DETAILED ACTION
Applicant’s arguments, filed 06/25/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has amended their claims, filed 06/25/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-14 are pending and hereby under examination.
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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
“A system for notifying cognitive impairment in a user” (claim 12) is identified as “In addition, the MCI RN device 200 includes an MCI RN display 240” (Paragraph 0019) and “The MCI Notification may be displayed on the MCI RN device 200 as a single MCI Risk figure, but may also include graphs indicating change of MCI Risk over time; details of change in Motion Assessment Data of different Motor Task types over time or the like” (Paragraph 0096).
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a wearable device” first recited in claim 1;
“a second wearable device” first recited in claim 4; and
“a second, different, wearable device” first recited in claim 6;
The identified structure for the corresponding claim limitations are as follows:
“a wearable device” is identified as “picking up or placing wearable devices on the body, such as earphones, head mounted displays, etc.” (Paragraph 0048), “the wearable devices may be earphones, a smart watch, Virtual Reality Headset or the like” (Paragraph 0098).
“a second wearable device” is identified as “picking up or placing wearable devices on the body, such as earphones, head mounted displays, etc.” (Paragraph 0048), “the wearable devices may be earphones, a smart watch, Virtual Reality Headset or the like” (Paragraph 0098).
“a second, different, wearable device” is identified as “picking up or placing wearable devices on the body, such as earphones, head mounted displays, etc.” (Paragraph 0048), “the wearable devices may be earphones, a smart watch, Virtual Reality Headset or the like” (Paragraph 0098).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 1 and 13:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 13 is directed to a computer implemented method, which describes one of the four statutory categories of patentable subject matter, i.e., a method.
Therefore, further consideration is necessary regarding claims.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1 and 13 recite an abstract idea. In particular, the claims generally recite
the following:
compare the motion data received during the second time period with stored reference motion data;
determine the predetermined task based upon the comparison;
select the motion data corresponding to the first time period for further processing based on a determination that the user performed the predetermined task during the first time period;
compare the motion data received during the first time period with further stored reference motion data; and
determine the indicator value of the cognitive impairment based upon a comparison between the motion data received during the first time period with the further reference motion data.
These elements recited in claims 1 and 13 are drawn to an abstract idea since they are directed towards mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
“compare the motion data received during the second time period with stored reference motion data” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably compare received data with stored reference data. There is nothing to suggest an undue level of complexity in “compare the motion data received during the second time period with stored reference motion data”.
“determine the predetermined task based upon the comparison” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably compare received data with stored data to determine a task the user was performing. There is nothing to suggest an undue level of complexity in “determine the predetermined task based upon the comparison”.
“select the motion data corresponding to the first time period for further processing based on a determination that the user performed the predetermined task during the first time period” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably select data for processing based on data that appears to be a user performing a predetermined task. There is nothing to suggest an undue level of complexity in “select the motion data corresponding to the first time period for further processing based on a determination that the user performed the predetermined task during the first time period”.
“compare the motion data received during the first time period with further stored reference motion data” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably compare received data with stored reference data. There is nothing to suggest an undue level of complexity in “compare the motion data received during the first time period with further stored reference motion data”.
“determine the indicator value of the cognitive impairment based upon a comparison between the motion data received during the first time period with the further reference motion data” is drawn to an abstract idea since it is a mental process that can be practically performed in the human mind, with the aid of pen and paper or a generic computer. A person of ordinary skill in the art could reasonably determine a level of cognitive impairment based on a comparison of received data and reference data. There is nothing to suggest an undue level of complexity in “determine the indicator value of the cognitive impairment based upon a comparison between the motion data received during the first time period with the further reference motion data”.
Prong Two: Claims 1 and 13 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are "directed to" the abstract idea. The additional elements merely:
Add insignificant extra-solution activity (the pre-solution activity of: using generic data gathering components (e.g., “receive motion data from a wearable device worn by the user during a time period comprised of a first time period and a second time period, the second time period being after the first time period” (claim 1) and "receiving motion data from a wearable device worn by the user during a time period comprised of a first time period and a second time period, the second time period being after the first time period" (claim 13); the post-solution activity of: (e.g., “output the determined indicator value of the cognitive impairment” (claim 1) and “outputting the determined indicator value of the cognitive impairment” (claim 13))).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment; rather, the result merely outputs a value. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 13 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. All elements are directed to implementing the abstract ideas on generic processing components, the pre-solution activity of using generic data-gathering components, and generic post-solution activities, which merely facilitate the abstract idea.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “a wearable device” as disclosed in the Applicant’s specification, “picking up or placing wearable devices on the body, such as earphones, head mounted displays, etc.” (Paragraph 0048) and “the wearable devices may be earphones, a smart watch, Virtual Reality Headset or the like” (Paragraph 0098). Additionally, "circuitry” as disclosed in Applicant’s specification, “processing circuitry 110 is any kind of circuitry such as programmable semiconductor circuitry (for example an Application Specific Integrated Circuit "ASIC") or a processor that is controlled using computer software” (Paragraph 0018).
Further, there is no improvement to the technology and/or the elements do not amount to significantly more as the arrangement is well-understood, routine, and conventional. For example, as disclosed by Wagner (US 20160262685), the motion analysis system is capable of being performed at home using wearable sensors (Fig. 1, motion sensors 102; Paragraph 0043, “the data and/or analysis results could be communicated through wired or wireless methods to clinicians who can evaluate the data, such as for example remotely through telemedicine procedures”).
These elements do not qualify as significantly more because these limitations are simply appending well understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception. For example, 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 in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well understood, routine and conventional activity previously known in the industry (see Electric PowerGroup, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int'/, 110 USPQ2d 1976 (2014); SAP Am. v. lnvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements include a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of dependent claims 2-12 and 14:
Claims 6 and 10 recite mental steps that may be performed in the human mind with the aid of pen and paper or a generic computer, which add to the abstract idea. The mental steps are identified as:
“determine a physical impairment from the motion data received from the second wearable device” (claim 6);
“wherein the circuitry is configured to correlate the indicator value of the cognitive impairment with other indicator values for the user” (claim 10);
Claim 3 recites steps that are mathematical concepts, which add to the abstract idea. The mathematical concepts are identified as:
“the circuitry is configured to determine the indicator value of the cognitive impairment by comparing the midpoint errors of the time-dependent acceleration or velocity received during the first time period and the further reference motion data” (claim 3).
Claims 2-12 and 14 recite limitation in addition to the abstract idea: they merely
Further describe the abstract idea (“determine the indicator value of the cognitive impairment using the periodically captured motion data” (claim 2), “wherein the motion data is one of time-dependent acceleration or velocity” (claim 3), “wherein the circuitry is further configured to determine the indicator value of the cognitive impairment using physiological data of the individual captured from a second wearable device worn by the user” (claim 4), “wherein the physiological data is a myoelectric signature” (claim 5), “a system for notifying cognitive impairment in a user, the system comprising circuitry configured to: receive the indicator value of the cognitive impairment from a system according to claim 1” (claim 12), and “a computer program comprising computer readable instructions which, when loaded onto a computer, configures the computer to perform a method according to claim 13” (claim 14)),
Further describe the pre-solution activity (“capture the motion data periodically over said time period” (claim 2), “wherein the circuitry is configured to receive motion data from a second, different, wearable device” (claim 6), “wherein the reference motion data is captured from the individual over a time longer than the time period” (claim 7), “wherein the reference motion data is captured from healthy individuals” (claim 8), and “wherein the healthy individuals are the same demographic as the user” (claim 9)), and
Further describe the post-solution activity (“in the event that the correlation is below a threshold, issuing a notification” (claim 10), “wherein the notification is issued to one or both of the user and a medical practitioner” (claim 11), and “issue a notification based on the indicator value of the cognitive impairment” (claim 12)).
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. The result of the abstract idea does not cause the computing device and/or application to perform differently.
Therefore, claims 1-14 are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 4-14 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner (US 20160262685) in view of Alam (“Automated Functional and Behavioral Health Assessment of Older Adults with Dementia”).
Regarding claim 1, Wagner discloses a system for determining an indicator value of cognitive impairment in a user comprising circuitry (Paragraph 0030, “The processor and the memory can be supplemented by, or incorporated in, special purpose logic circuitry”) configured to:
receive motion data from a wearable device worn by the user (Fig. 2, steps 201 and 202 wherein motion data is received from an image capture device / external body motion sensor; Paragraph 0047, wherein the image capture device is worn; Figs 5A-B showing a worn sensor 501) during a time period comprised of a first time period and a second time period, the second time period being after the first time period (Paragraph 0094, wherein data is captured at a first point in time and a second point in time);
select the motion data corresponding to the first time period for further processing based on a determination that the user performed the predetermined task during the first time period (Paragraph 0090, wherein two different sets of data are recorded. The operator/patient can initiate a motion analysis system to track a certain task (such as flexing a joint), and the initiation of the task can be marked on the data that is being recorded by the CPU to be used for analysis. This data may be stored and analyzed later or analyzed in real-time, in part or in full; Examiner interprets the marking of the task as selecting the motion data corresponding to the user performing the task. As a task is marked by its initiation and/or conclusion, the CPU is determining that the user performed a task and selects that data for further processing. As such, Wagner reads on this limitation);
compare the motion data received during the first time period with further stored reference motion data, the further stored reference motion data representing reference motion carried out when performing the determined predetermined task during the first time period (Paragraph 0042, “At step 203, the CPU calculates kinematic and/or kinetic information about the at least one joint of a subject from a combination of the first and second sets of motion data. That calculation can be based on comparing the received data from the subject to a reference set that includes motion data from age and physiologically matched healthy individuals”);
determine the indicator value of the cognitive impairment based upon a comparison between the motion data received during the first time period with the further reference motion data (Paragraph 0042, “At step 204, the CPU outputs the kinematic and/or kinetic information for purposes of assessing a movement disorder”; Paragraph 0095, determining a difference value between the measured and reference data to indicate a movement disorder of a subject and its severity); and
output the determined indicator value of the cognitive impairment (Paragraph 0043, “patient data can be displayed on a device that the patient can observe (such as on a monitor, a phone, and/or a watch)”; Paragraph 0042, “At step 204, the CPU outputs the kinematic and/or kinetic information for purposes of assessing a movement disorder”. While the output of the indicator value is not explicitly disclosed, the kinematic and/or kinetic information for purposes of assessing a movement disorder is output to the user. Per paragraph 0095, this data is used to assess the movement disorder of a subject and its severity. One of ordinary skill would necessarily want to display this evaluation to inform the user of the movement disorder and its severity).
While Wagner recognizes that subjects can perform many different tasks (Paragraph 0089) and is concerned with comparing measured tasks to healthy subjects / reference data as described above, Wagner fails to explicitly disclose comparing the motion data to reference motion data to determine the pre-determined task being performed.
Wagner and Alam are in the same field of cognitive impairment measurement. Alam teaches a sensor system for monitoring functional and behavioral health of older adults with dementia, wherein accelerometers are worn by subjects to extract features from the accelerometer data and the corresponding gestures are classified based on a comparison to a hand gesture dictionary (Pages 144-145, Section V, subsection B; Fig. 3) to recognize the complex activities of the subjects. As Wagner recognizes a wide range of daily activities that can be performed by a subject, Alam uses a gesture dictionary of predetermined activities to automatically differentiate between different activities being performed. Wagner would benefit from a dictionary of predetermined activities to automatically search for and select for specific activities being performed by the subject. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wagner to incorporate the comparison of data to a gesture dictionary taught by Wagner to differentiate between different activities performed by the user automatically.
Regarding claim 2, the combination of Wagner and Alam disclose the system of claim 1. Wagner further discloses wherein the circuitry is configured to capture the motion data periodically over said time period; and determine the indicator value of the cognitive impairment using the periodically captured motion data (Paragraph 0094, “This type of monitoring can be repeated numerous times (i.e., more than just a second time) to continuously monitor the progress of a subject”).
Regarding claim 4, the combination of Wagner and Alam disclose the system of claim 1. Wagner further discloses wherein the circuitry is further configured to determine the indicator value of the cognitive impairment using physiological data of the individual captured from a second wearable device worn by the user (Fig. 2, wherein the motion data is collected from an image capture device and an external accelerometer).
Regarding claim 5, the combination of Wagner and Alam disclose the system of claim 4. Wagner further discloses wherein the physiological data is a myoelectric signature (Paragraph 0083, “In alternative embodiments, data can be recorded from alternative electrophysiological analysis/recording systems, such as for example EMG or EEG systems”).
Regarding claim 6, the combination of Wagner and Alam disclose the system of claim 1. Wagner further discloses wherein the circuitry is configured to receive motion data from a second, different, wearable device (Fig. 2, steps 201 and 202 wherein motion data is received from an image capture device or external body motion sensor) and to determine a physical impairment from the motion data received from the second wearable device (Paragraph 0093, wherein the kinematic/kinetic information is used to assess for movement disorders; Paragraph 0095, determining a difference value to indicate a movement disorder of a subject and its severity).
Regarding claim 7, the combination of Wagner and Alam disclose the system of claim 1. Wagner further discloses wherein the reference motion data is captured from the individual over a time longer than the time period (Paragraph 0090, and in particular, “The data may be analyzed in real-time, in part or in full, and the results may be provided to the operator and or stored in one of the system components. The data and analysis results could be communicated through wired or wireless methods to clinicians who can evaluate the data, such as example remotely through telemedicine procedures (additionally in certain embodiments the system can be controlled remotely). The process could be run in part or entirely by a patient and/or another operator (such as for example a clinician). In an alternative embodiment, all of the components of the system can be worn, including the image capturing camera, to provide a completely mobile system (the CPU for analysis could be housed on the patient, or the synchronized data could be communicated to an external CPU for all or part of the analysis of the data)”; Examiner interprets this paragraph to mean that the data is analyzed over time and parts of the data is analyzed to track certain tasks for comparison, wherein triggers are used to determine the specific tasks within the data).
Regarding claim 8, the combination of Wagner and Alam disclose the system of claim 1. Wagner further discloses wherein the reference motion data is captured from healthy individuals (Paragraph 0042, “That calculation can be based on comparing the received data from the subject to a reference set that includes motion data from age and physiologically matched healthy individuals”)
Regarding claim 9, the combination of Wagner and Alam disclose the system of claim 8. Wagner further discloses wherein the healthy individuals are the same demographic as the user (Paragraph 0042, “That calculation can be based on comparing the received data from the subject to a reference set that includes motion data from age and physiologically matched healthy individuals”).
Regarding claim 10, the combination of Wagner and Alam disclose the system of claim 1. Wagner further discloses wherein the circuitry is configured to correlate the indicator value of the cognitive impairment with other indicator values for the user (Paragraph 0095, “for example: a statistical model based on 10 different movement task characteristics could be assessed which makes a diagnosis based on a weighted probabilistic model, a disease diagnosis model based on derived results or grouped result”); and in the event that the correlation is below a threshold (Paragraph 0095, wherein the determination of a movement disorder / severity of said movement disorder is determined based on setting a specific difference value percentage and/or probability; Examiner interprets setting a difference value to determine the movement disorder / severity of the movement disorder as a threshold), issuing a notification (Paragraph 0043, “Additionally, in certain embodiments, patient data can be displayed on a device that the patient can observe (such as on a monitor, a phone, and/or a watch). This data can be used for self-evaluation and/or as part of a training and/or therapeutic regimen. In certain embodiments the data and/or analysis results could be communicated through wired or wireless methods to clinicians who can evaluate the data, such as for example remotely through telemedicine procedures”).
Regarding claim 11, the combination of Wagner and Alam disclose the system of claim 10. Wagner further discloses wherein the notification is issued to one or both of the user and a medical practitioner (Paragraph 0043, “Additionally, in certain embodiments, patient data can be displayed on a device that the patient can observe (such as on a monitor, a phone, and/or a watch). This data can be used for self-evaluation and/or as part of a training and/or therapeutic regimen. In certain embodiments the data and/or analysis results could be communicated through wired or wireless methods to clinicians who can evaluate the data, such as for example remotely through telemedicine procedures”; Paragraph 0161, wherein a doctor / the system indicate the cognitive impairment disorder of the patient and the doctor prescribes the patient a prescription to treat the disease; Examiner interprets this to mean that the notification would be displayed to a medical professional in addition to a patient).
Regarding claim 12, the combination of Wagner and Alam disclose the system of claim 1. Wagner further discloses a system for notifying cognitive impairment in a user, the system comprising circuitry configured to:
receive the indicator value of the cognitive impairment from a system according to claim 1; and issue a notification based on the indicator value of the cognitive impairment (Paragraph 0043, “Additionally, in certain embodiments, patient data can be displayed on a device that the patient can observe (such as on a monitor, a phone, and/or a watch). This data can be used for self-evaluation and/or as part of a training and/or therapeutic regimen. In certain embodiments the data and/or analysis results could be communicated through wired or wireless methods to clinicians who can evaluate the data, such as for example remotely through telemedicine procedures”).
Regarding claim 13, Wagner discloses a method (Paragraph 0028, “a central processing unit (CPU) 103 with storage coupled thereto for storing instructions that when executed by the CPU”; Paragraph 0030) for determining an indicator value of cognitive impairment in a user comprising:
receiving motion data from a wearable device worn (Fig. 2, steps 201 and 202 wherein motion data is received from an image capture device / external body motion sensor; Paragraph 0047, wherein the image capture device is worn; Figs 5A-B showing a worn sensor 501) by the user during a time period comprised of a first time period and a second time period, the second time period being after the first time period (Paragraph 0094, wherein data is captured at a first point in time and a second point in time);
selecting the motion data corresponding to the first time period for further processing based on a determination that the user performed the predetermined task during the first time period (Paragraph 0090, wherein two different sets of data are recorded. The operator/patient can initiate a motion analysis system to track a certain task (such as flexing a joint), and the initiation of the task can be marked on the data that is being recorded by the CPU to be used for analysis. This data may be stored and analyzed later or analyzed in real-time, in part or in full; Examiner interprets the marking of the task as selecting the motion data corresponding to the user performing the task. As a task is marked by its initiation and/or conclusion, the CPU is determining that the user performed a task and selects that data for further processing. As such, Wagner reads on this limitation);
comparing the motion data received during the first time period with further stored reference motion data, the further stored reference motion data representing reference motion carried out when performing the determined predetermined task during the first time period (Paragraph 0042, “At step 203, the CPU calculates kinematic and/or kinetic information about the at least one joint of a subject from a combination of the first and second sets of motion data. That calculation can be based on comparing the received data from the subject to a reference set that includes motion data from age and physiologically matched healthy individuals”); and
determining the indicator value of the cognitive impairment based upon a comparison between the motion data received during the first time period with the further reference motion data (Paragraph 0042, “At step 204, the CPU outputs the kinematic and/or kinetic information for purposes of assessing a movement disorder”; Paragraph 0095, determining a difference value between the measured and reference data to indicate a movement disorder of a subject and its severity); and
outputting the determined indicator value of the cognitive impairment (Paragraph 0043, “patient data can be displayed on a device that the patient can observe (such as on a monitor, a phone, and/or a watch)”; Paragraph 0042, “At step 204, the CPU outputs the kinematic and/or kinetic information for purposes of assessing a movement disorder”. While the output of the indicator value is not explicitly disclosed, the kinematic and/or kinetic information for purposes of assessing a movement disorder is output to the user. Per paragraph 0095, this data is used to assess the movement disorder of a subject and its severity. One of ordinary skill would necessarily want to display this evaluation to inform the user of the movement disorder and its severity).
While Wagner recognizes that subjects can perform many different tasks (Paragraph 0089) and is concerned with comparing measured tasks to healthy subjects / reference data as described above, Wagner fails to explicitly disclose comparing the motion data to reference motion data to determine the pre-determined task being performed.
Wagner and Alam are in the same field of cognitive impairment measurement. Alam teaches a sensor system for monitoring functional and behavioral health of older adults with dementia, wherein accelerometers are worn by subjects to extract features from the accelerometer data and the corresponding gestures are classified based on a comparison to a hand gesture dictionary (Pages 144-145, Section V, subsection B; Fig. 3) to recognize the complex activities of the subjects. As Wagner recognizes a wide range of daily activities that can be performed by a subject, Alam uses a gesture dictionary of predetermined activities to automatically differentiate between different activities being performed. Wagner would benefit from a dictionary of predetermined activities to automatically search for and select for specific activities being performed by the subject. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wagner to incorporate the comparison of data to a gesture dictionary taught by Wagner to differentiate between different activities performed by the user automatically.
Regarding claim 14, the combination of Wagner and Alam disclose the method of claim 13. Wagner further discloses computer program comprising computer readable instructions which, when loaded onto a computer, configures the computer to perform a method according to claim 13 (Paragraph 0028, “a central processing unit (CPU) 103 with storage coupled thereto for storing instructions that when executed by the CPU”; Paragraph 0030).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Wagner (US 20160262685) and Alam (“Automated Functional and Behavioral Health Assessment of Older Adults with Dementia”) as applied to claim 1 above, and further in view of Najafi (US 12011282).
Regarding claim 3, the combination of Wagner and Alam disclose the method of claim 1. Wagner further discloses wherein the motion data is one of time-dependent acceleration or velocity (Fig. 6D depicting velocity data; Paragraph 0060, “The output from the board is linear acceleration and angular velocity data in the form of output voltages”) for comparison between the data and the reference data as described above. Wagner modified by Alam fails to disclose determining the indicator value of the cognitive impairment by comparing the midpoint errors of the time-dependent acceleration or velocity received during the first time period and the further reference motion data.
Wagner, Alam, and Najafi are in the same field of measuring cognitive impairment. Najafi teaches a platform with wearable sensors to identify cognitive-cognitive impairment in individuals (Abstract), wherein the velocity data measured from young, healthy individuals and frail individuals. A comparison was made between frail and non-frail individuals of the motor planning error (Figs. 7-8B), the error between the midpoint (peak velocity) of a task and the midpoint (middle of the time duration) of the task (Col 12, lines 20-63). This error is used to assess motor performance / physical frailty (Col 4, lines 15-20), and the error showed significant differences between the two populations (Col 12, lines 58-63). The combination of Wagner and Alam is concerned with measuring the motion of individuals to determine the probability and severity of cognitive impairment and movement disorders, and it would be useful to measure the midpoint error as another way of assessing the motor performance of individuals as Najafi shows there is a significant difference between the healthy and “frail” groups. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Wagner to incorporate the motor planning error method taught by Najafi to assess the motor performance of individuals.
Response to Arguments
Applicant’s arguments, see page 7, filed 06/25/2026, with respect to the 35 U.S.C. §112(b) rejection have been fully considered and are persuasive. Applicant has amended claims 10-11 to recite that the circuitry transmits the notification. Examiner agrees with Applicant’s arguments that the breadth of a claim is not to be equated with indefiniteness; thus, the method of claim 13, in light of the specification, can be interpreted as a computer-implemented method. Therefore, the rejection of the claims is withdrawn.
Applicant’s arguments, see pages 9-11, filed 06/25/2026, with respect to the 35 U.S.C. §101 rejection have been fully considered but are not persuasive.
Applicant disagrees that any of the claim limitations recite an abstract idea, specifically a mental process, as none of the identified limitations can be practically performed in the human mind. Examiner respectfully disagrees. As identified above, the claims are directed towards mental steps as they can be practically performed in the human mind, with the aid of pen and paper or a generic computer. While the identified limitations of an abstract idea may not solely be performed in the human mind, the steps as claimed appear to be comparing measured data with reference data, determining a predetermined task from the comparison, selecting a set of data based on the predetermined task being performed, comparing the data with further stored reference data, and determining an indicator value of the cognitive impairment based on the comparison. A person of ordinary skill could reasonably view this data on a screen or paper and make such comparisons/determinations using pen and paper or a generic computer. Without specific steps recited that only a specialized computer or processor could perform, these limitations are directed towards mental steps.
Applicant further asserts that the claims are patent-eligible as they recite an improvement to the technology of testing for cognitive impairments. Applicant points out that existing methods are carried out in a clinical setting requiring the individual to test at a particular location, which is inconvenient. By selecting two sets of data collected during two different time periods when a user naturally performs the same motor task, cognitive impairments can be tested outside of a clinical setting. Examiner respectfully disagrees. As discussed above, Wagner discloses a system that can be performed at home (or outside of a clinical setting), and a clinician can view and evaluate the data remotely. As such, the claimed invention does not provide an improvement to the technology.
Further, the improvement cannot rely solely within the judicial exception. That is, the judicial exception alone cannot provide the improvement.
The judicial exception, as described above, is identified as the abstract ideas of comparing measured data with reference data, determining a predetermined task from the comparison, selecting a set of data based on the predetermined task being performed, comparing the data with further stored reference data, and determining an indicator value of the cognitive impairment based on the comparison. Applicant asserts that the improvement of the method (i.e., performing the identified steps above) is by performing the method outside of a clinical setting; however, this improvement is the abstract idea, and the abstract idea itself is not an improvement in the technology (see MPEP 2106.05(a)). Therefore, Applicant’s argument is found not persuasive. The rejection above has been updated to reflect the amendments made to the claims.
Applicant’s arguments, see pages 7-9, filed 06/25/2026, with respect to the 35 U.S.C. §103 rejections have been fully considered but are not persuasive. Applicant argues that Wagner and Alam fail to disclose the step of selecting the motion data corresponding to the first time period for further processing based on a determination that the user performed the predetermined task during the first time period. Examiner respectfully disagrees.
Wagner discloses a system that receives two sets of motion data which can be collected in staggered order, i.e., at two different times (Paragraph 0042). While Wagner discloses that many different types of tasks may be performed and measured, Wagner fails to explicitly disclose that the task is “predetermined”. As such, Wagner fails to compare the motion data during the second time period with the stored reference motion when performing a predetermined task to determine the predetermined task based on that comparison. However, Wagner does disclose selecting motion data based on a task being performed (Paragraph 0090). Alam teaches a hand gesture dictionary, which Examiner interprets as a set of “predetermined” tasks that the system can use to identify in the method. As such, in combination, Wagner and Alam read on claims. Therefore, the claims remain rejected. The rejection above has been updated to reflect the amendments to the claims.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NOAH M HEALY/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
Prosecution Insights