Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
This Non-Final Office Action is in response to Applicant communication dated 05/11/2026. Applicants’ response amended claims 1 and 14, cancelled claims 2 and 15, and added new claims 40-41. Claims 1, 3-14, 16-20 and 40-41 are pending and rejected as follows.
Response to Amendment
The 35 U.S.C. 101 rejection is withdrawn in view of the amendments to the claims. The claims now recite additional elements of implementing the nutrition plan by “operating a motor of the wearable nutrition device to drive a pump that pumps a fluid from a container of the wearable nutrition device through a cross-cutaneous access point and into a patient” and implementing an updated nutrition plan “with the wearable nutrition device by delivering the fluid to the patient in accordance with the updated nutrition plan”. These elements are directed to a particular machine integral to implementation of the method and/or are otherwise found to provide a meaningful limit on the recited abstract idea such that when viewed as a whole the claimed invention integrates the recited abstract idea into a practical application.
The declaration filed 05/11/2026 is acknowledged. Applicant’s remarks regarding the prior art rejections over Piper US 20220087904 A1 are persuasive. The 35 U.S.C. 102 rejection and 103 rejections in the prior office action are therefore withdrawn. However, the claims are newly rejected under 35 U.S.C. 103 as set forth below.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 3-6, 8-12, 16, 18, 20, and 40-41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francis US 20200163843 A1 (hereinafter “Francis”) in view of Gaines et al. US 20150342835 A1 (hereinafter “Gaines”).
Regarding Claim 1, Francis teaches: A method comprising: ([0002]: “method for monitoring administration of nutrition”, [0013]: “enteral” nutrition)
inputting patient data of a patient; ([0088]: “The processor assembly 101 can access information about the patient from digital information systems, such as databases 114a-c, other computer systems, and/or user input. Such information can include, for example, demographic information”)
generating a nutrition plan based on the patient data; ([0090]-[0091]: “If there is a substantial difference, the processor assembly 101 determines an adjustment, which can include changing the formula to be administered or administration parameters for the formula. Administration parameters include, for example, administration rate (weight/time or volume/time), duration, and/or total weight or volume, for a selectable number of time intervals.”; [0089]: “An analysis can be performed that compares formulas and determines the optimal formula for the patient in view of the patient's medical and nutritional status and history.”, [0092]: “An adjustment can be calculated to adjust the administration parameters to compensate for a difference between the patient's nutritional requirements and the patient's nutritional intake.”)
implementing the nutrition plan with a … nutrition device; ([0093]: “the processor assembly 101 can control the pump 102 to output the formula in accordance with selected administration parameters.”, [0069])
wherein implementing the nutrition plan comprises operating a motor of the … nutrition device to drive a pump that pumps a fluid from a container of the … nutrition device through a cross-cutaneous access point and into a patient; ([0067]-[0069]: “The pump 102 can be used to administer enteral formula to patients that are unable to normally ingest food due to, for example, the inability to swallow. The term administer, with reference to formula administration refers to outputting the formula so that it flows toward the patient, e.g., via a catheter. The pump 102 can administer enteral formula to a patient via an implantable or temporary enteral access device, such as a naso-gastric feeding tube (NGT), a percutaneous endoscopic gastrostomy (PEG) device”)
detecting a parameter with the … nutrition device; ([0075]: “the measurement capture device 108 includes a flow meter, or the equivalent, that measures a rate of flow of formula that exits the pump 102”)
generating an updated nutrition plan based on the nutrition plan and the parameter; and ([0086]: “The processor assembly 101 processes the received measurement data to determine the patient's nutritional intake.”; [0090]-[0091]: “If there is a substantial difference, the processor assembly 101 determines an adjustment, which can include changing the formula to be administered or administration parameters for the formula.”)
implementing the updated nutrition plan with the … nutrition device by delivering the fluid to the patient in accordance with the updated nutrition plan. ([0091]: “The adjustment can be implemented by providing a supplemental bolus or a series of supplemental boluses of the selected formula using selected administration parameters. Alternatively, the administration parameters already being used for administering the formula can be adjusted, e.g., for each time interval or indefinitely.”; [0092]-[0093])
Francis fails to disclose that the nutrition device is “wearable”. Gaines however teaches a wearable enteral nutrition device (Fig. 1-3; [0063]: “Battery back-up may also be advantageous, for example, for using the module 48 in an ambulatory mode that enables the patient to move within and potentially at a distance from a treatment location, for example, with a pump 1 that is a portable feeding device. In this configuration, for example, the pump 1, the transceiver 17, and module 48 may be conveniently carried in a patient-wearable backpack.”; ) which provides monitoring and delivery of nutritional solutions (e.g. see [0051], [0053]-[0054]: “monitor the pumping parameters and intermittently, continuously, or continually adjust the instantaneous operating flow rate for the pump 1 to achieve a target feeding rate.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have modified Francis’ method for generating nutrition plans for enteral nutrition to include using a wearable enteral nutrition device for delivery of the formulations in view of Gaines with the motivation to provide a more convenient device for enteral nutrition that allows the patient to be ambulatory (e.g. see Gaines [0063]) (see MPEP 2143 G).
Regarding claim 3,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis further teaches: wherein patient data includes gender, date of birth, height, weight, activity level, goal weight, organic preference, time preference, or any combination thereof. ([0115]: “The demographic information can include, for example, birthdate, age, gender, height,”)
Regarding claim 4,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis further teaches: wherein the parameter includes nutritional intake. ([0086]: “The processor assembly 101 processes the received measurement data to determine the patient's nutritional intake.”)
Regarding claim 5,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis further teaches: further including generating a nutrition report, wherein the nutrition report includes a historical view of patient nutrition. (see Fig. 3A-3D; [0124]: “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.”)
Regarding claim 6,
Francis in view of Gaines teach all the elements of parent claim 5 as described above.
Francis further teaches: wherein the nutrition report includes a score, and wherein the score is determined based on calories consumed, activity level, water consumed, micronutrition, patient demographic information, or any combination thereof. (see Fig. 3A “318”; [0131]: “A second bar 318 indicates that on day 2, the patient met his/her daily caloric requirement along with a surplus of +710 calories. A bar 320 indicates that on the day 3, the daily caloric goal was again met, with a surplus of +177 calories.”)
Regarding claim 8,
Francis in view of Gaines teach all the elements of parent claim 5 as described above.
Francis further teaches: wherein the nutrition report is accessible via a network. (Fig. 1A and [0112]-[0113])
Regarding claim 9,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis further teaches: wherein generating the nutrition plan is based on a database of parameters from a plurality of users. ([0098] “The processor assembly 101 can use the information about the patient, as well as aggregated data about other patients with similar conditions or demographics (e.g., by consulting aggregated knowledge base 122), to perform data analysis, conduct research studies, make diagnoses, and make recommendations with respect to which formula to administer and selection of optimal administration parameters.”)
Regarding claim 10, Francis further teaches: wherein the nutrition plan includes a custom formulation. ([0089]: “An analysis can be performed that compares formulas and determines the optimal formula for the patient in view of the patient's medical and nutritional status and history.”; [0098]; [0153]: “a recommendation for compensating for the nutritional deficit can be calculated using the patient's present nutritional requirements, predicted nutritional requirements for the patient, and information in nutrition database 118.”)
Regarding claim 11, Francis further teaches: wherein the nutrition plan includes a caloric goal, a plurality of feed times, a flow rate, a formulation, or any combination thereof. ([0091]: “the processor assembly 101 determines an adjustment, which can include changing the formula to be administered or administration parameters for the formula. Administration parameters include, for example, administration rate (weight/time or volume/time), duration, and/or total weight or volume, for a selectable number of time intervals.”; [0122]: “This can include determining a nutritional surplus or deficits accrued over a specified time period relative to the nutritional goals, and suggesting compensation over specified time”)
Regarding claim 12, Francis further teaches: wherein the nutrition plan includes a caloric goal ([0118]: “determine estimated nutritional requirements (e.g., goals). The goals include, for example, a daily caloric goal,”), a plurality of feed times, a flow rate, and a formulation. ([0091]: “the processor assembly 101 determines an adjustment, which can include changing the formula to be administered or administration parameters for the formula. Administration parameters include, for example, administration rate (weight/time or volume/time), duration, and/or total weight or volume, for a selectable number of time intervals.”; [0142])
Regarding claim 16,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis does not teach, however Gaines further teaches: wherein detecting the parameter includes detecting an acceleration with an accelerometer positioned within the wearable nutrition device. ([0050]: “Other pump electronics can include an accelerometer (not shown) for detecting motion of the pump 1.”, [0064]: “to remotely verify that certain parameters and components of the pump 1 are functioning properly, within predetermined operational ranges. The parameters of the pump 1 can include but are not limited to… accelerometer”)
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have modified Francis’ method for generating nutrition plans for enteral nutrition to include with an accelerometer positioned within the wearable nutrition device in view of Gaines with the motivation to ensure consistent and accurate delivery of nutritional solutions to patients and ensure proper functioning for health and safety of the patient (see Gaines [0053], [0064]).
Regarding claim 18,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis further teaches: wherein detecting the parameter includes receiving a user input from a user interface…, and wherein the user input is in response to nausea, bloating, discomfort, regurgitation, dislodgment, an error message, or any combination thereof. ([0195] A change in the patient's status that warrants a recommendation for an updated formula calculation, a new formula, new formula administration parameters, and/or a compensation, can occur, for example, due to a user-entered update to the patient's status parameters or formula parameters; [0196] Patient status parameters that can affect the patient's nutritional requirements include, … feedback (about, e.g., energy level, gastric comfort, etc.); [0067]: The pump 102 can further include a control panel with a user interface, including a display and a user entry device…The user entry device includes, for example, a touch screen or keypad via which a user can enter information.)
Francis fails to describing receiving the user input from an interface “on the wearable nutrition device”.
Gaines however further teaches a user interface screen for receiving user input on the wearable nutrition device (see Fig. 1 “21” and [0047]: “The pump 1 may include a user interface with a display screen indicated at 21 on the front of the housing that is capable of displaying information about the status and operation of the pump (FIG. 1). … the display screen 21 to facilitate exchanging information, such as providing and obtaining information, between the pump 1 and a user… Various user interfaces for displaying information to the user and receiving user input may be implemented. Any of the various configurations of the user interface can involve utilizing one or more graphical display subcomponents. As an example, the display screen 21 may be a graphical user interface having a touch screen by which the user can provide the input information. ”; also [0054]; [0063]: “portable”)
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have modified Francis’ method for generating nutrition plans for enteral nutrition based on user feedback to include receiving user status information via a user interface of the wearable nutrition device in view of Gaines with the motivation to provide a more convenient device for enteral nutrition that allows the patient to be ambulatory (e.g. see Gaines [0063]) and enables the user to provide input for more accurate and effective nutrition delivery (see [0053]-[0054]: “used to ensure consistent and accurate delivery of nutritional or medicinal solutions to patients”) (see MPEP 2143 G).
Regarding claim 20,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis further teaches: further including displaying the parameter on a display
of the … nutrition device. ([0067]: “The pump 102 can further include a control panel with a user interface, including a display and a user entry device. The display displays information about the output of pump 102, such as the volume of formula that has been pumped, and/or alerts.”)
Francis fails to describe displaying “on the wearable nutrition device”.
Gaines however further teaches a user interface screen for displaying status information on the wearable nutrition device (see Fig. 1 “21” and [0047]: “The pump 1 may include a user interface with a display screen indicated at 21 on the front of the housing that is capable of displaying information about the status and operation of the pump (FIG. 1); [0063]: “with a pump 1 that is a portable feeding device… may be conveniently carried in a patient-wearable backpack”)
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have modified Francis’ method for generating nutrition plans for enteral nutrition and providing status information and alerts to the user to include displaying the information via a user interface of the wearable nutrition device in view of Gaines with the motivation to provide a more convenient device for enteral nutrition that allows the patient to be ambulatory (e.g. see Gaines [0063]) and enables the user to conveniently view and provide input for more accurate and effective nutrition delivery (see [0053]-[0054]: “used to ensure consistent and accurate delivery of nutritional or medicinal solutions to patients”) (see MPEP 2143 G).
Regarding Claim 40,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis further teaches: wherein generating the updated nutrition plan comprises determining an updated flow rate based on the parameter ([0080]: “measures a rate of flow of formula”), and wherein implementing the updated nutrition plan comprises adjusting operation of the motor to deliver the fluid at the updated flow rate. ([0091]: “ determines an adjustment, which can include changing the formula to be administered or administration parameters for the formula. Administration parameters include, for example, administration rate (weight/time or volume/time), duration, and/or total weight or volume, for a selectable number of time intervals.”; [0092]-[0093])
Regarding claim 41,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis further teaches: wherein generating the updated nutrition plan comprises determining an updated formulation based on the parameter, and wherein implementing the updated nutrition plan comprises operating the motor to drive the pump to deliver the updated formulation to the patient. ([0091]: “ determines an adjustment, which can include changing the formula to be administered or administration parameters for the formula. Administration parameters include, for example, administration rate (weight/time or volume/time), duration, and/or total weight or volume, for a selectable number of time intervals.”; [0092]-[0093])
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francis in view of Gaines, and further in view of Hogg et al. US 20200164209 A1 (hereinafter “Hogg”).
Regarding claim 7,
Francis in view of Gaines teach all the elements of parent claim 5 as described above.
Francis further teaches: wherein the nutrition report includes a score, and wherein the score is determined based on calories consumed, (see Fig. 3A “318”; [0131]: “A second bar 318 indicates that on day 2, the patient met his/her daily caloric requirement along with a surplus of +710 calories. A bar 320 indicates that on the day 3, the daily caloric goal was again met, with a surplus of +177 calories.”)
Francis describes receiving data regarding activity level (Fig. 3A “362”, Fig. 3C), water consumed ([0212]: “settings include…the formula (or water) used”), micronutrition ([0086], [0170]), and patient demographic information ([0192]; [0115]), but does not describe determining a score based on all of these metrics.
Hogg however teaches determining an aggregate/composite score based on all of the tracked metrics (see [0984]: “or an aggregate/composite weight management performance score which aggregates any of the data tracked by the third party device with any of the data tracked by the EDP device and/or Health Management application to yield a single composite score.”; [0217], [0988])
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have modified Francis in view of Gaines’ method for generating nutrition plans for enteral nutrition and providing nutritional reports of user goal compliance, as described above, to further include determining a composite score based on calories consumed, activity level, water consumption, micronutrition, and demographic information in view of Hogg with the motivation to provide the user with the ability to easily monitor and compare overall nutritional performance as well as using the scores to determine optimum and personalized settings/recommendations for nutritional plans (e.g. Hogg: [0910]: “The user can share her composite score (along with treatment or stimulation settings that led to the composite score) with friends and family via social networking (and/or with an online coaching or concierge service), to illicit advice, encouragement and compare progress with fellow dieters.”; [0912]) (see MPEP 2143 G).
Claim(s) 13, 14, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francis in view of Gaines, and further in view of Elia et al. US 10682288 B1 (hereinafter “Elia”).
Regarding claim 13,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis further teaches: wherein the patient data is collected by a …device. ([0106]: “The enteral facility server 104 can receive sensor data from sensor device(s) 116 that sense characteristics of the patient.)
Francis fails to clearly articulate that the data is collected by “a wearable device”.
Elia however teaches: wherein the patient data is collected by a wearable device. (col. 20 lines 8-40; col. 20 line 59 “wearable computer”; col. 12 lines 55-59 : “Wearable data may be integrated with EHR data, including data from sensors continuously measuring physical activity and glucose level”)
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have modified Francis in view of Gaines’ method for monitoring and managing nutrition delivery via a wearable device, as described above, to further include collecting patient data by a wearable device in view of Elia with the motivation to more easily and accurately monitor patient status and manage the patient’s nutritional plans and goals (e.g. see Francis [0195] and Elia col. 12 lines 55-59 : “ described herein may help to ensure that a patient's nutritional plan and goals are constantly measured, monitored and achieved”).
Regarding claim 14,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis further teaches: further including detecting a second parameter with a … device; ([0106]: “The enteral facility server 104 can receive sensor data from sensor device(s) 116 that sense characteristics of the patient.) and wherein generating the updated nutrition plan is at least partially based on the second parameter. ([0195]: “A change in the patient's status that warrants a recommendation for an updated formula calculation, a new formula, new formula administration parameters, and/or a compensation, can occur, for example, due to … a condition detected by a sensor device 116;”)
Francis fails to clearly articulate that the second parameter is detected by “a wearable device”.
Elia however teaches: further including detecting a second parameter with a wearable device; (col. 20 lines 8-40; col. 20 line 59 “wearable computer”; col. 12 lines 55-59 : “Wearable data may be integrated with EHR data, including data from sensors continuously measuring physical activity and glucose level”)
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have modified Francis in view of Gaines’ method for monitoring and managing nutrition delivery via a wearable nutrition device, as described above, to further include detecting a second parameter with a wearable device and generating the updated nutrition plan based on the detected second parameter in view of Elia with the motivation to more easily and accurately monitor patient status and manage the patient’s nutritional plans and goals (e.g. see Francis [0195] and Elia col. 12 lines 55-59 : “ described herein may help to ensure that a patient's nutritional plan and goals are constantly measured, monitored and achieved”).
Regarding claim 17,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Francis does not teach, however Gaines further teaches: wherein detecting the parameter includes detecting …with an accelerometer positioned within the wearable nutrition device. ([0050]: “Other pump electronics can include an accelerometer (not shown) for detecting motion of the pump 1.”, [0064]: “to remotely verify that certain parameters and components of the pump 1 are functioning properly, within predetermined operational ranges. The parameters of the pump 1 can include but are not limited to… accelerometer”)
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have modified Francis’ method for generating nutrition plans for enteral nutrition to include with an accelerometer positioned within the wearable nutrition device in view of Gaines with the motivation to ensure consistent and accurate delivery of nutritional solutions to patients and ensure proper functioning for health and safety of the patient (see Gaines [0053], [0064]).
Although Gaines describes using an accelerometer to detect motion, Gaines fails to describe specifically detecting orientation.
Elia however clearly describes detecting an orientation with an accelerometer (col. 26 lines 46-51: “The patient change in orientation may be detected … based on a sensor monitor orientation of a patient that may be worn on the patient (e.g., accelerometer, compass, angle sensor).”)
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have modified Francis in view of Gaines’ method for monitoring and delivering nutrition via a wearable device having an accelerometer, as described above, to further include detecting orientation using the accelerometer in view of Elia with the motivation to better manage automatic feeding by pausing feeding based on patient movement and orientation to improve delivery and prevent reflux (e.g. see Elia: col. 26 lines 16-51, col. 26 lines 63-65: “It is noted that pausing feeding during the detected change in patient orientation may prevent or reduce reflux.”).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francis in view of Gaines further in view of Bennett-Guerrero US 20120323091 A1 (hereinafter “Bennet”).
Regarding claim 19,
Francis in view of Gaines teach all the elements of parent claim 1 as described above.
Although Francis describes a PEG device which includes a gastric access device (see [0069]: “The pump 102 can administer enteral formula to a patient via an implantable or temporary enteral access device, such as a naso-gastric feeding tube (NGT), a percutaneous endoscopic gastrostomy (PEG) device”). Francis does not describe using the device to detect a pH, microbiome or gas.
Bennett however does teach: wherein detecting the parameter includes detecting with a gastric access device a pH, a microbiome, a gas, or any combination thereof. ([0496]: “For example, sensors can be attached to Percutaneous Endoscopic Gastrostomy (PEG) tubes often used for long term patient feeding. In one exemplary embodiment, a pH sensor is attached to a PEG tube to provide continuous, semi-continuous or intermittent pH measurements.”)
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to have modified Francis in view of Gaines’ method for monitoring and delivering nutrition via a wearable device, as described above, to further include detecting pH with a gastric access device in view of Bennett with the motivation to improve the monitoring of the patient’s response to feeding in order to provide more effective nutrition adjustments (see Bennett: [0496]: “The pH measurements provided by this pH sensor can provide data indicating the gastric system's response to the feed, whether the feed is being processed properly, necessity of further feeding or different types of feeding, etc.”).
Conclusion
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/SHELBY A TURNER/Supervisory Patent Examiner, Art Unit 2857
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