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.
The Amendment filed 9/7/25 has been entered. Claims 1, 7, 15-17, 20-25, 28 and 30-31 are pending in the application and are under examination.
Claim Objections
Claim 23 is objected to because of the following informalities: Claim 23 is dependent on canceled claim 4. Appropriate correction is required.
Claim Rejections - 35 USC § 101
Claims 1, 7, 15-17, 20-25, 28, and 30-31 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 motor skills in an individual affected by a movement disorder, said method comprising:
. . . receive data related to the individual and the movement disorder wherein . . . generates a therapy intervention plan based on the data (mental process: observation and evaluation; certain methods of organizing human activity: interaction between people);
implementing the . . . therapy intervention plan for the individual . . . , wherein the . . . therapy intervention plan comprises at least one . . . intervention configured for the interaction of the individual in a physical intervention comprising: 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 response of the individual (mental process: 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 responses 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 said interaction is selected from: touch gesture, motion gesture, voice commands, text input . . . or a combination thereof (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 data (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., by a provided personal electronic device 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. 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 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. 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, and 30-31 are not directed to patent eligible subject matter.
RESPONSE TO ARGUMENTS
35 USC § 101 – Rejections
Applicant's arguments filed 9/7/25 have been fully considered but they are not persuasive.
Applicant argues that the claims do not recite an abstract idea, as Applicant asserts that claim 1 removed the human from carrying out the generating step. However, but for the generic recitation of a computer, e.g., personal electronic device, to perform this claimed function, the generating step is practically capable of performance by a human, as indicated in the rejection by mental process and certain methods of organizing human activity, e.g., receive data related to the individual and the movement disorder wherein . . . generates a therapy intervention plan based on the data. As provided under Step 2A, Prong 2, the use of a personal electronic device to implement this step, and others, does not add meaningful limitations beyond merely defining a generic technological environment in which to perform the abstract idea. Moreover, the rejection does not identify the personal electronic device or the digital nature of the claimed invention as part of the abstract idea. These additional elements are addressed under Step 2A, Prong 2 and Step 2B. Therefore, Applicant’s argument that these physical elements cannot be performed in the human mind is not persuasive. Implementing the therapy plan in a digital environment using a computing device, i.e., device external to the individual, as claimed, merely defines a field of use because the claims lack any technological implementation details defining a technical solution to a technological problem. Thus, the claims do not provide technical details that improve the personal electronic device or any other computer component claimed, and thus do not represent a technical improvement to a technological problem. Moreover, the claims do not provide technical details defining how a sensory modality input is modified. The claims merely define the modifying as being generically implemented on the personal electronic device without technical detail that represents a technical improvement to how that physical device carries it out. Thus, the use of the personal electronic device to present the digital intervention, and thus modifying of the sensory modalities, amounts to insignificant post-solution data output activity. But for the generic recitation of a device to perform this step, modifying sensory modality inputs can likewise be performed through human interactions, e.g., by changing how the person interacts with another person, e.g., through speech, body movement, and/or touch. To the extent such interactions elicit a response in the individual, that is interpreted as a result of the human interaction, and thus part of the abstract idea itself. Although Applicant asserts the “improvement” is “in the operation of the personal electronic device itself, enabling closed-loop sensory modulation and adaptive therapy” and “physical modifications to device generated signals”, the claims are not commensurate in scope with Applicant’s arguments which do not refer to “closed-loop sensory modulation” or “physical modifications to device-generated signals”. Moreover, to the extent the claims do refer to “adapt[ing] the next digital intervention of the at least one digital interventions when a threshold performance score is achieved,” the claim lacks any detail whatsoever how the adapting is achieved, and thus but for generically referring to the intervention as “digital”, the step is practically performable by humans through mental process, e.g., evaluation and/or certain methods of human activity, e.g., a teaching interaction between two people. 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. Lastly, improving motor skills in an individual affected by a movement disorder is not a technical improvement to the personal electronic device, or any other technology, and at best merely describes an improvement to a human being. Thus, to the extent a human performing the claimed steps experiences improved motor skills, that merely describes the abstract idea itself, not a technical improvement of any kind, and thus does not indicate an integration of the judicial exception into a practical application under Step 2A, Prong 2 and Step 2B. Therefore, Applicant’s arguments are not persuasive.
Applicant further argues that the claims affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. Although Applicant contends the claims “recites ‘interaction of the individual in a physical intervention,” an interaction by presenting sensory modalities to a user describes the abstract idea itself (i.e., certain method of organizing human activity, including interaction between individuals, such as teaching), and does not require a particular treatment or prophylaxis for a disease or medical condition. Applicant has not identified any claim limitations that recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. Rather, the claims merely describe the digital therapy plan implemented “for the individual” and “for the interaction with the individual.” 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. Thus, the claims do not require any actual administration steps. The individual is merely an intended recipient of the plan, but the claims do not expressly require that person to ingest the information conveyed. This is merely prescribing information for the individual to consider, and thus the claims do not require administration of said information claimed. Moreover, adapting the intervention based on a performance score merely further describes the abstract idea itself because but for the generic identification of a personal electronic device to perform this step, a teacher could practically perform the task by mental process. Therefore, Applicant’s arguments are not persuasive.
Applicant further argues the claimed steps involve physical interactions for directly improving motor skills in an individual. For the same reasons provided by Examiner to this argument under Step 2A, Prong 2, Applicant’s arguments are not persuasive. Moreover, the “‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) (“a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty.”). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C. 103. See, e.g., BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1350, 119 USPQ2d 1236, 1242 (Fed. Cir. 2016) (“The inventive concept inquiry requires more than recognizing that each claim element, by itself, was known in the art. . . . [A]n inventive concept can be found in the non-conventional and non-generic arrangement of known, conventional pieces.”). Specifically, lack of novelty under 35 U.S.C. 102 or obviousness under 35 U.S.C. 103 of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements. Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C. 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C. 101. The distinction between eligibility (under 35 U.S.C. 101) and patentability over the art (under 35 U.S.C. 102 and/or 103) is further discussed in MPEP § 2106.05(d). Lastly, Applicant has not identified limitations claimed that result in a technological improvement. At best, the improvement of motor-related brain connectivity describes an improvement to a human being, not an improvement to the personal electronic device or any other technology or technical field. Therefore, Applicant’s arguments are not persuasive.
Therefore, the rejection under 35 USC 101 is maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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.
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