DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
In the submission dated 10/16//2025, no amendments were made.
Claims 1 – 18 and 27 – 30 have been previously canceled.
Claims 19 – 26 and 31 – 41 are pending.
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 19 – 26 and 31 – 41 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The claim(s) recite(s) subject matter within a statutory category as a process (claims 19 – 26 and 31 – 35), a machine (claims 36 – 41) which recite steps of
receiving instruction to initiate an infusion of at least a first drug to a patient by an infusion device, the infusion being consistent with one or more first parameters of a first care area in a hospital and including at least a drug/fluid information and a usage context;
establishing an in-progress infusion to a patient by the infusion device;
determining that the infusion device is transitioning from a first care area to a second care area;
determining that a modular portion of the infusion device is physically removed from the first care area and moved to the second care area;
comparing the drug/fluid information and usage context of the in-progress infusion against the corresponding second parameters defined for the second care area;
from the compared drug/fluid information and usage context, making a compatibility determination by matching the drug/fluid information and usage context of the in-progress infusion to an allowable range of the second parameters defined for the seconds care area,
wherein the making of the compatibility determination comprises identifying whether the in-progress infusion is a good match or a partial match,
wherein the good match comprises a match between the drug/fluid information and the usage context for the in-progress infusion and the second parameters and all infusion parameters fall within the allowable range specified for the second care area and
wherein the partial match comprises a match between the drug/fluid information and the usage context for the in-progress infusion and the second parameters but one or more in-progress infusion parameters of the in-progress infusion fall outside of an allowable range specified in the second parameters;
selecting a handling mode of the in-progress infusion in the second care area based on the compatibility determination; and
continuing and modifying the in-progress infusion by applying operations specified in the selected handling mode,
wherein the handling mode comprises transitioning the infusion device from the first profile of the first care area to the second profile of the second care area while the in-progress infusion is allowed to continue, each profile comprising general care-area-specific configuration settings and a list of drugs/fluid-specific settings, wherein according to the good match said transitioning is provided by applying all configuration settings from the second care area and wherein according to the partial match the handling mode comprises notifying a user to bring all parameters violating limits in the second care area into compliance
activating a visual or audio alarm.
The Examiner notes his claim interpretation. The claim ends with:
activating a visual or audio alarm to notify a user to bring all parameters violating limits in the second care area into compliance and automatically stopping the in-progress infusion.
The question regards what the last clause, “and automatically stopping the in-progress infusion.” Because it is after another clause, the Examiner understands that they are related. As in
activating a visual or audio alarm to notify a user to…
bring all parameters violating limits in the second care area into compliance
and
automatically stopping the in-progress infusion.
Therefore, the Examiner believes that the final limitation, “automatically stopping the in-progress infusion” is a potential action performed by the user.
The Examiner makes this determination by reviewing the claimed invention in light of the Specification. The invention is generally described in paragraph 2:
TECHNICAL FIELD
[0002] The subject matter described herein relates to infusion devices and uses thereof in a treatment setting, such as for example a hospital. In particular, the current subject matter is directed to management of infusions of drugs, fluids, and the like as a patient is transitioned between different care areas within the treatment setting.
To note how the prior-art manual process works, the Specification describes this in paragraphs 14 – 16:
[0014] As part of the infusion setup process, the end user (for example a nurse) can be required to select an appropriate, current care area for a patient. As noted above, the care area can be based on one or more of a physical location (e.g. ICU, NICU, trauma, surgery, etc.), a patient type (e.g. adult medical/surgical), and the like depending on how the care areas are partitioned or otherwise defined within the hospital.
[0015] An issue that frequently arises with DERS systems in a hospital environment involves handling of ongoing infusions when a patient is transferred from a first care area to a second care area. One approach to dealing with infusions that are in process or otherwise ongoing when a patient is transferred from the first care area to the second care area is to force a shutdown of the infusion system. When the system is subsequently powered on, infusions consistent with one or more parameters or settings defined for the second care area can be selected by the end user (e.g. a nurse).
[0016] A hard shutdown approach as discussed in the preceding paragraph can be effective in assuring that each infusion occurring after transition to the second care area is consistent with parameters, settings, etc. that are appropriate for the second care area. However, a hard shutdown and restart of infusions based on a new set of parameters, settings, etc. appropriate to the second care area can be very disruptive of the infusion process. Each infusion must be stopped, reprogrammed, and restarted, which can result in delay, additional clinician (e.g. nurse, other end user, etc.) time, and potential negative clinical consequences (for example for drugs for which an interruption in delivery of even a very brief duration can alter the pharmacological effect). Additionally, a drug or fluid infusion initiated in the first care area might not be available under the parameters established for the second care area to which the patient has been transitioned. If the clinically appropriate approach would be to continue to infuse a given drug or fluid according to the parameters of the first care area until the current dosing of that drug of fluid has completed, the end user would be required either to delay switching the patient from the first care areas to the second care area for all of the currently ongoing drug or fluid infusions for that patient, or to switch the care area to the second care area and continue delivery of the given drug or fluid independently of the DERS system. Neither of these options is desirable from a patient care and safety standpoint.
Note how the Specification describes the invention in paragraph 18 as overcoming these manual problems.
[0018] To address these and potentially other difficulties with currently available solutions, implementations of the current subject matter can provide capabilities that allow for hospital management, end users (e.g. clinicians, nurses, etc.) caring for a patient, etc. to seamlessly and safely transition a patient from a first care area to a second care area without requiring that one or more infusion devices providing drugs, fluids, etc. to the patient be power cycled, reprogrammed, etc.
The invention is described as one that improves the user process. The invention is not described as overcoming a technical problem. Further, the end result of the invention is data with a potential usage and therefore there is no practical application.
The Examiner understands “modifying” in light of the Specification. Here are the instances where the word appears:
[0031] If a partial match infusion is indicated or otherwise determined, the infusion device can complete the transition from the first care area to the second care area. The end user can be notified ( e.g. via a user interface or other communication approaches) that the DERS limits are being violated. While the infusion is running, the end user is allowed to modify the infusion parameters, and such modifications are validated against the limits defined in the second care area. The end user can be allowed to repeat or resume this infusion. However all parameters that violate limits in the second care area can be required to be brought into compliance.
[0033] If a bad match is indicated or otherwise determined, the infusion can be allowed to complete under the first care area. While the infusion is running, the end user can be permitted to modify the infusion parameters, which are validated against the limits defined for the first care area. The end user can repeat or resume this infusion. However all parameters that violate limits in the second care area can be required to be brought into compliance.
[0038] An alternative but related scenario occurs in the case of a modular infusion system where each infusion module has the ability to function independently, or may be attached to an aggregate system and function as an integrated part of it. In this situation, an implicit change in care area can occur when the module with its active infusion and care area is attached to the larger system, which has its own running infusions and care area. The described resolution process can be used to assimilate the new infusion into the aggregate system, with some modifications. In particular, the user choices for a blocked infusion might be to (1) remove the module or (2) to leave it and have the system stop the infusion.
Therefore, it is understood that all in process modifications are considered applied manually. As stated within paragraph 16, “Each infusion must be stopped, reprogrammed, and restarted, which can result in delay, additional clinician (e.g. nurse, other end user, etc.) time, and potential negative clinical consequences (for example for drugs for which an interruption in delivery of even a very brief duration can alter the pharmacological effect).”
The patient “transitioning” is described as a manual operation. This is emphasized in paragraph 18, copied above, as “seamlessly and safely transition a patient from a first care area to a second care area.” The concept that the patient and the infusion device are moved together to different hospital care areas is repeated in paragraph 24, “Subsequent to initial programming of an infusion device, during which settings and limits from a first care area in which the infusion device is being operated are applied, implementations of the current subject matter enable a seamless transition of the infusion device, and the patient receiving an infusion from the infusion device, from a first care area to a second care area "on the fly." The invention describes what happens as a patient is physically moved between care areas.
Understanding the patient movement is relevant to understanding how this invention relates to organizing human activity. The invention is directed to care provided during patient movements. This limitation, “determining that a modular portion of the infusion device is physically removed from the first care area and moved to the second care area” was a manual activity as shown above in paragraph 18. It is the application of technology to the abstract idea that achieves all the benefits of applying that technology. Paragraph 40 explicitly describes the use of technology
[0040] The transitioning from the first care area to the second care area can be performed in response to a user input identifying to an infusion device or infusion system including an infusion device that the transition is occurring. Alternatively, in the case of a modular infusion device that can be removed from a first central system in the first care area, moved with a patient to a second care area, and reattached to a second central system in the second care area, the transition can occur through communication of the modular diffusion device with the second central system to indicate that the modular device is now in the second care area. In yet another alternative, one or more location indication devices, such as for example a global positioning system (GOS) signal or other locator beacon, a wireless location signal of some other kind, etc., can be received by the infusion device to indicate that the transition has occurred.
Notice that the alternative to the manual process is the application of technology.
These steps of claims 19 – 26 and 31 – 41, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claim 20, reciting particular aspects of how associating drugs may be performed but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of by the infusion device amounts to invoking computers as a tool to perform the abstract idea)
add insignificant extra-solution activity to the abstract idea (such as recitation of receiving instructions amounts to mere data gathering, recitation of modifying behavior amounts to insignificant application, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 20 – 26, 31 – 35, and 37 – 41, additional limitations which amount to invoking computers as a tool to perform the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 19 – 26 and 31 – 41; instructions for execution by the at least one programmable processor, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii))
Additional Elements:
The Examiner believes that the claim is written from the standpoint of the Infusion Management System or Figure 3, #350. The Management system communicates to the remote pumps, #340(A). These pumps are designed to “apply” the results of the instant invention. As noted in more detail below, the result may be that nothing is change and therefore nothing is applied.
[0056] As noted above, containers housing fluids such as medication often vary from the volumes ordered by a pharmacist / clinician. A software-implemented infusion management platform 350 can be provided that includes a graphical user interface for tracking and monitoring infusions for one or more patients. The infusion management platform 350 communicates with the infusion modules 340A via the network 305. The infusion modules 340A can directly or indirectly provide various attributes relating to a particular infusion to the infusion management platform 350 (e.g., patient identifier, medication container identifier, medication type, rate of medication administration, infusion module identifier, etc.). Such attributes can be provided, for example, via messages sent from the infusion modules 340A. In some cases, the infusion management platform 350 receives medication orders from the medication ordering system 345 and then associates such orders with particular infusion modules 340A and/or particular patients (who are later associated with the infusion modules 340A).
The generic nature of the Infusion Management System and associated software is described within paragraphs 58 – 63.
Infusion device (emphasis added)
[0022] As shown in FIG. 1, each drug/fluid entry in the list of drugs/fluid-specific settings 110 can include several types of information. The drug/fluid information 112 contains information that unambiguously establishes the drug or fluid and its form. Examples of this type of information include the drug or fluid name and concentration (if applicable). A usage context 114 contains information that defines the particular clinical context for the use of this drug or fluid. Examples of this type of information can include therapy/indication, infusion device type (L VP, syringe ... ), or the like. Together, the drug/fluid information 112 and usage context 114 establish a clinical context for applying DERS limits and settings for delivery of that specific drug in a given care area. These limits and settings are contained in a drug/fluid settings entry 116 for each drug or fluid as shown in FIG. 1.
[0046] An infusion device can be part of an infusion system as noted above. Implementations of the current subject matter of the current subject matter are not restricted to any specific type of infusion devices or infusion systems.
[0052] Various types of medical devices 340 can be used as part of the computing landscape 300. For example, the landscape can include comprise various systems/ units for delivering fluid (including medication) to a patient. On particular type of medical device 340 is an infusion module 340A, which is an example of an infusion device consistent with the description above. The infusion modules 340A can include various types of infusion pumps including peristaltic infusion pumps, large volume infusion pumps, and syringe pumps. The infusion modules 340A can be directly coupled to the network 305 and/or they can be coupled to a medical device 340 which is, in tum, coupled to the network 340.
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 20 – 26, 31 – 35, and 37 – 41, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Response to Arguments
Applicant's arguments filed 10/16/2025 have been fully considered but they are not persuasive.
35 USC §101
The Applicant states, “The Applicant's claims include limitations that encompass processes in a way that cannot be practically performed in the human mind. For example, independent claims 19 and 36 recite making a compatibility determination by matching the drug/fluid information and usage context of the in-progress infusion to an allowable range of the second parameters defined for the seconds care area, wherein the making of the compatibility determination comprises identifying whether the in-progress infusion is a good match or a partial match, wherein the good match comprises a match between the drug/fluid information and the usage context for the in-progress infusion and the second parameters and all infusion parameters fall within the allowable range specified for the second care area and wherein the partial match comprises a match between the drug/fluid information and the usage context for the in-progress infusion and the second parameters but one or more in-progress infusion parameters of the in-progress infusion fall outside of an allowable range specified in the second parameters.” Yet, Specification paragraph 16 states that this check was performed by an “end user.” The result of this compatibility check was then (from paragraph 16)
If the clinically appropriate approach would be to continue to infuse a given drug or fluid according to the parameters of the first care area until the current dosing of that drug of fluid has completed, the end user would be required either to delay switching the patient from the first care areas to the second care area for all of the currently ongoing drug or fluid infusions for that patient, or to switch the care area to the second care area and continue delivery of the given drug or fluid independently of the DERS system. Neither of these options is desirable from a patient care and safety standpoint.
The instant invention was designed to apply technology to the abstract idea to achieve the benefits of applying that technology to the abstract idea. As stated by paragraph 18
[0018] To address these and potentially other difficulties with currently available solutions, implementations of the current subject matter can provide capabilities that allow for hospital management, end users (e.g. clinicians, nurses, etc.) caring for a patient, etc. to seamlessly and safely transition a patient from a first care area to a second care area without requiring that one or more infusion devices providing drugs, fluids, etc. to the patient be power cycled, reprogrammed, etc.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Davis et al Pub. No.: US 2009/0171289 A method and system is disclosed for operating a medical device with or without a cassette in place.
Bentwich Pub. No.: US 2012/022107 An implantable (and/or non-implantable) 'Brain Optimizer' neuronal stimulator system aimed at optimizing neurophysiological brain functions associated with different brain diseases ( or enhancing normal brain functioning or traits)
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 Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571)272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626