DETAILED ACTION
Notice to Applicant
This communication is in response to the application submitted June 11, 2025. The present application is a continuation of United States Patent Application Serial Number 17/180,309, filed February 19, 2021. Claims 1 – 20 are pending.
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 .
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 (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step One
Claims 1 – 20 are drawn to methods and a system, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1, 10, and 19 recite obtaining a macronutrient content associated with a meal, wherein the macronutrient content includes a first macronutrient and a second macronutrient; predicting glucose amounts to be absorbed into a bloodstream of a patient as a result of consumption of the meal, to account for a difference in glucose level rise due to consumption of the first macronutrient compared to consumption of the second macronutrient; and determining a dosage of insulin to deliver to the patient based on the glucose amounts to be absorbed into the bloodstream.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover Mental Processes, as reflected in the specification, which states that “managing a glucose level of a patient based on information about one or more macronutrients (e.g., protein and/or fat) other than carbohydrates (paragraph 15 of the published specification). If a claim limitation, under its broadest reasonable interpretation, covers concepts performed in the human mind including an observation, evaluation, judgment, or opinion, then it falls within the “Mental Processes” grouping of abstract ideas. The present claims cover mental processes because use protein and/or fat, in addition to carbohydrates, to determine an insulin dosage (paragraph 54 of the published specification). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claims 1, 19: “processor-implemented method”, “patient-specific physiological simulator”
Claim 2: “infusion device”
Claims 3, 7, 20: “patient-specific physiological simulator”
Claim 10: “system”, “one or more processors”, “one or more processor-readable media storing instructions which, when executed by one or more processors”, “patient-specific physiological simulator”
Claim 11: “system”, “infusion device”
Claims 12, 16: “system”, “patient-specific physiological simulator”
Claims 13 – 15, 17: “system”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0117] Various aspects of the techniques may be implemented within one or more processors, including one or more microprocessors, DSPs, ASICs, FPGAs, or any other equivalent integrated or discrete logic circuitry, as well as any combinations of such components, embodied in programmers, such as physician or patient programmers, electrical stimulators, or other devices. The term "processor" or "processing circuitry" may generally refer to any of the foregoing logic circuitry, alone or in combination with other logic circuitry, or any other equivalent circuitry.
[0118] In one or more examples, the functions described in this disclosure may be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functions may be stored on, as one or more instructions or code, a computer-readable medium and executed by a hardware-based processing unit. Computer readable media may include computer-readable storage media forming a tangible, non-transitory medium. Instructions may be executed by one or more processors, such as one or more DSPs, ASICs, FPGAs, general purpose microprocessors, or other equivalent integrated or discrete logic circuitry. Accordingly, the term "processor," as used herein may refer to one or more of any of the foregoing structure or any other structure suitable for implementation of the techniques described herein.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 2 – 9, 11 – 18, and 20 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Narayanswami et al. (U.S. Publication Number 2022/0361812 A1) discloses systems and methods for providing optimized, individualized bolus dosing of insulin based on macronutrient information of meals ingested by the patient
Constantin et al. (U.S. Patent Number 11,723,560 B2) discloses a system that determines guidance and a time to deliver guidance that is calculated to be useful to a user (e.g. patient, caregiver, or clinician) may help a user sleep better, for example to get uninterrupted sleep due because glucose levels are controlled, or to go to be with peace of mind and avoid highs and lows while sleeping, or know what to do to improve sleep by acting on pre-sleep guidance, or to know when there are potential problems that need to be addressed.
Ladyzynski et al. (Ladyzynski P, Krzymien J, Foltynski P, Rachuta M, Bonalska B. Accuracy of Automatic Carbohydrate, Protein, Fat and Calorie Counting Based on Voice Descriptions of Meals in People with Type 1 Diabetes. Nutrients. 2018; 10(4):518. https://doi.org/10.3390/nu10040518) discloses assessing the accuracy of automatic macronutrient and calorie counting based on voice descriptions of meals provided by people with unstable type 1 diabetes
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KRISTINE K. RAPILLO
Examiner
Art Unit 3626
/KRISTINE K RAPILLO/Examiner, Art Unit 3682
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