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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
Reference to “pharmacy system 134” (see Para 24) not present in Fig.1 or any figure.
In Para 69 recites, “line plots 400 and 401”, however 401 does not appears in any figure, only 400.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
Numeral reference “215” appears in Fig.2 but not in description.
Numeral reference “418 and 420” appears in Fig.4B but not in description.
In Fig.2 “EHR 228” does not appear in description, however in Para 45 “electronic medical record (EMR) system or database 228” is recited. Terminology mismatch between drawing and description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because the abstract should generally be limited to a single paragraph within the range of 50 to 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
In Para 33 recites, “direct network connection 154 (as shown in FIG. 1)”, however, “154” is “user interface device” (see Fig.1, Para 31, 34) and “152” is the “network connection”.
In Para 74-75 recites, “timeline 308”, however, “308” is “time plot” within “timeline 300”.
In Fig.2 and Para 45-46, “hospital network” is “226”, however in the specification Para 61 recites “hospital network 244”.
Appropriate correction is required.
Claim Objections
Claim 3, 8, 13, and 18 is/are objected to because of the following informalities:
In claim 3 and 13, “a medication” should read “the/said medication”.
In claim 8 and 18, “an instrument is in at least one of an in-use status or a not-in-use status” should read “an instrument is in an in-use status or a not-in-use status”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-2, 4-5, 8, and 11-12, 14-15, 18 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about to occur” in claim 1, 4-5, 8 and 11, 14-15, 18 is a relative term which renders the claim indefinite. The term “about to occur ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification gives 10 minutes and/or 20 minutes [para 100, 103] examples but no definition/standard/objective threshold for measuring it.
Regarding claim 1-2 and 11-12, the claims recites medication administration and “is prescribed”, it is unclear if it requires a physician’s order or merely clinical suitability. Such that the scope of the claim is indefinite.
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 1-20 are rejected under 35 U.S.C. 101 because the claim invention is directed to abstract ideas such as mental processes without significantly more.
Step 1: Claims 1-20 are directed either to a system/device and to a method/process.
Step 2A, Prong One: The claims recite abstract ideas including steps such as " identify a set of events … determine that the procedural event …" (see e.g. claim 1) using physiological information gathered from a patient (data gathering) recite a mental process, which could be performed by the human mind and/or by a human of a diagnostician with physical aid such as pen and paper and/or certain methods of human activity.
Step 2A, Prong Two: This judicial exception is not integrated into a practical application because the claims merely implement the mental process concepts using generic processing technology and add insignificant extra-solution activity. Specifically: the step of "a control interface configured to exchange infusion information … a processor; and a non-transitory, computer-readable storage medium … a display device …" is considered insignificant pre-solution activity of mere data gathering using generic computer components to perform the abstract idea, since it merely collects the data necessary to carry out the mental process; the steps of "provide, via a display device … receive, via the user interface …" is considered insignificant extra-solution activity since it merely supplies the input on which the mental process operates; and the steps of "prompt …. cause adjustment of the infusion device …; or cause …" is considered insignificant post-solution activity since it merely outputs the result of the mental process using a generic output modality. Causing the adjustment of the infusion device is not considered a particular treatment or prophylaxis since it is adjusting a non-specified medication under non-specific conditions. Furthermore, merely carrying out mental steps using generic computing technology is well established to not amount to an integration into a practical application under the § 101 analysis. See, MPEP §§ 2106.
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The only additional elements in the claims, individually and in combination, are well-understood routine and conventional components commonly found in a wide variety of medical devices including: a control interface, one or more sensors (e.g. microphone, sensor, etc.), processor, storage, display, RFID tag together with a generic infusion device. The Examiner takes official notice that these are basic, generic components which are well understood, routine and conventional in the medical diagnostic arts, individually and in combination, and the claims here merely use them for their well-understood, routine, and conventional functions. The reference cited in this action also demonstrates the use of these conventional elements. As such, those additional elements cannot be considered "significantly more" than the judicial exception in Step 2B of the § 101 analysis.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 7, and 11-13, 15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20200337648 A1 to Saripalli et al. (hereinafter “Saripalli”) in view of US 20110078608 A1 to Gannon et al. (hereinafter “Gannon”).
Regarding Claim 1 and 11, Saripalli teaches an intelligent control device for intelligent infusion (see Abstract, Para 57: “an example system 100 of FIG. 1, one or more medical devices 110 (e.g., ventilator, anesthesia machine, intravenous (IV) infusion drip, etc.) administer to a patient 120”(processor-based apparatus that act on an IV infusion drip); Fig.1-14) and a computer-implemented method of intelligent infusion (see Para 09: “a computer-implemented method for medical machine”), comprising:
a control interface configured to exchange infusion information with an infusion device and physiological information with a patient sensor (see Para 57-58: “an example system 100 … one or more monitoring devices 130 (sensor)… machine data 210 and physiological (e.g., vitals, etc.) data 220 from one or more medical devices 230 … provided in a data stream 260 … to a preprocessor 270 to pre-process … an actionable alert can be provided by the output 290 to adjust an IV drip …” and Para 148-149, Fig. 2, 11(communication interface 1110));
a processor (see Abstract: “at least one processor”; Para 07-08, Fig.11); and
a non-transitory, computer-readable storage medium storing instructions that, when executed by the processor (see Para 08: “one tangible computer-readable storage medium including instructions that, when executed, cause at least one processor to at least: execute one or more artificial intelligence models”; Para 26, 153, 184, Fig.14)), cause the intelligent control device to:
provide, via a display device, a user interface (see Para 96-98: “visualization can be generated … display and interaction with the data … a graphical user interface can display”; Para 144-147: “a sequence of user interface screens … a multi-patient view interface 1000 … a patient representation 1010-1020 can be selected to trigger an expanded single-patient view 1040 …”; Fig. 10A-10B) comprising;
operate, via the control interface, the infusion device to administer a medication at a first rate (see Para 58, 115-116: “An anesthetic infusion rate is learned from simulations run on a first physiological model 802 and a second physiological model 804 for a patient 806. The infusion rate is calculated (based on Equation 1) …”, Fig.8);
identify a set of events associated with the selected medical procedure, wherein the set of events comprises a procedural event that is expected to cause a physiological change for which an administration of the medication is prescribed (see Para 109-115: “Examples of OR decisions are transferring patients to post-anesthesia care units … applicable to event prediction … applied to predict an end of surgery event … monitoring infusion of an anesthetic such as propofol, etc., and correlating the monitored anesthesia with other patient events (e.g., beginning of surgery, end of surgery, patient distress, etc.)”; Para 165);
determine that the procedural event is about to occur based on the infusion information, the physiological information, or the selected medical procedure (see Para 58: “the event predictor 280 can predict, based on model(s) applied to the streaming 1D data, occurrence of event(s) such as heart attack, stroke, high blood pressure, accelerated heart rate …”; Para 111: “hybrid RL system can be applied to predict an end of surgery event … hybrid RL system can be used for emergence prediction, such as to predict when a patient wakes up post turning off anesthesia”; Para 115: “a patient model is used to train an RL agent … monitoring infusion of an anesthetic such as propofol, etc., and correlating the monitored anesthesia with other patient events …”; Para 165); and
responsive to determining that the procedural event is about to occur, and prior to an occurrence of the procedural event (see abstract: “when the artificial intelligence model(s) are executed to predict the future medical machine event, output an alert related to the predicted future medical machine event to trigger a next action”; Para 115-116: “RL agent or controller 820 is to minimize (or otherwise reduce) the error … (difference between the target and measured values of BIS and MAP and the action taken based on this)”; and Para 100, 167):
prompt, via the display device, an operator of the infusion device to cause an adjustment of the infusion device to administer the medication at a second rate different from the first rate (see Para 06, 58: “event predictor 280 forms an output 290 including one or more insights, alerts … an actionable alert can be provided by the output 290 to adjust an IV drip … change a medication dosage (from one rate to a different rate)”; Para 152, 167); or
cause, via the control interface, the adjustment of the infusion device to administer the medication at the second rate (optional feature but see Para 58 for medication dosage adjustment; Para 56 (“a machine can send a notification to another machine to lower anesthesia, reduce ventilator”), Para 115-116).
Saripalli teaches the intelligent control device for intelligent infusion, where the display has multiple patients data and can be selected to display only one patient data, also teaches medical procedures and treatment can be applied to corresponding predicted events. However, fails to disclose the display option to select a medical procedure via a user interface, receipt of that selection, and retrieval of an event set tied to the selected procedure.
Another reference, Gannon disclose methods, computer systems and computer readable media for receiving data from infusion pumps in a healthcare setting and displaying the data on a user device (see Abstract, Fig.2), where provide, via a display device, a user interface comprising an option to select a medical procedure (see Para 87-88: “the user device communication component 240 displays available data to a clinician … protocol component 246 presents the clinician with an interface that, in one embodiment, comprises a drop down box, shown in FIG. 15, allowing the clinician to select”;); receive, via the user interface, a selection of the medical procedure (see Fig.15, Para 89); and a set of events associated with the selected medical procedure (see 54: “a post-operative cardiothoracic surgery order may require monitoring vital signs at specific intervals, providing medications at varying doses through various methods of delivery, such as through an infusion pump … or performing other actions or activities that are time dependent”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed apparatus and methods of Saripalli which already teaches the intelligent infusion controller to be combined with the disclosed teaching of Gannon’s drop-down interface for selecting procedure-specific protocol, because Saripalli already requires procedure specific event models (see Para 54 and 115 “surgery data being collected). Such combination would provide user option to select for specific procedure, thereby would yield the predictable result of loading correct event set/data for procedure and eliminate error of inferring the procedure type, also one controller serve multiple different procedure type and avoid time consuming task of collect/record/review data.
Regarding Claim 2 and 12, Saripalli further discloses the intelligent control device and computer-implemented method of intelligent infusion, wherein: the physiological change expected to be caused by the procedural event comprises a physiological metric of a patient exiting a target zone (see Para 115-116: “a patient model is used to train an RL agent … used to monitor … bispectral index (BIS) and mean arterial pressure (MAP) values by monitoring infusion of an anesthetic … Action is taken based on a current state of the environment, which is observed as a difference of error 808 between target 810, 812 and measured 814, 816 values of BIS and MAP … A goal of the RL agent or controller 820 is to minimize (or otherwise reduce) the error” (target BIS/Map values define the target zone; control doses to drive the measured value back to target)); and
administering the medication to the patient, via the infusion device and after the occurrence of the procedural event, is prescribed for returning the physiological metric of the patient to the target zone (see Para 115-116: “Action is taken based on a current state of the environment, which is observed as a difference of error 808 between target 810, 812 and measured 814, 816 values of BIS and MAP”).
Regarding Claim 3 and 13, Saripalli further discloses the intelligent control device and computer-implemented method of intelligent infusion, wherein causing the administration of the medication via the infusion device comprises adjusting an amount of a medication currently being administered to a patient (see Para 58: “an actionable alert can be provided by the output 290 to adjust an IV drip, … change a medication dosage, … send data to another machine to adjust its settings/configuration, etc.”; and Para 115: “anesthetic infusion rate … calculated as shown below in Equation 1 …”).
Regarding Claim 5 and 15, Saripalli discloses the intelligent control device and computer-implemented method of intelligent infusion as described above, however, fails to disclose wherein: the set of events associated with the selected medical procedure comprises a detectable event that is to begin at a predetermined time; the procedural event is to occur at an amount of time after the predetermined time; and determining that the procedural event is about to occur comprises: detecting that the detectable event began at the predetermined time; and determining that a predetermined portion of the amount of time has passed since the predetermined time.
Gannon disclose intelligent infusion pumps in a healthcare setting, wherein: the set of events associated with the selected medical procedure comprises a detectable event that is to begin at a predetermined time (see Para 53-54: “data acquired from the infusion pump and vital signs collected by other medical devices are displayed to the user … a post-operative cardiothoracic surgery order may require monitoring vital signs at specific intervals, providing medications at varying doses through various methods of delivery, such as through an infusion pump … or performing other actions or activities that are time dependent”); the procedural event is to occur at an amount of time after the predetermined time (see Para 57-66); and determining that the procedural event is about to occur comprises: detecting that the detectable event began at the predetermined time; and determining that a predetermined portion of the amount of time has passed since the predetermined time (see Para 54-89 (protocol expressly sequences events/actions at different intervals (on arrival to ICU/post-operative monitoring)).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed apparatus and methods of Saripalli which already teaches the intelligent infusion controller to be combined with the disclosed teaching of Gannon’s event-timing techniques to determine when the procedural event occur and thereby initiate required/needed medication rate adjustment at appropriate time. Such modification would provide the predictable benefit of coordinating the administration of the medication with appropriate events associated with medical procedure, allowing medication adjustment as necessary.
Regarding Claim 7 and 17, Saripalli further discloses the intelligent control device and computer-implemented method of intelligent infusion, wherein: the selected medical procedure comprises a surgery (see Para 83, 109, 111-115); the procedural event comprises a step in the surgery (see Para 83: “a patient undergoing surgery …”); the medication comprises an analgesic, an anesthetic, or an antihypotensive agent (see Para 83: “an anesthetic device”); and causing the infusion device to administer the medication prior to the occurrence of the procedural event comprises causing the infusion device to administer the analgesic, the anesthetic, or the antihypotensive agent prior to the step in the surgery (see Para 115: “monitoring infusion of an anesthetic such as propofol … correlating the monitored anesthesia with other patient events (e.g., beginning of surgery, end of surgery …”).
Claims 4, 8-9 and 14, 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saripalli in view of Gannon as applied to claim 1 and 7 above, and further in view of US 20180247023 A1 to Divine et al. (hereinafter “Divine”).
Regarding Claim 4 and 14, Saripalli in view of Gannon discloses the intelligent control device and computer-implemented method of intelligent infusion as described above. Saripalli further disclose the interface circuit having an audio sensor, a microphone, a voice recognition system (see Para 187-190), and outputting an alert related to the predicted future medical machine event to trigger a next action (see Para 08-09).
However, fails to disclose the control interface is further configured to receive audio data from a microphone; and determining that the procedural event is about to occur; receiving, from the microphone, audio data captured in a predetermined space associated with the selected medical procedure and during a predetermined time associated with the selected medical procedure, wherein the audio data includes human speech data corresponding to the selected medical procedure; and determining, based on the selected medical procedure, the procedural event, and the human speech data, that the procedural event is about to occur.
Another reference, Divine disclose systems and computer-implemented methods providing auxiliary information regarding healthcare procedure and system performance (see Abstract and Para 04-07), wherein: the control interface is further configured to receive audio data from a microphone (see Para 29-30: “input/feedback can include audio spoken by the healthcare professional, the patient, other healthcare professionals involved in the procedure”, Para 58-60); and determining that the procedural event is about to occur comprises: receiving, from the microphone, audio data captured in a predetermined space associated with the selected medical procedure and during a predetermined time associated with the selected medical procedure, wherein the audio data includes human speech data corresponding to the selected medical procedure (see Para 63-65: “a certain phrase is captured in audio data (“I'm going to be administering your prescription now”) … based on reception of audio input from healthcare professional involved in a procedure stating “I'm preparing the IV site,” the procedure characterization component 114 can determine and/or generate corresponding descriptive data corresponding to keywords identified in the audio signal (e.g., prepare, IV, and site)”); and determining, based on the selected medical procedure, the procedural event, and the human speech data, that the procedural event is about to occur (see Para 64-65, 81-85: “information can identify one or more steps or actions that should be performed prior to the step or action the healthcare professional is initiating or currently performing … based on information determined by the procedure assessment component 116 that the healthcare professional has completed step 1 and/or is initiating step 2, the guidance component 126 can determine or retrieve information describing how to perform step 2 and provide this information to the healthcare professional at this time”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed apparatus and methods of Saripalli in view of Gannon which already teaches the intelligent infusion controller to be combined with the disclosed teaching of Divine to use procedure specific human speech/audio information to identify an impending procedural event. Such modification would provide the predictable benefit of more accurate identification of particular event of selected medical procedure is about to occur, thereby allowing the system to initiate appropriate medication adjustment at an appropriate time.
Regarding Claim 8 and 18, Saripalli further discloses the intelligent control device and computer-implemented method of intelligent infusion, wherein: the control interface is further configured to receive an instrument status from an instrument sensor, wherein the instrument status indicates whether an instrument is in at least one of an in-use status or a not-in-use status (see Para 57-58: “one or more monitoring devices 130 … data regarding … medical device operation … event predictor 280 forms an output 290 including one or more insights, alerts, actions, etc., for a system, machine, user”); the selected medical procedure requires that the instrument status change from the not-in-use status to the in-use status prior to the occurrence of the procedural event (see Para 56: “DL model, etc., can determine or predict when to react to an alarm versus turn the alarm off”); and determining that the procedural event is about to occur comprises detecting, via the control interface, that the instrument status changed from the not-in-use status to the in-use status (Para 75-77).
However, fails to explicitly disclose instruments status from a sensor and status changes to predict upcoming procedural events.
Divine disclose the systems and computer-implemented methods, wherein: the control interface is further configured to receive an instrument status from an instrument sensor, wherein the instrument status indicates whether an instrument is in at least one of an in-use status or a not-in-use status; the selected medical procedure requires that the instrument status change from the not-in- use status to the in-use status prior to the occurrence of the procedural event; and determining that the procedural event is about to occur comprises detecting, via the control interface, that the instrument status changed from the not-in-use status to the in-use status (see Para 30: “feedback can include motion data regarding motion of a medical instrument or device used during the procedure”; Para 64: “certain type of medical instrument is found in image data … for the system to detect the procedure is underway”; and Para 53 (information regarding operating status … associated with the equipment); Para 60: “characteristics can relate to a state, status, or appearance of systems and equipment used in a procedure”; Para 78: “the procedure characterization component 114 can identify the objects in the environment, as well as the state or status of the objects, including medical instruments, supplies and devices (e.g., on/off, used/unused, working properly/improperly, etc.), and the relative positions of the objects”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed apparatus and methods of Saripalli in view of Gannon which already teaches the intelligent infusion controller to be combined with the disclosed teaching of Divine to have instruments status information to detect when a required surgical instrument changes used/unused status. Doing such modification would provide the benefit of using identifiable instruments status as an additional indication that associates with procedural events status, thereby permitting the medication adjustment time to be more accurate.
Regarding Claim 9 and 19, Saripalli in view of Gannon discloses the intelligent control device and computer-implemented method of intelligent infusion as described above.
However, fail to disclose a radio-frequency identification (RFID) tag to detect the instrument status change.
Divine disclose the systems and computer-implemented methods, wherein: the instrument comprises a radio-frequency identification (RFID) tag (see Para 67: “radio frequency identification tag (RFID) detection methods”); and detecting that the instrument status changed comprises detecting a change in an RFID signal from the RFID tag (see Para 67, 134-135).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed apparatus and methods of Saripalli in view of Gannon which already teaches the intelligent infusion controller to be combined with the disclosed teaching of Divine to have a radio-frequency identification (RFID) tag for detecting the instrument status, thereby providing automatic instruments identification without adding additional task for the surgical team.
Claims 6 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saripalli in view of Gannon as applied to claim 5 above, and further in view of WO 2021119593 A1 to Kovacheva et al. (hereinafter “Kovacheva”).
Regarding Claim 6 and 16, Saripalli in view of Gannon discloses the intelligent control device and computer-implemented method of intelligent infusion as described above. However, fails to disclose determining that the detectable event began at the predetermined time comprises determining that the physiological information satisfies a predetermined threshold.
Another reference, Kovacheva disclose a system and method to control a therapeutic delivery system (see Abstract and Para 4-6), wherein determining that the detectable event began at the predetermined time comprises determining that the physiological information satisfies a predetermined threshold (see Para 18: “the patient parameters can be used to assign a plurality of categorical parameters to the user according to thresholds for monitored patient parameters or rule sets that act upon time series of values for the monitored patient parameters, for example, representing the presence or absence of a given condition or behavior”; and Para 37: “the model can alert the user if the patient behavior is unusual … provide an alert if a monitored patient parameter deviates from a desired range … alerts if the predicted phenylephrine dosage rises above a threshold … to administer at the infusion system 152”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed apparatus and methods of Saripalli in view of Gannon which already teaches the intelligent infusion controller to be combined with the disclosed teaching of Kovacheva to use predetermined physiological threshold to determine when the detectable event has begun. Such modification would benefit using objective physiological information to detect initiation of the events and thereby would improve determination of procedural event and corresponding medication adjustment.
Claims 10 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saripalli in view of Gannon as applied to claim 1 above, and further in view of “The control of blood glucose in the critical diabetic patient: a neuro-fuzzy method” to Dazzi et al. (hereinafter “Dazzi”).
Regarding Claim 10 and 20, Saripalli further discloses the intelligent control device and computer-implemented method of intelligent infusion, wherein Gannon further disclose infusion pumps infuse fluids, medications and/or nutrients into the circulatory system of an individual or patient (see Para 34) including insulin medication, current rate of the infusion, and administration of the medication (see Para 114: “user interface 800 showing infusion data for a selected patient … include dopamine 810, insulin 815, …”).
However, fails to disclose administer the medication prior to the occurrence of the procedural event comprises causing the infusion device to administer the insulin prior to the administration of the nutrition to the patient via the medical device.
Another reference, Dazzi disclose conventional algorithms for regulating insulin infusion rates (see Abstract), wherein: the medication comprises insulin (see Introduction: “the parenteral administration of nutrients is needed … algorithms to adjust insulin infusion rates have been proposed”); and causing the infusion device to administer the medication prior to the occurrence of the procedural event comprises causing the infusion device to administer the insulin prior to the administration of the nutrition to the patient via the medical device (see Materials and methods: “the insulin infusion rate is the input to be adjusted to reach the desired BG value. In a conventional control system, observed and desired outputs are compared. The input is modified to reach the desired output according to a mathematical model that defines the relationships between the input and the output of the system …”; and Abstract: “insulin infusion rates were adjusted, every 4 h at any step between −1.5 and +1.5 U/h … the neuro-fuzzy control system is effective in improving the BG control in critical diabetic patients”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the disclosed apparatus and methods of Saripalli in view of Gannon which already teaches the intelligent infusion controller to be combined with the disclosed teaching of Dazzi to coordinate insulin administration with the administration of the nutrition to the patient, thereby coordinating medication delivery with a known physiological event associated with nutrition.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20220265143-A1- Art relevant as whole (see Abstract and invention summary)
US-11324880-B2 - Art relevant as whole (see Abstract and summary)
US-20210361863-A1 - Art relevant as whole (see Abstract and summary)
US-9501619-B2 - Art relevant as whole (see Abstract and summary)
US-7945452-B2 - Art relevant as whole (see Abstract and summary)
US-20100271218-A1 - Art relevant as whole (see Abstract and summary)
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/I.J./Examiner, Art Unit 3792 /JOHN R DOWNEY/Primary Examiner, Art Unit 3792
