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 .
DETAILED ACTION
The present Office Action is in response to the Request for Continued Examination filed 12/05/2025.
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/05/2025 has been entered.
Priority
Acknowledgement is made of applicant’s claim for foreign priority under 35 U.S.C. 119(a)-(d) to German Patent Application No. DE 10 2021 127 476.1 filed 10/22/2021. The certified copy has been received.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 12/05/2025 is in compliance with the provisions of 37 CFR 1.97 and has been fully considered by the Examiner.
Response to Amendment
In the amendment dated 8/25/2025, the following occurred: Claims 1, 7 and 11 were or have been canceled; claims 9 and 13-15 were amended.
Claims 2-6, 8-10 and 12-15 are pending and have been examined.
Claim Objections
Claims 9 and 14 are objected to because of the following informalities:
For claim 9 in the last step, “the appropriate infusion drug dataset” of the previous steps is recited as “the infusion drug dataset”. The Examiner suggests amending to add the word “appropriate”.
For claim 14, the “appropriate infusion drug dataset” of parent claim 9 is recited as “the appropriate drug infusion dataset”.
For claim 15, “selects the updated infusion drug dataset as the most current version of infusion drug dataset” is missing the word “the”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 103
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.
The factual inquiries 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 2-6, 8-9 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Butterfield et al. (US 2013/0110538 A1; “Butterfield” herein) in view of Gupta et al. (US 2021/0151146 A1; “Gupta” herein).
Re. Claim 13, Butterfield teaches a system for providing drug therapy to a patient (Abstract, [107] teach a system and method for creating, managing and loading selected configuration datasets used to program a patient care device that administers medication), comprising:
at least one infusion pump that is external to the patient’s body and decentralized (patient care devices 44, 46, 48) ([17] teaches patient care devices may be infusion pumps. Applicant’s disclosure at pg. 4, lines 28-29 describes an infusion pump as an external, decentral medical device.);
a central drug database comprising a plurality of infusion drug datasets for the at least one infusion pump (Fig. 6, [57], [60], [63] teach the configuration management system 42 (central drug database) universal configuration database 84 may contain multiple elements, e.g., configuration data, drug infusion parameters, rules, device operating characteristics.), the central drug database configured […] to select a most current version of an infusion drug dataset corresponding to the received drug prescription from the central drug database for transfer to the at least one infusion pump (Fig. 6 [57], [60], [63] teach the configuration management system 42 universal configuration database 84 may contain multiple elements, e.g., configuration data, drug infusion parameters, rules, device operating characteristics; and facilitate installation of a selected mode / appropriate configuration dataset (selection of “a most current version of” an infusion drug dataset… from the central drug database) that defines desired pump behaviors and may be customized in accordance with the device type; and the defined behaviors of the pump may be changed as necessary depending on… the patient specific information, medications or other therapeutic agents to be delivered (corresponding to the received drug prescription).); and
an interface (30) associated with the infusion pump that receives a drug prescription input by a user (Fig. 1, [7], [42], [110] teach routing an order/prescription (necessarily received) from one subsystem to another subsystem connected via communication system 30 through various interfaces), retrieves the most current version of the infusion drug dataset corresponding to the received drug prescription from the central drug database via a network connection (Fig. 4, [57], [60], [63]-[64] teach the configuration management system 42 universal configuration database 84 facilitates installation of a selected mode / appropriate configuration dataset that defines desired pump behaviors, e.g., available infusion parameters, and may be customized in accordance with the device type. Fig. 1, [57]-[58], [60] teach configuration management system 42 installation tool 88 facilitates transfer/loading of the appropriate portions of the universal configuration database into each patient care device (that retrieves “the most current version of” the infusion drug dataset). [59] teaches a network connection 94 for installing the device-specific configuration into patient care devices via the comm system 30), and supplies the most current version of the infusion drug dataset to the at least one infusion pump (additionally, Fig. 1, [42], [105] teach the aforementioned transfer/loading over communication system 30 via interfaces 32. Fig. 4, [23], [60], [101] teach performing installation of the selected Dataset for a configuration to (A) Devices/patient care devices via the communication means. See additionally Fig. 1, 5, [80], [83]-[85].), wherein the at least one infusion pump is configured by the supplied most current version of the infusion drug dataset and administers the drug therapy to the patient in accordance with the supplied most current version of the infusion drug dataset ([97], [106] teach the loading tool 88 then communicates the device-specific configuration datasets 558, 560 and 562 to a patient care device 564, which is, for example, a type A device and loads the datasets into the device to appropriately configure it (configuring). See additionally [105]. Fig. 1, 5, [80], [83]-[85] teach features supported by the patient care device interface unit 50: a user can simply select the appropriate regimen from the list of infusion protocols stored and have the appropriate parameters retrieved (also configuring), then simply confirm the parameters and start the infusion (administer).)
Butterfield may not teach the central drug database configured to receive updates to the plurality of infusion drug datasets for the at least one infusion pump or to match and validate a received drug prescription for the drug therapy with a plurality of infusion drug datasets.
Gupta teaches
the central drug database configured to receive updates to the plurality of infusion drug datasets for the at least one infusion pump ([0030], [0036] teach the medication guidelines database 60… may be stored on a device, such as a server, or centrally located in the memory 42 of the control system 40 (the central drug database); and the database 60 may have preestablished values for infusion parameters, which may be updated from time to time.) and to match and validate the inputted drug prescription for the drug therapy with the plurality of infusion drug datasets at the central drug database ([0006]-[0007], [0055]-[0056] teach the processor 212 of the control system 40 is configured to compare (match) acceptable operating parameters in the medication guidelines database 60 (the plurality of infusion drug datasets) with the patient-specific information from the patient information database 62, e.g., a medication order including infusion parameters (the inputted drug prescription); and provide a modification (e.g., by instructing a processor 143 of the medical device 80) [of] the operating parameters 234 in the memory 234 of the medical device 80 for providing the medication to the patient (necessarily validate the inputted drug prescription) based on the comparison of the acceptable operating parameters with the patient-specific information.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system and method for managing medical databases for patient care devices of Butterfield (including the transfer of configuration datasets to one or more patient care devices) to provide the drug therapy information for the at least one infusion pump and to match and validate the information at the central drug database and to use this information as part of patient-specific medication management systems for use with and for controlling an infusion device as taught by Gupta (see Abstract), with the motivation of improving patient care management, medication delivery, asset identification, and verification of drug delivery as well as reducing medication errors during ordering, dispensing and administering of an intravenous (IV) drug by an automated or semi-automated administration device, such as an infusion pump (see Gupta at para. 0002-0003, 0006).
Re. Claim 2, Butterfield/Gupta teaches the system according to claim 13, wherein the at least one infusion pump is designed to communicate and interact directly with the central drug database via the network connection after the input of the drug prescription into the interface (Butterfield Fig. 1, [7], [42], [110] teaches routing an order/prescription (necessarily received) from one subsystem to another subsystem connected via communication system 30 through various interfaces (after input into the interface); and the device 48 automatically retrieves a configuration dataset from memory or from another location (the central drug database) in communication system 30 once the patient-specific information is entered. Butterfield Fig. 1, [57]-[60] teaches the configuration management system 42 installation tool 88 facilitates transfer/loading of the appropriate portions of the universal configuration database into each patient care device; and a network connection 94 for installing the device-specific configuration into patient care devices via the comm system 30.)
Re. Claim 3, Butterfield/Gupta teaches the system according to claim 13, further comprising a patient data management system, wherein the interface is a gateway for forwarding data that is designed to communicate and to interact with the patient data management system, with the central drug database (see Butterfield element 42), and with the at least one infusion pump (see Butterfield elements 44, 46, 48), and wherein the patient data management system provides drug therapy information for the at least one infusion pump via the interface (Gupta Figs. 1-2, [28]-[29] teaches a medication guidelines database 60 (Butterfield’s system 42), which may include institutionally-established guidelines or limits on drug administration parameters (drug therapy information), may be interfaced to the nurse station computer system 46 or any other of the information systems (a patient data management system) of the central system of an institution through a cradle or other docking device that provides a connection between the medications guidelines database 60 and the computer system 46… use of the cradle allows information to flow between the medications guidelines database 60 and the nurse computer system 46… This information may then be processed and stored on the computer system 46, or the information may be communicated (provided) by the computer system 46 through the interface 48 (gateway for forwarding data) to various other facility information systems over the communication system 30.)
Re. Claim 4, Butterfield/Gupta teaches the system according to claim 13, wherein the central drug database (Butterfield system 42) is designed to process the received drug prescription before the received drug prescription is provided to the at least one infusion pump (Gupta ([0006]-[0007], [0028], [0055]-[0056] teach the processor 212 of the control system 40 (Butterfield system 42) is configured to compare acceptable operating parameters in the medication guidelines database 60 with the patient-specific information from the patient information database 62, e.g., a medication order including infusion parameters (process the received drug prescription before the received drug prescription is provided to the pump); and provide a modification (e.g., by instructing a processor 143 of the infusion pump 80) [of] the operating parameters 234 in the memory 234 of the infusion pump 80 for providing the medication to the patient based on the comparison of the acceptable operating parameters with the patient-specific information. Butterfield [17], [83] teaches altering operation in response to the information received… a user can have the appropriate parameters automatically retrieved (provide the processed drug prescription to the infusion pump), then simply confirm the parameters and start the infusion.)
Re. Claim 5, Butterfield/Gupta teaches the system according to claim 13, wherein the system sends an error description to the at least one infusion pump for visual display by the at least one infusion pump (intended use) in the case of an unsuccessful validation (Butterfield [113]-[114] teaches after the correct patient, prescription and time are verified, device 48 (the at least one infusion pump) recalls from the active configuration database the protocol or other program information identified… once all required settings have been entered, central unit 50 (see Fig. 1) displays the values… for verification… The configuration dataset is also accessed to check the entered infusion parameters according to the protocols, rule sets or other guidelines for that configuration… If any incorrect or out of range entries are detected, an alert may be activated to inform the operator (in the case of an unsuccessful validation). Butterfield [13] teaches the alert is communicated to the care-giver that the parameter entered is either incorrect or outside of a range established by the institution (sends the error description). See additionally Gupta Fig. 3, [0071].)
Re. Claim 6, Butterfield/Gupta teaches the system according to claim 13, wherein the interface is configured to request and/or transfer the selected infusion drug dataset corresponding to the received drug prescription independently of the at least one infusion pump (Butterfield Fig. 1, [42], [105] teaches the aforementioned transfer/loading over communication system 30 via interfaces 32. Butterfield Fig. 4, [23], [60], [101] teaches performing installation of the selected Dataset for a configuration to (A) Devices/patient care devices (the at least one infusion pump) via the communication means. Also, Butterfield Fig. 1, [58] teaches the configuration management system 42 installation tool 88 facilitates transfer of the appropriate portions of the universal configuration database into each device or system according to its type. The Examiner notes it is unclear what “independently” entails. See additionally Butterfield [101], [105].)
Re. Claim 8, Butterfield/Gupta teaches the system according to claim 13, wherein the central drug database is configured to provide site-specific infusion drug datasets (Butterfield Fig. 7, [101], [109]-[110] teaches selecting the appropriate configuration dataset 724 defining a particular, treatment location-specific (e.g., NICU, Pediatrics, ICU, Surgery, Oncology, etc.), operating behavior for the device. Butterfield [83], [113]-[114] teaches the device 48 recalls from the active configuration database the selected infusion protocol from the list of infusion protocols (site-specific infusion drug datasets) and have the appropriate parameters retrieved (necessarily provided).)
Re. Claim 9, Butterfield teaches a method for providing a drug therapy to a patient (Abstract, [107] teach a system and method for creating, managing and loading selected configuration datasets used to program a patient care device that administers medication), the method comprising the steps of:
(a) inputting a drug prescription for the drug therapy into at least one infusion pump (Fig. 1, [7], [112] teach the pharmacy system 36 translates the infusion order (drug prescription)… onto a label with encoded message and accompanying text. Fig. 1, [45], [47], [60] teach the patient care information may be entered through an interface device… simply by the patient care device / infusion pump bar code reader 66 scanning the coded drug label.) or via an interface into a patient data management system […] (Fig. 1, [7], [42], [110] teach routing an order/prescription (necessarily input) from one subsystem to another subsystem (patient data management system) connected via communication system 30 through various interfaces (via an interface).);
(b) transmitting […] from the at least one infusion pump to a central drug database (Fig. 6 [57], [60] teach the configuration management system 42 (central drug database) universal configuration database 84 may contain multiple elements, e.g., configuration data, drug infusion parameters, rules, device operating characteristics; and facilitate installation of a selected mode in accordance with the device type A (transmitted)… a particular behavior stored in a patient care device is selected based on patient-specific information such as medical characteristics including the treatment prescription (the inputted drug prescription). Also, [110] teaches automatically retrieving a configuration dataset from memory or from another location in communication system 30 once the patient-specific information is entered into device or system 48.) or from the patient data management system via the interface to the central drug database (Fig. 1, [7], [42], [60], [110] teach patient care information may be entered into patient care device through an interface device and may originate from anywhere in network 30 (38) (the patient data management system); and routing the order/prescription from one subsystem to another subsystem connected via communication system 30 through various interfaces.);
(c) […] and selecting a most current version of an appropriate infusion drug dataset corresponding to the inputted drug prescription from the central drug database (Fig. 6, [57], [60], [63] teach the configuration management system 42 universal configuration database 84 may contain multiple elements, e.g., configuration data, drug infusion parameters, rules, device operating characteristics; and facilitate installation of a selected mode / appropriate configuration dataset (selecting “a most current version” of an appropriate infusion drug dataset… from the central drug database) that defines desired pump behaviors and may be customized in accordance with the device type; and the defined behaviors of the pump may be changed as necessary depending on… the patient specific information, medications or other therapeutic agents to be delivered (corresponding to the inputted drug prescription).);
(d) returning the selected most current version of the appropriate infusion drug dataset corresponding to the inputted drug prescription to the at least one infusion pump (Fig. 4, [57], [60], [63]-[64] teach the configuration management system 42 universal configuration database 84 facilitates installation of a selected mode / appropriate configuration dataset that defines desired pump behaviors, e.g., available infusion parameters, and may be customized in accordance with the device type. Fig. 1, [57]-[58], [60] teach configuration management system 42 installation tool 88 facilitates transfer/loading (return) of the appropriate portions of the universal configuration database into each patient care device.) or returning the selected most current version of the appropriate infusion drug dataset corresponding to the inputted drug prescription via the interface to the at least one infusion pump (Additionally, Fig. 1, [42], [105] teach the aforementioned transfer/loading (return) over communication system 30 via interfaces 32.); and
(e) configuring the infusion pump with the selected most current version of the appropriate infusion drug dataset ([97], [106] teach the loading tool 88 then communicates the device-specific configuration datasets 558, 560 and 562 to a patient care device 564, which is, for example, a type A device and loads the datasets into the device to appropriately configure it (configuring). See additionally [105]. Fig. 1, 5, [80], [83]-[85] teach features supported by the patient care device interface unit 50: a user can simply select the appropriate regimen from the list of infusion protocols stored and have the appropriate parameters retrieved (also configuring), then simply confirm the parameters and start the infusion.); and
(f) administering, by the configured infusion pump, the drug therapy to the patient in accordance with the selected most current version of the infusion drug dataset (Fig. 1, 5, [80], [83]-[85] teach features supported by the patient care device interface unit 50: a user can simply select the appropriate regimen from the list of infusion protocols stored and have the appropriate parameters retrieved, then simply confirm the parameters and start the infusion (administering).)
Butterfield may not teach transmitting the inputted drug prescription from the at least one infusion pump (element 44, 46 or 48) to the central drug database (element 42).
However, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the noted features of Butterfield with teachings thereof, since the combination is merely combining prior art elements according to known methods to yield predictable results (KSR rational A). It can be seen that each element claimed is present in Butterfield. Transmitting patient-specific information related to selection of a device mode (as taught by Butterfield) does not change or affect the normal communication-related functionality of the system and method for managing medical databases for patient care devices of Butterfield. Transmitting device type information to a configuration management system 42 would be performed the same way even with the addition of communicating patient-specific information. Since the functionalities of the elements in Butterfield do not interfere with each other, the results of the combination would be predictable.
Alternately, Butterfield may not teach transmitting the inputted drug prescription from the patient data management system (element 38) via the interface (element 30) to the central drug database (element 42).
However, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the noted features of Butterfield with teachings thereof, since the combination is merely combining prior art elements according to known methods to yield predictable results (KSR rational A). It can be seen that each element claimed is present in Butterfield. Providing communication technology (as taught by Butterfield) does not change or affect the normal communication-related functionality of the system and method for managing medical databases for patient care devices of Butterfield. Routing patient-specific information from the physician order entry system 38 (or any other system in the network 30, see Butterfield para. 0060) to the pharmacy information system 36 would be performed the same way even with the addition of communicating patient-specific information from the pharmacy information system 36 to the configuration management system 42. Since the functionalities of the elements in Butterfield do not interfere with each other, the results of the combination would be predictable.
Butterfield may not teach
a patient data management system that provides drug therapy information for the at least one infusion pump; or
matching and validating the inputted drug prescription for the drug therapy with a plurality of infusion drug datasets that are updated at the central drug database for the at least one infusion pump.
Gupta teaches
a patient data management system that provides drug therapy information for the at least one infusion pump (Figs. 1-2, [28]-[29] teach a medication guidelines database 60 stores information that is provided to monitor medication parameters or other information used by a caregiver to program a medication administration device 80 to deliver medication to a patient; the various types of information include information about drug interactions, possible contraindications and/or side-effects of medications, and established guidelines for the administration of various medications; the medications guidelines database 60 may be interfaced to the nurse station computer system 46 (patient data management system) or any other of the information systems of the central system of an institution through a cradle or other docking device that provides a connection between the medications guidelines database 60 (central drug database) and the computer system 46; information contained within the medications guidelines database 60 may be communicated (provided) through the nurse station computer system 46, the interface 48, and the communication system 30 to any of the interconnected systems 34, 36, 38, 40, or 62.); and
matching and validating the inputted drug prescription for the drug therapy with a plurality of infusion drug datasets that are updated at the central drug database for the at least one infusion pump ([0006]-[0007], [0055]-[0056] teach the processor 212 of the control system 40 is configured to compare (match) acceptable operating parameters in the medication guidelines database 60 (a plurality of infusion drug datasets) with the patient-specific information from the patient information database 62, e.g., a medication order including infusion parameters (the inputted drug prescription); and provide a modification (e.g., by instructing a processor 143 of the medical device 80) [of] the operating parameters 234 in the memory 234 of the medical device 80 for providing the medication to the patient (necessarily validating the inputted drug prescription) based on the comparison of the acceptable operating parameters with the patient-specific information. [0030], [0036] teach the medication guidelines database 60… may be stored on a device, such as a server, or centrally located in the memory 42 of the control system 40; and the database 60 may have preestablished values for infusion parameters, which may be updated from time to time.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system and method for managing medical databases for patient care devices of Butterfield (including the transfer of configuration datasets to one or more patient care devices) to provide the drug therapy information for the at least one infusion pump and to match and validate the information at the central drug database and to use this information as part of patient-specific medication management systems for use with and for controlling an infusion device as taught by Gupta (see Abstract), with the motivation of improving patient care management, medication delivery, asset identification, and verification of drug delivery as well as reducing medication errors during ordering, dispensing and administering of an intravenous (IV) drug by an automated or semi-automated administration device, such as an infusion pump (see Gupta at para. 0002-0003, 0006).
Re. CLAIM 12, Butterfield/Gupta teaches the method according to claim 9, further comprising preselecting the appropriate infusion drug dataset based on a site of the at least one infusion pump (Butterfield Fig. 7, [101], [109]-[110] teaches selecting the appropriate configuration dataset 724 (infusion drug dataset), which defines a particular, treatment location-specific (e.g., NICU, Pediatrics, ICU, Surgery, Oncology, etc.), operating behavior for the device, based on the current device location 708 (site) determined by information received through the communication system 30 within the hospital or alternately based on the current device location 708 determined by a sensor or other means. Butterfield [83], [113]-[114] teaches the device 48 recalls from the active configuration database the (pre)selected infusion protocol from the list of infusion protocols and has the appropriate parameters retrieved.)
Re. CLAIM 14, Butterfield/Gupta teaches the method according to claim 9, wherein matching and validating the inputted drug prescription for the drug therapy with a plurality of infusion drug datasets that are updated at the central drug database (see claim 9 prior art rejection) comprises matching and validating the inputted drug prescription for the drug therapy with an infusion drug dataset updated at the central drug database (The Examiner notes that an infusion drug dataset of the plurality is matched and validated. The Examiner interprets Gupta’s modification of the operating parameters 234 / Butterfield’s appropriate configuration dataset as corresponding to Gupta’s infusion order.) and selecting the updated infusion drug dataset as the most current version of the appropriate drug infusion dataset when it corresponds to the inputted drug prescription (Butterfield Fig. 6, [0057], [0060], [0063] teach the configuration management system 42 universal configuration database 84 may contain multiple elements, e.g., configuration data, drug infusion parameters, rules, device operating characteristics; and facilitate installation of a selected mode / appropriate configuration dataset (selecting).)
Re. CLAIM 15, Butterfield/Gupta teaches the method according to claim 8, wherein the central drug database selects the updated infusion drug dataset as the most current version of infusion drug dataset corresponding to the inputted drug prescription (Gupta [0030], [0036] teaches the medication guidelines database 60… may have preestablished values for infusion parameters, which may be updated from time to time. Butterfield Fig. 6 [57], [60], [63] teaches the configuration management system 42 (central drug database) universal configuration database 84 may contain multiple elements, e.g., configuration data, drug infusion parameters, rules, device operating characteristics; and facilitate installation of a selected mode / appropriate configuration dataset (necessarily selects the updated infusion drug dataset) that defines desired pump behaviors and may be customized in accordance with the device type; and the defined behaviors of the pump may be changed as necessary depending on… the patient specific information, medications or other therapeutic agents to be delivered (corresponding to the received drug prescription input). See claim 13 prior art rejection.)
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Butterfield in view of Gupta and Jones (US 2015/0371004 A1).
Re. CLAIM 10, Butterfield/Gupta teaches the method according to claim 9, further comprising performing the input of the drug prescription and returning the appropriate infusion drug dataset via the interface (see claim 9 prior art rejection) […]
Butterfield/Gupta may not teach performing various functions in accordance with the IHE-/HL7 standard.
Jones teaches performing various functions in accordance with the IHE-/HL7 standard ([111] teaches the data may for example be parameterized using existing definitions of parameterizing drugs, as for example known from the so called HL7/IHE representations and the HIBC barcoding standard for smart pumps/IV medication.)
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the system and method for managing medical databases for patient care devices of Butterfield/Gupta to parameterize data using existing definitions of parameterizing drugs, as for example known from the HL7/IHE representations for smart pumps/IV medication, and to use this information as part of a system and method for providing drug library data to a medical device located within a healthcare environment as taught by Jones, with the motivation of improving safety controls for drug delivery and improving data management throughout a healthcare environment (see Jones at para. 0005, 0007-0008).
Response to Arguments
Note: 35 U.S.C. §101
The reason for subject matter eligibility is provided in Office action mailed 10/07/2025.
Rejection under 35 U.S.C. §103
Regarding the rejection of Claims 2-15, Applicant has canceled claims 7 and 11, rendering rejection of those claims moot. Regarding the remaining claims 2-6, 8-10 and 12-15, the Examiner has considered the Applicant’s arguments but does not find them persuasive for at least the following reasons. Applicant argues.
A1. “Applicant submits that Butterfield in view of Gupta does not suggest updating the drug datasets at the central drug database but instead provides modifications that are personalized to the patient based on the patient-specific data… The examiner acknowledged at page 5 of the Final Rejection that Butterfield does not further describe a central drug database configured to "match and validate a received drug prescription with a plurality of infusion drug datasets" as claimed” (Remarks, pgs. 6-7 and 7-8).
Re. argument A1: The Examiner respectfully submits the basis of rejection as afforded by RCE. Given the broadest reasonable interpretation in light of the specification, the Examiner respectfully asserts that Butterfield in view of Gupta teaches or renders obvious the claim limitations. For example, the rejection of independent claim 9 shows how Butterfield in view of Gupta teaches or renders obvious the recited “matching and validating the inputted drug prescription for the drug therapy with a plurality of infusion drug datasets that are updated at the central drug database for the at least one infusion pump.”
Butterfield Fig. 1 and para. 7, 45, 47, 60, 112 teaches translating the infusion order onto an encoded message label that is then entered with a bar code reader part of the infusion pump or by some other means (“the inputted drug prescription for the drug therapy”).
Gupta para. 6-7 and 55-56 teaches comparing acceptable operating parameters in the medication guidelines database with, e.g., a medication order including infusion parameters (“matching… with a plurality of infusion drug datasets”); and then providing a modification of the operating parameters 234 in the memory 234 of the medical device for providing the medication to the patient (necessarily “validating the inputted drug prescription for the drug therapy” that was matched with the plurality of infusion drug datasets).
Gupta para. 30 and 36 teaches the medication guidelines database may be stored on a device, such as a server, or centrally located in the memory of the control system; and may have preestablished values for infusion parameters that may be updated from time to time (“that are updated at the central drug database for the at least one infusion pump”).
A2. “Butterfield does not describe “selecting a most current version of an appropriate infusion drug dataset corresponding to the inputted drug prescription from the central drug database” and further “configuring the infusion pump with the selected most current version of the appropriate infusion drug dataset" and "administering, by the configured infusion pump, the drug therapy to the patient in accordance with the selected most current version of the infusion drug dataset" as now claimed” (Remarks, pg. 8).
Re. argument A2: The Examiner respectfully disagrees and submits the basis of rejection as afforded by RCE. Given the broadest reasonable interpretation (BRI), Butterfield in view of Gupta teaches or renders obvious the claim limitations. See, e.g., Office action at pg. 13-14. The Examiner further submits that calling the recited dataset a "most current version" does not limit the selected dataset because the claim does not recite any other versions of datasets. In other words, identifying the selected dataset as "most current" is relative but nothing is recited to compare versions. Thus, any selected dataset is encompassed by the recitation.
A3. “… In Gupta's system, the patient-specific information may include laboratory information such as blood coagulation measure, vitamin level, platelet count value, thromboplastin time, and/or a serum level, whereby the administration of the medication may be prevented based on comparing the operating parameters with the operating limit parameters in view of the laboratory information… A notification is sent regarding modification of the operating limit parameters in view of the laboratory information. In response to a determination that any of the operating parameters are out of range in view of the patient-specific information, soft and hard limits may be imposed to control locking and unlocking of the medical device 80 (paragraph [0070]). Modified operating parameters also may be provided to the medical device 80 to keep the operating
parameters within the imposed limits (paragraph [0071])” (Remarks, pg. 8-9).
Re. argument A3: The Examiner respectfully submits that the prior art references teach the claimed features. That the references teach additional features is immaterial. Further, Applicant's arguments 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.
A4. “Gupta's system does not match and validate the inputted drug prescription for the drug therapy with a plurality of infusion drug datasets that are updated at the central drug database for the at least one infusion pump and selecting a most current version of an appropriate infusion drug dataset corresponding to the inputted drug prescription from the central drug database as claimed. Gupta does not suggest updating and retrieving infusion drug datasets from a central drug database” (Remarks, pg. 9).
Re. argument A4: The Examiner respectfully asserts that Gupta does in fact teach a central drug database configured to “receive updates to the plurality of infusion drug datasets for the at least one infusion pump” and to “match and validate the inputted drug prescription for the drug therapy with the plurality of infusion drug datasets at the central drug database”. See Office action at pg. 6-7.
As for the “selecting…” limitation, the Examiner respectfully submits that Butterfield teaches this. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
A5. “even if one skilled in the art would have considered modifying the system of Butterfield in accordance with the noted description by Gupta, there still would have been no collective teaching of a system or method for matching and validating… and selecting… and then configuring… and administering… Butterfield in view of Gupta does not describe updating the datasets at the central drug database and matching and validating datasets as claimed but instead suggests comparing the traditionally entered values to limits that are modified based on patient-specific data.” (Remarks, pg. 9).
Re. argument A5: See response to arguments A1-A4 and the basis of rejection. The Examiner respectfully asserts that the prior art references teach or render obvious the recited claim limitations.
Regarding the rejection of dependent claims 2-6, 8, 10, 12 and 14-15, the Applicant has not offered any arguments with respect to these dependent claims other than to reiterate the arguments present for claims 9 and 13 from which they depend. As such, the rejection of these claims is also respectfully maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Howard et al. (US 2012/0065990 A1) for teaching a system for maintaining drug information and communicating with medication delivery devices / infusion pumps. See, e.g., Fig. 4A.
Jones (US 2015/0370973 A1) for teaching method for transferring operational data to a medical device, e.g., infusion pump, located within a healthcare environment (as well as the HL7/IHE standard recited in the instant Application at claim 10). See, e.g., Abstract and para. 0086.
Xavier et al. (US 2020/0035355 A1) for teaching a drug library manager with customized worksheets.
Xavier et al. (US 2020/0035346 A1) for teaching drug library dynamic version management.
Vanderveen (US 2005/0171815 A1) for teaching centralized medication management system. Database 122 includes a protocol module comprising a plurality of protocols. Each protocol includes a plurality of fields of default operating parameters. In some cases, an infusion protocol may include a complete detailed infusion instruction with all of the default parameter values defined. Other infusion protocols may have partially defined parameters with additional data entry required by the user at the point of care. For example, protocol A 126 of FIG. 9 includes fields of default operating parameter values and other data for controlling a medication infusion pump. The fields of this example include… record pointer 160 for identifying or “calling” the protocol record… Some fields, such as drug interactions 154, include a reference or link to another database or drug library… Such references to commonly used data libraries allow data to be shared between protocols and to avoid duplicate storage and entry and to allow efficient updating of database information. See para. 0069.
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/J.M.W./Examiner, Art Unit 3683
/CHRISTOPHER L GILLIGAN/Primary Examiner, Art Unit 3683