DETAILED ACTION
Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/10/26 has been entered. Claim(s) 1, 7, 15-17, 20-25, 28, 30-31, and 35-37 is/are pending and under examination.
The amendment filed 6/10/26 overcomes the previous objection of claim 23, and therefore, the objection is withdrawn.
Claim Rejections - 35 USC § 101
Claims 1, 7, 15-17, 20-25, 28, 30-31, and 35-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1 = YES: The claimed invention is to a process, and thus fall under one of the four statutory categories (Step 1: YES).
STEP 2A, Prong 1 = YES: The claims recite a series of steps which can be practically performed by one or more humans through mental process (i.e., observation, evaluation, judgement, and/or opinion)(see MPEP § 2106.04(a)(2), subsection III), and/or certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)(see MPEP § 2106.04(a)(2), subsection II). Moreover, the claims recite steps akin to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, which the court in Electric Power Group held to recite a mental process. Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). Lastly, this process identified below is akin to a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982), which the court held to constitute a certain method of organizing human activity.
The claims recite the following abstract idea: a method of improving a motor skill impaired by a movement disorder in an individual, said method comprising:
implementing… a…therapy intervention plan for the individual, wherein the…therapy intervention plan comprises at least one…intervention configured to elicit a motor response from the individual, and wherein the at least one…intervention utilizes sensory inhibition, sensory substitution, sensory integration, or a combination thereof, wherein the at least one… intervention is implemented by modifying at least one sensory modality input…, presenting it to the individual and monitoring the motor response of the individual… (mental process: observation and evaluation/analysis; certain methods of organizing human activity: interaction between people);
wherein the sensory inhibition comprises at least partial reduction of at least one sensory modality input, wherein the at least one sensory modality input is selected from: visual, auditory, and tactile (further defines limitation above, and thus falls within the same abstract idea previously identified);
wherein the sensory substitution comprises at least partial replacement of at least one sensory modality input with at least one other sensory modality input selected from: visual to auditory and/or tactile; auditory to visual and/or tactile; and tactile to visual and/or auditory (further defines limitation above, and thus falls within the same abstract idea previously identified);
wherein the sensory integration comprises at least partial combination of at least two sensory modalities inputs, wherein said at least two sensory modalities inputs are selected from: visual, auditory, and tactile (further defines limitation above, and thus falls within the same abstract idea previously identified); and
. . . generates a performance score based on the response of the individual in the at least one … intervention and adapts the next … intervention of the at least one … interventions when a threshold performance score is achieved (mental process: evaluation/analysis; certain methods of organizing human activity: interaction between people);
delivering instructions to said individual before, during and/or after any stage of the . . . therapy intervention plan (certain methods of organizing human activity: interaction between people);
wherein the individual interacts… using touch gesture, motion gesture, voice commands, text input . . . or a combination thereof, and wherein the adapting is executed in response to the motor response (further defines limitation above, and thus falls within the same abstract idea previously identified);
wherein said touch gesture is selected from: tapping, swiping, scrolling, pinching, dragging, double-tapping, or a combination thereof (further defines limitation above, and thus falls within the same abstract idea previously identified);
wherein said motion gesture is selected from: tilting, shaking, rotating, body motion, waving, or a combination thereof (further defines limitation above, and thus falls within the same abstract idea previously identified);
wherein said at least one . . . intervention is performed in any of the following formats: . . . game, instructional prompts, question and answer survey with feedback . . . or a combination thereof (further defines limitation above, and thus falls within the same abstract idea previously identified);
wherein said at least one . . . intervention spans a duration ranging from 1 second to 60 minutes (further defines limitation above, and thus falls within the same abstract idea previously identified);
wherein said . . . therapy intervention plan is carried out over the course of between 1 day to 10 years (further defines limitation above, and thus falls within the same abstract idea previously identified);
monitors the individual's progress and dynamically adjusts the … intervention plan based on the detected interactions (mental process: observation and evaluation/analysis; certain methods of organizing human activity: interaction between people);
wherein the adapting further comprises generating an updated . . . therapy intervention plan for said individual in response to the motor response of the individual (further defines limitation above, and thus falls within the same abstract idea previously identified);
wherein said adaptation comprises a change in any of the following selected from: type of intervention, intervention sequence, frequency of intervention, intensity of intervention, length of intervention, difficulty of intervention, sensory modality inputs used, level of interaction, or a combination thereof (further defines limitation above, and thus falls within the same abstract idea previously identified);
. . . transfer data between said individual . . . (certain methods of organizing human activity: interaction between people);
provide and implement the at least one sensory modality input to carry out the sensory inhibition, sensory substitution, sensory integration, or a combination thereof (certain methods of organizing human activity: interaction between people);
wherein said movement disorder is selected from: Parkinsonism, ataxia, dystonia, tremor, chorea, tics, spasticity, gait disorders, multiple system atrophy (MSA), progressive supranuclear palsy (PSP), Lewy body dementia (LBD), corticobasal degeneration, Huntington’s disease, Friedreich’s ataxia, essential tremor, myoclonus, Tourette syndrome, restless leg syndrome, tardive dyskinesia, and Wilson’s disease (further defines limitation above, and thus falls within the same abstract idea previously identified); and
wherein said at least one . . . intervention is administered together with a conditioning stimulus selected from: visual, auditory, tactile, or a combination thereof (further defines limitation above, and thus falls within the same abstract idea previously identified).
The steps identified above are akin to organizing human activity and/or mental processes, and thus fall within an enumerated category of abstract ideas. Note that even if most humans would use a physical aid (e.g., pen and paper) to help them complete the recited steps above, the use of such physical aid does not negate the mental nature of these limitations. Therefore, the claims recite an abstract idea (Step 2A, Prong 1: YES).
STEP 2A, Prong 2 = NO: This judicial exception is not integrated into a practical application.
To the extent the claims recite additional elements related to implementing the abstract idea above in a computer environment (i.e., defining the abstract idea, including the intervention plan as being digital, and in the context of a physical device, i.e., on a personal electronic device that is configured to perform the steps identified as abstract ideas under Prong 1; and further including wherein the at least one digital interaction is defined as the individual interacting with said personal electronic device (such as, but not limited to camera and media interaction . . . and/or sensor-based interactions); wherein the digital interaction further includes instructional video, interactive video comprising input and feedback from the individual, virtual reality, and/or augmented reality; and at least one additional device configured to provide and implement the abstract idea identified under Prong 1 selected from: health monitoring system, medical device, haptic device, external speakers, headphones, virtual reality set, augmented reality glasses/devices, biofeedback sensors, wearable activity trackers, smartphone, personal computational device, smart speakers, voice assistants, motion tracking sensor, virtual assistant systems, internet hub, or a combination thereof; wherein said at least one additional device is configured to transfer data between said individual, said personal electronic device, or a combination thereof; and wherein said at least one additional device is configured to perform steps identified as an abstract idea under Prong 1; and lastly wherein said personal electronic device, said at least one additional device, or a combination thereof, are configured to perform the steps identified as an abstract idea under Prong 1), they are recited at a high level of generality such that they do not amount to a particular machine or technical improvement thereof, nor do they represent an improvement in any other technology. Each of the additional elements is referred to by name alone in conjunction with a result to be achieved or performed, and thus do not recite any particular technical details, including any particular structure or rules for how the generic features operate. Likewise, the specification does not disclose these elements providing a technical solution to a technical problem, and thus do not represent a technical improvement. Rather, the generic manner which these additional elements are claimed amount to mere instructions to implement the abstract idea in a digital-format through a computer-based environment with no particular arrangement or particular structures, i.e., field of use, and thus do not represent a technical improvement to a technical problem.
To the extent the claims recite additional elements related to physical components for collecting and outputting data (i.e., defining the user interactions as via a personal electronic device wherein data is collected through one or more components of the personal electronic device, such as using any of the following means selected from: touch gesture, motion gesture, voice commands, text input, camera and media interaction, sensor-based interactions, or a combination thereof; wherein said touch gesture is selected from: tapping, swiping, scrolling, pinching, dragging, double-tapping, or a combination thereof; wherein said motion gesture is selected from: tilting, shaking, rotating, body motion, waving, or a combination thereof; wherein said at least one digital intervention is performed in any of the following formats: instructional video, interactive video comprising input and feedback from the individual, game, instructional prompts, question and answer survey with feedback, virtual reality, augmented reality, or a combination thereof), the claims do not recite a particular structure or configuration of the recited personal electronic device, sensors or camera, nor do the claims recite a particular method of using the raw data in order to achieve a technical improvement. At best, any claimed personal electronic device, sensors or camera are merely recited, in the alternative in many instances, to perform insignificant pre-and post-solution data gathering and output activity, which but for the generic recitation of these physical components, is practically capable of being performed by human analog, e.g., by mental observation and evaluation and certain methods of organizing human activity, e.g., interactions between humans, including social activities, teaching, and following rules or instructions. Likewise, the specification does not disclose these elements providing a technical solution to a technical problem, and thus do not represent a technical improvement. The claims lack any technological implementation details, but instead merely refer to these physical hardware elements by name to perform what has been identified under Prong 1 as an abstract idea. Therefore, these additional elements to not represent a technical improvement to a technical problem.
Additionally, the additional elements do not represent a particular treatment because the claims do not affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. The claims do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2). Instead, the claims of the instant application merely provide a digital therapy intervention plan to an individual, which is claimed as being carried out on a personal electronic device. First, a digital therapy intervention plan as claimed is interpreted as information, not a treatment or prophylaxis. For example, the claimed plan is not akin to acupuncture, administration of medication, dialysis, organ transplants, phototherapy, physiotherapy, radiation therapy, surgery, or the like, as provided as examples of a treatment or prophylaxis in MPEP § 2106.04(d)(2). Second, providing a digital therapy intervention plan as claimed does not actually require the digital therapy intervention plan be administered, but rather amounts to presenting a user with said digital therapy intervention plan which may or may not be received or understood by the individual. Lastly, the method is performed regardless of the particular user, and thus does not effect a particular treatment or prophylaxis for a disease or medical condition. Therefore, the claims do not recite a particular treatment or prophylaxis according to MPEP § 2106.04(d)(2).
It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of the physical components identified above does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014). Even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception. Therefore, the claims are directed to an abstract idea (Step 2A, Prong 2: YES).
STEP 2B = NO: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because as provided under Prong 2, the additional elements are recited at a high level of generality and for the purpose of insignificant extra-solution activity.
Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d). Generally linking the use of the judicial exception to a particular technological environment or field of use, e.g., a claim describing how the abstract idea of hedging could be used in the commodities and energy markets, as discussed in Bilski v. Kappos, 561 U.S. 593, 595, 95 USPQ2d 1001, 1010 (2010)(see MPEP § 2106.05(h).
In this case, the specification demonstrates that the additional elements are recited for their well-understood, routine and conventional functionality, by referring to these elements in a manner that indicates they are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a)(e.g., the Background of the Invention section describes digital therapy, including digital interventions using smartphones, tablets, and computers, as known (i.e., “gaining recognition and importance”); paragraph 0237 describing the digital interventions are administered through the operation of a software application and may be delivered via any screen connected to the Internet (including, without limitation, Mobile, PC, TV, AR Glasses, VR headsets, smart watches, or other wearable devices) and/or any audio devices connected to the Internet (including, without limitation, headset, speakers) and/or any connected haptic devices (such as bracelet, watch, ring, sleeve, belt, wrist bands, vest and more); and paragraph 0237 describing the system includes an interface including, without limitation, smart watches and bracelets), sensors attached to the body (including, without limitation, scalp, finger, and earlobe sensors) and other devices capable of monitoring activity and detecting various measures of health and other information about the user's body (par. 0238), thus demonstrating the claimed digital implementation, including the claimed physical structure, relies on well-known, routine, and conventional components, which are recited for their basic functions). Thus, the additional elements are interpreted in light of the specification as conventional, and the claims are silent as to any unconventional arrangement or unconventional manner of operation. Thus, the claims generally link the additional elements to a field of use in order to automate a manual process (i.e., implementing the abstract idea, a therapy or physical intervention, digitally using generic computer components), which the courts have held to be insufficient in showing an improvement in computer-functionality. See Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055, 123 USPQ2d 1100, 1108-09 (Fed. Cir. 2017); see also LendingTree, LLC v. Zillow, Inc., 656 Fed. App'x 991, 996-97 (Fed. Cir. 2016) (non-precedential). Additionally, the additional elements also do not represent a particular treatment or prophylaxis for the same reasons provided under Prong 2 and incorporated herein by reference.
Therefore, the claims are not directed to significantly more than the abstract idea (Step 2B: NO).
Therefore, claims 1, 7, 15-17, 20-25, 28, 30-31, and 35-37 are not directed to patent eligible subject matter.
RESPONSE TO ARGUMENTS
35 USC § 101 – Rejections
Applicant's arguments filed 6/10/26 have been fully considered but they are not persuasive. Applicant’s arguments repeat several arguments Examiner responded to in the final Office Action mailed on 6/10/26. Accordingly, Examiner’s response to arguments from that Office Action are incorporated herein by reference.
Applicant argues Regarding Step 2A, Prong 1, Applicant submits that the amended claims do not recite an abstract idea based on the assertion that the limitations “a digital intervention "configured to elicit a motor response from the individual" wherein the personal electronic device monitors "the motor response of the individual through one or more input components of the personal electronic device" is not an abstract mental process that can be performed in the human mind. However, the rejection does not state that the claimed physical devices are an abstract idea. Rather, the steps for which they are claimed as performing constitute the abstract idea (see Prong 1). Further, requiring an individual to physical perform motor skills, e.g., require the individual to physically perform specific therapeutic exercises, is an abstract idea because it is merely a person thinking and moving their body, which is a mental process and certain methods of human activity. Likewise, it would be practically capable for another human, e.g., a teacher or coach, to monitor the first person performing motor actions (i.e., observe) and provide feedback (i.e., interact or teach), and thus monitoring and feedback as claimed is also akin to a mental process and certain methods of organizing human activity. The recited computer components, e.g., device input components, claimed as performing this step are recited at a high level of generality with no details whatsoever how they perform or achieve the claimed monitoring, and thus do not offer meaningful limitations beyond linking the abstract idea to a generic computer environment. Thus, these additional elements do not represent a technical improvement of any kind.
Applicant argues the claims integrate any abstract idea into a practical application as Applicant argues the claims recite a particular treatment for movement disorders. In particular, Applicant contends that the digital intervention administered via sensory modulation (sensory inhibition, sensory substitution, sensory integration) constitutes therapeutic treatment, not merely presenting information for the individual to consider. However, sensory modulation (sensory inhibition, sensory substitution, sensory integration) and an intervention defined as modifying at least one sensory modality input is an abstract idea because under the broadest reasonable interpretation it can be performed by an interaction between individuals. That is, a human is capable of presenting an intervention for eliciting a motor response that utilizes sensory inhibition, substitution, integration, or some combination thereof to another person, modifying and presenting a sensory modality input to the person, and subsequently monitoring the motor response of that person. The claims describe information, e.g., visual, auditory, or tactile information, for an individual to view and consider, but do not recite affirmative steps the individual must take to ingest the claimed information, and thus is merely prescribing information for the user to either interact with or ignore. The process as claimed does not require a user to participate as Applicant argues, but to the extent it does (which Examiner does not concede), it merely describes the personal interaction between two individuals, and thus constitutes certain methods of human activity, which is one of the judicial exception groupings. Thus, the claims do not require any actual administration steps. The claims do not require any specific technological implementation, but rather recites the use of physical hardware drafted at a high level of generality to perform the otherwise abstract idea. That is, modifying a sensory modality input is defined in the claim as simply being perform on the personal electronic device, and thus does not offer meaningful limitations beyond generally linking the abstract idea to a generic technological environment, and thus not a technical improvement. Applicant’s assertion that this limitation “represents a specific technological solution to the problem of treating movement disorders” is neither supported by the claimed or the specification, and amounts to a conclusory statement.
Applicant further argues that the amended claims now require a digital intervention "configured to elicit a motor response from the individual" and require "monitoring the motor response of the individual through one or more input components of the personal electronic device." As previous discussed, providing an intervention that elicits a motor response from the individual and monitoring the motor response of the individual describes a process practically capable of performance by human analog, including mental observation and evaluation, and certain methods of human activity, including an interaction between individuals. Defining this process in the claims as being digital and through one or more input components of the personal electronic device do not represent technical details that result in a technical improvement, but rather are recited at a high level of generality with no technical details whatsoever. Further, the claims do not require the user to perform any actions. At best, the claims require an intervention, which could include information, being presented to an individual and their response to that information is monitored. To the extent that the claims require the individual to actually perform a motor response, which Examiner does not concede, it describes an interaction between individuals, and thus still an abstract idea because it falls under the certain methods of organizing human activity judicial exception grouping. Further, adapting the intervention describes a mental process and certain method of organizing human activity because it can be practically performed by a human through mental evaluation and subsequent interactions between individuals. For example, the “adapting” may include a change in any of the following selected from: type of intervention, intervention sequence, frequency of intervention, intensity of intervention, length of intervention, difficulty of intervention, sensory modality inputs used, level of interaction, or a combination thereof (see claim 24). Thus, to the claims recite the use of physical hardware, i.e., personal electronic device, to perform sensory output, input capture, and adaption, it is recited at a high level of generality with no particular details resulting in a technical improvement of any kind, but rather merely rely on these generic physical components to define a generic field of use to perform the abstract idea identified under Prong 1. Thus, the adaptation does not amount to a particular treatment, as it falls under the mental process and certain methods of organizing human activity judicial exception grouping.
Applicant further argues that a human therapist cannot provide real-time visual feedback meters showing volume levels as described in the specification, cannot detect and score tapping precision on a touchscreen, and cannot provide the specific sensory modulation (inhibition, substitution, integration) that the device provides. See As-Filed Specification, paragraph [000144] (describing how "the digital platform (e.g., an app, a software application) provides real time feedback on how close the detected volume is to the required volume"). Applicant’s argument is not commensurate in scope with the claimed invention, and thus is not persuasive.
Applicant argues the technical improvement lies in how the device implements the therapy-through real-time monitoring, performance scoring, and adaptive intervention adjustment-not merely in the therapeutic outcome, that the claims recite a specific technological solution wherein the personal electronic device modifies sensory modality inputs, monitors responses, generates performance scores, and adapts interventions based on threshold scores, and that this represents a technical improvement in how digital therapy is delivered, not merely an improvement to the human recipient. However, Applicant has not identified any technical details that define how the device implements these steps. As provided under Prong 1, these steps (e.g., real-time monitoring, performance scoring, adapting interventions, modify sensory modality inputs, monitor responses, generate performance scores, and adapt interventions based on threshold scores) are practically capable of being performed by human analog, e.g., mental processes and certain methods of organizing human activity, and to the extent physical hardware is relied upon in the claims to perform these steps (e.g., defining the digital intervention as being “on a personal electronic device”), they are recited at a high level of generality such that they do not integrate the judicial exception into a practical application. The claims lack any specific technological solution.
Applicant argues the specific combination of a digital intervention configured to elicit a motor response, sensory modulation (inhibition, substitution, integration), device-based monitoring of the motor response through input components, and a closed-loop adaptive system on a personal electronic device is not well-understood, routine, or conventional. This is contradictory to the manner for which the identified additional elements are disclosed in the written description (e.g., the Background of the Invention section describes digital therapy, including digital interventions using smartphones, tablets, and computers, as known (i.e., “gaining recognition and importance”); paragraph 0237 describing the digital interventions are administered through the operation of a software application and may be delivered via any screen connected to the Internet (including, without limitation, Mobile, PC, TV, AR Glasses, VR headsets, smart watches, or other wearable devices) and/or any audio devices connected to the Internet (including, without limitation, headset, speakers) and/or any connected haptic devices (such as bracelet, watch, ring, sleeve, belt, wrist bands, vest and more); and paragraph 0237 describing the system includes an interface including, without limitation, smart watches and bracelets), sensors attached to the body (including, without limitation, scalp, finger, and earlobe sensors) and other devices capable of monitoring activity and detecting various measures of health and other information about the user's body (par. 0238), thus demonstrating the claimed digital implementation, including the claimed physical structure, relies on well-known, routine, and conventional components, which are recited for their basic functions). Thus, to the extent the claims require the use of a “personal electronic device” to perform certain steps, it is both recited in the claims and described in the written description at a high level of generality and under the broadest reasonable interpretation includes any known device capable of performing the claimed steps. As indicated under Prong 2 and Step 2B, the use of this and other additional elements in the claims serve merely as a generic tool to perform steps that are practically capable of being performed by a human through mental process and certain methods of organizing human activity, and the claims lack any particular technical detail that provide a technical solution.
Therefore, Applicant’s arguments are not persuasive and the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715
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