DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of species II, i.e. claims 5-13 & 17-20 in the reply filed on August 27, 2025 is acknowledged.
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.
The following analysis supersedes the previous subject matter eligibility analysis. Claims 1, 5, 13, 17 and 25 are addressed individually and in their respective combinations below.
Step 1- Statutory Category
Claims 1, 5, and 25 recited systems within the statutory category of machines. Claims 13 and 17 recite methods within the statutory category of processes. Accordingly, each claim satisfies Step 1.
Step 2A, Prong One-Recitation of a Judicial Exception:
Claims 1 and 13
Claim 1 and 13 recite determining patient compliance by comparing physical activity information occurring over a first period with prescribed treatment, including an activity threshold. They further recite determining patient condition using physical activity information occurring over a second period or with respect to a previously determined patient condition.
These limitations encompass evaluations and judgements that can practically be performed mentally or with the aid of pen and paper. For example, given activity information for a stated period and a prescribed activity limit, a person can compare the activity with that limit and determine compliance. Likewise, a person can evaluate the supplied activity information in relation to an earlier condition assessment to determine whether the patient’s condition has improved or declined.
The claims do not require these determinations to employ a particular signal-processing technique or a volume or complexity of information that places the recited evaluations beyond practical mental performance. The claimed temporal relationships identify the information used in the evaluations but do not require a nonmental technique for performing them. Accordingly, these particular determination limitations recite mental processes under MPEP § 2106.04(a)(2), subsection III.
For example, given activity information for a specified period and a prescribed activity limit, a person can compare the information with the limit and determine whether the patient complied. A person can likewise evaluate activity information for a period, or in relation to an earlier condition assessment, to determine an indication of patient condition. Paragraph [0055] illustrates the distinction between these evaluations by explaining that a patient’s activity may indicate noncompliance with prescribed treatment while nevertheless indicating improvement in condition.
The claims do not require the determinations to involve a volume or complexity of information that makes these evaluation impractical to perform mentally or with pen or paper. Nor do they require a particular signal processing operation for deriving the determinations. The temporal limitations specify the information used in the evaluations but do not place the evaluations themselves beyond practical mental performance.
This identification of the judicial exception does not characterize physical detection by the motion sensor or physical control of an indicator as mental processes. Those operations, the control circuit, and the receiving and output limitations are separately evaluated as additional elements.
Claims 5 and 17.
Claims 5 and 17 incorporate the foregoing determination limitations through their respective dependencies. Their additional limitations concerning separate control signals and different indicators do not remove the recited mental processes. Those additional physical operations are evaluated under Prong Two and Step 2B.
Claim 25.
Claim 25 incorporates the determinations of claim 1 and further specifies determining noncompliance when activity information occurring over the first period exceeds an upper limit of the prescribed treatment.
Comparing supplied activity information with an upper limit and determining that the limit has been exceeded is an evaluation that can practically be performed mentally or with pen or paper. The expressly included indicator and its state transition are additional elements, rather than part of the identified mental process.
Accordingly, claims 1, 5, 13, 17 and 25 recite abstract ideas within the mental-process grouping.
Step 2A, Prong Two- Judicial Exception is Integrated into a Practical Application:
Claims 1 and 13.
The additional elements include the motion sensor and detection of patient activity; the control circuit; receipt of activity information and prescribed treatment information; provision of the compliance and condition determinations to a user or process; and control of an indicator-state transition based on at least one determination.
The motion sensor detects activity and supplies information for the recited evaluations. In the claimed arrangement, its function is acquisition of the information to be evaluated. The claims do not specify a sensing configuration, acquisition technique, or interaction with the subsequent evaluations that improves the detection of patient activity. This acquisition therefore constitutes data gathering ancillary to the identified evaluations. See MPEP § 2106.05(g).
Receipt of prescribed treatment information similarly supplies the criterion used to evaluate compliance. The control circuit carries out the evaluations and associated input and output operations. The claims identify the results to be obtained but do not specify a circuit arrangement or processing mechanism providing a technological improvement. In this context, reciting the control circuit instructs implementation of the evaluations through circuitry. See MPEP § 2106.05(f).
The limitation providing both determinations to a user or process communicates the evaluation results. Providing those results to an unspecified process does not require that process to perform any further operation.
The indicator-state transition is separately considered as a physical control operation. It is not disregarded or treated as identical to the preceding provision of the determinations. Nevertheless, its claimed role is to indicate an outcome of the evaluations. Paragraph [0081] describes notifying a patient through an audible, haptic, or visible indicator when activity exceeds a prescribed boundary. Paragraph [0110] likewise describes indicators communicating compliance and condition.
The claimed state transition thus implements notification of an analytical result. The claims do not specify a further interaction through which that transition changes the sensing or evaluation operation. Considered in this context, the indicator operation constitutes output activity appended to the evaluations. See MPEP § 2106.05(g).
The additional elements have also been considered together with the identified evaluations. The complete arrangement acquires activity information, evaluates it for compliance and condition using the recited temporal relationships, provides both determinations, and controls an indicator based on at least one determination. The requirement for two determinations is given effect; the claims are not reduced to an unspecified assessment of patient activity. Nevertheless, the claimed interaction supplies information to the evaluations and communicates their results without specifying a technological improvement in the monitoring operation.
The recited first-period and second-period relationships do not establish a particular sensing or processing architecture. Moreover, the condition determination alternatively may be made with respect to a previously determined condition. Although both compliance and condition are determined, indicator control need be based on only one of those determinations.
No finding of conventionality is relied upon in the Prong Two analysis.
Applicant’s Asserted Technological Improvement:
Paragraph [0055] establishes that compliance and condition are distinct assessment and may diverge. The claims reflect that distinction. However, distinguishing the conclusions drawn from patient information does not, by itself, establish an improvement in the technology used to obtain or process that information.
Paragraph [0081] describes embodiments providing notifications without an expensive display and, in certain examples, without wireless circuitry or a rechargeable battery. The claims do not require the self-contained arrangement or other configuration producing those asserted hardware savings. Reciting indicator control does not itself impose that architecture.
The claims need not expressly state a benefit such as reduced cost. They must, however, reflect the features providing the asserted technological improvement. See MPEP §§ 2106.04(d)(1) and 2106.05(a). The broad acquisition, evaluation, and notification arrangement presently claimed does not require the configuration relied upon for the asserted savings.
Paragraph [0110] explains that notifications can improved patient compliance. That benefit is acknowledged, but an improvement in a patient’s response to information does not establish an improvement in the operation of the claimed monitoring technology.
The absence of therapy delivery or adjustment is not independently relied upon to establish ineligibility. Such operations are not mandatory for eligibility; the question is whether the operations actually claimed integrate the exception into a practical application.
Claims 5 and 17
Claims 5 and 17 require a first control signal activating a first indicator to provide the compliance determination and a second control signal activating a different indicator to provide the condition determination.
These limitations add separate physical output-control operations. They are not merely further limitations on determining compliance. Their claimed function, however, remain communication of the respective evaluation results. Considered with the inherited limitations, the separate signals and indicators distinguish compliance information form condition information. The claims do not specify an interaction between those outputs that changes how activity is sensed or evaluated, or otherwise improves the monitoring technology.
Paragraph [0110] supports the distinct notifications functions but does not establish that the claimed output arrangement provides a technological improvement. Accordingly, the additional limitations, considered individually and in the complete combinations, do not integrate the recited mental processes into a practical application.
Claim 25
Claim 25 expressly includes the indicator as a system component and requires its transition from a first state to a second state based on at least one determination. It also specifies the upper-limit comparison used to determine noncompliance.
The physical indicator and its transition are given effect. The upper-limit limitation further defines the evaluation; the state-transition limitation defines a physical output based on an evaluation result. The claim does not define a particular state-control arrangement or further operational consequences beyond the indication.
Paragraph [0081] describes such an indicator as notifying the patient that activity is outside prescribed bounds. Considered with limitations of claim 1, claim 25 therefore remains directed to acquiring activity information, evaluating compliance and condition, and communicating the results, including through a physical state change. The additional limitations do not integrate the exception into a practical application.
Accordingly, claims 1, 5, 13, 17 and 25 are directed to the identified abstract ideas under Step 2A.
Step 2B-Whether the Additional Elements Amount to Significant More
The additional elements are evaluated individually and as ordered combinations. The analysis does not rely solely on the Prong Two conclusion. In particular, the acquisition and indicator-control operations identified as ancillary input and output activity are reevaluated to determine whether they supply an inventive concept.
The comparisons and condition evaluations identified above constitute the recited exception. Their implementation through circuitry and their interaction with the other additional elements are considered here. The abstract evaluations themselves are not separately treated as additional elements merely because they are performed electronically.
Claims 1 and 13-individual Elements
The motion sensor performs activity detection and supplies corresponding information. The control circuit receives the activity and treatment information, implements the evaluations, provides their results, and control an indicator. The indicator operation communicates a result through a change in state.
The sensor supplies the evaluation inputs, the circuit implements the evaluations and output instructions, and the indicator communicates an evaluation result. The claim language does not identify an additional technical operation beyond those functions.
The absence of a particular architecture or implementation is considered in determining the scope of these limitations. It is not, standing alone, evidence that their implementation is conventional.
Claims 1 and 13- Ordered Combination
The complete arrangement requires sensor-derived information to be received by the circuit, evaluated for compliance and condition, and used to provide determinations and control an indicator. The arrangement provides no inventive concept beyond implanting the evaluations using the supported acquisition and output functions. The distinct analytical purposes and temporal relationships define what is evaluated and reported; they do not independently supply an additional technological operation.
Claims 5 and 17
The additional elements include separate control signals activating different indicators for the compliance and condition results. Both physical output paths are considered, together with all limitations of the respective independent claims.
The first output communicates compliance and the second condition through the respective indicator activations. Their distinct informational roles do not themselves provide significantly more. The conclusion must rest on the supported assessment of the actual output arrangement, not merely on describing the indicators as conventional in isolation.
Claim 25
Claim 25 includes the indicator, specifies a first-to-second-state transition, and further defines the compliance evaluation through an upper-limit comparison. The upper-limit comparison is part of the identified mental process. The additional physical indicator and the circuit’s control of its transition are evaluated with the inherited acquisition, implementation, and output limitations.
The requires noncompliance to be determined when the upper limit is exceeded, but the indicator transition may be based on compliance or condition. Accordingly, this analysis does not narrow the claim to a transition necessarily triggered only by exceeding the upper limit. The indicator and defining two states does not add an inventive concept beyond the supported notification operation. The physical transition is acknowledged, but its significance must be assessed in the complete arrangement rather than inferred from physicality alone.
Response to Arguments
Applicant correctly states that the claims must be considered in their entirety. The foregoing analysis considers the sensor, circuit, temporal relationships, separate determinations, and physical output-control limitations in their claimed combinations. The analysis does not disregard an element merely because it may have been known.
Applicant also correctly observes that a human mind cannot physically detect activity through the claimed sensor or control the claimed indicator through circuitry. Those operations are not identified as mental processes. The judicial exception is identified in the particular comparison and evaluation limitations, with the physical operations separately considered as additional elements.
Applicant’s reliance on PowerBlock Holdings, Inc. v. iFIt, Inc., 146 F.4th 1366 (Fed. Cir. 2025), has been considered. That decision addressed a particular mechanical arrangement in which a motor moved a selector to coupled selected weight plates to a dumbbell handle. Its claim-as-a-whole analysis does not establish eligibility merely from the presence of physical components.
Here, the claimed indicator control communicates the evaluation results. The particular hardware-saving arrangement relied upon in the specification is not required by the claims. The distinction concerns the claimed function and interaction of the components, rather than whether the components are physical.
Separately reciting provision of the determinations and control of the indicator does not establish that the indicator operation provides a technological improvement. Both operations have been evaluated. The latter adds a physical notification based on a determination, but the claim does not specify the further technological interaction asserted by applicant.
The separate signals and indicators of claims 5 and 17, and the included indicator and state transition of claim 25, are likewise expressly addressed. They are not treated as absent or as part of the mental process.
Applicant’s challenge to the previous Step 2B support requires a response directed to the actual additional elements and their combinations. The unrelated electrode and network-transmission discussion is not relied upon in this replacement analysis.
Therefore, claims 1, 5, 13, 17 and 25 recite mental processes and do not integrate those processes into a practical application. For the supported reasons set forth under Step 2B, the additional elements, considered, individually and in their respective ordered combinations, do not amount to significantly more than the recited exception. Accordingly, claims 1, 5, 13, 17 and 25 are rejected under 35 U.S.C. § 101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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