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 .
Status of Amendments
Claims 1, 4, 6-12, and 14- 22 are currently pending in this case and have been examined and addressed below. This communication is a Final Rejection in response to the Amendment to the Claims and Remarks filed on 12/11/2025.
Claims 1, 4, 6-12, and 14-22 are amended claims.
Claims 2-3, 5, and 13 have been cancelled and will not be considered at this time.
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, 4, 6-12, and 14-22 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e. an abstract idea) without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 1, 4, 6-12, and 14-22 are drawn to a method, system, and article of manufacture, which are statutory categories of invention.
Step 2A – Judicial Exception Analysis, Prong 1:
Independent claim 1 recites a method comprising obtaining pathway data associated with all available medication delivery pathways for delivering medication to a patient, wherein each the medication delivery pathway of the available medication delivery pathways includes at least one of the following: at least one catheter, at least one lumen, at least one port, or any combination thereof, and wherein the pathway data is associated with at least one material of a medication delivery pathway; obtaining first prescription data associated with one or more second medications prescribed for delivery to the patient from the medication delivery pathway sensor system and second prescription data associated with at least one first medication delivered, being delivered, or prescribed to be delivered to the patient; determining according to at least one rule set, the pathway data, the first prescription data, and the second prescription data, one or more medication delivery pathways from the available medication delivery pathways for delivery of the one or more second medications to the patient, wherein the at least one rule set comprises: a rule associated with whether a medication including an attribute is compatible to be delivered to a patient via a same medication delivery pathway as another medication including another attribute; a rule associated with whether a medication is compatible to be delivered to a patient via a same medication delivery pathway as another medication if the same medication delivery pathway is flushed between deliveries of the medication and the another medication; and a rule associated with whether a medication is compatible to be delivered to a patient via a material of a medication delivery pathway; wherein determining the one or more medication delivery pathways from the available medication delivery pathways for delivery of the one or more second medications to the patient comprises: (i) determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via a same medication delivery pathway as the at least one first medication based on an attribute of the one or more second medications and an attribute of the at least one first medication, (ii) determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication if the same medication delivery pathway is flushed in between deliveries of the one or more second medications and the at least one first medication; and (iii) determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication based on one or more materials of the same medication delivery pathway; and in response to determining that the one or more second medications are not compatible to be delivered to the patient via the same medication delivery pathway as the at least one medication in each of (i), (ii), and (iii); and prompting a user to install a new medication delivery pathway at a body of the patient to provide for delivery of the one or more second medications; and assigning the one or more second medications for delivery to the patient via the new medication delivery pathway.
Independent claim 21 recites a system comprising obtain pathway data associated with all available medication delivery pathways for delivering medication to a patient from a medication delivery pathway sensor system, wherein each medication delivery pathway of the available medication delivery pathways includes at least one of the following: at least one catheter, at least one lumen, at least one port, or any combination thereof, and wherein the pathway data is associated with at least one material of a medication delivery pathway, obtain first prescription data associated with one or more second medications prescribed for delivery to the patient from the medication delivery pathway sensor system and second prescription data associated with at least one first medication delivered, being delivered, or prescribed to be delivered to the patient; determine according to at least one rule set, the pathway data, the first prescription data, and the second prescription data, one or more medication delivery pathways from the available medication delivery pathways for delivery of the one or more second medications to the patient, wherein the at least one rule set comprises: a rule associated with whether a medication including an attribute is compatible to be delivered to a patient via a same medication delivery pathway as another medication including another attribute; a rule associated with whether a medication is compatible to be delivered to a patient via a same medication delivery pathway as another medication if the same medication delivery pathway is flushed between deliveries of the medication and the another medication; and a rule associated with whether a medication is compatible to be delivered to a patient via a material of a medication delivery pathway; wherein when determining the one or more medication delivery pathways from the available medication delivery pathways for delivery to the one or more medications to the patient:(i) determine, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via a same medication delivery pathway as the at least one first medication based on an attribute of the one or more second medications and an attribute of the at least one first medication, (ii) determine, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication if the same medication delivery pathway is flushed in between deliveries of the one or more second medications and the at least one first medication; and (iii) determine, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication based on one or more materials of the same medication delivery pathway; and in response to determining that the one or more second medications are not compatible in each of (i), (ii), and (iii): prompt a user to install a new medication delivery pathway at a body of the patient to provide the one or more medication delivery pathways for delivery of the one or more second medications, and assign the one or more second medications for delivery to the patient via the new medication delivery pathway.
Claim 22 recites a computer program product comprising obtain pathway data associated with all available medication delivery pathways for delivering medication to a patient from a medication delivery pathway sensor system, wherein each medication delivery pathway of the available medication delivery pathways includes at least one of the following: at least one catheter, at least one lumen, at least one port, or any combination thereof, and wherein the pathway data is associated with at least one material of a medication delivery pathway; obtain first prescription data associated with one or more second medications prescribed for delivery to the patient from the medication delivery pathway sensor system and second prescription data associated with at least one first medication delivered, being delivered, or prescribed to be delivered to the patient; determine according to at least one rule set, the pathway data, the first prescription data, and the second prescription data, one or more medication delivery pathways from the available medication delivery pathways for delivery of the one or more second medications to the patient, wherein the at least one rule set comprises: a rule associated with whether a medication including an attribute is compatible to be delivered to a patient via a same medication delivery pathway as another medication including another attribute; a rule associated with whether a medication is compatible to be delivered to a patient via a same medication delivery pathway as another medication if the same medication delivery pathway is flushed between deliveries of the medication and the another medication; and a rule associated with whether a medication is compatible to be delivered to a patient via a material of a medication delivery pathway; wherein when determining the one or more medication delivery pathways from the available medication delivery pathways for delivery to the one or more medications to the patient:(i) determine, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via a same medication delivery pathway as the at least one first medication based on an attribute of the one or more second medications and an attribute of the at least one first medication, (ii) determine, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication if the same medication delivery pathway is flushed in between deliveries of the one or more second medications and the at least one first medication; and (iii) determine, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication based on the one or more materials of the same medication delivery pathway; and in response to determining that the one or more second medications are not compatible in each of (i), (ii), and (iii): and prompt a user to install a new medication delivery pathway at a body of the patient to provide for delivery of the one or more second medications; and assign the one or more second medications for delivery to the patient via the new medication delivery pathway.
These steps amount to certain methods of organizing human activity which includes functions relating to managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people – also note MPEP § 2106.04(a)(2)(II) stating certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping).
Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer [MPEP 2106.05(f)].
The claims recite the additional elements of at least one processor, one or more processors, a computer program product, and at least one non-transitory computer readable medium.
These elements are recited at a high-level of generality such that it amounts to mere instructions to apply the exception because this is an example of applying the abstract idea by use of general-purpose computer which does not integrate the abstract idea into a practical application.
Claims 1, 21, and 22 recite wherein the medication delivery pathway sensor system comprises a plurality of sensors coupled to the available medication delivery pathways to sense the pathway data associated with the available medication delivery pathways. The sensor is being used in its ordinary capacity. The specification states: “The one or more sensors 202a, 202b, ... 202n may be configured to sense, detect, and/or determine pathway data associated with the one or more medication delivery pathways 203a, 203b, ... 203n (e.g., pathway data associated with the one or more ports 204a, 204b, ... 204n and/or the one or more lumens 206a, 206b, ... 206n of the one or more catheters, etc.) and/or one or more medications delivered or being delivered to a patient via the one or more medication delivery pathways 203a, 203b, ... 203n (e.g., via the one or more ports 204a, 204b, ... 204n and/or the one or more lumens 206a, 206b, ... 206n of the one or more catheters, etc.),” (Para. 0057). The specification and the instant claims do not provide any indication that the sensor is being utilized beyond its ordinary capacity. Therefore, this step is directed towards the medical sensor being used in its ordinary capacity which amounts to merely being a tool to execute the abstract idea, and thus does not integrate a judicial exception into a practical application or provide significantly more (MPEP § 2106.05(f)(2) see TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016)).
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer.
As discussed above with respect to integration of the abstract idea into a
practical application, the claims recite the additional elements of at least one processor, one or more processors, a computer program product, and at least one non-transitory computer readable medium.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide conventional computer implementation.
Claims 1, 21, and 22 recite wherein the medication delivery pathway sensor system comprises a plurality of sensors coupled to the available medication delivery pathways to sense the pathway data associated with the available medication delivery pathways. The sensor is being used in its ordinary capacity. Therefore, this step is directed towards the medical sensor being used in its ordinary capacity which amounts to merely being a tool to execute the abstract idea, and thus does not integrate a judicial exception into a practical application or provide significantly more (MPEP § 2106.05(f)(2) see TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016)).
For the reasons stated, these claims are consequently rejected under 35 U.S.C. § 101.
Analysis of Dependent Claims
Dependent claim 4 recites wherein the available medication delivery pathways include the same medication delivery pathway as the at least one first medication, and wherein assigning the one or more second medications for delivery to the patient via the one or more medication delivery pathways from the available medication delivery pathways includes: prompting a user to flush the one or more medication delivery pathways from the available medication delivery pathways at least one of before and after delivering the one or more second medications and after delivering the at least one first medications via the one or more medication delivery pathways.
Dependent claim 6 recites segmenting according to the at least one rule set, the one or more second medications and the at least one first medication into a plurality of medication groups based on whether the one or more second medications and the at least one first medication are compatible to be delivered to the patient via the same medication delivery pathway; and determining according to the at least one rule set, the pathway data, the first prescription date, and the second prescription data, the one or more medication delivery pathways for delivery of the plurality of medication groups to the patient based on an attribute of the plurality of medication groups.
Dependent claim 7 recites wherein determining whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication includes: determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more medications are compatible to be delivered to the patient via a same catheter as the at least one first medication.
Dependent claim 8 recites wherein determining whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication includes: determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via a same lumen of the same catheter as the at least one first medication.
Dependent claim 9 recites wherein determining whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication includes: determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via a same port of the same catheter as the at least one first medication.
Dependent claim 10 recites wherein the pathway data is associated with at least one type of the at least one medication delivery pathway, and wherein determining the one or more medication delivery pathways includes: determining, according to the at least one rule set, based on the pathway data and the prescription data, whether the one or more medications are compatible to be delivered to the patient via the one or more types of the at least one medication delivery pathway.
Dependent claim 11 recites wherein the one or more types of the available medication delivery pathways include at least one of the following: a peripheral intravenous line (PIV), a peripherally inserted central catheter (PICC), a central catheter, a midline catheter, or any combination thereof.
Dependent claim 12 recites wherein the pathway data is associated with at least one location of a body of the patient to which each medication delivery pathway is configured to deliver medication, and wherein determining the one or more medication delivery pathways includes: determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient at the one or more locations of the body of the patient.
Dependent claim 14 recites wherein determining whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication based on one or more materials of the same medication delivery pathway includes: determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, an amount of time the one or more second medications are compatible to be delivered to the patient via the pathway including the one or more materials.
Dependent claim 15 recites wherein the first prescription data is associated with one or more delivery types of the one or more second medications, one or more dosage amounts of the one or more second medications, one or more dosage rates of the one or more second medications, one or more time periods acceptable for delivering the one or more second medications to the patient, or any combination thereof.
Dependent claim 16 recites wherein determining the one or more medication delivery pathways includes: determining, according to the at least one rule set, the pathway data the first prescription data, and the second prescription data, one or more first time periods for delivery of the one or more second medications via the one or more medication delivery pathways.
Dependent claim 17 recites wherein determining the one or more medication delivery pathways includes: determining, according to the at least one rule set, the pathway data the first prescription data, and the second prescription data, one or more second time periods after the one or more first time periods for delivery of one or more second doses of the one or more second medications via the one or more medication delivery pathways.
Dependent claim 18 recites wherein the at least one rule set includes a priority of delivery for the one or more second medications and the at least one first medication.
Dependent claim 19 recites wherein the at least one rule set includes a priority of delivery of for the one or more second medications via a type, material, and/or a location of medication delivery pathway.
Each of these steps of the preceding dependent claims 4, 6-12, and 14-19 only serve to further limit or specify the features of independent claim 1 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
Dependent claim 20 recites wherein the at least one first medication was delivered or is being delivered via a medication delivery pathway of the available medication delivery pathways, wherein the pathway data is received from at least one sensor of the plurality of sensors coupled to the same medication delivery pathway as the at least one first medication, and wherein the pathway data is associated with the at least one first medication delivered or being delivered via the at least one same medication delivery pathway.
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.
Claim(s) 1, 4, 6-12, 14-19, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottin (WO 2019001879 A1) in view of Vanderveen (US 20050171815 A1) in view of Isaacson (US 20220115106 A1).
REGARDING CLAIM 1
Cottin teaches a computer-implemented method, comprising:
obtaining, with at least one processor, pathway data associated with all available one medication delivery pathways for delivering medication to a patient from a medication delivery pathway sensor system, wherein each medication delivery pathway of the available medication delivery pathways includes at least one of the following: at least one catheter, at least one lumen, at least one port, or any combination thereof, and wherein the pathway data is associated with at least one material of a medication delivery pathway, ([Pg. 3, Col. 1. Lines 23-25] A multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient, and a control device for controlling the multiplicity of infusion devices [Pg. 5, Col. 3, Lines 9-14] infusions shall be multiplexed for administration to a patient. For administering the infusions a (single) infusion line having a (single) lumen may be employed, the multiple infusions being administered via the lumen towards the patient. For the administration of the multiple infusions a single port such as a catheter or the like may be used, thereby reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. [Col. 10, Lines 31 – Col. 11, Lines 11] The infusion devices 10 are controlled by a control device 2 being linked to the rack 11 and via the rack 11 to the infusion devices 10. The control device 2 may be implemented for example on a computing device, such as a personal computer, a tablet, a laptop, or mobile device such as a smart phone, or the like. Examiner interprets that it would be obvious that at least one processor was contained in the one or more computing devices. The control device 2 controls the infusion devices 10 for an orchestrated infusion of multiple medical solutions. As illustrated in Fig. 2 (Pg. 25), the infusion devices (10A-N) may be connected to a connection device 101 via delivery lines (100A-N) the connection device 101 for example comprising switchable valves for switching valves for switching between infusions of the different infusion devices (10A-N) for delivery via single infusion line 102 connected to the patient (P). Therefore, multiple infusions of the multiple infusion devices (10A-N) may be applied to the patient via a single infusion line having a single lumen and providing single access to the patient. [Col. 9, Lines 5-13] A multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set (i.e. one or more materials) to the patient (i.e. one or more materials).)
determining, with at least one processor, according to at least one rule set, the pathway data, the first prescription data, and the second prescription data, one or more medication delivery pathways from the available medication delivery pathways for delivery of the one or more second medications to the patient, wherein the at least one rule set comprises: ([Col. 3 Lines 9-27] Infusions shall be multiplexed for administration to a patient. Herein, for administering the infusions a (single) infusion line having a (single) lumen may be employed (i.e. one or more medication delivery pathways), the multiple infusions being administered via the lumen towards the patient. Hence, for the administration of the multiple infusions a single port such as a catheter or the like may be used, hence reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. For administering the multiple infusions to the patient, the control device (in a setup phase) shall define a sequence of packets of medical solutions. The control device (i.e. processor) herein is configured to define packets, each packet comprising one or multiple medical solutions (i.e. one or more medications) which, within the packet, shall be administered in parallel. A packet is a combination of any number of medical solutions, in particular drug solutions, intended to be infused to the patient in parallel via the infusion line. By forming packets, hence, multiple (compatible) medical solutions may be administered to the patient in parallel and hence in an effective manner, multiple packets being arranged in a sequence such that, during the actual administration, one packet of medical solutions after another is administered to the patient. [Col. 4, Lines 17-21] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet.)
wherein determining the one or more medication delivery pathways from the available medication delivery pathways for delivery of the one or more second medications to the patient comprises: ([Col. 3 Lines 9-27] Infusions shall be multiplexed for administration to a patient. Herein, for administering the infusions a (single) infusion line having a (single) lumen may be employed (i.e. one or more medication delivery pathways), the multiple infusions being administered via the lumen towards the patient. Hence, for the administration of the multiple infusions a single port such as a catheter or the like may be used, hence reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. For administering the multiple infusions to the patient, the control device (in a setup phase) shall define a sequence of packets of medical solutions. The control device (i.e. processor) herein is configured to define packets, each packet comprising one or multiple medical solutions (i.e. one or more medications) which, within the packet, shall be administered in parallel. A packet is a combination of any number of medical solutions, in particular drug solutions, intended to be infused to the patient in parallel via the infusion line. By forming packets, hence, multiple (compatible) medical solutions may be administered to the patient in parallel and hence in an effective manner, multiple packets being arranged in a sequence such that, during the actual administration, one packet of medical solutions after another is administered to the patient. [Col. 4, Lines 17-21] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet.)
(ii)determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication if the same medication delivery pathway is flushed in between deliveries of the one or more second medications and the at least one first medication; ([Col. 7, Lines 28-35] The packets in particular are defined by grouping compatible medical solutions together. Hence, different packets may comprise medical solutions which are incompatible with each other, hence requiring a sufficient separation between the packets during the sequential administration. For this, a separator fluid may be arranged in the sequence in between packets having incompatible medical solutions, such that a fluid separation between the packets is obtained. The separator fluid may in particular be a neutral, solution that does not contain a drug such as a saline (NaCI) solution or a glucose solution. Examiner interprets the user of a separator fluid to be indicative of flushing. [Col. 13, Lines 21-27] During administration a separator fluid may have to be inserted in between the two packets in order to sufficiently separate the packets and their medical solutions from each other. The separator fluid may be a neutral fluid not containing a drug, such as a saline solution or a glucose solution, which may be administered, during the actual administration, using a dedicated infusion device 10N, as illustrated in Fig. 2 (Pg. 25). The separator fluid may also serve to flush the infusion line 1 02 in between the two packets during the actual administration.)
and determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication based on one or more materials of the same medication delivery pathway; ([Col. 9, Lines 5-13] A multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient. Herein, in a set-up phase, using a multiplex module of the control device the multiplicity of medical fluids are multiplexed for a multiplexed administration of the medical fluids through said infusion line of the infusion set (i.e. one or more materials) in that 10 the multiplex module defines at least two packets, each packet comprising at least one medical fluid out of the multiplicity of medical fluids, and arranges the at least two packets in a sequence for administration of the medical fluids of the at least two packets (i.e. one or more medications).
prompting, with at least one processor, a user to install a new medication delivery pathway at a body of the patient to provide for delivery of the one or more second medications; ([Col. 3, Lines 10-11] Administering the infusions a (single) infusion line having a (single) lumen may be employed, the multiple infusions being administered via the lumen towards the patient. [Col. 12, Lines 1-9] An analyzing module 221 serves to analyze compatibilities/incompatibilities between the different medical solutions and provides its input in particular to the scheduling module 222 for defining packets of medical solutions. A layout module 223 contains information relating to the layout of a tubing set 103 comprising delivery lines 100A, 100B, 100C, 100D, 100E, 100N, the connection device 101 and the infusion line 102 as illustrated in Fig. 2. The layout module 223 for example allowing a user N to define, input and/or modify the layout of the lines (i.e. new medication delivery pathway) of the infusion set 103 such that the layout may be taken into account for controlling the infusion operation.)
Cottin do not explicitly teach, however Vanderveen teaches
obtaining, with at least one processor, first prescription data associated with one or more second medications prescribed for delivery to the patient from the medication delivery pathway sensor system and second prescription data associated with at least one first medication delivered, being delivered, or prescribed to be delivered to the patient; ([Para. 0043] The bedside CPU 80 can be used by a nurse, physician or technician to access a variety of institutional databases to display a variety of information about a particular patient. This information can include an on-line, real-time, graphical patient medication administration record (MAR) that is derived from the patient's medication profile maintained by the hospital's pharmacy information system 20. The bedside CPU 80 also allows remote access to a patient's records stored by the file server 45 to display medication history for the patient. This medication history includes a listing of all drug or other treatments including past, present, and future deliveries (i.e. one or more medications prescribed and at least one other medication delivered, being delivered, or prescribed.) to the patient. [Para. 0044] The bedside CPU further includes a database including a library or libraries of information concerning past and present medical administration activities and/or institutional guidelines for appropriate parameters for administration of various medications. For example, the guidelines may include institutionally established guidelines or limits on drug administration parameters, such as dosage, frequency of administration, and other delivery related information such as, for example, appropriate flow rates and infusion durations for programming infusion pumps. [Para. 0039] The processors or CPUs . [Para. 0027] FIG. 5 (Pg. 28) shows a patient IMAR (integrated medication administration record) showing scheduled medications (i.e. other medications) and windows around the scheduled times.
and a rule associated with whether a medication is compatible to be delivered to a patient via a material of a medication delivery pathway; ([Para. 0069] Shown in FIG. 9, database 122 includes a protocol module 124 comprising a plurality of protocols 126, 128, 130, 132, 134. 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 drug name 136, concentration 138, container size(s) 140, nominal dose rate 142, initial bolus 144, maximum dose rate 146, minimum dose rate 148, maximum cumulative dose 150, volume/dose 152, adverse drug interactions 154, side effects 156, patient condition incompatibilities 158 and an ID field, record pointer 160, for identifying or "calling" the protocol record. Each field typically includes stored default parameter values that collectively define a specific infusion protocol. Some fields, such as drug interactions 154, include a reference or link to another database or drug library containing relevant information. 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.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient as taught by Cottin and incorporate controlling medication delivery from a central location as taught by Vanderveen, with the motivation of with the motivation of monitoring, managing and controlling medication orders and medication delivery from a central location (Vanderveen Para. 0001.)
Cottin/ Vanderveen do not explicitly teach, however Isaacson teaches
wherein the medication delivery pathway sensor system comprises a plurality of sensors coupled to the available medication delivery pathways to sense the pathway data associated with the available medication delivery pathways; ([Para. 0087] As shown in FIG. 2A, the plurality of medication source devices 206a, 206b, . . . 206n may be connected to a plurality of lumens (e.g., fluid lines, etc.) 202a, 202b, . . . 202n (e.g., for receiving a fluid and/or a medication at medication source system 102) and/or a plurality of lumens (e.g., fluid lines, etc.) 212a, 212b, 212n (e.g., for delivering a fluid and/or a medication from medication source system 102, etc.). [Para. 0095] The sensor 254 includes at least one of: one or more force sensors (e.g., one or more piezoelectric elements or transducers, one or more force sensitive resistive (FSR) sensors, one or more strain gauges, etc.); one or more pressure sensors; one or more acoustic sensors; one or more optical sensors (e.g., an optical sensor configured to detect at least one of a color signature and a reflectance of a medical device connected to smart device 104, etc.), one or more identification sensors (e.g., an identification sensor configured to detect an identification tag on a medical device connected to or being connected to the needleless connector 214, such as a magnetometer configured to detect a magnetic material, a barcode scanner configured to read a bar code, etc.); one or more position sensors (e.g., a position sensor configured to detect movement of smart device 104, etc.); one or more RBG color sensors; or any combination thereof.)
a rule associated with whether a medication including an attribute is compatible to be delivered to a patient via a same medication delivery pathway as another medication including another attribute; ([Para. 0009] The first type of medication is delivered via the same lumen to the patient, wherein the second type of medication is scheduled to be delivered via the same lumen to the patient, and wherein the one or more processors are programmed and/or configured to provide the indication of whether the second type of medication is compatible for delivery via the same lumen associated with the same type of visual output by: controlling the medication source device to inhibit or prevent delivery of the second medication via the same lumen associated with the same type of visual output. [Para. 0019] Delivering, with the same lumen associated with the same type of visual output, the first type of medication to the patient, wherein the second type of medication is scheduled to be delivered via the same lumen to the patient, and wherein providing the indication of whether the second type of medication is compatible for delivery via the same lumen associated with the same type of visual output further comprises: controlling the medication source device to inhibit or prevent delivery of the second medication via the same lumen associated with the same type of visual output.)
a rule associated with whether a medication is compatible to be delivered to a patient via a same medication delivery pathway as another medication if the same medication delivery pathway is flushed between deliveries of the medication and the another medication; ([Para. 0088] The patient is connected to a single lumen, the order can indicate to deliver give saline on the “pink” line and to deliver antibiotics on the same “pink” line, etc. However, if there is a drug incompatibility ordered, the order can alter the user that additional flushing is indicated for the “pink” line to ensure that the pink line properly flushed before subsequent medications that may be incompatible with medications or fluids previously delivered via the “pink” line are delivered.)
determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via a same medication delivery pathway as the at least one first medication based on an attribute of the one or more second medications and an attribute of the at least one first medication; ([Para. 0137] The medication source system 102 may obtain medication data. As an example, medication source system 102 may obtain medication data associated with a first type of medication delivered or scheduled to be delivered via the same lumen to a patient and a second type of medication delivered or scheduled to be delivered via the same lumen to the patient. [Para. 0138] The medication data (i.e. attribute data of first and one or more second medication(s)) is associated with at least one of the following: an identifier of a type of a medication, a scheduled delivery of the medication via a particular medication source device, and/or lumen, a previous delivery of the medication via a particular medication source device and/or lumen, an amount of the medication, an identifier of a patient to which the medication is scheduled to be delivered (or delivered), one or more identifiers of one or more different types of medication that are incompatible for delivery via a same lumen with the medication, and/or the like. [Para. 0139] As shown in FIG. 9, at step 904, process includes determining compatibility of medications. For example, medication source system 102 may determine compatibility of medications. As an example, medication source system 102 may determine, based on the medication data, a compatibility of the second type of medication for delivery via the same lumen as the first type of medication.
and in response to determining that the one or more second medications are not compatible to be delivered to the patient via the same medication delivery pathway as the at least one medication in each of (i), (ii), and (iii): ([Para. 0075] automatically determining a compatibility of medications delivered and/or scheduled to be delivered via a same lumen and/or inhibiting or preventing delivery of incompatible medications via the same lumen, which may enable improved reduction or elimination of IV line complexity and/or medication delivery errors and/or improved compliance with lumen maintenance procedures (e.g., line flushing, etc.). [Para. 0088] For example, li the patient is connected to a single lumen, the order can indicate to deliver give saline on the “pink” line and to deliver antibiotics on the same “pink” line, etc. However, if there is a drug incompatibility ordered, the order can alter the user that additional flushing is indicated for the “pink” line to ensure that the pink line properly flushed before subsequent medications that may be incompatible with medications or fluids previously delivered via the “pink” line are delivered. As an example, if there are two lumens connected to a single patient (e.g., a single “pink”′ line and a single “blue” line) an order may indicate to deliver saline via the “pink” lumen or line and deliver antibiotics via the “blue” lumen or line, and/or the like. [Para. 0141] If medication source device 102 determines that the second type of medication is incompatible for delivery via a first lumen 212a, medication source device 102 may determine a compatibility of the second type of medication for delivery via an alternative lumen, such as a second lumen 212b based a third type of medication delivered or scheduled to be delivered via the second lumen 212b and, if the second type of medication is compatible for delivery via the same lumen as the third type of medication, provide the indication that the second type of medication is compatible for delivery via the second lumen 212b.)
and assigning, with at least one processor, the one or more second medications for delivery to the patient via the new medication delivery pathway; ([Para. 0088] A first patient may have a “pink” LED light illuminated on smart device 104, and an order from a doctor and/or a pharmacy that includes a new type of medication or therapy to be delivered and instructions for a user (e.g., a nurse, etc.) to deliver the new type of medication on the one and only “pink” line to implement an error checking process. If smart device 104 is emitting a color of light other than the “pink” light (e.g., a “green” light or a “blue” light) and the order for the medication indicates a that the medication should only be delivered via a “pink” colored lumen, the user (e.g., the nurse, etc.) may initiation of delivery to the patient (e.g., not deliver the medication to the patient, etc.) because the user can determine that the order and the color does not match, which indicates that there may be an issue and/or an incompatibility with medication for the patient and/or the lumen. As an example, if there are two lumens connected to a single patient (e.g., a single “pink”′ line and a single “blue” line) an order may indicate to deliver saline via the “pink” lumen or line and deliver antibiotics via the “blue” lumen or line, and/or the like.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient as taught by Cottin, controlling medication delivery from a central location as taught by Vanderveen, and incorporate a plurality of sensors and automatically determining a compatibility of medications delivered and/or scheduled to be delivered via a same lumen as taught by Isaacson, with the motivation of with the motivation of enabling improved reduction or elimination of IV line complexity and/or medication delivery errors and/or improved compliance with lumen maintenance procedures (Isaacson Para. 0075).
REGARDING CLAIM 4
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 1, Cottin further teaches wherein the available medication delivery pathways include the same medication delivery pathway as the at least one first medication, and wherein assigning the one or more second medications for delivery to the patient via the one or more medication delivery pathways from the available medication delivery pathways includes: prompting a user to flush the one or more medication delivery pathways from the available medication delivery pathways at least one of before and after delivering the one or more second medications and after delivering the at least one first medications via the one or more medication delivery pathways. ([Col.11, Lines 26-29] a computing device implementing the control device 2, comprises a (graphical) user interface 220 via which a user N, for example a nurse, may interact with the control device 2 and may input control commands, such as information relating to medical solutions to be infused to a patient P. [Col. 12, Lines 33 to Col. 13, Lines 1-2] the multiplex module 22 takes as input from the external database 24 information with regard to the compatibilities/ 35 incompatibilities of the different medical solutions. The compatibilities/incompatibilities are for example defined in an association table stored in the database 24, the table defining whether a certain drug is compatible or incompatible with another drug, as illustrated in the bottom of Fig. 4 (Pg. 27). [Col. 13, Lines 21-27] during administration a separator fluid may have to be inserted in between the two packets in order to sufficiently separate the packets and their medical solutions from each other. The separator fluid may be a neutral fluid not containing a drug, such as a saline solution or a glucose solution, which may be administered, during the actual 25 administration, using a dedicated infusion device 10N, as illustrated in Fig. 2. The separator fluid may also serve to flush the infusion line 102 in between the two packets during the actual administration. Examiner interprets the determination of the incompatibilities of the medical solutions indicates that the user must insert a separator fluid to flush the infusion line between the two packets.)
REGARDING CLAIM 6
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 1, Cottin teaches further comprising:
segmenting, with at least one processor, according to the at least one rule set, the one or more second medications and the at least one first medication into a plurality of medication groups based on whether the one or more second medications and the at least one first medication are compatible to be delivered to the patient via the same medication delivery pathway; ([Col. 4, Lines, 16-29] the multiplex module of the control device (i.e. processor) may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet (i.e. plurality of medication groups). Within the database it is stored and defined whether different medical solutions are compatible with one another or not. For example, the database defines whether drug solution A (i.e. medication) is compatible with drug solutions B, C, D, and E (i.e. one or more medications), and so on, such that the different drugs 25 may be administered together via a single infusion line (or not). The defining of packets takes the compatibility of medical solutions into account in that only such medical solutions may be grouped together in a packet which are compatible and hence which may be administered to the patient in a parallel fashion, i.e. synchronously via the same infusion line comprising a single lumen and providing a single access to the patient. [Col. 13, Lines 4-8] In the example of Fig. 4 (Pg. 29), drug A is compatible with drug B, but is incompatible with drug C, drug D and drug E. This means, that drug A may be administered together with drug B, but may not be administered together with drug C, drug D and/or drug E, such that a sufficient separation of administration between drug A and drugs C, D and E must be provided.]
and determining, with at least one processor, according to the at least one rule set, the pathway data, the first prescription date, and the second prescription data, the one or more medication delivery pathways for delivery of the plurality of medication groups to the patient based on an attribute of the plurality of medication groups. ([Col. 3 Lines 9-27] Infusions shall be multiplexed for administration to a patient. Herein, for administering the infusions a (single) infusion line having a (single) lumen may be employed (i.e. one or more medication delivery pathways), the multiple infusions being administered via the lumen towards the patient. Hence, for the administration of the multiple infusions a single port such as a catheter or the like may be used, hence reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. For administering the multiple infusions to the patient, the control device (in a setup phase) shall define a sequence of packets of medical solutions. The control device (i.e. processor) herein is configured to define packets (i.e. plurality of medication groups), each packet comprising one or multiple medical solutions (i.e. one or more medications) which, within the packet, shall be administered in parallel. A packet is a combination of any number of medical solutions, in particular drug solutions, intended to be infused to the patient in parallel via the infusion line. By forming packets, hence, multiple (compatible) medical solutions may be administered to the patient in parallel and hence in an effective manner, multiple packets being arranged in a sequence such that, during the actual administration, one packet of medical solutions after another is administered to the patient. [Col. 4, Lines 17-21] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet.)
REGARDING CLAIM 7
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 1, Cottin further teaches wherein determining whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication includes: determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more medications are compatible to be delivered to the patient via a same catheter as the at least one first medication. ([Col. 3, Lines 12-14] for the administration of the multiple infusions a single port such as a catheter or the like may be used, hence reducing the number of ports to be provided on a patient and hence increasing the patient's comfort.)
REGARDING CLAIM 8
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 7, Cottin further teaches wherein determining whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication includes: determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via a same lumen of the same catheter as the at least one first medication. ([Col. 4, Lines, 16-29] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet. Within the database it is stored and defined whether different medical solutions are compatible with one another or not. For example, the database defines whether drug solution A is compatible with drug solutions B, C, D, and E, and so on, such that the different drugs 25 may be administered together via a single infusion line (or not). The defining of packets takes the compatibility of medical solutions into account in that only such medical solutions may be grouped together in a packet which are compatible and hence which may be administered to the patient in a parallel fashion, i.e. synchronously via the same infusion line comprising a single lumen and providing a single access to the patient. [Col. 1, Line 34] additional (peripheral) catheters.)
REGARDING CLAIM 9
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 8, Cottin further teaches wherein determining whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication includes: determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via a same port of the same catheter as the at least one first medication. (([Col. 4, Lines, 16-29] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet. Within the database it is stored and defined whether different medical solutions are compatible with one another or not. For example, the database defines whether drug solution A is compatible with drug solutions B, C, D, and E, and so on, such that the different drugs 25 may be administered together via a single infusion line (or not). The defining of packets takes the compatibility of medical solutions into account in that only such medical solutions may be grouped together in a packet which are compatible and hence which may be administered to the patient in a parallel fashion, i.e. synchronously via the same infusion line comprising a single lumen and providing a single access to the patient. [Col. 3, Lines 12] for the administration of the multiple infusions a single port such as a catheter.)
REGARDING CLAIM 10
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 1, Cottin further teaches wherein the pathway data is associated with at least one type of the at least one medication delivery pathway, and wherein determining the one or more medication delivery pathways includes: determining, according to the at least one rule set, based on the pathway data and the prescription data, whether the one or more medications are compatible to be delivered to the patient via the one or more types of the at least one medication delivery pathway. ([Col. 4, Lines, 16-29] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet. Within the database it is stored and defined whether different medical solutions are compatible with one another or not. For example, the database defines whether drug solution A is compatible with drug solutions B, C, D, and E, and so on, such that the different drugs 25 may be administered together via a single infusion line (or not). The defining of packets takes the compatibility of medical solutions into account in that only such medical solutions may be grouped together in a packet which are compatible and hence which may be administered to the patient in a parallel fashion, i.e. synchronously via the same infusion line comprising a single lumen (i.e. delivery pathway) and providing a single access to the patient.)
REGARDING CLAIM 11
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 10, Cottin further teaches wherein the one or more types of the available medication delivery pathways include at least one of the following: a peripheral intravenous line (PIV), a peripherally inserted central catheter (PICC), a central catheter, a midline catheter, or any combination thereof. ([Col. 1, Line 34] additional (peripheral) catheters. Examiner interprets this to be indicative of a peripherally inserted central catheter (PICC).)
REGARDING CLAIM 12
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 1, Cottin further teaches wherein the pathway data is associated with at least one location of a body of the patient to which each medication delivery pathway is configured to deliver medication, and wherein determining the one or more medication delivery pathways includes: determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient at the one or more locations of the body of the patient. ([Col. 4, Lines, 16-29] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet. Within the database it is stored and defined whether different medical solutions are compatible with one another or not. For example, the database defines whether drug solution A is compatible with drug solutions B, C, D, and E, and so on, such that the different drugs 25 may be administered together via a single infusion line (or not). The defining of packets takes the compatibility of medical solutions into account in that only such medical solutions may be grouped together in a packet which are compatible and hence which may be administered to the patient in a parallel fashion, i.e. synchronously via the same infusion line comprising a single lumen and providing a single access to the patient. [Col. 1, Lines 27-28] Intravenous (IV) therapy is one of the most common forms of treatment in hospitals worldwide. Examiner interprets that intravenous therapy is well-known in the art, which allows for the administration of medication directly into the bloodstream via the veins in the arm and/ or hand. This is indicative of one or more locations of the body of the patient.)
REGARDING CLAIM 14
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 1, Cottin further teaches wherein determining whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication based on one or more materials of the same medication delivery pathway includes: determining, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, an amount of time the one or more second medications are compatible to be delivered to the patient via the pathway including the one or more materials. ([Col. 5, Lines 1-9] the scheduling module may further be configured to obtain, from a database, information relating to permissible interruption times of medical fluids of the at least two packets. The interruption time (i.e. an amount of time the one or more medications are compatible to be delivered to the patient ) is defined as the time period for which the administration of a medical solution may be temporarily stopped while having no (or at 5 least insignificant) therapeutic impact as compared to a continuous infusion. The interruption time of a medical solution hence defines an admissible gap in between two instances of administration of a medical solution. The interruption time is correlated to the period of the (periodic) administration of the medical solution, the period is derived from the administration duration and the interruption time. [Col. 8, Lines 35- Col. 9, Lines 1-2] The database (i.e. rule set), in particular comprising information with regard to compatibility of different medical solutions such as drug solutions, permissible interruption times of medical solutions and the like, may for example be an SQL database. [Col. 9, Lines 5-13] a multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient. Herein, in a set-up phase, using a multiplex module of the control device the multiplicity of medical fluids are multiplexed for a multiplexed administration of the medical fluids through said infusion line of the infusion set (i.e. one or more materials) in that 10 the multiplex module defines at least two packets, each packet comprising at least one medical fluid out of the multiplicity of medical fluids, and arranges the at least two packets in a sequence for administration of the medical fluids of the at least two packets.)
REGARDING CLAIM 15
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 1, Cottin further teaches wherein the first prescription data is associated with one or more delivery types of the one or more second medications, one or more dosage amounts of the one or more second medications, one or more dosage rates of the one or more second medications, one or more time periods acceptable for delivering the one or more second medications to the patient, or any combination thereof. ([Col. 7, Lines 1-3 and 8-11] the scheduling module of the multiplex module may further be configured to assign a flow rate to each of the medical fluids of the at least two packets based on the duration of the packet to which the medical fluid is assigned. For each medical fluid the flow rate (i.e. dosage rate) for administration during each instance of the packet may be determined by dividing the total volume of the medical solution to be infused by 10 the time of administration, which corresponds to the combined duration of all instances of the packet the medical solution is associated with. [Col. 5, Lines 1-9] the scheduling module may further be configured to obtain, from a database, information relating to permissible interruption times of medical fluids of the at least two packets. The interruption time is defined as the time period for which the administration of a medical solution may be temporarily stopped while having no (or at 5 least insignificant) therapeutic impact as compared to a continuous infusion. The interruption time of a medical solution hence defines an admissible gap in between two instances of administration of a medical solution. The interruption time is correlated to the period of the (periodic) administration of the medical solution (i.e. one or more time periods acceptable for delivering the one or more medications to the patient), the period is derived from the administration duration and the interruption time.)
REGARDING CLAIM 16
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 15, Cottin further teaches wherein determining the one or more medication delivery pathways includes: determining, according to the at least one rule set, the pathway data the first prescription data, and the second prescription data, one or more first time periods for delivery of the one or more second medications via the one or more medication delivery pathways. ([Col. 3, Lines 32-35] During the actual administration, then, first drug solutions A and Bare administered in parallel for a predefined duration, followed by the administration of the second packet comprising drug solution C for another predefined 35 duration. [Col. 4, Lines 1-4] the control device may control the administration of the sequence of packets in a repetitive fashion (i.e. one or more first period), such that the administration of the sequence is repeated for a predefined number of times until the administration of the medical solutions is completed. [Col. 10, Lines 11-13] Fig. 7(Pg. 30) shows an example of a sequence of packets of multiple medical solutions for administration to a patient. Fig. 7 (Pg. 30) displays the use of a repeated dosages of the Paket 1 (Drug A and Drug B). [Col. 5, Line 8] the period of the (periodic) administration of the medical solution. [Col. 5, Lines 18-22] the duration of a packet, which is the duration of administration of the packet within the sequence (i.e. time period duration), may be determined 20 based on an administration time assigned to at least one medical fluid of the packet or a permissible interruption time assigned to at least one medical fluid of another packet, in particular the packet interruption time of the other packet.)
REGARDING CLAIM 17
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 16, Cottin further teaches wherein determining the one or more medication delivery pathways includes: determining, according to the at least one rule set, the pathway data the first prescription data, and the second prescription data, one or more second time periods after the one or more first time periods for delivery of one or more second doses of the one or more second medications via the one or more medication delivery pathways. ([Col. 3, Lines 32-35] During the actual administration, then, first drug solutions A and Bare administered in parallel for a predefined duration, followed by the administration of the second packet comprising drug solution C for another predefined 35 duration. [Col. 4, Lines 1-4] the control device may control the administration of the sequence of packets in a repetitive fashion (i.e. one or more second time period), such that the administration of the sequence is repeated for a predefined number of times until the administration of the medical solutions is completed. [Col. 10, Lines 11-13] Fig. 7 (Pg. 30) shows an example of a sequence of packets of multiple medical solutions for administration to a patient. Fig. 7 (Pg. 30) displays the use of a repeated dosages of the Paket 1 (Drug A and Drug B). [Col. 5, Line 8] the period of the (periodic) administration of the medical solution. [Col. 5, Lines 18-22] the duration of a packet, which is the duration of administration of the packet within the sequence (i.e. time period duration), may be determined 20 based on an administration time assigned to at least one medical fluid of the packet or a permissible interruption time assigned to at least one medical fluid of another packet, in particular the packet interruption time of the other packet. )
REGARDING CLAIM 18
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 16, Cottin further teaches wherein the at least one rule set includes a priority of delivery for the one or more second medications and the at least one first medication. ([Col. 7, Lines 17-26] After having defined the packets (each packet comprising one or multiple medical solutions) the packets are arranged in a sequence, according to which the infusion devices then may be controlled for the actual administration. For placing the packets in 20 the sequence, in particular for determining the order of the packets in the sequence, the packets may be prioritized, which may take place by assigning a priority to each packet for example based on an administration deadline of a medical fluid of the packet, and placing the packets in the sequence according to their priority. For example, the packet comprising the medical solution having the earliest administration deadline may be 25 placed first in the sequence, followed by the packet comprising the medical solution with the next urgent administration deadline.)
REGARDING CLAIM 19
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 16, wherein the at least one rule set includes a priority of delivery of for the one or more second medications via a type, material, and/or a location of medication delivery pathway. ([Col. 7, Lines 19-23] For placing the packets in 20 the sequence, in particular for determining the order of the packets in the sequence, the packets may be prioritized, which may take place by assigning a priority to each packet for example based on an administration deadline of a medical fluid of the packet, and placing the packets in the sequence according to their priority. [Col. 11, Lines 8-11] multiple infusions of the multiple infusion devices 10 (A-N) may be applied to the patient P via a 10 single infusion line (i.e. material) 102 having a single lumen (i.e. medication delivery pathway) and providing single access to the patient P.)
REGARDING CLAIM 21
Cottin teaches a system comprising: one or more processors programmed and/or configured to:
obtain pathway data associated with all available medication delivery pathways for delivering medication to a patient from a medication delivery pathway sensor system, wherein each medication delivery pathway of the available medication delivery pathways includes at least one of the following: at least one catheter, at least one lumen, at least one port, or any combination thereof, and wherein the pathway data is associated with at least one material of a medication delivery pathway, ([Pg. 3, Col. 1. Lines 23-25] A multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient, and a control device for controlling the multiplicity of infusion devices [Pg. 5, Col. 3, Lines 9-14] infusions shall be multiplexed for administration to a patient. For administering the infusions a (single) infusion line having a (single) lumen may be employed, the multiple infusions being administered via the lumen towards the patient. For the administration of the multiple infusions a single port such as a catheter or the like may be used, thereby reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. [Col. 10, Lines 31 – Col. 11, Lines 11] The infusion devices 10 are controlled by a control device 2 being linked to the rack 11 and via the rack 11 to the infusion devices 10. The control device 2 may be implemented for example on a computing device, such as a personal computer, a tablet, a laptop, or mobile device such as a smart phone, or the like. Examiner interprets that it would be obvious that at least one processor was contained in the one or more computing devices. The control device 2 controls the infusion devices 10 for an orchestrated infusion of multiple medical solutions. As illustrated in Fig. 2 (Pg. 25), the infusion devices (10A-N) may be connected to a connection device 101 via delivery lines (100A-N) the connection device 101 for example comprising switchable valves for switching valves for switching between infusions of the different infusion devices (10A-N) for delivery via single infusion line 102 connected to th patient (P). Therefore, multiple infusions of the multiple infusion devices (10A-N) may be applied to the patient via a single infusion line having a single lumen and providing single access to the patient. [Col. 9, Lines 5-13] A multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set (i.e. one or more materials) to the patient (i.e. one or more materials).)
determining according to at least one rule set, the pathway data, the first prescription data, and the second prescription data, one or more medication delivery pathways from the available medication delivery pathways for delivery of the one or more second medications to the patient, wherein the at least one rule set comprises: ([Col. 3 Lines 9-27] Infusions shall be multiplexed for administration to a patient. Herein, for administering the infusions a (single) infusion line having a (single) lumen may be employed (i.e. one or more medication delivery pathways), the multiple infusions being administered via the lumen towards the patient. Hence, for the administration of the multiple infusions a single port such as a catheter or the like may be used, hence reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. For administering the multiple infusions to the patient, the control device (in a setup phase) shall define a sequence of packets of medical solutions. The control device (i.e. processor) herein is configured to define packets, each packet comprising one or multiple medical solutions (i.e. one or more medications) which, within the packet, shall be administered in parallel. A packet is a combination of any number of medical solutions, in particular drug solutions, intended to be infused to the patient in parallel via the infusion line. By forming packets, hence, multiple (compatible) medical solutions may be administered to the patient in parallel and hence in an effective manner, multiple packets being arranged in a sequence such that, during the actual administration, one packet of medical solutions after another is administered to the patient. [Col. 4, Lines 17-21] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet.)
wherein when determining the one or more medication delivery pathways from the available medication delivery pathways for delivery to the one or more medications to the patient, the one or more processors are programmed and/or configured to: ([Col. 3 Lines 9-27] Infusions shall be multiplexed for administration to a patient. Herein, for administering the infusions a (single) infusion line having a (single) lumen may be employed (i.e. one or more medication delivery pathways), the multiple infusions being administered via the lumen towards the patient. Hence, for the administration of the multiple infusions a single port such as a catheter or the like may be used, hence reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. For administering the multiple infusions to the patient, the control device (in a setup phase) shall define a sequence of packets of medical solutions. The control device (i.e. processor) herein is configured to define packets, each packet comprising one or multiple medical solutions (i.e. one or more medications) which, within the packet, shall be administered in parallel. A packet is a combination of any number of medical solutions, in particular drug solutions, intended to be infused to the patient in parallel via the infusion line. By forming packets, hence, multiple (compatible) medical solutions may be administered to the patient in parallel and hence in an effective manner, multiple packets being arranged in a sequence such that, during the actual administration, one packet of medical solutions after another is administered to the patient. [Col. 4, Lines 17-21] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet.)
determine, according to the at least one rule set, based on the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication if the same medication delivery pathway is flushed in between deliveries of the one or more second medications and the at least one first medication; ([Col. 7, Lines 28-35] The packets in particular are defined by grouping compatible medical solutions together. Hence, different packets may comprise medical solutions which are incompatible with each other, hence requiring a sufficient separation between the packets during the sequential administration. For this, a separator fluid may be arranged in the sequence in between packets having incompatible medical solutions, such that a fluid separation between the packets is obtained. The separator fluid may in particular be a neutral, solution that does not contain a drug such as a saline (NaCI) solution or a glucose solution. Examiner interprets the user of a separator fluid to be indicative of flushing. [Col. 13, Lines 21-27] During administration a separator fluid may have to be inserted in between the two packets in order to sufficiently separate the packets and their medical solutions from each other. The separator fluid may be a neutral fluid not containing a drug, such as a saline solution or a glucose solution, which may be administered, during the actual administration, using a dedicated infusion device 10N, as illustrated in Fig. 2 (Pg. 25). The separator fluid may also serve to flush the infusion line 1 02 in between the two packets during the actual administration.)
determine, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication based on one or more materials of the same medication delivery pathway; ([Col. 9, Lines 5-13] A multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient. Herein, in a set-up phase, using a multiplex module of the control device the multiplicity of medical fluids are multiplexed for a multiplexed administration of the medical fluids through said infusion line of the infusion set (i.e. one or more materials) in that 10 the multiplex module defines at least two packets, each packet comprising at least one medical fluid out of the multiplicity of medical fluids, and arranges the at least two packets in a sequence for administration of the medical fluids of the at least two packets (i.e. one or more medications).
prompt a user to install a new medication delivery pathway at a body of the patient to provide for delivery of the one or more second medications, ([Col. 3, Lines 10-11] Administering the infusions a (single) infusion line having a (single) lumen may be employed, the multiple infusions being administered via the lumen towards the patient. [Col. 12, Lines 1-9] An analyzing module 221 serves to analyze compatibilities/incompatibilities between the different medical solutions and provides its input in particular to the scheduling module 222 for defining packets of medical solutions. A layout module 223 contains information relating to the layout of a tubing set 103 comprising delivery lines 100A, 100B, 100C, 100D, 100E, 100N, the connection device 101 and the infusion line 102 as illustrated in Fig. 2. The layout module 223 for example allowing a user N to define, input and/or modify the layout of the lines (i.e. new medication delivery pathway) of the infusion set 103 such that the layout may be taken into account for controlling the infusion operation.)
Cottin do not explicitly teach, however Vanderveen teaches
obtain first prescription data associated with one or more second medications prescribed for delivery to the patient from the medication delivery pathway sensor system and second prescription data associated with at least one first medication delivered, being delivered, or prescribed to be delivered to the patient; ([Para. 0043] The bedside CPU 80 can be used by a nurse, physician or technician to access a variety of institutional databases to display a variety of information about a particular patient. This information can include an on-line, real-time, graphical patient medication administration record (MAR) that is derived from the patient's medication profile maintained by the hospital's pharmacy information system 20. The bedside CPU 80 also allows remote access to a patient's records stored by the file server 45 to display medication history for the patient. This medication history includes a listing of all drug or other treatments including past, present, and future deliveries (i.e. one or more medications prescribed and at least one other medication delivered, being delivered, or prescribed.) to the patient. [Para. 0044] The bedside CPU further includes a database including a library or libraries of information concerning past and present medical administration activities and/or institutional guidelines for appropriate parameters for administration of various medications. For example, the guidelines may include institutionally established guidelines or limits on drug administration parameters, such as dosage, frequency of administration, and other delivery related information such as, for example, appropriate flow rates and infusion durations for programming infusion pumps. [Para. 0039] The processors or CPUs . [Para. 0027] FIG. 5 (Pg. 28) shows a patient IMAR (integrated medication administration record) showing scheduled medications (i.e. other medications) and windows around the scheduled times.)
and a rule associated with whether a medication is compatible to be delivered to a patient via a material of a medication delivery pathway; ([Para. 0069] Shown in FIG. 9, database 122 includes a protocol module 124 comprising a plurality of protocols 126, 128, 130, 132, 134. 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 drug name 136, concentration 138, container size(s) 140, nominal dose rate 142, initial bolus 144, maximum dose rate 146, minimum dose rate 148, maximum cumulative dose 150, volume/dose 152, adverse drug interactions 154, side effects 156, patient condition incompatibilities 158 and an ID field, record pointer 160, for identifying or "calling" the protocol record. Each field typically includes stored default parameter values that collectively define a specific infusion protocol. Some fields, such as drug interactions 154, include a reference or link to another database or drug library containing relevant information. 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.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient as taught by Cottin and incorporate controlling medication delivery from a central location as taught by Vanderveen, with the motivation of with the motivation of monitoring, managing and controlling medication orders and medication delivery from a central location (Vanderveen Para. 0001.)
Cottin/ Vanderveen do not explicitly teach, however Isaacson teaches
wherein the medication delivery pathway sensor system comprises a plurality of sensors coupled to the available medication delivery pathways to sense the pathway data associated with the available medication delivery pathways; ([Para. 0087] As shown in FIG. 2A, the plurality of medication source devices 206a, 206b, . . . 206n may be connected to a plurality of lumens (e.g., fluid lines, etc.) 202a, 202b, . . . 202n (e.g., for receiving a fluid and/or a medication at medication source system 102) and/or a plurality of lumens (e.g., fluid lines, etc.) 212a, 212b, 212n (e.g., for delivering a fluid and/or a medication from medication source system 102, etc.). [Para. 0095] The sensor 254 includes at least one of: one or more force sensors (e.g., one or more piezoelectric elements or transducers, one or more force sensitive resistive (FSR) sensors, one or more strain gauges, etc.); one or more pressure sensors; one or more acoustic sensors; one or more optical sensors (e.g., an optical sensor configured to detect at least one of a color signature and a reflectance of a medical device connected to smart device 104, etc.), one or more identification sensors (e.g., an identification sensor configured to detect an identification tag on a medical device connected to or being connected to the needleless connector 214, such as a magnetometer configured to detect a magnetic material, a barcode scanner configured to read a bar code, etc.); one or more position sensors (e.g., a position sensor configured to detect movement of smart device 104, etc.); one or more RBG color sensors; or any combination thereof.)
a rule associated with whether a medication including an attribute is compatible to be delivered to a patient via a same medication delivery pathway as another medication including another attribute; ([Para. 0009] The first type of medication is delivered via the same lumen to the patient, wherein the second type of medication is scheduled to be delivered via the same lumen to the patient, and wherein the one or more processors are programmed and/or configured to provide the indication of whether the second type of medication is compatible for delivery via the same lumen associated with the same type of visual output by: controlling the medication source device to inhibit or prevent delivery of the second medication via the same lumen associated with the same type of visual output. [Para. 0019] Delivering, with the same lumen associated with the same type of visual output, the first type of medication to the patient, wherein the second type of medication is scheduled to be delivered via the same lumen to the patient, and wherein providing the indication of whether the second type of medication is compatible for delivery via the same lumen associated with the same type of visual output further comprises: controlling the medication source device to inhibit or prevent delivery of the second medication via the same lumen associated with the same type of visual output.)
a rule associated with whether a medication is compatible to be delivered to a patient via a same medication delivery pathway as another medication if the same medication delivery pathway is flushed between deliveries of the medication and the another medication; ([Para. 0088] The patient is connected to a single lumen, the order can indicate to deliver give saline on the “pink” line and to deliver antibiotics on the same “pink” line, etc. However, if there is a drug incompatibility ordered, the order can alter the user that additional flushing is indicated for the “pink” line to ensure that the pink line properly flushed before subsequent medications that may be incompatible with medications or fluids previously delivered via the “pink” line are delivered.)
determine, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via a same medication delivery pathway as the at least one first medication based on an attribute of the one or more second medications and an attribute of the at least one first medication, ([Para. 0137] The medication source system 102 may obtain medication data. As an example, medication source system 102 may obtain medication data associated with a first type of medication delivered or scheduled to be delivered via the same lumen to a patient and a second type of medication delivered or scheduled to be delivered via the same lumen to the patient. [Para. 0138] The medication data (i.e. attribute data of first and one or more second medication(s)) is associated with at least one of the following: an identifier of a type of a medication, a scheduled delivery of the medication via a particular medication source device, and/or lumen, a previous delivery of the medication via a particular medication source device and/or lumen, an amount of the medication, an identifier of a patient to which the medication is scheduled to be delivered (or delivered), one or more identifiers of one or more different types of medication that are incompatible for delivery via a same lumen with the medication, and/or the like. [Para. 0139] As shown in FIG. 9, at step 904, process includes determining compatibility of medications. For example, medication source system 102 may determine compatibility of medications. As an example, medication source system 102 may determine, based on the medication data, a compatibility of the second type of medication for delivery via the same lumen as the first type of medication.
and in response to determining that the one or more second medications are not compatible in each of (i), (ii), and (iii): ([Para. 0075] automatically determining a compatibility of medications delivered and/or scheduled to be delivered via a same lumen and/or inhibiting or preventing delivery of incompatible medications via the same lumen, which may enable improved reduction or elimination of IV line complexity and/or medication delivery errors and/or improved compliance with lumen maintenance procedures (e.g., line flushing, etc.). [Para. 0088] For example, li the patient is connected to a single lumen, the order can indicate to deliver give saline on the “pink” line and to deliver antibiotics on the same “pink” line, etc. However, if there is a drug incompatibility ordered, the order can alter the user that additional flushing is indicated for the “pink” line to ensure that the pink line properly flushed before subsequent medications that may be incompatible with medications or fluids previously delivered via the “pink” line are delivered. As an example, if there are two lumens connected to a single patient (e.g., a single “pink”′ line and a single “blue” line) an order may indicate to deliver saline via the “pink” lumen or line and deliver antibiotics via the “blue” lumen or line, and/or the like. [Para. 0141] If medication source device 102 determines that the second type of medication is incompatible for delivery via a first lumen 212a, medication source device 102 may determine a compatibility of the second type of medication for delivery via an alternative lumen, such as a second lumen 212b based a third type of medication delivered or scheduled to be delivered via the second lumen 212b and, if the second type of medication is compatible for delivery via the same lumen as the third type of medication, provide the indication that the second type of medication is compatible for delivery via the second lumen 212b.)
and assign the one or more second medications for delivery to the patient via the new medication delivery pathway. ([Para. 0088] A first patient may have a “pink” LED light illuminated on smart device 104, and an order from a doctor and/or a pharmacy that includes a new type of medication or therapy to be delivered and instructions for a user (e.g., a nurse, etc.) to deliver the new type of medication on the one and only “pink” line to implement an error checking process. If smart device 104 is emitting a color of light other than the “pink” light (e.g., a “green” light or a “blue” light) and the order for the medication indicates a that the medication should only be delivered via a “pink” colored lumen, the user (e.g., the nurse, etc.) may initiation of delivery to the patient (e.g., not deliver the medication to the patient, etc.) because the user can determine that the order and the color does not match, which indicates that there may be an issue and/or an incompatibility with medication for the patient and/or the lumen. As an example, if there are two lumens connected to a single patient (e.g., a single “pink”′ line and a single “blue” line) an order may indicate to deliver saline via the “pink” lumen or line and deliver antibiotics via the “blue” lumen or line, and/or the like.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient as taught by Cottin, controlling medication delivery from a central location as taught by Vanderveen, and incorporate a plurality of sensors and automatically determining a compatibility of medications delivered and/or scheduled to be delivered via a same lumen as taught by Isaacson, with the motivation of with the motivation of enabling improved reduction or elimination of IV line complexity and/or medication delivery errors and/or improved compliance with lumen maintenance procedures (Isaacson Para. 0075).
REGARDING CLAIM 22
Cottin teaches a computer program product comprising at least one non- transitory computer-readable medium including program instructions that, when executed by at least one processor, cause the at least one processor to:
obtain pathway data associated with all available medication delivery pathways for delivering medication to a patient from a medication delivery pathway sensor system, wherein each medication delivery pathway of the available medication delivery pathways includes at least one of the following: at least one catheter, at least one lumen, at least one port, or any combination thereof, and wherein the pathway data is associated with at least one material of a medication delivery pathway, ([Pg. 3, Col. 1. Lines 23-25] A multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient, and a control device for controlling the multiplicity of infusion devices [Pg. 5, Col. 3, Lines 9-14] infusions shall be multiplexed for administration to a patient. For administering the infusions a (single) infusion line having a (single) lumen may be employed, the multiple infusions being administered via the lumen towards the patient. For the administration of the multiple infusions a single port such as a catheter or the like may be used, thereby reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. [Col. 10, Lines 31 – Col. 11, Lines 11] The infusion devices 10 are controlled by a control device 2 being linked to the rack 11 and via the rack 11 to the infusion devices 10. The control device 2 may be implemented for example on a computing device, such as a personal computer, a tablet, a laptop, or mobile device such as a smart phone, or the like. Examiner interprets that it would be obvious that at least one processor was contained in the one or more computing devices. The control device 2 controls the infusion devices 10 for an orchestrated infusion of multiple medical solutions. As illustrated in Fig. 2 (Pg. 25), the infusion devices (10A-N) may be connected to a connection device 101 via delivery lines (100A-N) the connection device 101 for example comprising switchable valves for switching valves for switching between infusions of the different infusion devices (10A-N) for delivery via single infusion line 102 connected to th patient (P). Therefore, multiple infusions of the multiple infusion devices (10A-N) may be applied to the patient via a single infusion line having a single lumen and providing single access to the patient. [Col. 9, Lines 5-13] A multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set (i.e. one or more materials) to the patient (i.e. one or more materials).)
determine according to at least one rule set, the pathway data, the first prescription data, and the second prescription data, one or more medication delivery pathways from the available medication delivery pathways for delivery of the one or more second medications to the patient, wherein the at least one rule set comprises: ([Col. 3 Lines 9-27] Infusions shall be multiplexed for administration to a patient. Herein, for administering the infusions a (single) infusion line having a (single) lumen may be employed (i.e. one or more medication delivery pathways), the multiple infusions being administered via the lumen towards the patient. Hence, for the administration of the multiple infusions a single port such as a catheter or the like may be used, hence reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. For administering the multiple infusions to the patient, the control device (in a setup phase) shall define a sequence of packets of medical solutions. The control device (i.e. processor) herein is configured to define packets, each packet comprising one or multiple medical solutions (i.e. one or more medications) which, within the packet, shall be administered in parallel. A packet is a combination of any number of medical solutions, in particular drug solutions, intended to be infused to the patient in parallel via the infusion line. By forming packets, hence, multiple (compatible) medical solutions may be administered to the patient in parallel and hence in an effective manner, multiple packets being arranged in a sequence such that, during the actual administration, one packet of medical solutions after another is administered to the patient. [Col. 4, Lines 17-21] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet.)
wherein when determining the one or more medication delivery pathways from the available medication delivery pathways for delivery to the one or more medications to the patient, the program instructions cause the at least one processor to: ([Col. 3 Lines 9-27] Infusions shall be multiplexed for administration to a patient. Herein, for administering the infusions a (single) infusion line having a (single) lumen may be employed (i.e. one or more medication delivery pathways), the multiple infusions being administered via the lumen towards the patient. Hence, for the administration of the multiple infusions a single port such as a catheter or the like may be used, hence reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. For administering the multiple infusions to the patient, the control device (in a setup phase) shall define a sequence of packets of medical solutions. The control device (i.e. processor) herein is configured to define packets, each packet comprising one or multiple medical solutions (i.e. one or more medications) which, within the packet, shall be administered in parallel. A packet is a combination of any number of medical solutions, in particular drug solutions, intended to be infused to the patient in parallel via the infusion line. By forming packets, hence, multiple (compatible) medical solutions may be administered to the patient in parallel and hence in an effective manner, multiple packets being arranged in a sequence such that, during the actual administration, one packet of medical solutions after another is administered to the patient. [Col. 4, Lines 17-21] the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet.)
determine, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication if the same medication delivery pathway is flushed in between deliveries of the one or more second medications and the at least one first medication; ([Col. 7, Lines 28-35] The packets in particular are defined by grouping compatible medical solutions together. Hence, different packets may comprise medical solutions which are incompatible with each other, hence requiring a sufficient separation between the packets during the sequential administration. For this, a separator fluid may be arranged in the sequence in between packets having incompatible medical solutions, such that a fluid separation between the packets is obtained. The separator fluid may in particular be a neutral, solution that does not contain a drug such as a saline (NaCI) solution or a glucose solution. Examiner interprets the user of a separator fluid to be indicative of flushing. [Col. 13, Lines 21-27] During administration a separator fluid may have to be inserted in between the two packets in order to sufficiently separate the packets and their medical solutions from each other. The separator fluid may be a neutral fluid not containing a drug, such as a saline solution or a glucose solution, which may be administered, during the actual administration, using a dedicated infusion device 10N, as illustrated in Fig. 2 (Pg. 25). The separator fluid may also serve to flush the infusion line 1 02 in between the two packets during the actual administration.)
And determine, according to the at least one rule set, based on the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via the same medication delivery pathway as the at least one first medication based on one or more materials of the same medication delivery pathway; ([Col. 9, Lines 5-13] A multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient. Herein, in a set-up phase, using a multiplex module of the control device the multiplicity of medical fluids are multiplexed for a multiplexed administration of the medical fluids through said infusion line of the infusion set (i.e. one or more materials) in that 10 the multiplex module defines at least two packets, each packet comprising at least one medical fluid out of the multiplicity of medical fluids, and arranges the at least two packets in a sequence for administration of the medical fluids of the at least two packets (i.e. one or more medications).
prompt a user to install a new medication delivery pathway at a body of the patient to provide the one or more medication delivery pathways for delivery of the one or more second medications; ([Col. 3, Lines 10-11] Administering the infusions a (single) infusion line having a (single) lumen may be employed, the multiple infusions being administered via the lumen towards the patient. [Col. 12, Lines 1-9] An analyzing module 221 serves to analyze compatibilities/incompatibilities between the different medical solutions and provides its input in particular to the scheduling module 222 for defining packets of medical solutions. A layout module 223 contains information relating to the layout of a tubing set 103 comprising delivery lines 100A, 100B, 100C, 100D, 100E, 100N, the connection device 101 and the infusion line 102 as illustrated in Fig. 2. The layout module 223 for example allowing a user N to define, input and/or modify the layout of the lines (i.e. new medication delivery pathway) of the infusion set 103 such that the layout may be taken into account for controlling the infusion operation.)
Cottin do not explicitly teach, however Vanderveen teaches
obtain first prescription data associated with one or more second medications prescribed for delivery to the patient from the medication delivery pathway sensor system and second prescription data associated with at least one first medication delivered, being delivered, or prescribed to be delivered to the patient; ([Para. 0043] The bedside CPU 80 can be used by a nurse, physician or technician to access a variety of institutional databases to display a variety of information about a particular patient. This information can include an on-line, real-time, graphical patient medication administration record (MAR) that is derived from the patient's medication profile maintained by the hospital's pharmacy information system 20. The bedside CPU 80 also allows remote access to a patient's records stored by the file server 45 to display medication history for the patient. This medication history includes a listing of all drug or other treatments including past, present, and future deliveries (i.e. one or more medications prescribed and at least one other medication delivered, being delivered, or prescribed.) to the patient. [Para. 0044] The bedside CPU further includes a database including a library or libraries of information concerning past and present medical administration activities and/or institutional guidelines for appropriate parameters for administration of various medications. For example, the guidelines may include institutionally established guidelines or limits on drug administration parameters, such as dosage, frequency of administration, and other delivery related information such as, for example, appropriate flow rates and infusion durations for programming infusion pumps. [Para. 0039] The processors or CPUs . [Para. 0027] FIG. 5 (Pg. 28) shows a patient IMAR (integrated medication administration record) showing scheduled medications (i.e. other medications) and windows around the scheduled times.)
and a rule associated with whether a medication is compatible to be delivered to a patient via a material of a medication delivery pathway; ([Para. 0069] Shown in FIG. 9, database 122 includes a protocol module 124 comprising a plurality of protocols 126, 128, 130, 132, 134. 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 drug name 136, concentration 138, container size(s) 140, nominal dose rate 142, initial bolus 144, maximum dose rate 146, minimum dose rate 148, maximum cumulative dose 150, volume/dose 152, adverse drug interactions 154, side effects 156, patient condition incompatibilities 158 and an ID field, record pointer 160, for identifying or "calling" the protocol record. Each field typically includes stored default parameter values that collectively define a specific infusion protocol. Some fields, such as drug interactions 154, include a reference or link to another database or drug library containing relevant information. 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.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient as taught by Cottin and incorporate controlling medication delivery from a central location as taught by Vanderveen, with the motivation of with the motivation of monitoring, managing and controlling medication orders and medication delivery from a central location (Vanderveen Para. 0001.)
Cottin/ Vanderveen do not explicitly teach, however Isaacson teaches
wherein the medication delivery pathway sensor system comprises a plurality of sensors coupled to the available medication delivery pathways to sense the pathway data associated with the available medication delivery pathways; ([Para. 0087] As shown in FIG. 2A, the plurality of medication source devices 206a, 206b, . . . 206n may be connected to a plurality of lumens (e.g., fluid lines, etc.) 202a, 202b, . . . 202n (e.g., for receiving a fluid and/or a medication at medication source system 102) and/or a plurality of lumens (e.g., fluid lines, etc.) 212a, 212b, 212n (e.g., for delivering a fluid and/or a medication from medication source system 102, etc.). [Para. 0095] The sensor 254 includes at least one of: one or more force sensors (e.g., one or more piezoelectric elements or transducers, one or more force sensitive resistive (FSR) sensors, one or more strain gauges, etc.); one or more pressure sensors; one or more acoustic sensors; one or more optical sensors (e.g., an optical sensor configured to detect at least one of a color signature and a reflectance of a medical device connected to smart device 104, etc.), one or more identification sensors (e.g., an identification sensor configured to detect an identification tag on a medical device connected to or being connected to the needleless connector 214, such as a magnetometer configured to detect a magnetic material, a barcode scanner configured to read a bar code, etc.); one or more position sensors (e.g., a position sensor configured to detect movement of smart device 104, etc.); one or more RBG color sensors; or any combination thereof.)
a rule associated with whether a medication including an attribute is compatible to be delivered to a patient via a same medication delivery pathway as another medication including another attribute; ([Para. 0009] The first type of medication is delivered via the same lumen to the patient, wherein the second type of medication is scheduled to be delivered via the same lumen to the patient, and wherein the one or more processors are programmed and/or configured to provide the indication of whether the second type of medication is compatible for delivery via the same lumen associated with the same type of visual output by: controlling the medication source device to inhibit or prevent delivery of the second medication via the same lumen associated with the same type of visual output. [Para. 0019] Delivering, with the same lumen associated with the same type of visual output, the first type of medication to the patient, wherein the second type of medication is scheduled to be delivered via the same lumen to the patient, and wherein providing the indication of whether the second type of medication is compatible for delivery via the same lumen associated with the same type of visual output further comprises: controlling the medication source device to inhibit or prevent delivery of the second medication via the same lumen associated with the same type of visual output.)
a rule associated with whether a medication is compatible to be delivered to a patient via a same medication delivery pathway as another medication if the same medication delivery pathway is flushed between deliveries of the medication and the another medication; ([Para. 0088] The patient is connected to a single lumen, the order can indicate to deliver give saline on the “pink” line and to deliver antibiotics on the same “pink” line, etc. However, if there is a drug incompatibility ordered, the order can alter the user that additional flushing is indicated for the “pink” line to ensure that the pink line properly flushed before subsequent medications that may be incompatible with medications or fluids previously delivered via the “pink” line are delivered.)
determine, according to the at least one rule set, the pathway data, the first prescription data, and the second prescription data, whether the one or more second medications are compatible to be delivered to the patient via a same medication delivery pathway as the at least one first medication based on an attribute of the one or more second medications and an attribute of the at least one first medication; ([Para. 0137] The medication source system 102 may obtain medication data. As an example, medication source system 102 may obtain medication data associated with a first type of medication delivered or scheduled to be delivered via the same lumen to a patient and a second type of medication delivered or scheduled to be delivered via the same lumen to the patient. [Para. 0138] The medication data (i.e. attribute data of first and one or more second medication(s)) is associated with at least one of the following: an identifier of a type of a medication, a scheduled delivery of the medication via a particular medication source device, and/or lumen, a previous delivery of the medication via a particular medication source device and/or lumen, an amount of the medication, an identifier of a patient to which the medication is scheduled to be delivered (or delivered), one or more identifiers of one or more different types of medication that are incompatible for delivery via a same lumen with the medication, and/or the like. [Para. 0139] As shown in FIG. 9, at step 904, process includes determining compatibility of medications. For example, medication source system 102 may determine compatibility of medications. As an example, medication source system 102 may determine, based on the medication data, a compatibility of the second type of medication for delivery via the same lumen as the first type of medication.
and in response to determining that the one or more second medications are not compatible in each of (i), (ii), and (iii): ([Para. 0075] automatically determining a compatibility of medications delivered and/or scheduled to be delivered via a same lumen and/or inhibiting or preventing delivery of incompatible medications via the same lumen, which may enable improved reduction or elimination of IV line complexity and/or medication delivery errors and/or improved compliance with lumen maintenance procedures (e.g., line flushing, etc.). [Para. 0088] For example, li the patient is connected to a single lumen, the order can indicate to deliver give saline on the “pink” line and to deliver antibiotics on the same “pink” line, etc. However, if there is a drug incompatibility ordered, the order can alter the user that additional flushing is indicated for the “pink” line to ensure that the pink line properly flushed before subsequent medications that may be incompatible with medications or fluids previously delivered via the “pink” line are delivered. As an example, if there are two lumens connected to a single patient (e.g., a single “pink”′ line and a single “blue” line) an order may indicate to deliver saline via the “pink” lumen or line and deliver antibiotics via the “blue” lumen or line, and/or the like. [Para. 0141] If medication source device 102 determines that the second type of medication is incompatible for delivery via a first lumen 212a, medication source device 102 may determine a compatibility of the second type of medication for delivery via an alternative lumen, such as a second lumen 212b based a third type of medication delivered or scheduled to be delivered via the second lumen 212b and, if the second type of medication is compatible for delivery via the same lumen as the third type of medication, provide the indication that the second type of medication is compatible for delivery via the second lumen 212b.)
and assign the one or more second medications for delivery to the patient via the new medication delivery pathway. ([Para. 0088] A first patient may have a “pink” LED light illuminated on smart device 104, and an order from a doctor and/or a pharmacy that includes a new type of medication or therapy to be delivered and instructions for a user (e.g., a nurse, etc.) to deliver the new type of medication on the one and only “pink” line to implement an error checking process. If smart device 104 is emitting a color of light other than the “pink” light (e.g., a “green” light or a “blue” light) and the order for the medication indicates a that the medication should only be delivered via a “pink” colored lumen, the user (e.g., the nurse, etc.) may initiation of delivery to the patient (e.g., not deliver the medication to the patient, etc.) because the user can determine that the order and the color does not match, which indicates that there may be an issue and/or an incompatibility with medication for the patient and/or the lumen. As an example, if there are two lumens connected to a single patient (e.g., a single “pink”′ line and a single “blue” line) an order may indicate to deliver saline via the “pink” lumen or line and deliver antibiotics via the “blue” lumen or line, and/or the like.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient as taught by Cottin, controlling medication delivery from a central location as taught by Vanderveen, and incorporate a plurality of sensors and automatically determining a compatibility of medications delivered and/or scheduled to be delivered via a same lumen as taught by Isaacson, with the motivation of with the motivation of enabling improved reduction or elimination of IV line complexity and/or medication delivery errors and/or improved compliance with lumen maintenance procedures (Isaacson Para. 0075).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cottin (WO 2019001879 A1) in view of Vanderveen (US 20050171815 A1) in view of Isaacson (US 20220115106 A1) in view of Sigg (US 20100274221 A1).
REGARDING CLAIM 20
Cottin/ Vanderveen/ Isaacson teach the computer-implemented method of claim 1, wherein the at least one first other medication was delivered or is being delivered via a medication delivery pathway of the available medication delivery pathways, ([Pg. 3, Col. 1. Lines 23-25] A multiplicity of infusion devices for administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient, and a control device for controlling the multiplicity of infusion devices.)
Cottin does not explicitly teach, however Sigg teaches
wherein the pathway data is received from at least one sensor of the plurality of sensors coupled to the same medication delivery pathway as the at least one first medication, and wherein the pathway data is associated with the at least one first medication delivered or being delivered via the same medication delivery pathway. ([Para. 0009] The pressure sensor is configured and positioned such that the pressure sensor is capable of detecting pressure changes in the lumen of the catheter to control the rate that the therapeutic fluid is delivered from the reservoir to the lumen of the catheter and are configured to modify the rate of delivery based on intralumenal pressure detected by the pressure sensor. [Para. 0011] The pressure sensor is configured to measure internal pressure of the catheter.)
Therefore, it would be prima facie obvious to one of ordinary skill in the art, at the time of filing, to modify the method of administering a multiplicity of medical fluids through an infusion line of an infusion set to the patient as taught by Cottin, controlling medication delivery from a central location as taught by Vanderveen, and incorporate automatically determining a compatibility of medications delivered and/or scheduled to be delivered via a same lumen as taught by Isaacson, and incorporate a pressure sensor is configured to detecting pressure changes in the lumen of the catheter in order to control the delivery rate that the therapeutic fluid to the patient as taught by Sigg, with the motivation of delivering therapeutic agents for the treatment of pulmonary arterial hypertension (PAH) (Sigg Para. 0006).
Response to Arguments
Applicant's arguments, see pgs. 13-17 “Claim Rejections under 35 U.S.C. 101”, filed 12/11/2025, have been fully considered but they are not persuasive.
Applicant submits that independent claim 1 is directed to an improvement in the functioning of a computer or an improvement to other technology or technical field. Applicant further submits that independent claim 1 is directed to a unique and unconventional method of obtaining pathway data associated with pathways from a sensor system, obtaining prescription data associated with medications prescribed for delivery to a patient, and determining medication delivery pathways for delivery of the medications to the patient, which may be used to prompt installation of a new medication delivery pathway and to assign the medications for delivery to the patient via the new medication delivery pathway. Examiner respectfully disagrees. Examiner has identified the functions of obtaining prescription data associated with medications prescribed for delivery to a patient, and determining medication delivery pathways for delivery of the medications to the patient, which may be used to prompt installation of a new medication delivery pathway and to assign the medications for delivery to the patient via the new medication delivery pathway as being part of the abstract idea. The function of obtaining pathway data associated with pathways from a sensor system is directed towards the medical sensor being used in its ordinary capacity which amounts to merely being a tool to execute the abstract idea, and thus does not integrate a judicial exception into a practical application or provide significantly more (MPEP § 2106.05(f)(2)). An improvement to the abstract idea of improving data collection for medication delivery does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(III) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG,921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”). There is no indication in the instant disclosure that the involvement of a computer assists in improving the technology for the outlined problem statement. Here, the improvement is to data collection. The instant application and claim language fail to detail how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient.
Applicant submits that, under Step 2B, the claim recites an invention that is not merely the routine or conventional use of computers or the Internet. Taking the limitations of claim 1, individually or in combination, they provide meaningful limitations with regard to an alleged judicial exception of organizing human activity. Examiner respectfully disagrees. As Examiner has identified the use of obtaining prescription data associated with medications prescribed for delivery to a patient, and determining medication delivery pathways for delivery of the medications to the patient, which may be used to prompt installation of a new medication delivery pathway and to assign the medications for delivery to the patient via the new medication delivery pathway as part of the abstract idea, the conventionality of obtaining prescription data associated with medications prescribed for delivery to a patient, and determining medication delivery pathways for delivery of the medications to the patient, which may be used to prompt installation of a new medication delivery pathway and to assign the medications for delivery to the patient via the new medication delivery pathway is not considered under Step 2B. The consideration under Step 2B is if the additional elements, alone or in combination, are well-understood, routine, and conventional in the field – the novelty of the abstract idea is not considered relevant under the Step 2B analysis. Here, the additional elements of Claim 1 reciting at least one processor, Claim 21 reciting one or more processors, and Claim 22 reciting a computer program product comprising at least one non-transitory computer-readable medium, that when executed by at least one processor, alone or in combination, amount to instruction to implement the abstract idea using a general-purpose computer.
Claims 1, 21, and 22 recite obtaining pathway data associated with pathways from a sensor system and is directed towards the medical sensor being used in its ordinary capacity which amounts to merely being a tool to execute the abstract idea, and thus does not integrate a judicial exception into a practical application or provide significantly more (MPEP § 2106.05(f)(2)).
Applicant’s arguments, see pg. 18 “Claim Rejections under 35 U.S.C. 112”, filed 12/11/2025, with respect to Claims 1, 4, 6-12, and 12-22 have been fully considered and are persuasive. The rejection of the claims has been withdrawn.
Applicant's arguments, see pgs.18-20 Claim Rejections under 35 U.S.C. 103”, filed 12/11/2025, have been fully considered but they are not persuasive.
Applicant argues that the cited references do not teach or suggest all of the limitations of claim 1. For example, neither the cited prior art teach alone or in combination, disclose, among other things, obtaining pathway data associated with all available medication delivery pathways for delivering medication to a patient from a medication delivery pathway sensor system, where the medication delivery pathway sensor system comprises a plurality of sensors coupled to the available medication delivery pathways to sense the pathway data associated with the available medication delivery pathways; obtaining first prescription data associated with one or more second medications prescribed for delivery to the patient from the medication delivery pathway sensor system and second prescription data associated with at least one first medication delivered, being delivered, or prescribed to be delivered to the patient; and determining according to at least one rule set, the pathway data, the first prescription data, and the second prescription data, one or more medication delivery pathways from the available medication delivery pathways for delivery of the one or more second medications to the patient, a medication delivery pathway sensor system including a plurality of sensors coupled to all available medication delivery pathways to sense pathway data associated with each of the available medication delivery pathways, and obtaining the pathway data associated with all available medication delivery pathways for delivering medication to a patient from the medication delivery pathway sensor system, at least one rule set including a rule associated with whether a medication including an attribute is compatible to be delivered to a patient via a same medication delivery pathway as another medication including another attribute; a rule associated with whether a medication is compatible to be delivered to a patient via a same medication delivery pathway as another medication if the same medication delivery pathway is flushed between deliveries of the medication and the another medication; and a rule associated with whether a medication is compatible to be delivered to a patient via a material of a medication delivery pathway, as recited in amended independent claim 1.
Examiner respectfully disagrees. Isaacson teaches at Para. 0087 as shown in FIG. 2A, the plurality of medication source devices 206a, 206b, . . . 206n may be connected to a plurality of lumens (e.g., fluid lines, etc.) 202a, 202b, . . . 202n (e.g., for receiving a fluid and/or a medication at medication source system 102) and/or a plurality of lumens (e.g., fluid lines, etc.) 212a, 212b, 212n (e.g., for delivering a fluid and/or a medication from medication source system 102, etc.). [Para. 0095] The sensor 254 includes at least one of: one or more force sensors (e.g., one or more piezoelectric elements or transducers, one or more force sensitive resistive (FSR) sensors, one or more strain gauges, etc.); one or more pressure sensors; one or more acoustic sensors; one or more optical sensors (e.g., an optical sensor configured to detect at least one of a color signature and a reflectance of a medical device connected to smart device 104, etc.), one or more identification sensors (e.g., an identification sensor configured to detect an identification tag on a medical device connected to or being connected to the needleless connector 214, such as a magnetometer configured to detect a magnetic material, a barcode scanner configured to read a bar code, etc.); one or more position sensors (e.g., a position sensor configured to detect movement of smart device 104, etc.); one or more RBG color sensors; or any combination thereof. This is indicative of obtaining pathway data associated with all available medication delivery pathways for delivering medication to a patient from a medication delivery pathway sensor system, where the medication delivery pathway sensor system comprises a plurality of sensors coupled to the available medication delivery pathways to sense the pathway data associated with the available medication delivery pathways, a medication delivery pathway sensor system including a plurality of sensors coupled to all available medication delivery pathways to sense pathway data associated with each of the available medication delivery pathways, and obtaining the pathway data associated with all available medication delivery pathways for delivering medication to a patient from the medication delivery pathway sensor system.
Cottin teaches at Col. 3 Lines 9-27 that infusions shall be multiplexed for administration to a patient. Herein, for administering the infusions a (single) infusion line having a (single) lumen may be employed (i.e. one or more medication delivery pathways), the multiple infusions being administered via the lumen towards the patient. Hence, for the administration of the multiple infusions a single port such as a catheter or the like may be used, hence reducing the number of ports to be provided on a patient and hence increasing the patient's comfort. For administering the multiple infusions to the patient, the control device (in a setup phase) shall define a sequence of packets of medical solutions. The control device (i.e. processor) herein is configured to define packets, each packet comprising one or multiple medical solutions (i.e. one or more medications) which, within the packet, shall be administered in parallel. A packet is a combination of any number of medical solutions, in particular drug solutions, intended to be infused to the patient in parallel via the infusion line. By forming packets, hence, multiple (compatible) medical solutions may be administered to the patient in parallel and hence in an effective manner, multiple packets being arranged in a sequence such that, during the actual administration, one packet of medical solutions after another is administered to the patient. Col. 4, Lines 17-21 further teaches the multiplex module of the control device may comprise an analyzing module configured to determine, using information obtained from a database (i.e. rule set), whether medical fluids of the multiplicity of medical fluids are compatible for 20 administration to the patient in parallel, wherein the scheduling module is configured to group at least two compatible medical fluids together to define a packet.). This is indicative of determining according to at least one rule set, the pathway data, the first prescription data, and the second prescription data, one or more medication delivery pathways from the available medication delivery pathways for delivery of the one or more second medications to the patient.
Vanderveen teaches at Para. 0043 that the bedside CPU 80 can be used by a nurse, physician or technician to access a variety of institutional databases to display a variety of information about a particular patient. This information can include an on-line, real-time, graphical patient medication administration record (MAR) that is derived from the patient's medication profile maintained by the hospital's pharmacy information system 20. The bedside CPU 80 also allows remote access to a patient's records stored by the file server 45 to display medication history for the patient. This medication history includes a listing of all drug or other treatments including past, present, and future deliveries (i.e. one or more medications prescribed and at least one other medication delivered, being delivered, or prescribed.) to the patient. Para. 0044 further teaches the bedside CPU further includes a database including a library or libraries of information concerning past and present medical administration activities and/or institutional guidelines for appropriate parameters for administration of various medications. For example, the guidelines may include institutionally established guidelines or limits on drug administration parameters, such as dosage, frequency of administration, and other delivery related information such as, for example, appropriate flow rates and infusion durations for programming infusion pumps. Para. 0039 teaches the processors or CPUs. Para. 0027 teaches that in FIG. 5 (Pg. 28) shows a patient IMAR (integrated medication administration record) showing scheduled medications (i.e. other medications) and windows around the scheduled times. This is indicative of obtaining first prescription data associated with one or more second medications prescribed for delivery to the patient from the medication delivery pathway sensor system and second prescription data associated with at least one first medication delivered, being delivered, or prescribed to be delivered to the patient.
Isaacson teaches at Para. 0009 that the first type of medication is delivered via the same lumen to the patient, wherein the second type of medication is scheduled to be delivered via the same lumen to the patient, and wherein the one or more processors are programmed and/or configured to provide the indication of whether the second type of medication is compatible for delivery via the same lumen associated with the same type of visual output by: controlling the medication source device to inhibit or prevent delivery of the second medication via the same lumen associated with the same type of visual output. Para. 0019 further teaches delivering, with the same lumen associated with the same type of visual output, the first type of medication to the patient, wherein the second type of medication is scheduled to be delivered via the same lumen to the patient, and wherein providing the indication of whether the second type of medication is compatible for delivery via the same lumen associated with the same type of visual output further comprises: controlling the medication source device to inhibit or prevent delivery of the second medication via the same lumen associated with the same type of visual output. This is indicative of at least one rule set comprises including a rule associated with whether a medication including an attribute is compatible to be delivered to a patient via a same medication delivery pathway as another medication including another attribute.
Isaacson teaches at Para. 0088 that the patient is connected to a single lumen, the order can indicate to deliver give saline on the “pink” line and to deliver antibiotics on the same “pink” line, etc. However, if there is a drug incompatibility ordered, the order can alter the user that additional flushing is indicated for the “pink” line to ensure that the pink line properly flushed before subsequent medications that may be incompatible with medications or fluids previously delivered via the “pink” line are delivered. This is indicative of a rule associated with whether a medication is compatible to be delivered to a patient via a same medication delivery pathway as another medication if the same medication delivery pathway is flushed between deliveries of the medication and the another medication.
Vanderveen teaches at Para. 0069 shown in FIG. 9, database 122 includes a protocol module 124 comprising a plurality of protocols 126, 128, 130, 132, 134. 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 drug name 136, concentration 138, container size(s) 140, nominal dose rate 142, initial bolus 144, maximum dose rate 146, minimum dose rate 148, maximum cumulative dose 150, volume/dose 152, adverse drug interactions 154, side effects 156, patient condition incompatibilities 158 and an ID field, record pointer 160, for identifying or "calling" the protocol record. Each field typically includes stored default parameter values that collectively define a specific infusion protocol. Some fields, such as drug interactions 154, include a reference or link to another database or drug library containing relevant information. 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. This is indicative of a rule associated with whether a medication is compatible to be delivered to a patient via a material of a medication delivery pathway.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia K Edouard whose telephone number is (571)272-6084. The examiner can normally be reached Monday - Friday 7:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at 469-295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.K.E./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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