Cited 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 .
Domestic Benefit
Acknowledgement is made of applicant’s claim to domestic benefit.
Detailed Action
The following NON-FINAL Office Action is in response to application 18/387,614 filed on 11/07/2023.
Status of Claims
Claims 1-20 are currently pending and have been rejected as follows.
Drawings
The drawings filed on 11/07/2023 are accepted.
IDS
The information disclosure statements have been acknowledged and received.
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 claimed invention is directed to a judicial exception without significantly more. A subject matter eligibility analysis is set forth below. See MPEP 2106.
Representative claim 1 recites:
A method comprising:
inputting patient data;
generating a nutrition plan;
implementing the nutrition plan with a wearable nutrition device;
detecting a parameter with the wearable nutrition device;
and generating an updated nutrition plan based on the parameter.
The claim limitations in the abstract idea have been highlighted in bold; the remaining limitations are “additional elements.”
Under step 1 of the analysis, claim 1 does belong to a statutory category, namely it is a process claim.
Under Step 2A, Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04, subsection II, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Under Step 2A, Prong One, the broadest reasonable interpretation consistent with the specification of the steps recited in Claim 1 include at least one judicial exception, that being a mental process. This can be seen in the claim limitations of “Generating a nutrition plan” (Figure 3) and “Generating an updated nutrition plan based on the parameter”, where (0071) “the term "automated nutrition plan" is an optimized feeding regimen for a patient that is updated based on monitoring and data collection of system parameters, physiological inputs, and/or real-time monitoring of users”, where (0099) “Collected data is used in artificial intelligence and machine learning to make automated adjustments to a nutrition plan in real-time”, where (0101) “the automated feeding algorithm calculates calories and contents (carbohydrates, protein, fats) automatically”, and where (0101) “the automated feeding algorithm is executed on the network” or “executed locally on the wearable nutrition device (e.g., a processor in the module)”.
Given the broadest reasonable interpretation of what is recited in the claim language, “generating a nutrition plan” involves receiving a patient and their corresponding identification information, having the patient fill out a questionnaire, and recommending the patient nutrition types, water intake, feeding times, etc… This process can be reasonably completed within the human mind through a series of evaluations and judgements and is therefore considered to be a mental step. The process of “generating an updated nutrition plan” involves mental steps including calorie and macronutrient calculations based on input data, which can reasonably be done mathematically via evaluation within the human mind with the aid of pen and paper. Therefore, these claim limitations fall into the category of mental process.
Step 2A, Prong Two of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception(s) into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55.
In addition to the abstract ideas recited in claim 1, the claimed machine recites additional elements including “Implementing the nutrition plan with a wearable nutrition device”, which includes (0019) “operating a motor to drive a pump of the wearable device, whereby a fluid is pumped from a container to a patient”.
Under Step 2B, the claim limitation does not include an additional element that is sufficient to amount to significantly more than the judicial exception because the additional elements merely involve insignificant extra-solution activit(ies) (claim 1). Such insignificant extra-solution activity is further found to be well-understood, routine, and conventional according to MPEP 2106.05(d)(II) and as evidenced by Piper who discloses (0043) a method for mobile fluid infusion, which includes (0025) a wearable housing that facilitates simplified portable feeding, which references (0020) to a “Nutrient Reservoir” referring to a container that is used to hold enteral nutrient formula and deliver contents to the disposable pump head through the pump tubing where (0038) a drive motor operates to affect the action of a disposable pump for administration of the fluid.
In addition, as evidenced by Elia who discloses (0071) tubes delivering enteral nutrition to patients using a (0084) control unit which may include wearable computers or watch computers where the control unit includes (0085) a computer-controlled pump and/or valve which operates via a (0099) motor driven pinch valve mechanism.
In addition, claim 1 recites: “Inputting patient data” and “Detecting a parameter with the wearable nutrition device”, which includes (0020) “detecting an acceleration or (0021) orientation with an accelerometer positioned within the wearable nutrition device” or (0023) “detecting with a gastric access device a pH, a microbiome, a gas, or any combination thereof”.
Under Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements merely involve insignificant extra-solution activit(ies) (claim 1). Such insignificant extra-solution activity, e.g. data gathering and output, when re-evaluated under Step 2B is further found to be well-understood, routine, and conventional according to MPEP 2106.05(d)(II) (describing conventional activities that include transmitting and receiving data over a communication network).
With regards to dependent claims 2-20, they provide additional features/steps which are part of an expanded abstract idea of the independent claim (additionally comprising abstract idea steps) and, therefore, these claims are not eligible without meaningful additional elements that reflect a practical application and/or additional elements that qualify for significantly more for substantially similar reasons as discussed with regards to claim 1.
For example, claim 2 recites: implementing the updated nutrition plan with the wearable nutrition device, which is recited in generality and therefore not meaningful.
Claims 3-8, 11-14, and 16-20 recite specific parameters, the type of data that is collected/reported as well as how the data gets collected/reported, which narrows the scope of claim 1, but remains an extension of the additional elements recited in claim 1.
Claim 9 recites wherein generating the nutrition plan is based on a database of parameters from a plurality of users, which is recited in generality and therefore not meaningful.
Claim 10 recites wherein the nutrition plan includes a custom formulation, which is recited in generality and therefore not meaningful.
Claim 15 recites wherein implementing the nutrition plan includes operating a motor to drive a pump of the wearable nutrition device, whereby a fluid is pumped from a container to a patient, which is rejected for the same reasons as claim 1 given that this claim limitation is proven to be conventional.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 USC 102 as being unpatentable over Piper (US 20220087904 A1).
Regarding Claim 1, Piper discloses a method ([0043] a method of mobile fluid infusion) comprising: inputting patient data ([0057] the system may have the ability to link patient data to an electronic medical record (EMR) containing one or more data fields of patient data associated with a particular patient);
generating a nutrition plan ([0035] a system is provided that may be configured for the delivery of a medical fluid, including a medication or other therapeutic fluid, for the treatment of a patient condition for a specified duration of time, for a particular time or treatment, or for a specific and controllable rate of delivery; [0047] pre-programmed settings configurations may be created to provide customized fluid delivery programming);
implementing the nutrition plan with a wearable nutrition device ([0025] a wearable housing that facilitates simplified portable feeding; [0020] Reference herein to "Nutrient Reservoir" refers to a container that is used to hold enteral nutritional formula and deliver contents to the disposable pump head through the pump tubing; [0036] the system is capable of providing customized or standardized delivery of a nutritional formula configured in a system capable of being worn by the user; [0047] the device may include pre-programmed settings for the delivery of fluids such as nutritional fluids for feeding, including feeding times, frequency, speed, duration);
detecting a parameter with the wearable nutrition device ([0026] associated sensors for detection of pump occlusions, priming completion, and liquid volume recording capabilities; [0048] the device may track trends of feeding including volume delivered, calories delivered, duration of nutrition fluid delivery per feeding episode, time of feeding, number of daily, weekly, or monthly feeds. In an embodiment, a Machine Learning algorithm may analyze collected data from each user, or from groups of users having similar characteristics, to determine changes to the pre-established and pre-programmed feeding session settings or to determine when fluid delivery parameters have changed sufficiently to create an alert that is transmitted to a user, caregiver, or medical provider; [0057] This data link may also assist with monitoring the patient's progress and feedings); and
generating an updated nutrition plan based on the parameter ([0030] Prescribing physicians may be provided with access to synchronous or near-synchronous communication with the electronic communication element, providing insights into the home feeding environment and functioning of the system. These insights may include information regarding tracking features and processing utilizing one or more Machine Learning algorithms to assist with changes to the system and treatment; [0047] The programmed settings may be accessed, set, or changed by a user, caregiver, or medical provider, including in real-time and/or remotely; [0048] the device may track trends of feeding including volume delivered, calories delivered, duration of nutrition fluid delivery per feeding episode, time of feeding, number of
daily, weekly, or monthly feeds ... The trend analysis may be used to determine adequacy of the prescribed feedings and/or treatment, to determine necessary changes to the feedings and/or treatment).
Regarding Claim 2, Piper discloses the method of claim 1, further including implementing the updated nutrition plan with the wearable nutrition device ([0048] The trend analysis may he used to determine adequacy of the prescribed feedings and/or treatment, to determine necessary changes to the feedings and/or treatment; [0057] This data link may also assist with monitoring the patient's progress and
feedings, changing the specific control information for each of the feedings, such as amount, times, and duration, treating the patient).
Regarding Claim 3, Piper discloses the method of claim 1, wherein patient data includes gender, date of birth, height, weight, activity level, goal weight, organic preference, time preference, or any combination thereof ([0052] TABLE A).
Regarding Claim 4, Piper discloses the method of claim 1, wherein the parameter includes nutritional intake ([0033] This integration and communication capability permits the system to track fluid intake and feed times; [0035] a system is provided that may be configured for the delivery of a medical fluid, including a medication or other therapeutic fluid).
Regarding Claim 5, Piper discloses the method of claim 1, further including generating a nutrition report, wherein the nutrition report includes a historical view of patient nutrition ([0033] provide notifications and other communications, and provides the ability to share data with caregivers, including a medical provider/physician/nurse/caregiver/family member; [0037] The control electronics may be active to collect and store all data related to fluid delivery, fluid volume, feeding schedule, and information displayed and relayed to a user, caregiver, and/or medical professional; [0052] TABLE A [a historical view of patient nutrition]).
Regarding Claim 6, Piper discloses the method of claim 5, wherein the nutrition report includes a score ([0048] The trend analysis may be used to determine adequacy [score] of the prescribed feedings and/or treatment), and wherein the score is determined based on calories consumed, activity level, water consumed, micronutrition, patient demographic information, or any combination thereof ([0048] the device may track trends of feeding including volume delivered, calories delivered, duration of nutrition fluid delivery per feeding episode, time of feeding, number of daily, weekly, or monthly feeds; [0052] TABLE A).
Regarding Claim 8, Piper discloses the method of claim 5, wherein the nutrition report is accessible via a network ([0036] wireless or wired communication with an integrated computer or communication system/device (including, hy way of non-limiting example, a smartphone, a computer, a computer processing user, and/or the cloud) which is capable of communicating with interested parties ... alerting the user or a health care provider with information related to the system, patient/user, treatment. .. alarms or alerts may be transmitted to a smartphone, computer, server, the cloud, or other remote electronic device).
Regarding Claim 9, Piper discloses the method of claim 1, wherein generating the nutrition plan is based on a database of parameters from a plurality of users ([0048] the device may track trends of feeding including volume delivered, calories delivered, duration of nutrition fluid delivery per feeding episode, time of feeding, number of daily, weekly, or monthly feeds. In an embodiment, a Machine Learning algorithm may analyze collected data from each user, or from groups of users having similar characteristics [a database of parameters from a plurality of users]).
Regarding Claim 10, Piper discloses the method of claim 1, wherein the nutrition plan includes a custom formulation ([0036] the system is capable of providing customized ... delivery of a nutritional formula configured in a system capable of being worn by the user; [0047] pre-programmed settings configurations may be created to provide customized fluid delivery programming; [0066] pre-configured flow rate making possible initial rapid priming and then switching to a patient-specific low flow rate as customized fur a particular user).
Regarding Claim 11, Piper discloses the method of claim 1, wherein the nutrition plan includes a caloric goal, a plurality of feed times, a flow rate, a formulation, or any combination thereof ([0037] The control electronics may be active to collect and store all data related to fluid delivery, fluid volume, feeding schedule; [0039] the instant innovation may be used for Intermittent Infusions. This would include infusions up to 4 hours long for patients that may be able to tolerate higher flow rates during their feeds).
Regarding Claim 12, Piper discloses the method of claim 1, wherein the nutrition plan includes a caloric goal, a plurality of feed times, a flow rate, and a formulation ([0037] The control electronics may be active to collect and store all data related to fluid delivery, fluid volume, feeding schedule [a plurality of feed times]; [0039] the instant innovation may be used for Intermittent Infusions. This would include infusions up to 4 hours long for patients that may be able to tolerate higher flow rates during their feeds [flow rate]; [0036] the system is capable of providing customized or standardized delivery of a nutritional formula [a formulation]; [0052] TABLE A).
Regarding Claim 13, Piper discloses the method of claim 1, wherein the patient data is collected by a wearable device (Fig. 1).
Regarding Claim 14, Piper discloses the method of claim 1, further including detecting a second parameter with a wearable device; and generating the updated nutrition plan based on the second parameter ([0048] the device may track trends of feeding including volume delivered, calories delivered, duration of nutrition fluid delivery per feeding episode, time of feeding, number of daily, weekly, or monthly feeds ... The trend analysis may be used to determine adequacy of the prescribed feedings and/or
treatment, to determine necessary changes to the feedings and/or treatment).
Regarding Claim 15, Piper discloses the method of claim 1, wherein implementing the nutrition plan includes operating a motor to drive a pump of the wearable nutrition device, whereby a fluid is pumped from a container to a patient ([0020] Reference herein to "Nutrient Reservoir" refers to a container that is used to hold enteral nutritional formula and deliver contents to the disposable pump head through the pump tubing; [0038] the instant innovation includes a fluid reservoir for holding enteral nutrition fluids or other fluids as required by user needs, that is worn in a belt or other wearable device external to a patient. The electronic command and control device for administering the enteral nutrition fluid via a pump is integrated into the belt or other wearable device. The instant innovation includes a drive motor operative to affect the action of a disposable pump for administration of the fluid; [0043] the system may use an immersion pumping mechanism placed against the abdomen to deliver fluid to a patient).
Regarding Claim 19, Piper discloses the method of claim 1, wherein detecting the parameter includes detecting with a gastric access device a pH, a microbiome, a gas, or any combination thereof ([0028] delivery of enteral nutrition formula to a patient through nasal, gastric, or jejunal access; [0067] Such color change may be used to indicate the presence of inflammation or an infectious event, or the presence of Gastric Leakage [a gas]).
Regarding Claim 20, Piper discloses the method of claim l, further including displaying the parameter on a display of the wearable nutrition device ([0051] user interface components, such as a display screen, configured to receive input, instructions, and/or data, which may then be accepted, rejected, or manipulated by the user, caregiver, or practitioner to deliver formula at proper operating criteria, including standard criteria or specific criteria for the particular user; (Fig. 4).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Piper, US 20220087904 A1 (hereinafter “Piper”), in view of Connor, US 20200152312 A1 (hereinafter “Connor”), further in view of Rule, US 20100121170 A1 (hereinafter “Rule”).
Regarding Claim 7, Piper discloses the method of claim 5, wherein the nutrition report includes a score ([0048] The trend analysis may be used to determine adequacy [score] of the prescribed feedings and/or treatment), and wherein the score is determined based on calories consumed…([0048] the device may track
trends of feeding including volume delivered, calories delivered, duration of nutrition fluid delivery per feeding episode, time of feeding, number of daily, weekly, or monthly feeds; [0052] TABLE A where software application data may include Calories Consumed).
Piper fails to explicitly disclose wherein the score is determined based on …activity level, water consumed, micronutrition, and patient demographic information.
Furthermore, the type of patient data, "activity level, water consumed, micronutrition, and patient demographic information", would have been well known in the art and would have involved ordinary skills in the art at the time of the invention.
It would have been obvious to one of ordinary skill in the art before the priority date to modify Piper with the calories consumed, activity level, water consumed, micronutrition, and patient demographic information, the motivation being to add robustness to the collected patient data (Piper [0052]).
For example, Connor discloses a system for nutrition monitoring and management that takes into account, activity level, water consumed and micronutrition. (0166) “A system for nutrition monitoring and management can include an environmental sensor which detects and/or measures characteristics of a person's environment which can be related to food consumption and/or hydration requirements …A system can track activity level to better estimate a person’s hydration requirements.” (0266) “a system for nutritional monitoring and management can identify and quantify…a vitamin or mineral; vitamin A, vitamin B1, thiamin, vitamin B12, cyanocobalamin, vitamin B2, riboflavin, vitamin C, ascorbic acid, vitamin D, vitamin E,…”
For example, Rule discloses accounting for patient demographic information, (0207) “Additional demographic information may be available for the individuals whose sample measurements are included in the Sample Population” because (0210) “Demographic groups may be established for any suitable set of one or more distinctive factors for the group including, for example, medical, cultural, behavioral, biological, geographical, religious, and genealogical traits.”
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Piper, US 20220087904 A1 (hereinafter “Piper”), in view of Connor, US 20200152312 A1 (hereinafter “Connor”).
Regarding Claim 16, Piper discloses the method of claim 1, wherein detecting the parameter includes detecting with a sensor ([0026] associated sensors for detection).
Piper fails to explicitly disclose detecting an acceleration with an accelerometer positioned within the wearable nutrition device.
Connor is also in the field of wearable nutrition devices (Abstract) and teaches detecting an acceleration with an accelerometer positioned within the wearable nutrition device ([0022] a wearable biometric sensor which collects biometric data concerning a person whose nutritional intake is being monitored, wherein the biometric sensor is selected from the group consisting of: motion sensor (e.g. accelerometer);
It would have been obvious to one of ordinary skill in the art before the priority date to modify Piper with the accelerometer taught in Connor, the motivation being to effectively measure a person's steps and/or caloric expenditure (Connor [0145]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Piper, US 20220087904 A1 (hereinafter “Piper”), in view of Jin, US 20110144542 A1 (hereinafter “Jin”).
Regarding Claim 17, Piper discloses the method of claim 1, wherein detecting the parameter includes detecting with a sensor ([0026] associated sensors for detection).
Piper fails to explicitly disclose detecting an orientation with an accelerometer positioned within the wearable nutrition device.
Jin is also in the field of wearable devices (Abstract) and teaches detecting an orientation with an accelerometer positioned within the wearable device [0033] FIG. 1 shows a fall detection system in use by a user 2. The fall detection system comprises a sensor module 4 that is worn by the user 2 and a base unit 6. The sensor module 4 can be worn on any part of the user's body, but it is preferred that it is worn around
the user's waist or chest; [0034] The sensor module 4 comprises at least an accelerometer for measuring the acceleration experienced by the sensor module).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Piper with the accelerometer taught in Jin, the motivation being to effectively improve the detection of any falls (Jin [0033]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Piper, US 20220087904 A1 (hereinafter “Piper”), in view of Kohli, M., Andrade, A., & Dharmarajan, T. S. (2021). Enteral Nutrition. Springer EBooks, 473–494, https://doi.org/10.1007/978-3-030-30192-7_106.
Regarding Claim 18, Piper discloses the method of claim 1, wherein detecting the parameter includes receiving a user input from a user interface on the wearable nutrition device ([0051] user interface components, such as a display screen, configured to receive input ... which may then be accepted, rejected, or manipulated by the user, caregiver), and wherein the user input is in response to adverse event ([0057] Linking to the EMR may also provide for the ability to report adverse events during feeding from the patient to the clinician).
Piper fails to explicitly disclose nausea, bloating, discomfort, regurgitation, dislodgment, an error message, or any combination thereof.
Furthermore, the type of input, "in response to nausea, bloating, discomfort, regurgitation, dislodgment, an error message, or any combination thereof', would have been well known in the art and would have involved ordinary skills in the art at the time of the invention.
It would have been obvious to one of ordinary skill in the art before the priority date to modify Piper with the input in response to nausea, bloating, discomfort, regurgitation, dislodgment, an error message, or any combination thereof, the motivation being to add robustness to the adverse events reported during
feeding used to better track patient quality of life (QoL) (Piper [0057]).
For example, in non-patent literature on enteral nutrition, Kohli discloses a section on common adverse side effects such as (p. 487) “Gastrointestinal intolerance, abdominal discomfort, distention, high gastric residual volumes, nausea, diarrhea, and constipation”, which are “all distressing for patients. Furthermore, they can increase the nursing burden and delay the progression of EN.”
Conclusion
An inquiry concerning this communication or earlier communication from the examiner should be directed to LOGAN D COONS whose telephone number is
(571) 272-2698. (via email: logan.coons@uspto.gov “without a written authorization by applicant in place, the USPTO will not respond via internet e-mail to an internet correspondence” MPEP 502.02 II). The examiner can normally be reached on M-F 9:30am – 6pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SPE Shelby Turner, can be reached at (571) 272-6334. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOGAN D COONS/Examiner, Art Unit 2857
/ALEXANDER SATANOVSKY/Primary Examiner, Art Unit 2857