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 .
Receipt of Applicant’s Amendment filed March 9, 2026, is acknowledged.
Response to Amendment
Claims 1 and 14 have been amended. Claims 2, 15, and 16 have been canceled. Claims 21-23 are new. Claims 1, 3-14, and 17-23 are pending and are provided to be examined upon their merits.
Response to Arguments
Applicant's arguments filed March 9, 2026, have been fully considered but they are not persuasive. A response is provided below in bold where appropriate.
Applicant argues 35 USC §101 Rejection, starting pg. 13 of Remarks:
Claim Rejections - 35 U.S.C. §101
Claims 1, 3-14, and 16-20 stand rejected under 35 U.S.C. §101 as allegedly being directed to an abstract idea. The Applicant respectfully requests that the rejection be withdrawn.
Paragraphs 39-43 of the Larsen/Christiansen Declaration, together with the preceding paragraphs that provide their foundation, provide objective evidence to support subject matter eligibility for independent claims 1 and 14, as amended. These paragraphs show that the independent claims do not merely recite mental processes. The claimed system and method cannot practically be performed in the human mind. In addition, claims 1 and 14 are not directed to methods of organizing human activity as shown and explained in paragraphs 39-43. Instead, the claims are directed to a technological improvement that is not achievable with a general-purpose computing device. Id. Specifically, paragraph 43 makes clear that the claims 1 and 14 recite specific technological improvements: the single actuator, the proportional haptic feedback, the temporal separation of configuration and capture, and the coordinated contextual data acquisition. These claimed improvements are based on the technology disclosed in the Specification, and they are not directed to any abstract concept such as "self-tracking", "event-logging", "certain methods of organizing human activity", or "mental processes." Claims 1 and 14, as amended, are therefore patent-eligible.
Mental processes reason has been withdrawn.
Applicant is arguing paragraphs 39-43 offer foundation to provide support for eligibility. Support needs to be taught in Applicant’s specification. If there is an improvement to technology, Applicant needs to show where in the specification technology is improved. The claimed “portable data acquisition system” is a generic device.
Accordingly, the Applicant respectfully requests that the rejection be withdrawn. Claims 3-13 and 16-20 depend from claims 1 and 14, respectively, and should also be allowable, at least due to their dependency. New claims 21-23 should be allowable as well for substantially the same reasons.
The rejection is respectfully maintained but modified for the claim amendments.
Applicant argues 35 USC §112 Rejection, starting pg. 14 of Remarks:
Claim Rejections - 35 U.S.C. §112
Claims 1, 3-14, and 16-20 stand rejected under 35 U.S.C. §112(a). The Applicant has amended claims 1 and 14 to delete the language objected to in the rejection. Therefore, the Applicant respectfully requests that the rejection of the claims be withdrawn. Claims 3-13 and 16-20 should also be allowable, at least due to their dependency.
The prior rejection is withdrawn based on the claim amendment. However, the amendments have resulted in a new 35 USC 112(a) rejection.
Claims 1, 3-14, and 16-20 stand rejected under 35 U.S.C. § 112(b). The Applicant has amended the objected-to elements of claims 1 and 14 to follow the claim language before the most recent amendment. Therefore, the Applicant respectfully requests that the rejection of the claims be withdrawn. Claims 3-13 and 16-20 should also be allowable, at least due to their dependency
The rejections are withdrawn based on the claim amendment and further consideration. However, the claim amendments have resulted in new rejections.
Applicant argues 35 USC §103 Rejection, starting pg. 15 of Remarks:
Based on the claim amendments and further search and consideration, the prior art rejection is withdrawn.
Declarations
An Examiner’s response to the submitted declarations is provided below.
Declaration: Kasper Eskelund
The declaration filed by Kasper Eskelund is about a “One Button Tracker.” The claims are not directed to a “One Button Tracker” but rather “[a] system for treatment of a mental health condition of an individual…” (preamble, Claim 14) comprising an “assessment device,” and “a portable data acquisition system (Claim 14). Claim 21 is directed to “[a] system for substantially minimizing false negatives in observing occurrences of target phenomena…” (preamble) comprising a “portable acquisition system,” and “an “analysis component.”
There is no nexus in the above declaration between the one button tracker and the portable data acquisition device. The portable acquisition device may be a mobile phone, tablet or a computer. The declaration refers only to a device which is neither described in the above referenced application nor in the individual claims of the application. Thus, there is no showing that the objective evidence of nonobviousness or statutory eligibility is commensurate in scope with the claims. See MPEP § 716.
The claims are not directed to this specific one button device but to some broad portable data acquisition device. There is no evidence or facts provided that some generic portable data acquisition device would provide the same results. In fact, the above indicates a smartphone would not provide the same results, yet Applicants specification teaches a portable data acquisition system can be mobile phone (para. [0114]). The above does not seem to support use of Applicant’s portable device if it is a mobile phone.
The declaration under 37 CFR 1.132 filed March 9, 2026, is insufficient to overcome the rejection of claims 1, 3-14, and 17-23 based upon 35 USC 101 and 35 USC 103 rejections as set forth in the last Office action because: they fail to set forth facts germane to the issue of obviousness and statutory eligibility regarding abstract claims.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence fails to outweigh the evidence of obviousness and statutory eligibility.
Declaration: Lisa Riisager
The declaration filed by Lisa Riisager is about a “One Button Tracker.” The claims are not directed to a “One Button Tracker” but rather “[a] system for treatment of a mental health condition of an individual…” (preamble, Claim 14) comprising an “assessment device,” and “a portable data acquisition system (Claim 14). Also, Claim 21 is directed to “[a] system for substantially minimizing false negatives in observing occurrences of target phenomena…” (preamble) comprising a “portable acquisition system,” and “an “analysis component.”
There is no nexus in the above declaration between the one button tracker and the portable data acquisition device. The portable acquisition device may be a mobile phone, tablet or a computer. The declaration refers only to a device which is neither described in the above referenced application nor in the individual claims of the application. Thus, there is no showing that the objective evidence of nonobviousness or statutory eligibility is commensurate in scope with the claims. See MPEP § 716.
Thus, there is no showing that the objective evidence of nonobviousness or statutory eligibility is commensurate in scope with the claims. See MPEP § 716.
The declaration under 37 CFR 1.132 filed March 9, 2026 is insufficient to overcome the rejection of claims 1, 3-14, and 17-23 based upon 35 USC 101 and 35 USC 103 rejections as set forth in the last Office action because: they fail to set forth facts germane to the issue of obviousness and statutory eligibility regarding abstract claims.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence fails to outweigh the evidence of obviousness and statutory eligibility.
Declaration: Jakob Larsen and Thomas Christiansen
There are some specific paragraphs from the declaration that are provided a response in bold below.
8. A person of ordinary skill in this art would have experience in both portable or wearable electronic device design and self-monitoring or behavioral data collection systems. Such a person would be familiar with the interaction design constraints that govern real-time data capture from human users in uncontrolled environments.
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
IV. The Technical Problem: Interaction-Barrier False Negatives
9. In any active self-tracking system - that is, a system requiring deliberate user input to register events - measurement integrity depends on the user successfully completing a registration each time a target event occurs. When the user intends to register an event but fails to do so, the system produces a false negative: an event that occurred but was not captured.
10. False negatives in self-tracking systems are commonly attributed to computational causes (sensor noise, misclassification) or to volitional causes (the user chooses not to log). However, a significant and underappreciated category of false negatives arises from a distinct source: the interaction itself. We refer to these as interaction-barrier false negatives - instances where the user has the intention to register an event but fails to complete the registration because the interface imposes friction at the moment of capture.
The above false-negatives are not taught in the specification and are rejected as new matter in the claims under 35 USC 112(a).
17. A person of ordinary skill in the art would recognize that these limitations are structural properties of the interaction architecture, not incidental implementation details. They follow from the choice to embed event capture in a multipurpose, screen-based, multi-step interaction model.
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
VI. Technical Architecture of the Invention
18. The specification discloses and the claims recite a portable data acquisition system whose architecture is designed to address each of the failure modes described above. The core structural features are described in the following paragraphs.
A. Single Physical Actuator with Multi-Signal Extraction
19. The disclosed and claimed system provides a single physical actuator - such as a button, force-sensitive sensor, or touch sensor - through which the user registers events. See specification at [0076], [0108], [0182]. The user's interaction with the device is reduced to a single physical gesture: pressing or touching the actuator.
There is no “single physical actuator” or “actuator” claimed or taught.
From Applicant’s specification:
[0076] It should further be appreciated, that although the examples provided above relate to the magnitude and the duration of the observation of occurrence of the target phenomenon, the same principle may be applied to any property of the observation of occurrence of the target phenomenon. Preferably, the information provided to the portable data acquisition system, and that is subsequently stored on the device, comprises any information that is relevant for inferring an understanding, such as an updated understanding, of the suspected condition of the individual. The information is preferably provided to the portable data acquisition system by a small number of input components, such as a single button. A small number of input components, i.e. a small number of input modalities, may make the registration of observation of occurrences of the target phenomenon simpler for the individual. Therefore, in a preferred embodiment of the present disclosure, the portable data acquisition system comprises a single user input component, such as a single button or that the portable data acquisition system has a squeezable part, which is able to register several types of information related to the observation of occurrence of the target phenomenon, such as the type of target phenomenon, the duration of the observation, the magnitude of the observation, and/or any state of the individual, such as the mental state, or a combination thereof.
[0108] In a preferred embodiment of the present disclosure, the portable data acquisition system comprises a single user input component. A single user input component, may make the procedure of registering observations of occurrences of target phenomena and other types of events simpler for the individual, and may further make it possible to design the portable data acquisition system sufficiently small such that it can easily be concealed, for example as being worn as part of an attire, around the wrist, similar to a watch, or around the neck similar to an pendant.
[0182] The method according to any one of the preceding aspects, wherein the portable data acquisition system comprises a number of input component, for interaction with the portable data acquisition system, such as one or more buttons, a number of pressure sensors for registering squeezing of the portable data acquisition system, a touch screen, a fingerprint sensor, and/or a microphone.
Therefore, the “actuator” is an input on a portable data acquisition system. A touchscreen on a mobile phone is an “actuator.”
20. Although the physical interface is a single point of interaction, the system, in some embodiments, extracts multiple signal dimensions from each gesture. Specifically, the system measures characteristics of the input such as duration and force. See specification at [0073], [0074], [0103]. These measurable characteristics serve two functions. First, they provide additional data about the registered event (e.g., intensity or duration of the experience). Second, they encode which target phenomenon the user is registering, enabling a single actuator to serve as the input for multiple configured phenomena through distinguishable interaction patterns (e.g., a brief press for one phenomenon type, a sustained press for another).
21. This architecture collapses the distinction between initiating and completing a registration. In screen-based systems, the user must first navigate to the input state and then provide the input - two temporally and cognitively distinct acts. In the disclosed system, pressing the actuator is the complete registration. There is no intermediate state and therefore no opportunity for mid-flow abandonment.
B. Temporal Separation of Configuration and Capture
22. The specification discloses and the claims recite an architecture that separates the system's operation into two temporally distinct phases: a configuration phase and a capture phase. See specification at [0033], [0052]-[0053], [0077].
23. During the configuration phase, which occurs in advance of data collection, target phenomena are defined and observation protocols are generated. This phase may involve multi-step interaction - for example, a clinician or researcher specifying which phenomena the user will track, defining the observation schedule, and configuring the mapping between press characteristics and phenomenon types. The configuration phase tolerates complexity because it is not time-critical.
24. During the capture phase, the user interacts only with the single actuator. All configuration has already been completed; no selection, navigation, or decision-making is required at the moment of event occurrence. The capture phase is stripped to its minimum: one gesture, one registration.
25. A person of ordinary skill would recognize that this temporal separation is a deliberate architectural choice. By concentrating all configurational complexity in an advance phase and eliminating it entirely from the capture phase, the system ensures that capture-time interaction imposes the lowest possible friction at the moment when friction is most costly - that is, when a transient event is occurring and the user's attentional resources are directed at the experience itself.
The above regarding a person of ordinary skill would recognize a temporal separation is an opinion not fact based.
28. A person of ordinary skill would understand that this feedback mechanism closes the perceptual gap between user action and system response. In the absence of such feedback, the user cannot confirm that the gesture was detected, registered, and correctly classified without consulting a screen - which would reintroduce the multi-step interaction that the single-actuator design is intended to eliminate.
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
D. Contextual Data Acquisition
29. The specification discloses and the claims recite that the system captures contextual data at the time of event registration. At minimum, the system records a timestamp and the duration of the actuator press. The specification further discloses that the system may capture additional contextual data, including location information (see specification at [0110]) and physiological or environmental measurements (see specification at [0111]).
Timestamp is not claimed.
30. This contextual data acquisition is initiated by the single actuator gesture. The user does not perform separate actions to record the time, location, or physiological context of an event; these are captured automatically and associated with the registration. A person of ordinary skill would understand that this represents an integrated event-acquisition architecture in which the simplified user input serves as the trigger for coordinated multi-sensor data capture.
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
VII. How the Disclosed Architecture Reduces Missed Intended Registrations
31. The specification does not need to recite the exact phrase "minimize false negatives" or "substantially minimize false negatives" for a person of ordinary skill to understand that the disclosed architecture produces that result. The structural features described above form a coherent and predictable causal chain:
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
Also, and respectfully, the above is not the requirement. To support features not taught, the specification must teach what thing in the specification inherently had false-negatives. For example, a computer inherently has a processor.
From MPEP 2163.07(a)
“By disclosing in a patent application a device that inherently performs a function or has a property, operates according to a theory or has an advantage, a patent application necessarily discloses that function, theory or advantage, even though it says nothing explicit concerning it. The application may later be amended to recite the function, theory or advantage without introducing prohibited new matter. In reReynolds, 443 F.2d 384, 170 USPQ 94 (CCPA 1971); In reSmythe, 480 F. 2d 1376, 178 USPQ 279 (CCPA 1973); Yeda Research and Dev. Co. v. Abbott GMBH & Co., 837 F.3d 1341, 120 USPQ2d 1299 (Fed. Cir. 2016) (“Under the doctrine of inherent disclosure, when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties.” (citing Kennecott Corp. v. Kyocera Int’l, Inc., 835 F.2d 1419, 1423, 5 USPQ2d 1194, 1198 (Fed. Cir. 1987))). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill. Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.’” In re Robertson, 169 F.3d 743, 745, 49 USPQ2d 1949, 1950-51 (Fed. Cir. 1999) (citations omitted).”
Respectfully, exactly what thing inherently has false-negatives?
32. Step 1. Limiting user interaction to a single physical actuator reduces the number of required interaction steps from many (in a screen-based system) to one. See specification at [0076], [0108]. A person of ordinary skill would understand that reducing the number of required steps reduces the probability that the user will fail to complete any given step, and therefore reduces the overall probability of an incomplete registration.
The limiting user to a single physical actuator is not claimed.
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
33. Step 2. Collapsing initiation and completion into a single atomic gesture eliminates mid-flow abandonment entirely. There is no "flow" in which the user can become lost, distracted, or fatigued. See specification at [0072], [0076].
Collapsing and single atomic gesture that eliminates mid-flow abandonment is not taught.
34. Step 3. Providing a dedicated, always-ready device eliminates the startup barrier that causes non-initiation in multipurpose-device systems. The user does not need to wake, unlock, or navigate to begin capturing an event. See specification at [0029], [0105], [0108].
35. Step 4. Using a dedicated single-purpose device eliminates the distraction and context-switching inherent in multipurpose platforms. The device does not present competing stimuli at the moment of event capture. See specification at [0106].
36. Step 5. Providing proportional haptic feedback confirms both that the input was received and which phenomenon was registered. This eliminates the uncertainty that leads to unconfirmed-registration false negatives and reduces the need for redundant inputs. See specification at [0113].
37. Step 6. The combination of steps 1 through 5 materially reduces the probability that a user who intends to register an event will fail to do SO. Each structural feature addresses a specific failure mode; together, they address all three categories of interaction-barrier false negatives identified in Section IV.
38. We state, based on our expertise and our understanding of the specification, that a person of ordinary skill in the art would understand the disclosed architecture to substantially reduce the incidence of missed intended registrations compared to prior art systems requiring multi-step, screen-based interaction on multipurpose devices.
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
The “disclosed architecture” is not a thing. Also, amended Claim 21 indicates that the false negative system comprises a portable data acquisition system and analysis component. Therefore, it is not inherent from these devices if it is made up of them.
VIII. The Claimed Invention as a Technological Improvement
39. The disclosed and claimed methods and systems constitute a technological improvement in the field of event-acquisition devices. They are not methods and systems to manage personal behavior, organize human activity, mere automations of a mental process, or an abstract concept applied to generic hardware. Specifically:
40. The claimed invention improves the input reliability of the portable data acquisition system. By reducing the number of interaction steps and providing proportional haptic confirmation, the claimed methods and systems achieve a higher rate of successful event registrations per intended registration. This is a measurable improvement in the portable data acquisition system's functioning as an input system.
The “portable data acquisition system” can be a mobile phone (para. [0114] of Applicant’s specification). The above statement is an opinion.
41. The claimed invention improves the temporal fidelity of event capture. Because the user registers events at the moment of occurrence rather than retrospectively, the timestamps captured by the device are temporally proximate to the actual phenomena. In smartphone-based systems, the timestamp reflects the moment of registration completion, which may occur minutes or longer after the event - introducing a systematic temporal displacement. The disclosed and claimed architecture eliminates this displacement by making the registration instantaneous. This is a measurable improvement in the portable data acquisition system's functioning as an accurate data acquisition system.
The above timestamp is not commensurate with the scope of the claims.
42. The claimed invention improves the functional integration of the portable data acquisition system. The single actuator gesture triggers coordinated capture of multiple data channels - including event classification (via press characteristics), temporal data (timestamp and/or duration), and contextual data (location, physiological and environmental measures). This integration is a specific architectural feature of the disclosed and claimed system and method, not an inherent property of any general-purpose computing device.
The above “single actuator” is not taught or claimed.
43. These technological improvements are rooted in the specific structural choices disclosed in the specification and claimed in the claims of the application: the single actuator, the proportional haptic feedback, the temporal separation of configuration and capture, and the coordinated contextual data acquisition.
The above “single actuator” is not taught or claimed.
IX. Distinction from Prior Art
The prior art rejection has been withdrawn based on the claim amendments, rendering the following arguments moot.
67. A person of ordinary skill would understand that the initiation session - in which the clinician and individual collaboratively select target phenomena and define the observation protocol - produces a technical output: a set of parameters that configure the device's operational behavior. This is the same relationship that exists between a technician's configuration of a programmable sensor and the sensor's subsequent autonomous operation. The clinical workflow is the means by which the system is programmed; the observation period is the period in which the programmed
system operates.
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
XIV. Clinical Value of Improved Event Capture
68. A person of ordinary skill would understand that the structural improvements described in Sections III through X of this declaration in the patent application, and in the claims - specifically, the reduction of interaction-barrier false negatives - produce four distinct clinical consequences when the system is configured for mental health self-monitoring.
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
There is no inherency in the specification for false negatives.
105. The clinical workflow elements disclosed in the specification and recited in the claims - collaborative target definition, observation protocol configuration, quantitative hypothesis generation, evaluation sessions, and iterative protocol adaptation - are not abstract methods of organizing human activity. They are the means by which clinical domain knowledge is translated into machine-readable configuration parameters that govern the data acquisition system's operational behavior during the observation period. Each clinical step produces a concrete technical output: an interaction grammar, a set of computational rules for translating physical gestures into structured observations, or a set of comparison criteria for automated evaluation. A person of ordinary skill would understand these as system configuration steps analogous to the calibration or programming of a scientific instrument.
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
106. A person of ordinary skill in clinical self-monitoring systems would further understand, from the specification's disclosure of structured self-monitoring within a therapeutic framework, that the claimed haptic confirmation feedback - confirming the successful performance of a therapeutically defined behavior according to a collaboratively established observation protocol - reinforces the therapeutic behavioral pattern of attending to, registering, and encoding target phenomena. This understanding follows from the established role of self-monitoring as a therapeutic technique and requires no matter beyond what is disclosed in the specification.
The above statement regarding person of ordinary skill in the art is an opinion, not fact based.
Much of the declaration refers to the system described in the above referenced application and not to the individual claims of the application. Thus, there is no showing that the objective evidence of nonobviousness or statutory eligibility is commensurate in scope with the claims. See MPEP § 716.
Applicant should be addressing the claim language. For example, the above declaration recites an “actuator” which is neither taught nor claimed. This is interpreted to be a button, pressure sensor, touch screen (para. [0182]).
The declaration argues that smartphones cannot perform what their system does, yet a portable data acquisition system can be a mobile phone, tablet, computer.
The declarant argues in paragraph 68 that one of ordinary skill in the art would know false-negative is part of their application. Respectfully, the requirement is inherency. False-negative would have to be inherent with a thing such as a processor is inherently part of a computer. Claiming a false-negative system (Claim 21) that comprises various devices is actually showing that false-negative is not inherent to a thing.
The benefits argued such as unexpected results are considered but it is not clear how they relate to the claims if the claims read on a mobile or smart phone, which presumably could be a portable acquisition device.
The declaration under 37 CFR 1.132 filed March 9, 2026, is insufficient to overcome the rejection of claims 1, 3-14, and 17-23 based upon 35 USC 101 and 35 USC 103 rejections as set forth in the last Office action because: they fail to set forth facts germane to the issue of obviousness and statutory eligibility regarding abstract claims.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence fails to outweigh the evidence of obviousness and statutory eligibility.
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, 3-14, and 17-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1, 3-14, and 17-23 are directed to a method or system, which are statutory categories of invention. (Step 1: YES).
The Examiner has identified method Claim 1 as the claim that represents the claimed invention for analysis and is similar to system Claim 14 and Claim 21.
Claim 1 recites the limitations of:
A method for treatment of a mental health condition of an individual, the mental health condition being one of an anxiety disorder, a depressive disorder, and a trauma- and stressor-related disorder, the method comprising:
receiving, by an analysis component, collaborative identification data pertaining to one or more features of the mental health condition and one or more subject-specific phenomena of presentation;
selecting, by the analysis component, one or more target phenomena from the one or more subject-specific phenomena of presentation;
receiving, by the analysis component, one or more subject-specific quantitative hypotheses for the one or more target phenomena, the one or more quantitative hypotheses being based on the mental health condition of the individual;
defining, by the analysis component, an observation protocol comprising instructions for how the individual is to self-monitor and register observations, by interaction with a portable data acquisition system associated with the individual and communicatively coupled to the analysis component, upon each occurrence of the target phenomena is observed by the individual;
directing the individual, based on the observation protocol accessible to the portable data acquisition system, to provide one or more user inputs to the portable data acquisition system via a user input interface having exactly one input member, the input member selected from the group consisting of a physical button, a force-sensitive sensor, and a touch sensor, each user input corresponding to an observed target phenomenon and having at least one of a measurable duration and a measurable magnitude of force, wherein the portable data acquisition system and the one input member are collectively configured to substantially minimize false negatives associated with the one or more user inputs;
providing, by the portable data acquisition system, real-time haptic feedback to the individual in response to the one or more user inputs, wherein one or both of a duration and a magnitude of the haptic feedback corresponds to one or both of the duration and a magnitude of the one or more user inputs such that at least one of a longer duration and a higher magnitude of the one or more user inputs causes at least one of a longer duration and a higher magnitude of the haptic feedback;
receiving, by the analysis component, stored data from the portable acquisition system that corresponds to (1) the one or more user inputs from the individual including at least one of their duration and their magnitude, and (2) contextual information acquired by the portable data acquisition system at least at the time the one or more user inputs are received;
directing the individual to recall each observation period based on the stored data;
completing, by the analysis component, one or more quantitative comparisons between any of the stored data, the one or more quantitative hypotheses, and the recollection;
inferring, based on the quantitative comparison, the mental health condition of the individual; and
adjusting, based on the inference, at least one of a treatment progress report, the observation protocol, and an intervention protocol including updated behavioral instructions for the individual.
These above limitations, under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activity. The claim recites elements, in non-bold above, which covers performance of the limitation as managing personal behavior (e.g., determining a continued progress of the assessment of the individual) and following rules or instructions (e.g., defining an observation protocol comprising instructions for how the individual is to self-monitor and register observations, directing the individual to provide real-time inputs, directing the individual to recall each observation period). If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation as managing personal behavior or following rules or instructions, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. Claims 14 and 21 are also abstract for similar reasons. (Step 2A-Prong 1: YES. The claims are abstract)
This judicial exception is not integrated into a practical application. In particular, the claims only recite: portable data acquisition system, physical force button, force-sensitive sensor, touch sensor (Claim 1); assessment device, portable data acquisition system, external device, physical force button, force-sensitive sensor, touch sensor (Claim 14); portable data acquisition system, physical force button, force-sensitive sensor, touch sensor (Claim 21). The computer hardware is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function) such that it amounts no more than mere instructions to apply the exception using a generic computer component. The portable data acquisition system could be existing computer technology such as mobile phone, tablet, computer (para. [0115]) or a smart watch (see para. [0305] where the watch is a commonly worn accessory). The analysis component appears to be just software, however, it is undefined in the specification (e.g., a human brain could be an analysis component). The button or sensors are used by an individual to input based on their self-monitoring, are generic and recited at a high level of generality. The haptic feedback feedback is claimed at a high level of generality, and appear to be using existing devices (see para. [0305] where portable data acquisition system provides haptic or auditory feedback, and the system can be a commonly worn accessory such as a watch). Further, haptic is not a particular treatment for a disease as it depends on input from a user, which would vary by person (see para. [0133] where the haptic treatment is determined by user input). The haptic intervention is also part of a mental exercise to calm down (para. [0133]), where mental exercise and calm down could be anything and/or would vary by person. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore claims 1, 14, and 21 are directed to an abstract idea without a practical application. (Step 2A-Prong 2: NO. The additional claimed elements are not integrated into a practical application)
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and as an ordered combination, they do not add significantly more (also known as an “inventive concept”) to the exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer hardware amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Steps such as receiving, storing, and transmitting are steps that are considered insignificant extra solution activity and mere instructions to apply the exception using general computer components (see MPEP 2106.05(d), II). Thus claims 1, 14, and 21 are not patent eligible. (Step 2B: NO. The claims do not provide significantly more)
Dependent claims 3-13, 17-20, 22, and 23 further define the abstract idea that is present in their respective independent claims 1 and 14 and thus correspond to Certain Methods of Organizing Human Activity and hence are abstract for the reasons presented above. The dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Claims 3-13 are further limiting abstract ideas or are themselves abstract. Claims 16-20 are interacting with data acquisition device, which is using computer component to receive and provide data. This is claimed at a high level of generality and is using existing technology for interfacing with a computer device. Therefore, the claims 3-13, 17-20, 22, and 23 are directed to an abstract idea. Thus, the claims 1, 3-14, and 17-23 are not patent-eligible.
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, 3-14, and 17-23 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:
“directing the individual, based on the observation protocol accessible to the portable data acquisition system, to provide one or more user inputs to the portable data acquisition system via a user input interface having exactly one input member, the input member selected from the group consisting of a physical button, a force-sensitive sensor, and a touch sensor, each user input corresponding to an observed target phenomenon and having at least one of a measurable duration and a measurable magnitude of force, wherein the portable data acquisition system and the one input member are collectively configured to substantially minimize false negatives associated with the one or more user inputs;”
An adequate written description for a computer-implemented functional claim limitation contains both the computer and the algorithm that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement (MPEP § 2161.01).
The claims recite “the portable data acquisition system and the one input member are collectively configured to substantially minimize false negatives associated with the one or more user inputs.” The instant disclosure fails to adequately disclose the method of performing the portable data acquisition and one input collectively configured to minimize false negative associated with one or more user inputs. While the level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology, the claims read in light of the specification fail to disclose false negatives and the algorithm for determining false negatives. Claim 14 has a similar problem.
Claim 21 recites “A system for substantially minimizing false negatives in observing occurrences of target phenomena, the system comprising:…” and “wherein the portable data acquisition system and the one input member are collectively configured to substantially minimize false negatives associated with one or more user inputs by limiting interaction complexity;” where there is no teaching of a false negatives system in the specification or the original filed disclosure. Further, there are no figures of such a system.
The specification teaches:
“In another aspect, a system for assessment of one or more suspected conditions of an individual, includes an assessment device, a portable data acquisition system communicatively coupled to the assessment device, and an external device coupled to the assessment device. The assessment device is configured to receive collaborative identification data pertaining to one or more features of a suspected condition and one or more subject-specific phenomena of presentation, receive one or more quantitative hypotheses for the one or more target phenomena, and define an observation protocol comprising instructions for how the individual is to self-monitor and register observations. The portable data acquisition system is configured to receive the registered observations from the individual in accordance with the observation protocol upon observation of a target phenomenon of the one or more target phenomena during one or more observation periods. The assessment device is further configured to obtain the data from the portable data acquisition system, direct the individual to recall each observation period, complete one or more quantitative comparisons between any of the stored data, the quantitative hypotheses, and the recollection, infer, based on the quantitative comparison, the one or more suspected conditions of the individual, and determine, based on the inferred one or more conditions of the individual, a continued progress of the assessment of the individual. The external device receives a data file from the assessment device, the data file containing the continued progress of the assessment of the individual and presents the data file to a user.” [0005]
Therefore, a system for assessment of conditions, not a system for minimizing false negatives.
Claims 3-13, 17-20, 22, and 23 are rejected as they depend from their respective independent claims.
Examiner Request
The Applicant is requested to indicate where in the specification there is support for amendments to claims should Applicant amend. The purpose of this is to reduce potential 35 U.S.C. §112(a) or §112 1st paragraph issues that can arise when claims are amended without support in the specification. The Examiner thanks the Applicant in advance.
Prior Art
An updated search was conducted but does not result in a prior art rejection at this time. The best prior art found to data is Patent No. US 11342051 to Jain et al. Jain et al. teaches mental health and mobile device. However, they fail to teach or render obvious analysis component and duration, pressure and magnitude, as well as a false-negative system as claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/KENNETH BARTLEY/Primary Examiner, Art Unit 3684
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