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 .
Status of Claim(s)
Claims 1-11, 13-16 have been examined.
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 1-11, 13-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1 and 13 recite(s) a system for tracking patient medication protocol adherence, which is within a statutory category (machine).
Step 2A - Prong One:
Regarding Prong One of Step 2A (MPEP2106.04-07), the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
The limitations of Independent claims 1, 13 recite at least one abstract idea. Specifically, claim 1 recites the steps of
A system for tracking patient medication protocol adherence, the system comprising:
a computing device having one or more processors and one or more memories, the computing device communicatively coupled to a communication network, the computing device being configured to allow one or more remote user devices to access the computing device via the communication network; the computing device being further configured to,
provide an interface of an application to the one or more remote user devices,
receive, via the interface, identification data on a subject, the identification data including a pathology data for the subject,
determine from the identification data a desired medication protocol for the subject, and
convert the desired medication protocol into augmented utensil configuration data for the subject, the augmented utensil configuration data comprising (i) a desired amount of an active pharmaceutical ingredient (AI) to be administered to the subject using an augmented utensil comprising a working end having layered Al delivery structure formed thereon and (ii) augmented utensil data and/or usage data and/or patient data containing at least one parameter of the augmented utensil;
the computing device being communicatively coupled, through the communication network, to a detection stage configured to analyze the augmented utensil and detect an amount of used Al,
the computing device being further configured to,
receive from the detection stage the amount of used Al and compare the amount of used Al to the desired amount of the Al stored in the augmented utensil configuration data, and
from the comparison of the amount of used Al to the desired amount of the AI, determine an adherence score indicating a predicted adherence of the subject to the medication protocol.
The above underlined limitations, under broadest reasonable interpretation, constitutes b) certain methods of organizing human activity ,because these limitations could be performed by the professionals, the researchers to estimating the active ingredient associated with the medication adherence…. Accordingly, the claim is directed toward at least one abstract idea.
Furthermore, the abstract idea for claim 13 is identical as the abstract idea for claim 1, because both claims 1 and claim 13 recite a system
Furthermore, the following depending claims further define the at least one abstract idea, and thus fail to make the abstract idea any less abstract.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim, as a whole, integrates the abstract idea into a practical application. As noted in MPEP2106.04-07, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
Claim 1 recites
A system for tracking patient medication protocol adherence, the system comprising:
a computing device having one or more processors and one or more memories, the computing device communicatively coupled to a communication network, the computing device being configured to allow one or more remote user devices to access the computing device via the communication network; the computing device being further configured to,
provide an interface of an application to the one or more remote user devices,
receive, via the interface, identification data on a subject, the identification data including a pathology data for the subject,
determine from the identification data a desired medication protocol for the subject, and
convert the desired medication protocol into augmented utensil configuration data for the subject, the augmented utensil configuration data comprising (i) a desired amount of an active pharmaceutical ingredient (AI) to be administered to the subject using an augmented utensil comprising a working end having layered Al delivery structure formed thereon and (ii) augmented utensil data and/or usage data and/or patient data containing at least one parameter of the augmented utensil;
the computing device being communicatively coupled, through the communication network, to a detection stage configured to analyze the augmented utensil and detect an amount of used Al,
the computing device being further configured to,
receive from the detection stage the amount of used Al and compare the amount of used Al to the desired amount of the Al stored in the augmented utensil configuration data, and
from the comparison of the amount of used Al to the desired amount of the AI, determine an adherence score indicating a predicted adherence of the subject to the medication protocol. ((merely data gathering steps as noted below, see MPEP 2106.05(g))).
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the limitations “provide an interface of an application to the one or more remote user devices, receive, via the interface, identification data on a subject, the identification data including a pathology data for the subject, determine from the identification data a desired medication protocol for the subject”, this is a pre-solution activity. The examiner submits that this additional limitation merely adds insignificant extra-solution activity to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract (using a computer as tools to carry out the abstract idea as noted below, See MPEP 2106.05(f)).
Regarding the limitations “convert the desired medication protocol into augmented utensil configuration data for the subject, the augmented utensil configuration data comprising (i) a desired amount of an active pharmaceutical ingredient (AI) to be administered to the subject using an augmented utensil comprising a working end having layered Al delivery structure formed thereon and (ii) augmented utensil data and/or usage data and/or patient data containing at least one parameter of the augmented utensil”, this is a pre-solution activity. The examiner submits that this additional limitation merely adds insignificant extra-solution activity to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract (using a computer as tools to carry out the abstract idea as noted below, See MPEP 2106.05(f))
Regarding the additional limitation of ”receive from the detection stage the amount of used Al and compare the amount of used Al to the desired amount of the Al stored in the augmented utensil configuration data, and from the comparison of the amount of used Al to the desired amount of the AI, determine an adherence score indicating a predicted adherence of the subject to the medication protocol.”, this is a post-solution activity. The examiner submits that this additional limitation merely adds insignificant extra-solution activity of gathering data to the at least one abstract idea in a manner of post solution activity that does not meaningfully limit the at least one abstract idea ((merely data gathering steps as noted, see MPEP 2106.05(g))).
Particularly, the recitation of a memory, a processor, a communication network in claims 1, 13 (Spec.; page 0041), is not positively claimed in the claim as it defines the service but is claimed at such a high level of generality that it represents mere instructions to implement an abstract idea MPEP 2106.05(f).
Dependent claims 2-11, 14-16, recite the identification of an active ingredient and the use of the utensil in the claims as it defines the service but is claimed at such a high level of generality that it represents mere instructions to implement an abstract idea MPEP 2106.05(f)
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to implement and revise a wellbeing plan, a productivity, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (MPEP § 2106.05).
For these reasons, representative independent claims 1, 13 do not recite additional elements that integrate the judicial exceptions into a practical application. (The Examiner notes the mere recitation of a memory, a processor, a communication networkdoes not take the claim out of Mathematical concepts. Thus, the claim recites an abstract idea)
The remaining dependent claim limitations are not addressed above fail to integrate the abstract idea into a practical application
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Step 2B:
Regarding Step 2B, independent claims 1, 13 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
For claims 1, 13 limit the use of a server, a processor, a data processing system/device, etc.... The specification merely describes the use of these computing components. The Examiner submits that these limitations amount to merely using these computer devices as well-understood, routine, conventional activity (Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018).), and MPEP 2106.05(d)(I)(2). Further the use of generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patient-ineligible abstract idea into a patent-eligible invention”).
For the reasons stated, the claims fail the Subject Matter Eligibility Test and are consequently rejected under 35 USC 101. Therefore, claims 1, 13 are being held patent ineligible under 35USC101.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the step of “convert the desired medication protocol into augmented utensil configuration data for the subject, the augmented utensil configuration data comprising (i) a desired amount of an active pharmaceutical ingredient (AI) to be administered to the subject using an augmented utensil comprising a working end having layered Al delivery structure formed thereon and (ii) augmented utensil data and/or usage data and/or patient data containing at least one parameter of the augmented utensil”. However, the disclosure does not provide adequate structure to perform claim function of converting the desired medication protocol into augmented utensil configuration data for the subject. The specification does not demonstrate that applicant has made an invention that achieves the claim function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the claim inventor had possession of the claim invention.
Claim 13 recites “determine, from the usage measurement, an actual amount of the Al remaining on the utensil or an actual amount of the Al removed from the utensil; and determine a projected patient regimen adherence from a comparison of the actual amount of the Al remaining on the utensil or an actual amount of the Al removed from the utensil and the desired amount of the Al to be provided to the subject”.
However, the disclosure does not provide adequate structure to perform claim function of converting the desired medication protocol into augmented utensil configuration data for the subject. The specification does not demonstrate that applicant has made an invention that achieves the claim function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the claim inventor had possession of the claim invention.
Response to Arguments
Applicant's arguments filed 01/05/2026 regarding claim rejections under35USC101 and 35USC112(a) have been fully considered but they are not persuasive.
In the Remark filed 01/05/2026, the Applicant argued that
For claim rejection under 35 USC 101, the claims integrate any alleged abstract idea into a practical application because the claims recite a specific technological improvement in medication adherence monitoring through directly monitoring the amount of medication taken by the patient.
In response to the Applicant’s argument, the examiner respectfully disagrees. Under broadest reasonable interpretation of the recited claim, claims 1 and 13 recite the computer device having one or more processor “to convert the desired medication protocol into augmented utensil configuration data”. As described in Prong 2 of step 2A above, the recitation of a memory, a processor, a communication network, (Spec.; page 0041-0042) to provide, to receive, to determine a desired medication protocol to convert the desired medication protocol into augmented utensil configuration data in the claims, is not positively claimed in the claim as it defines the service but is claimed at such a high level of generality that it represents mere instructions to implement an abstract idea MPEP 2106.05(f).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to implement and revise a wellbeing plan, a productivity, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (MPEP § 2106.05).
For these reasons, representative independent claims 1, 13 do not recite additional elements that integrate the judicial exceptions into a practical application. (The Examiner notes the mere recitation of a memory, a processor, a communication network does not take the claim out of organizing human activities or mental process grouping. Thus, the claim recites an abstract idea).
For claim rejection under 35USC112(a), the Applicant argued that the specificationexplicitly describes an augmented utensil configurator that accesses the utensil data (Para 0069) and th medication adherence cloud platform applied data for conversion that assign different combination of active ingredient identifiers.
In response to the Applicant’s argument, Claim 1 recites the step of “convert the desired medication protocol into augmented utensil configuration data for the subject, the augmented utensil configuration data comprising (i) a desired amount of an active pharmaceutical ingredient (AI) to be administered to the subject using an augmented utensil comprising a working end having layered Al delivery structure formed thereon and (ii) augmented utensil data and/or usage data and/or patient data containing at least one parameter of the augmented utensil”. However, the disclosure does not provide adequate structure to perform claim function of converting the desired medication protocol into augmented utensil configuration data for the subject. There no foes not demonstrate the structure to demonstrate the identification of a plurality of excipients. The specification does not demonstrate that applicant has made an invention that achieves the claim function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the claim inventor had possession of the claim invention.
Claim 13 recites “determine, from the usage measurement, an actual amount of the Al remaining on the utensil or an actual amount of the Al removed from the utensil; and determine a projected patient regimen adherence from a comparison of the actual amount of the Al remaining on the utensil or an actual amount of the Al removed from the utensil and the desired amount of the Al to be provided to the subject”.
However, the disclosure does not provide adequate structure to perform claim function of generate an amount of desired or used active ingredient. Para 0042, Specification does not provide the structure of augmented configuration protocol. The description of the generic processors does not demonstrate that applicant has made an invention that achieves the claim function because the invention is not described with sufficient detail that one of ordinary skill in the art can reasonably conclude that the claim inventor had possession of the claim invention.
For claim rejection under 35USC103, Applicant’s arguments, see Remark, filed 01/05/2026, with respect to the rejection(s) of claim(s) 1, 13 regarding prior arts Jafari/Tran/McIntyre have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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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/HIEP V NGUYEN/Primary Examiner, Art Unit 3686
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