DETAILED ACTION
This action is in reference to the communication filed on 21 MAY 2026.
Per the claims filed on 19 DEC 2025, and the claims as filed on 21 MAY 2026, amendments to claims 1, 10, entered and considered, as is the cancellation of claims 6, 9, 15.
Claims 1-5, 7, 8, 10-14, 16, 17 are present and have been examined.
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 1-5, 7, 8, 10-14, 16, 17 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.
Claims 1, 10 each recite a limitation of “acquiring at least one of…” three pieces of specific information. Claim 1 then recites determining a parameter as at least one of the 3 pieces of information, by steps including comparing all three pieces of information. Claim 10 recites the actual acquiring step of at least one of the three pieces is accomplished by comparing and matching all three pieces of information, and the determination of the parameters is done according to at least one of the three pieces. As it is unclear which pieces of information are required or used at the identified limitations, the scope of the claim is indefinite. For example, in claim 1 the subject information could be “acquired,” and then it would be unclear if the additional information (i.e. the infusion demand and a vital sign parameter) would be acquired and/or required at a subsequent limitation of the claim during the determining/comparing steps. Similarly in claim 10, it is unclear how the comparing/matching of all three pieces of information occurs if only one piece is required to be acquired, and then how the determination of the parameter occurs with all three pieces. As such the scope of the claim is indefinite as it is not clear what pieces of information are required and/or acquired to execute the determination.
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 1-9 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1-9 the independent claim(s) 1, 9 recite(s) recite a method and an apparatus, each of which is a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1-5, 7, 8, the independent claim(s) (claims 1) is/are directed, in part, to (exemplary claim 1):
A nutrient infusion control method, comprising:
acquiring at least one of: nutrient infusion demand information, subject information, and a vital sign status parameter of a current subject;
automatically determining a first nutrient infusion parameter as at least one of the nutrient infusion demand information, the subject information, and the vital sign status parameter by;
retrieving historical feeding parameters of the current subject;
comparing and matching the nutrient infusion demand information, the subject information and the vital sign status parameter with the historical feeding parameters of the current subject; and
determining the historical feeding parameter of the current subject with the highest degree of matching as the first nutrient infusion parameter; and
controlling according to the first nutrient infusion parameter.
These claim elements are considered to be abstract ideas because they are directed to a mental process, in that the claims ensconce concepts performed in the human mind including observation, evaluation, judgment, and opinion functions. Acquiring subject information, determining a parameter based on the information, and applying the parameter are concepts requiring observation, evaluation and judgement. If a claim limitation, under its broadest reasonable interpretation, covers a concept performed in the human mind, then it/they falls/ fall into the “mental processes” category.
These claim elements are further considered to be abstract ideas because they are directed to a method of organizing human activity which include managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Acquiring information of a subject, determining a parameter, and performing a nutrient infusion according to said parameter is an interaction between the acquirer and the patient according to the rules/instructions in determining the parameter. If a claim limitation, under its broadest reasonable interpretation, covers commercial and legal interactions, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
As per claims 1-8, this judicial exception is not integrated into a practical application. Examiner notes claim 1 has been amended to recite a “nutrient infusion device” which is “controlled.” This device recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use (see MPEP 2106.05h). Examiner finds no improvement to the functioning of the device itself or any other technology or technical field as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general like between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e). While Examiner does not doubt the discomfort of enteral feeding, absent a computer controlling the feeding device or the actual device being positively recited, claim 1 is analogous to a pet owner determining how much and when to feed their dog. Examiner notes no other additional elements are presented for consideration at this step.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
As per claims 1-8, this judicial does not recite significantly more. Examiner notes claim 1 has been amended to recite a “nutrient infusion device” which is “controlled.” Turning to Applicant’s specification:
[066] As shown in FIG. 4, the nutrient infusion device 400 may include components such as a display 41, one or more buttons 42, a drive actuator 43, a silicone tube 44, a pump door 45, a consumable support plate 46, a nutrient solution line 47, and a flush solution line 48. In addition, the nutrient infusion device 400 includes at least a controller (not shown in the figures), and a drive member (not shown in the figures). The controller is electrically connected to the drive member, the drive member is drivingly connected to the drive actuator 43, and the drive actuator 43 is provided in a piping path of the delivery tube 40 (e.g., silicone tube 44, nutrient fluid line 47, or fluid solution line 48). The drive member, under the control of the controller, drives the drive actuator 43 to rotate so as to drive the fluid flow in the delivery tube 40 for nutrient infusion.
[0157] In the specific implementation of the above-described nutrient infusion device, it should be understood that the processor may be a Central Processing Unit (CPU), and may be other general purpose processors, a Digital Signal Processors (DSP), an Application Specific Integrated Circuit (ASIC), a Digital Signal Processor (DSP), and a Specialized Integrated Circuit (ASIC). The general-purpose processor may be a microprocessor or the processor may also be any conventional processor. The method disclosed in conjunction with embodiments of the invention may be directly embodied in a hardware processor to perform the completion, or performed with a combination of hardware and software modules in the processor to perform the completion.
From these paragraphs at least, it is readily apparent that the claim itself does not improve the functioning of the device itself nor any other technical aspect/element. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. the mere controlling of a feeding device. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. As such, the claims are directed to an abstract idea without significantly more.
Examiner notes these claims as presented do not recite any additional elements appropriate for consideration at this step.
As per dependent claims 2-8:
Dependent claims 2, 6, 7, 8 do not recite any additional abstract ideas than those identified above . Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as the information used to select parameters, and collect the information used to determine or find the parameters. While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Dependent claims 3, 4 do not recite any additional abstract ideas than those identified above. However, claim 3, 4 (claim 4 nominally, included for the sake of compact prosecution) disclose the display of information on an interface. Displaying information is merely insignificant extra solution activity, and as such is insufficient to support a finding of a practical application. No improvement nor anything more than a general link between the abstract idea(s) identified and the additional elements are found in the claims. As such the claims recite an abstract idea without significantly more.
Dependent claims 5 further recites the abstract idea(s) identified above, and at least nominally recites limitations which are directed to a model, which is within the mathematical process category of abstract ideas. Examiner notes there are no additional elements for consideration as a practical application or significantly more.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francis (US 20200163843 A1) in view of Sadeghzadeh et al (US 20230282328 A1, hereinafter Sadeghzadeh).
In reference to claim 1:
Francis teaches: A nutrient infusion control method, and apparatus, comprising:
acquiring at least one of: nutrient infusion demand information, subject information, and a vital sign status parameter of a current subject (at least [fig 2 and related text] “Fig 2 shows the patient's nutritional requirement information displayed in screen 200. Screen 200 includes a patient demographic area 202, patient status area 204, weight calculation area 206, nutritional requirement calculation area 208,…” i.e. nutritional requirement is the infusion demand; this information “can be entered by the user, imported from the HIS database 114a, the AIS database 114b, or the patient's EMR, etc.” see also [fig 1 and related text]) ;
automatically determining a first nutrient infusion parameter as at least one of the nutrient infusion demand information, the subject information, and the vital sign status parameter (at least [fig 2 and related text] “Formula and Schedule Calculations area 210 displays information such as the enteral formula selected, formula administrative parameters, the feed type (continuous, bolus, bolus duration, enteral or parenteral, or orally administered nutrition), the enteral goal rate, a start rate for administration to start at, and an increment rate. The rates can be described in terms of volume or nutrient amount per a time interval, such as calories per day. The start rate can be lower than the goal rate to gradually accustom the patient to administration of nutrition in the current form.“ “For example, it can be determined when patients having similar demographic, physical, or diagnostic characteristics respond well or poorly to a nutrition plan that has specific nutritional requirements… For example, when the patient's medical records indicate that the patient has osteoporosis or a family history of osteoporosis, the patient's nutritional requirement for calcium can be increased. When the patient has a history of iron deficiency, the patient's nutritional requirement for iron can be increased. However, when the patient has a medical condition of constipation, the patient's nutritional requirement for iron can be decreased.” See also [091-093, 0134-0136, 0144, and fig 7 and related text] for further discussion of parameters/calculation/selection); by
retrieving historical feeding parameters of the current subject (at least [0124] “ With reference to FIGS. 3A-3C, the GUI displays historical and/or predictive nutritional information for a selected patient. Screens 300, 370, 390, and 300′ shown in FIGS. 3A, 3B, 3C, and 3D, respectively, display nutritional history information for the selected patient based on information about the patient's nutritional intake that is recorded and stored over time.”);
comparing and matching the nutrient infusion demand information, the subject information, and the vital sign status parameter with [historical information] (at [0120] “The demographics and physical characteristics of patients having data stored in the databases 114a-114c can be analyzed and correlated with nutrition information. Trends can be determined. For example, it can be determined when patients having similar demographic, physical, or diagnostic characteristics respond well or poorly to a nutrition plan that has specific nutritional requirements.”); and
determining the historical feeding parameter [most suitable for the patient] (at least [0144] “The predicted data is calculated using the assumption that the present formula parameters will continue to be used during the time period of the anticipated future event. Alternatively, theoretical formula or formula administration data can be entered and processed. Additionally, the predicted data is calculated using the patient's present nutritional requirements or predicted nutritional requirements for the patient. The patient's predicted nutritional requirements can be determined based on a prediction of the patient's response to the formula to be administered using the predicted formula administration parameters, a medical procedure planned for a future time, and aggregated data from aggregated knowledge base 122, including data about patients with similar demographic, medical, nutritional history, and/or nutritional requirements as the patient.” – i.e. using the historical data of the user and demographics, a predicted formula administration parameter is determined based on best suited information); and
controlling a nutrient infusion device to infuse a nutrient into the current subject according to the first nutrient infusion parameter (at least [fig 8 and related text] “Area 820 displays current settings related to the current formula administration session. Tabs 812 and 816 are used to start and end a formula administration session. A formula administration session can correspond to administration of a formula for a particular time interval, such as a calendar day, a nurse's shift (e.g., a night shift or a day shift), or a continual feed until an event occurs, such as an administration parameter setting is changed). Actuation of tab 814 causes formula administration (or simulation thereof) to pause while a formula bag is being changed, or if there is an intentional interruption to the enteral feeding.”).
Francis as cited teaches the limitations above. In view of the rejection under 35 USC 112b, Examiner notes that the amended limitations regarding the historical feeding parameters of the individual user are not necessarily required by the claim, however, in the interest of compact prosecution, Examiner notes that Sadeghzadeh does teach:
Retrieving historical feeding parameters of the current subject (at least [fig 9 and related text] “ For example, one of an infusion device 102, 200, 502, 802, a client device 106, 806, or a remote computing device 108, 814 may retrieve or otherwise obtain the historical meal data associated with the patient from the database 816 and analyze the historical meal data to identify previous meal events logged, entered, or otherwise input by the patient or other user of the client device 106, 806.”);
Comparing and matching the nutrient infusion demand information, the subject information, and the vital sign status parameter with the historical feeding parameters of the current subject (at least [fig 9 and related text] “Based on the timestamps associated with those previous meal events and potentially other contextual information pertaining to operation of the infusion device 102, 200, 502, 802 (e.g., geolocation data, and/or the like), the probability of the patient consuming a meal at a particular point in time in the future or within a future prediction window (or horizon) in advance of the current time may be calculated based at least in part on the current operational context (e.g., the current time of day, the current day of the week, current geographic location of the infusion device 102, 200, 502, 802 or the client device 106, 806, and the like)” see also [095-96]); and
Determining the historical feeding parameter of the current subject with the highest degree of matching as the first nutrient infusion parameter (at least [fig 9/10 and related text including 093-097] “or example, each day (or 24-hour period) may be divided into a number of smaller time segments, with past meal events being assigned to particular individual segments of the day. In one exemplary embodiment, each day is divided into 15 minute segments (or 96 total segments per day). For each 15 minute segment, any meal event timestamped within a prediction horizon (e.g., the next 60 minutes) is assigned to that segment. The probability of meal presence within the prediction horizon can be determined using a conditional probabilistic model by dividing the number of days where there was a meal event within the prediction horizon for the current segment by the total number of days of meal history that exist. For example, if the current segment corresponds to the period between 8:00 A.M. and 8:15 A.M., the prediction horizon is 60 minutes, and for 7 days out of the 10 days of meal history the patient consumed a meal within the period between 8:00 A.M. and 9:00 A.M., the future meal probability may be estimated to be 70% at or within the time period between 8:00 A.M. and 8:15 A.M…. or each segment, the probability of a particular size or type of meal being consumed within the prediction horizon may also be determined by dividing the number of meals assigned to a particular size or type by the total number of meals within that prediction horizon. For example, for the 7 meals consumed within the period between 8:00 A.M. and 9:00 A.M., 4 meal events may have been indicated as having a small size, 2 meal events may have been indicated as having a medium or normal size, and 1 meal event may have been indicated as having a large size... should be noted that the historical meal data utilized to determine the future meal probabilities may be filtered to account for the current day of the week, the current geographic location of the patient, or potentially other factors.” At [fig 10] “ the event pattern control process 1000 continues by receiving or otherwise obtaining current measurement data for the patient and detecting or otherwise identifying the occurrence of an event based on the relationship or correlation between the patient's current measurement data and the patient's historical measurement data associated with occurrences of that type of event (tasks 1008, 1010). “) ; and
Controlling a nutrient infusion device to infuse a nutrient into the current subject according to the first nutrient infusion parameter (at least [fig 9/10 and related text including 0100-0103] “…the prospective closed-loop control process 900 automatically adjusts or modifies control information associated with the closed-loop control scheme to proactively increase insulin delivery in anticipation of a future meal in advance of receiving any meal indication from the patient (tasks 906, 908). For example, in one or more embodiments, the pump control system 520, 600 may automatically reduce the target glucose value 702 for a temporary duration of time corresponding to the prediction horizon when the predicted future meal probability within the prediction horizon is greater than a threshold value (e.g., greater than 50%). In some embodiments, the amount by which the target glucose value 702 is reduced is dependent on or influenced by the probable meal size… In one or more embodiments, after a period of time has elapsed without receiving a meal indication, the prospective closed-loop control process 900 may automatically revert to the original or normal closed-loop control information.”). Francis and Sadeghzadeh are analogous references as both use user specific historical data in a closed loop system. One of ordinary skill in the art would have found it obvious to limit the historical data/parameter information to the specific user as taught by Sadeghzadeh, as the reference teaches “Moreover, it should be noted that the event pattern control process 1000 may be performed in concert with the prospective closed-loop control process 900 of FIG. 9 to improve the patient's glucose management.”; and that such improvements would reduce the likelihood of any manual errors while also reducing patient workload (see 0101, 005). As such it would be obvious to consider the historical parameters of the specific patient when providing nutrients via closed loop system(s).
In reference to claim 2:
Francis further teaches: wherein the nutrient infusion demand information includes at least one of the following: a nutrient solution type (at least [fig 5 and related text] nutrient types), a feeding mode, a feeding rate, a feeding amount, and a feeding time (at least [fig 2, 3a-3c and related text] feed mode, feed type, feed rate, and scheduling considerations in 3a-3c in particular);
the subject information includes at least one of the following: weight, weight change, age, caloric consumption (at least [fig 2, 3a-3c] patient info includes weight, age, caloric consumption shown at element 208);
the vital sign status parameter includes at least one of the following: an end-expiratory carbon dioxide indicator, a hemodynamic indicator, a blood glucose indicator, a heart rate, a blood pressure, an electrocardiogram, a body temperature, a blood oxygen saturation, a pulse (at least [0105] lab tests/vitals [0162] blood sugar – Examiner notes this is a limitation recited in the alternative above, and is therefore not required.); and
the first nutrient infusion parameter includes at least one of the following: a type of nutrient solution, an infusion mode, an infusion rate, an infusion volume (at least [fig 2 and related text] “Formula and Schedule Calculations area 210 displays information such as the enteral formula selected, formula administrative parameters, the feed type (continuous, bolus, bolus duration, enteral or parenteral, or orally administered nutrition), the enteral goal rate, a start rate for administration to start at, and an increment rate. The rates can be described in terms of volume or nutrient amount per a time interval, such as calories per day. The start rate can be lower than the goal rate to gradually accustom the patient to administration of nutrition in the current form.“ “For example, it can be determined when patients having similar demographic, physical, or diagnostic characteristics respond well or poorly to a nutrition plan that has specific nutritional requirements… For example, when the patient's medical records indicate that the patient has osteoporosis or a family history of osteoporosis, the patient's nutritional requirement for calcium can be increased. When the patient has a history of iron deficiency, the patient's nutritional requirement for iron can be increased. However, when the patient has a medical condition of constipation, the patient's nutritional requirement for iron can be decreased.” See also [091-093, 0134-0136, 0144, and fig 7 and related text] for further discussion of parameters/calculation/selection).
In reference to claim 3:
Francis further teaches: displaying an interface for adjusting at least the first nutrient infusion parameter (at least [fig 2, 7m 8 and related text] fig 2 shows calculation parameters, fig 7 shows a deficit compensation parameter, fig 8 shows a level change element 818);
receiving input from the user in the interface for adjusting at least the first nutrient infusion parameter to determine a second nutrient infusion parameter (at least [figs 2, 7, 8 and related text] adjustments made in the calculation areas as well as the manual change, see also fig 11 and related text – a steps 112-1120 the deficit is corrected or accounted for with the parameters);
adjusting at least the first nutrient infusion parameter according to a second nutrient infusion parameter input by the user (at least [figs 2, 7, 8 and related text] parameters/flow/types of infusion are changed in the interface, “The increment rate is an amount by which the administration rate can be adjusted per a selected time increment to adjust the administration rate from the start rate to the goal rate during the administration session. Some of the data fields, e.g., formula selected, feed type, and start rate, can accept user entry data by an authorized user. When one data field is updated, the other fields can then be calculated and updated in accordance with the patient's nutritional requirements.” See also [fig 11 and related text] steps 1120/1122 apply the parameter change).
In reference to claim 4:
Francis further teaches: wherein, before the step of performing the nutrient infusion according to at least the first nutrient infusion parameter, the method further comprises:
displaying at least the first nutrient infusion parameter (at least [fig 8 and related text] “start feed” 812 shows the feed start and parameters including the formula and goal rate);
receiving a confirmation operation from the user to accept and apply at least the first nutrient infusion parameter (at least [fig 8 and related text] “start feed” 812 shows the feed start and parameters including the formula and goal rate).
Claim(s) 5, 7-8, 10-14, 16, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francis in view of Sadeghzadeh further in view of Elia et al (US 20200281819 A1, hereinafter Elia).
In reference to claim 5, 14:
Francis/Sadeghzadeh with regard to claim 1, or Francis/ Sadeghzadeh/Elia with regard to claim 10, teaches all the limitations above. Francis does teach a learning/prediction process it does not specifically teach a modeling process. Elias however does teach: wherein the step of determining the first nutrient infusion parameter as at least one of the nutrient infusion demand information, the subject information, and the vital sign status parameter, comprises:
inputting at least one of: the nutrient infusion demand information, the subject information, and the vital sign status parameter into a predetermined data analysis model, and determining an infusion strategy output from the predetermined data analysis model as the first nutrient infusion parameter (at least [0124] “Current patient-related parameters are fed into the trained model for outputting instructions for adjustment of the enteral delivered substances (e.g., water, medication, enteral formula), optionally for reducing likelihood of a future reflux event. The enteral delivered substances are adjusted according to the instructions.” At [0140] “At least some of the systems, methods, apparatus, and/or code instructions described herein address the technical problem by computing a risk of likelihood of a future reflux event by a model (e.g., classifier component of the model) that is dynamically updated by correlations computed for monitored reflux-related parameters and reflux events that occurred for the patient being enteral fed according to a baseline feeding profile. The risk of future reflux event is computed based on scheduled and/or predicted reflux-related parameters. The baseline feeding profile is dynamically adjusted based on the predicted likelihood of future reflux events, for reducing risk of the future reflux event. “ at [0100] “he model (e.g., classifier component) is trained according to computed correlations between the reflux-related parameters and the reflux event(s). Scheduled and/or predicted reflux-related events are fed into the model (e.g., classifier component) for outputting risk of likelihood of a future reflux event. The baseline feeding profile is adjusted for reducing likelihood of the future reflux event and for meeting the target nutritional goal. At least some implementations of the systems, methods, apparatus, and/or code instructions described herein include a learning and/or training model that automatically adjusts operating parameters to obtain a best fit for the specific patient. For example, when a certain medication has been previously associated with high risk of reflux, and the medication is scheduled to be administered again in the near future, the feeding rate may be reduced or even stopped in advance of the administration to prevent or further reduce risk of reflux.”). Elia and Francis are analogous as both references disclose adjusting nutrient dosing for a patient via parameters associated with the feeding/patient. Francis as cited does consider parameters and vital signs, and as such one of ordinary skill in the art would have found the use of a model/classifier as taught by Elia an obvious addition/modification to the calculations of Francis, as Elia teaches that modifications to a baseline profile using a trained model can mitigate potentially undesirable affects common to enteral feeding such as reflux, while meting target nutrition goals (see 008). Elia specifically teaches that “ Medical outcomes of patients may be improved by better control of enteral feeding, breathing, and/or urination.” (see 004).
In reference to claim 7, 16:
Francis/Sadeghzadeh with regard to claim 1, or Francis/ Sadeghzadeh/Elia with regard to claim 10, teaches all the limitations above. Francis teaches vital signs, but does not specifically disclose acquiring during the infusion process. Elia however does teach: acquiring the vital sign status parameter and an infusion parameter of the current subject during the nutrient infusion process (at least [fig 2c and related text] “Reference is now made to FIG. 2C which is a schematic of an environmental perspective of a patient 850 being fed via a feeding tube 852 by automatic adjustment of enteral feeding according to computed correlations for reduction of reflux computed by a main console 854 (e.g., including the computing device described herein that executes code of the model, e.g., AI machine), in accordance with some embodiments of the present invention. Patient-related parameters and/or reflux-related parameters of patient 850 are obtained from output of sensors 856 (e.g., skin sensors, impedance electrodes, inertial sensors, SpO2 sensor, cardiac sensor, vital sign sensors, skin electrodes, lung fluid measurement electrodes, limb electrodes, and others) and/or patient monitoring camera 858 and/or urine analyzer 860, as described herein. Data outputted from sensors may be fed into a hub 862, which communicates with main console 854 and/or may include an enteral feeding controller and/or pump… “); and
adjusting the first nutrient infusion parameter according to a preset parameter adjustment strategy when it is determined that at least one of the vital sign status parameter and the infusion parameter satisfies a preset parameter adjustment condition (at least [fig 2c and related text] “…Hub 826 and/or main console 854 may communicate with the server storing the EHR of the patient. Console 854 receives the data, computes correlations (e.g., to detect cross effects between feeding parameters, water, and/or medication administration), and generates instructions for adjusting enteral substances fed into the patient (e.g. formula, water, medications), as described herein.”). Elia and Francis are analogous as both references disclose adjusting nutrient dosing for a patient via parameters associated with the feeding/patient. Francis as cited does consider parameters and vital signs, and as such one of ordinary skill in the art would have found the ongoing monitoring of vital signs taught by Elia to be an obvious addition to ensure appropriate and adequate nutrient dosing for the patient. Such an improvement in monitoring would improve enteral feeding of a patient, and Elia specifically teaches that “ Medical outcomes of patients may be improved by better control of enteral feeding, breathing, and/or urination.” (see 004).
In reference to claim 8, 17 :
Francis/Sadeghzadeh with regard to claim 1, or Francis/ Sadeghzadeh/Elia with regard to claim 10, teaches all the limitations above. Elia further teaches: recording details of parameter adjustment during the nutrient infusion process; wherein the details of parameter adjustment comprise at least one of a parameter adjustment time and values before and after parameter adjustment (at least [fig 2 and related text] “monitoring database 214A that stores monitored data, for example indications of: reflux-related parameters, reflux-event parameters, and reflux events. “ at [fig 2a and related text] “Correlations are computed between reflux-related parameters 802 and reflux events 804, as described herein. Reflux events 804 may be denoted by appearance of reflux, which may be in a pattern (e.g., intensity, volume, over a time interval) posing a significant risk for triggering inspiration pneumonia. For example, high correlation values between reflux-related parameter 802 and reflux events 804 over a threshold (e.g., about 0.7, or 0.8, or 0.9, or 0.95, or other intermediate, smaller, or larger values) may generate instructions for adaption of patient management, for example, pausing the enteral feeding or reducing the rate of enteral feeding.” See also [fig 10/11 and related text] – during the enteral feeding the patient is monitored and that data/baseline is used to adjust the future feeding, i.e. recorded). The motivation to combine Francis/Elia pertaining to the adjustment during the feeding process is the same as explained under claims 8, 10 above, and is incorporated herein.
In reference to claim 10:
Francis teaches: A nutrient infusion device (at least [fig 1b, 1a and related text
wherein the nutrient infusion device further comprises a processor and a memory communicatively connected to the processor (at least figs 1a, 1b and related text] processor 101 and databases as shown, at [fig 12 and related text] processor 1220, memory 1203/memory 1206 – computing system connects to pumps 102/124);
the memory stores computer-executable instructions (at least [ fig 12 and related text] instructions 1220 stored on both main memory 1203, static memory 1206);
the processor is configured to execute the computer-executable instructions stored in the memory to (at least [fig 12 and related text] processor 1220 executing instructions 1202):
acquire at least one of nutrient infusion demand information, subject information, and vital sign status parameter of a current subject (at least [fig 2 and related text] “Fig 2 shows the patient's nutritional requirement information displayed in screen 200. Screen 200 includes a patient demographic area 202, patient status area 204, weight calculation area 206, nutritional requirement calculation area 208,…” i.e. nutritional requirement is the infusion demand; this information “can be entered by the user, imported from the HIS database 114a, the AIS database 114b, or the patient's EMR, etc.” see also [fig 1 and related text]) ;
determine a first nutrient infusion parameter according to at least one of the nutrient infusion demand information, the subject information, and the vital sign status parameter (at least [fig 2 and related text] “Formula and Schedule Calculations area 210 displays information such as the enteral formula selected, formula administrative parameters, the feed type (continuous, bolus, bolus duration, enteral or parenteral, or orally administered nutrition), the enteral goal rate, a start rate for administration to start at, and an increment rate. The rates can be described in terms of volume or nutrient amount per a time interval, such as calories per day. The start rate can be lower than the goal rate to gradually accustom the patient to administration of nutrition in the current form.“ “For example, it can be determined when patients having similar demographic, physical, or diagnostic characteristics respond well or poorly to a nutrition plan that has specific nutritional requirements… For example, when the patient's medical records indicate that the patient has osteoporosis or a family history of osteoporosis, the patient's nutritional requirement for calcium can be increased. When the patient has a history of iron deficiency, the patient's nutritional requirement for iron can be increased. However, when the patient has a medical condition of constipation, the patient's nutritional requirement for iron can be decreased.” See also [091-093, 0134-0136, 0144, and fig 7 and related text] for further discussion of parameters/calculation/selection) by:
retrieving historical feeding parameters of the current subject (at least [0124] “ With reference to FIGS. 3A-3C, the GUI displays historical and/or predictive nutritional information for a selected patient. Screens 300, 370, 390, and 300′ shown in FIGS. 3A, 3B, 3C, and 3D, respectively, display nutritional history information for the selected patient based on information about the patient's nutritional intake that is recorded and stored over time.”);
comparing and matching the nutrient infusion demand information, the subject information, and the vital sign status parameter with [historical information] (at [0120] “The demographics and physical characteristics of patients having data stored in the databases 114a-114c can be analyzed and correlated with nutrition information. Trends can be determined. For example, it can be determined when patients having similar demographic, physical, or diagnostic characteristics respond well or poorly to a nutrition plan that has specific nutritional requirements.”); and
determining the historical feeding parameter [most suitable for the patient] (at least [0144] “The predicted data is calculated using the assumption that the present formula parameters will continue to be used during the time period of the anticipated future event. Alternatively, theoretical formula or formula administration data can be entered and processed. Additionally, the predicted data is calculated using the patient's present nutritional requirements or predicted nutritional requirements for the patient. The patient's predicted nutritional requirements can be determined based on a prediction of the patient's response to the formula to be administered using the predicted formula administration parameters, a medical procedure planned for a future time, and aggregated data from aggregated knowledge base 122, including data about patients with similar demographic, medical, nutritional history, and/or nutritional requirements as the patient.” – i.e. using the historical data of the user and demographics, a predicted formula administration parameter is determined based on best suited information); and
controlling the nutrient infusion device to perform a nutrient infusion according to the first nutrient infusion parameter (at least [fig 8 and related text] “Area 820 displays current settings related to the current formula administration session. Tabs 812 and 816 are used to start and end a formula administration session. A formula administration session can correspond to administration of a formula for a particular time interval, such as a calendar day, a nurse's shift (e.g., a night shift or a day shift), or a continual feed until an event occurs, such as an administration parameter setting is changed). Actuation of tab 814 causes formula administration (or simulation thereof) to pause while a formula bag is being changed, or if there is an intentional interruption to the enteral feeding.”).
However, Francis does not teach the monitoring module as claimed. Elias however does teach: A nutrient infusion device provided with an integrated monitoring module; the integrated monitoring module being configured to collect vital sign status parameter of the subject (at least [fig 2c and related text] “Reference is now made to FIG. 2C which is a schematic of an environmental perspective of a patient 850 being fed via a feeding tube 852 by automatic adjustment of enteral feeding according to computed correlations for reduction of reflux computed by a main console 854 (e.g., including the computing device described herein that executes code of the model, e.g., AI machine), in accordance with some embodiments of the present invention. Patient-related parameters and/or reflux-related parameters of patient 850 are obtained from output of sensors 856 (e.g., skin sensors, impedance electrodes, inertial sensors, SpO2 sensor, cardiac sensor, vital sign sensors, skin electrodes, lung fluid measurement electrodes, limb electrodes, and others) and/or patient monitoring camera 858 and/or urine analyzer 860, as described herein. Data outputted from sensors may be fed into a hub 862, which communicates with main console 854 and/or may include an enteral feeding controller and/or pump… “) Elia and Francis are analogous as both references disclose adjusting nutrient dosing for a patient via parameters associated with the feeding/patient. Francis as cited does consider parameters and vital signs, and as such one of ordinary skill in the art would have found the ongoing monitoring of vital signs taught by Elia to be an obvious addition to ensure appropriate and adequate nutrient dosing for the patient. Such an improvement in monitoring would improve enteral feeding of a patient, and Elia specifically teaches that “ Medical outcomes of patients may be improved by better control of enteral feeding, breathing, and/or urination.” (see 004).
Francis/Elia as cited teaches the limitations above. In view of the rejection under 35 USC 112b, Examiner notes that the amended limitations regarding the historical feeding parameters of the individual user are not necessarily required by the claim, however, in the interest of compact prosecution, Examiner notes that Sadeghzadeh does teach:
Retrieving historical feeding parameters of the current subject (at least [fig 9 and related text] “ For example, one of an infusion device 102, 200, 502, 802, a client device 106, 806, or a remote computing device 108, 814 may retrieve or otherwise obtain the historical meal data associated with the patient from the database 816 and analyze the historical meal data to identify previous meal events logged, entered, or otherwise input by the patient or other user of the client device 106, 806.”);
Comparing and matching the nutrient infusion demand information, the subject information, and the vital sign status parameter with the historical feeding parameters of the current subject (at least [fig 9 and related text] “Based on the timestamps associated with those previous meal events and potentially other contextual information pertaining to operation of the infusion device 102, 200, 502, 802 (e.g., geolocation data, and/or the like), the probability of the patient consuming a meal at a particular point in time in the future or within a future prediction window (or horizon) in advance of the current time may be calculated based at least in part on the current operational context (e.g., the current time of day, the current day of the week, current geographic location of the infusion device 102, 200, 502, 802 or the client device 106, 806, and the like)” see also [095-96]); and
Determining the historical feeding parameter of the current subject with the highest degree of matching as the first nutrient infusion parameter (at least [fig 9/10 and related text including 093-097] “or example, each day (or 24-hour period) may be divided into a number of smaller time segments, with past meal events being assigned to particular individual segments of the day. In one exemplary embodiment, each day is divided into 15 minute segments (or 96 total segments per day). For each 15 minute segment, any meal event timestamped within a prediction horizon (e.g., the next 60 minutes) is assigned to that segment. The probability of meal presence within the prediction horizon can be determined using a conditional probabilistic model by dividing the number of days where there was a meal event within the prediction horizon for the current segment by the total number of days of meal history that exist. For example, if the current segment corresponds to the period between 8:00 A.M. and 8:15 A.M., the prediction horizon is 60 minutes, and for 7 days out of the 10 days of meal history the patient consumed a meal within the period between 8:00 A.M. and 9:00 A.M., the future meal probability may be estimated to be 70% at or within the time period between 8:00 A.M. and 8:15 A.M…. or each segment, the probability of a particular size or type of meal being consumed within the prediction horizon may also be determined by dividing the number of meals assigned to a particular size or type by the total number of meals within that prediction horizon. For example, for the 7 meals consumed within the period between 8:00 A.M. and 9:00 A.M., 4 meal events may have been indicated as having a small size, 2 meal events may have been indicated as having a medium or normal size, and 1 meal event may have been indicated as having a large size... should be noted that the historical meal data utilized to determine the future meal probabilities may be filtered to account for the current day of the week, the current geographic location of the patient, or potentially other factors.” At [fig 10] “ the event pattern control process 1000 continues by receiving or otherwise obtaining current measurement data for the patient and detecting or otherwise identifying the occurrence of an event based on the relationship or correlation between the patient's current measurement data and the patient's historical measurement data associated with occurrences of that type of event (tasks 1008, 1010). “) ; and
Controlling a nutrient infusion device to infuse a nutrient into the current subject according to the first nutrient infusion parameter (at least [fig 9/10 and related text including 0100-0103] “…the prospective closed-loop control process 900 automatically adjusts or modifies control information associated with the closed-loop control scheme to proactively increase insulin delivery in anticipation of a future meal in advance of receiving any meal indication from the patient (tasks 906, 908). For example, in one or more embodiments, the pump control system 520, 600 may automatically reduce the target glucose value 702 for a temporary duration of time corresponding to the prediction horizon when the predicted future meal probability within the prediction horizon is greater than a threshold value (e.g., greater than 50%). In some embodiments, the amount by which the target glucose value 702 is reduced is dependent on or influenced by the probable meal size… In one or more embodiments, after a period of time has elapsed without receiving a meal indication, the prospective closed-loop control process 900 may automatically revert to the original or normal closed-loop control information.”). Francis and Sadeghzadeh are analogous references as both use user specific historical data in a closed loop system. One of ordinary skill in the art would have found it obvious to limit the historical data/parameter information to the specific user as taught by Sadeghzadeh, as the reference teaches “Moreover, it should be noted that the event pattern control process 1000 may be performed in concert with the prospective closed-loop control process 900 of FIG. 9 to improve the patient's glucose management.”; and that such improvements would reduce the likelihood of any manual errors while also reducing patient workload (see 0101, 005). As such it would be obvious to consider the historical parameters of the specific patient when providing nutrients via closed loop system(s).
In reference to claim 11:
Francis/ Sadeghzadeh/Elia teaches all the limitations above. Elia further teaches: wherein the integrated monitoring module comprises one or more of the following modules: a respiratory parameter detection module, a hemodynamic detection module, and a blood glucose detection module; wherein the respiratory parameter detection module is configured to collect end-expiratory carbon dioxide indicators, the hemodynamic detection module is configured to collect hemodynamic indicators (at least [0157] “Data may include output by one or more other patient sensors 202E, for example, urinalysis device, pulse oximeter (e.g., for sensing SpO2), urine sensor (e.g., sensing amount of urine and/or concentration of urine), calorimetry sensor, blood test machine, lung function machine, vital sign measurement devices (e.g., blood pressure sensor, heart rate sensor, breathing rate sensor, temperature sensor). Other sensors 202E may be described in the applications incorporated by reference listed herein. “, and the blood glucose detection module is configured to collect blood glucose indicators. Elia and Francis are analogous as both references disclose adjusting nutrient dosing for a patient via parameters associated with the feeding/patient. Francis as cited does consider parameters and vital signs, and as such one of ordinary skill in the art would have found the ongoing monitoring of vital signs taught by Elia to be an obvious addition to ensure appropriate and adequate nutrient dosing for the patient. Such an improvement in monitoring would improve enteral feeding of a patient, and Elia specifically teaches that “ Medical outcomes of patients may be improved by better control of enteral feeding, breathing, and/or urination.” (see 004).
In reference to claim 12:
Francis/ Sadeghzadeh/Elia teaches all the limitations above. Francis further teaches: displaying an interface for adjusting at least the first nutrient infusion parameter (at least [fig 2, 7m 8 and related text] fig 2 shows calculation parameters, fig 7 shows a deficit compensation parameter, fig 8 shows a level change element 818);
receive input from the user in the interface for adjusting at least the first nutrient infusion parameter to determine a second nutrient infusion parameter (at least [figs 2, 7, 8 and related text] adjustments made in the calculation areas as well as the manual change, see also fig 11 and related text – a steps 112-1120 the deficit is corrected or accounted for with the parameters);
adjust at least the first nutrient infusion parameter according to a second nutrient infusion parameter input by the user (at least [figs 2, 7, 8 and related text] parameters/flow/types of infusion are changed in the interface, “The increment rate is an amount by which the administration rate can be adjusted per a selected time increment to adjust the administration rate from the start rate to the goal rate during the administration session. Some of the data fields, e.g., formula selected, feed type, and start rate, can accept user entry data by an authorized user. When one data field is updated, the other fields can then be calculated and updated in accordance with the patient's nutritional requirements.” See also [fig 11 and related text] steps 1120/1122 apply the parameter change).
In reference to claim 13:
Francis/ Sadeghzadeh/Elia teaches all the limitations above. Francis further teaches: wherein, before the step of performing the nutrient infusion according to at least the first nutrient infusion parameter, the method further comprises:
display the first nutrient infusion parameter (at least [fig 8 and related text] “start feed” 812 shows the feed start and parameters including the formula and goal rate);
receive a confirmation operation from the user to accept and apply at least the first nutrient infusion parameter (at least [fig 8 and related text] “start feed” 812 shows the feed start and parameters including the formula and goal rate).
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20160143817 A1 to Elia discloses calculating enteral feeding needs for a patient.
US 20080306353 A1 to Douglas discloses metabolic and other vital sign considerations for nutritional needs.
Response to Arguments
Applicant’s response to the Notice of non-compliant response are noted on 21 MAY 2026.
Applicant’s remarks as filed on 19 DEC 2026 are fully considered.
Applicant’s remarks regarding the 101 rejection begin on page 7. Applicant’s remarks are noted; Examiner does not dispute the actual tube feeding process, however, claim 1 is still directed to controlling a machine, rather than the machine itself performing the actions. The amendments/ remarks are not persuasive.
Applicant’s remarks regarding claim 9 are noted, the cancellation of claim 9 negates the rejections under 35 USC 112a/b.
Examiner notes that Applicant does not respond at all to the rejections of claims 1-5, 7, 8, 10-14, 16, 17 under 35 USC 112b, and that said rejections affect the prior art rejection.
Applicant’s remarks regarding the prior art begin on page 8. Applicant’s remarks appear focused on the newly amended limitations, and as such the remarks are found to be moot in view of the updated grounds of rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
