, a number of infusion events that occurred for the drug, a number of override events that occurred for the drug, a percentage of override events that occurred for the drug, a number of reprogram events that occurred for the drug, and a percentage of reprogram events that occurred for the drug, wherein the percentage of reprogram events that occurred for the drug is a percentage of the number of infusion events, wherein the display data further comprises a care area within a medical facility associated with the infusion pump and a drug name of the drug;
wherein the processing circuit is configured to receive a user selection of a drug name for the drug and to generate the display data based on the selected drug name;
after generating the display data, receive a change from the second user to a data set; and
download the changed data set to the infusion pump to program the infusion pump with the changed data set based on the received change;
wherein the infusion pump administers the drug to the patient pursuant to parameters entered by a clinician into the infusion pump and using the changed data set.”
Claim 15 recites similar limitations.
The limitations of “receiving infusion pump history data…, storing a plurality of reprogram events and override events…, generating display data…, downloading the changed data set to the infusion pump…” corresponds to additional elements, which described in the section below.
The limitations of “receive a user selection of the drug name for the drug…, receiving a change from the second user to a data set” corresponds to “certain methods of organizing human activity” (such as user following rules and instructions), based on the displayed data. This is a method of managing interactions between people, such as user following rules and instructions. The mere nominal recitation of a generic processing circuit, generic network and memory devices does not take the claim out of the methods of organizing human interactions grouping. Thus, the claims recite an abstract idea.
The limitation of “wherein the infusion pump administers the drug to the patient pursuant to parameters entered by a clinician into the infusion pump and using the changed data set “corresponds to insignificant application (see the details below).
After considering all claim elements, both individually and in combination and in ordered combination, it has been determined that the claims do not amount to significantly more than the abstract idea itself.
Claims 3, 6-7, 10, 12-14 and 17-20 are ultimately dependent from claims 1, 8, 15 and include all the limitations of claims 1, 8, 15. Therefore, claims 3, 6-7, 10, 12-14 and 17-20 recite the same abstract idea. Claims 3, 6-7, 10, 12-14 and 17-20 describe a further limitation regarding the basis for changing a data set on an infusion pump. These are all just further describing the abstract idea recited in claims 1, 8, 15, without adding significantly more.
Step 2A, Prong 2:
This judicial exception is not integrated into a practical application. In particular, claims recite the additional elements of “receiving/transmitting infusion pump history data…, storing a plurality of reprogram events and override events…, generating display data…, downloading the changed data set to the infusion pump…” using a processing circuit. The processing circuit in these steps are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of receiving, storing, generating information and downloading data to the generic infusion pump based on a displayed information) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
The processing circuit is described in the current specification as a generic processing circuit (such as in [0048]), and the infusion pump is described in the current specification as a generic infusion pump (such as in [0025]).
Claims also recite other additional limitations beyond abstract idea, including functions such as the infusion pump administers the drug to the patient, which corresponds to an “insignificant application” (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea.
Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processing circuit to perform receive, store and generate data steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
Claim Rejections - 35 USC § 112
Claims 8, 10-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 has been amended to recite the limitation " wherein the processing circuit is configured to receive a user selection of a drug name for the drug and to generate the display data based on the selected drug name " in lines 17-19. There is insufficient antecedent basis for this limitation in the claim, because of the added “processing circuit” term in the claim.
Claims 10-14 inherit the deficiencies of claim 8 through dependency and are therefore also rejected.
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 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 1, 3, 6-8, 10, 12-15, and 17-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bello et al. (hereinafter Bello) (WO 2005/101279 A2).
Claim 1 recites a server computer configured to change a data set on an infusion pump for administering a drug to a patient, comprising:
a network interface circuit configured to provide communications over a network (Bello discloses “…The system also has a central computer in communication with the plurality of interface devices over a communications network for receiving and storing the identifier data and all information associated with such identifier…” on page 144, lines 12-14); and
a processing circuit configured to: receive infusion pump history data from a plurality of infusion pumps over the network interface circuit, the infusion pump history data comprising a reprogram event indicating that a dose rate parameter was inputted to an infusion pump which was outside of a prestored limit, the dose rate parameter was then returned to within the prestored limit, and infusion was then started on the pump at the dose rate parameter within the prestored limit, the infusion pump history data further comprising an override event indicating that a second dose rate parameter was inputted to the infusion pump which was outside of a second prestored limit and that a second infusion was started on the infusion pump at the dose rate parameter outside of the second prestored limit (Bello discloses “Medication delivery data tracking and reporting…Specifically, the reports will at least allow clinicians to view and print a history of flow rate changes made on the Colleague Pump for a specific medication on a specific channel;… allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning,…” on page 142, line 31 to page 144, line 7, “…Upon request for manipulated data from an interface device, or as a result of some other occurrence, the central computer can add, calculate, combine, compare, analyze, compute, separate, tabulate and/or perform some other processing function to and/or on the identifier data and/or medical pump data and/or the use thereof in delivering medication. This manipulated information can then be transmitted to the interface device for review by a caregiver.” on page 144, lines 26-31);
store a plurality of the reprogram events and the override events in a memory (Bello discloses “Medication delivery data tracking and reporting…allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning, including an out of limit summary report by specific medication on infusions hung with the use of handheld interface devices connected to central computers in communication with such pumps, as described in. prior embodiments…” on page 143, line 17 to page 144, line 7);
generate display data for presentation on a display to a second user, the display data indicating, for a drug, a number of infusion events that occurred for the drug, a number of override events that occurred for the drug, a percentage of override events that occurred for the drug, a number of reprogram events that occurred for the drug, and a percentage of reprogram events that occurred for the drug, wherein the percentage of reprogram events that occurred for the drug is a percentage of the number of infusion events, wherein the display data further comprises a care area within a medical facility associated with the infusion pump and a drug name of the drug (Bello discloses “Medication delivery data tracking and reporting…allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning, including an out of limit summary report by specific medication on infusions hung with the use of handheld interface devices connected to central computers in communication with such pumps, as described in prior embodiments…” on page 143, line 17 to page 144, line 7, page 61, line 32 to page 62, line 7 and fig. 103);
wherein the processing circuit is configured to receive a user selection of a drug name for the drug and to generate the display data based on the selected drug name (Bello; page 32, line 28 to page 33, line 7)
after generating the display data, receive a change from the second user to a data set (Bello discloses “Medication delivery data tracking and reporting…allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning, including an out of limit summary report by specific medication on infusions hung with the use of handheld interface devices connected to central computers in communication with such pumps, as described in. prior embodiments…” on page 143, line 30 to page 144, line 1, “…This arrangement further allows for the ability to change infusion pump settings from the central station. This arrangement further allows for the comparison of drug label, rate/dose, and/or concentration programmed on infusion pumps to a pre-defined list of high and low dose and/or concentration limits and generates a message at the central station if limits are exceeded.” on page 140, lines 20-24); and
download the changed data set to the infusion pump to program the infusion pump with the changed data set based on the received change (Bello discloses “Medication delivery data tracking and reporting…allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning, including an out of limit summary report by specific medication on infusions hung with the use of handheld interface devices connected to central computers in communication with such pumps, as described in. prior embodiments…” on page 143, line 30 to page 144, line 1, “…This arrangement further allows for the ability to change infusion pump settings from the central station. This arrangement further allows for the comparison of drug label, rate/dose, and/or concentration programmed on infusion pumps to a pre-defined list of high and low dose and/or concentration limits and generates a message at the central station if limits are exceeded.” on page 140, lines 20-24);
wherein the infusion pump administers the drug to the patient pursuant to parameters entered by a clinician into the infusion pump and using the changed data set (Bello discloses “…This arrangement further allows for the ability to change infusion pump settings from the central station. This arrangement further allows for the comparison of drug label, rate/dose, and/or concentration programmed on infusion pumps to a pre-defined list of high and low dose and/or concentration limits and generates a message at the central station if limits are exceeded.” on page 140, lines 20-24 and page 115, lines 30-33).
Claim 3 recites the server computer of Claim 2, wherein the care area is selected from the group comprising an intensive care area and an ambulatory care unit (Bello; page 69, line 24 to page 70, line 2).
Claim 6 recites the computer of Claim 1, wherein the display comprises a bar chart representing the number of override events (Bello; Fig. 105).
Claim 7 recites the server computer of Claim 1, wherein the display comprises a report type input device to allow a user to select among different report types (Bello; page 45, lines 4-10).
Claim 8 has been amended to recite a method, comprising:
receiving infusion pump history data from a plurality of infusion pumps over a network interface circuit, the infusion pump history data comprising: a reprogram event indicating that a dose rate parameter was inputted to an infusion pump which was outside of a prestored limit, the dose rate parameter was returned to within the prestored limit, and infusion was started on the pump at the dose rate parameter within the prestored limit; and an override event indicating that a second dose rate parameter was inputted to the infusion pump which was outside of a second prestored limit and that a second infusion was started on the infusion pump at the dose rate parameter outside of the second prestored limit (Bello discloses “Medication delivery data tracking and reporting…Specifically, the reports will at least allow clinicians to view and print a history of flow rate changes made on the Colleague Pump for a specific medication on a specific channel;… allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning,…” on page 142, line 31 to page 144, line 7, “…Upon request for manipulated data from an interface device, or as a result of some other occurrence, the central computer can add, calculate, combine, compare, analyze, compute, separate, tabulate and/or perform some other processing function to and/or on the identifier data and/or medical pump data and/or the use thereof in delivering medication. This manipulated information can then be transmitted to the interface device for review by a caregiver.” on page 144, lines 26-31);
storing a plurality of the reprogram events and the override events in a memory; generating display data for presentation on a display to a second user, the display data indicating, for a drug, a number of infusion events that occurred for the drug, a number of override events that occurred for the drug, a percentage of override events that occurred for the drug, a number of reprogram events that occurred for the drug, and a percentage of reprogram events that occurred for the drug, wherein the display data further comprises a care area within a medical facility associated with the infusion pump and a drug name of the drug, wherein the processing circuit is configured to receive a user selection of a drug name for the drug and to generate the display data based on the selected drug name (Bello; page 32, line 28 to page 33, line 7, page 61, line 32 to page 62, line 7);
after generating the display data, receiving a change from the second user to a data set (Bello discloses “Medication delivery data tracking and reporting…allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning, including an out of limit summary report by specific medication on infusions hung with the use of handheld interface devices connected to central computers in communication with such pumps, as described in. prior embodiments…” on page 143, line 30 to page 144, line 1, “…This arrangement further allows for the ability to change infusion pump settings from the central station. This arrangement further allows for the comparison of drug label, rate/dose, and/or concentration programmed on infusion pumps to a pre-defined list of high and low dose and/or concentration limits and generates a message at the central station if limits are exceeded.” on page 140, lines 20-24);
downloading the changed data set to the infusion pump to program the infusion pump with the changed data set based on the received change, wherein a drug is administered to a patient pursuant to parameters entered by a clinician into the infusion pump and using the changed data set (Bello discloses “Medication delivery data tracking and reporting…allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning, including an out of limit summary report by specific medication on infusions hung with the use of handheld interface devices connected to central computers in communication with such pumps, as described in. prior embodiments…” on page 143, line 30 to page 144, line 1, “…This arrangement further allows for the ability to change infusion pump settings from the central station. This arrangement further allows for the comparison of drug label, rate/dose, and/or concentration programmed on infusion pumps to a pre-defined list of high and low dose and/or concentration limits and generates a message at the central station if limits are exceeded.” on page 140, lines 20-24).
Claim 10 recites the method of Claim 9, wherein the care area is selected from the group comprising an intensive care area and an ambulatory care unit (Bello; page 69, line 24 to page 70, line 2).
Claim 12 recites the method of Claim 8, wherein the percentage of reprogram events that occurred for the drug is a percentage of the number of infusion events (Bello; page 143, line 17 to page 144, line 7).
Claim 13 recites the method of Claim 8, wherein the display comprises a bar chart representing the number of override events (Bello; Fig. 105).
Claim 14 recites the method of Claim 8, wherein the display comprises a report type input device to allow a user to select among different report types (Bello; page 45, lines 4-10).
Claim 15 has been amended to recite a method of administering a drug to a patient with an infusion pump, comprising:
transmitting infusion pump history data from the infusion pump over a network to a server computer, the infusion pump history data comprising: a reprogram event indicating that a dose rate parameter was inputted to an infusion pump which was outside of a prestored limit, the dose rate parameter was then returned to within the prestored limit, and infusion was then started on the pump at the dose rate parameter within the prestored limit; and an override event indicating that a second dose rate parameter was inputted to the infusion pump which was outside of a second prestored limit and that a second infusion was started on the infusion pump at the dose rate parameter outside of the second prestored limit (Bello discloses “Medication delivery data tracking and reporting…Specifically, the reports will at least allow clinicians to view and print a history of flow rate changes made on the Colleague Pump for a specific medication on a specific channel;… allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning,…” on page 142, line 31 to page 144, line 7, “…Upon request for manipulated data from an interface device, or as a result of some other occurrence, the central computer can add, calculate, combine, compare, analyze, compute, separate, tabulate and/or perform some other processing function to and/or on the identifier data and/or medical pump data and/or the use thereof in delivering medication. This manipulated information can then be transmitted to the interface device for review by a caregiver.” on page 144, lines 26-31);
storing a plurality of the reprogram events and the override events in a memory; generating display data for presentation on a display to a second user, the display data indicating, for a drug, a number of infusion events that occurred for the drug, a number of override events that occurred for the drug, a percentage of override events that occurred for the drug, a number of reprogram events that occurred for the drug, and a percentage of reprogram events that occurred for the drug, wherein the display data further comprises a care area within a medical facility associated with the infusion pump and a drug name of the drug; receiving a change from the server computer to a data set comprising hard limits and soft limits for pump programming parameters (Bello discloses “Medication delivery data tracking and reporting…allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning, including an out of limit summary report by specific medication on infusions hung with the use of handheld interface devices connected to central computers in communication with such pumps, as described in. prior embodiments…” on page 143, line 30 to page 144, line 1, “…This arrangement further allows for the ability to change infusion pump settings from the central station. This arrangement further allows for the comparison of drug label, rate/dose, and/or concentration programmed on infusion pumps to a pre-defined list of high and low dose and/or concentration limits and generates a message at the central station if limits are exceeded.” on page 140, lines 20-24 and “…After infusion orders are entered into the infusion system 210, preparation instructions are routed to a preparation location. The preparation location depends upon the infusion system's 210 preparation program 506 and the infusion components. The infusion system 210 can include adjustable databases, such as preparation area database 546a, that specify where the infusion order is to be prepared. The infusion order can be prepared in the pharmacy or in a remote location, such as on the floor or at the treatment location 106. The clinician 116 is guided through the preparation process, including bar code verification of ingredients, using event management information that can be displayed on digital assistant 118 or another device having a display.” on page 61, line 32 to page 62, line 7);
downloading the changed data set to the infusion pump to program the infusion pump with the changed data set based on the received change (Bello discloses “Medication delivery data tracking and reporting…allow hospitals/clinicians to view and print pump dose/rate out of limits alert summary including when the warning was accepted and overridden and when the pump was reprogrammed as a result of the warning, including an out of limit summary report by specific medication on infusions hung with the use of handheld interface devices connected to central computers in communication with such pumps, as described in. prior embodiments…” on page 143, line 30 to page 144, line 1, “…This arrangement further allows for the ability to change infusion pump settings from the central station. This arrangement further allows for the comparison of drug label, rate/dose, and/or concentration programmed on infusion pumps to a pre-defined list of high and low dose and/or concentration limits and generates a message at the central station if limits are exceeded.” on page 140, lines 20-24); and
administering the drug to the patient pursuant to parameters entered by a clinician into the infusion pump and using the changed data set (Bello discloses “…This arrangement further allows for the ability to change infusion pump settings from the central station. This arrangement further allows for the comparison of drug label, rate/dose, and/or concentration programmed on infusion pumps to a pre-defined list of high and low dose and/or concentration limits and generates a message at the central station if limits are exceeded.” on page 140, lines 20-24 and page 115, lines 30-33).
Claim 17 recites the method of Claim 16, wherein the care area is selected from the group comprising an intensive care area and an ambulatory care unit (Bello; page 69, line 24 to page 70, line 2).
Claim 18 recites the method of Claim 15, further comprising receiving a user selection of a drug name and generating the display data based on the selected drug name (Bello; page 32, line 28 to page 33, line 7).
Claim 19 recites the method of Claim 15, wherein the percentage of reprogram events that occurred for the drug is a percentage of the number of infusion events (Bello; page 143, line 17 to page 144, line 7).
Claim 20 recites the method of Claim 15, wherein the display comprises a bar chart representing the number of override events, wherein the display comprises a report type input device to allow a user to select among different report types (Bello; Fig. 105; page 45, lines 4-10).
Response to Arguments
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed below in the order in which they appear.
Argument about Double Patenting rejection:
Applicant argues that the current claims and the claims of 783’ patent are different, since the current claims recite “dose rate” and the 783’ patent does nor recite “dose rate.
In response, Examiner submits that the 783’ patent recites “infusion pump parameter” and the current claims recite “dose rate parameter”, which described in the specification as a parameter ([0034] recites “…parameters regarding the infusion, such as flow rate, volume to infuse, dose rate, dose infused…”). The double patenting rejection has been updated in response to amendments made to the claims, and the amended claims are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-19 of U.S. Patent No. 10,881,783 (hereinafter 783’ patent).
Argument about 35 USC 101 rejection:
Applicant argues that claim recite “wherein the infusion pump administers the drug to the patient pursuant to parameters entered by a clinician into the infusion pump and using the changed data set“, and therefore, claims provide functions beyond the alleged abstract idea.
In response, Examiner submits that this the limitation of “wherein the infusion pump administers the drug to the patient pursuant to parameters entered by a clinician into the infusion pump and using the changed data set“ corresponds to an “insignificant application” (see MPEP 2106.05 (g)), which do not provide a practical application for the abstract idea. This limitation is insignificant, since it is not nominally or tangentially related to the invention, which is directed to generating a presentation indicating historical drug data, so that the user can make a selection of a drug name for the drug to be downloaded to the infusion device.
The MPEP recites:
“Limitations the courts have found indicative that an additional element (or combination of elements) may have integrated the exception into a practical application include:
• An improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
• Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
• Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b); [AltContent: rect]
• Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
• Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).”.
The current claims do not recite any improvement to the technology.
Therefore, the argument is not persuasive and claims are rejected under 35 U.S.C. §101 as being directed to non-statutory subject matter.
Argument about 35 USC 102 rejection:
Applicant argues that Bello fails to teach “generating display data indicating a percentage of override events that occurred for the drug and percentage of reprogram events that occurred for the drug”.
In response, Examiner submits that Bello teaches in Figures 107-108 and on pages 157-158, “…a GUARDIAN type dose/rate range out of limit summary by medication report is shown, which lists total alerts by medication for unit(s) and time period in the hospital.”, Bello also teaches “Referring to Figures 101-102, an infusion flow rate comparison by patient report is shown, which lists the history of flow rate comparisons for medication(s) hung on infusion pumps.” on page 155, lines 10-12, and the summary graphs table shows “comparison results (%)=percentage each of matches, mismatches and no comparisons of total rate comparisons in the report unit”.
Conclusion
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.
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/DILEK B COBANOGLU/Primary Examiner, Art Unit 3687
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