DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
Claims 1, 2, 4, 6-10, 14-17, 20-23, 25, 26, 28, and 29 are currently pending. Claims 1, 2, 4, 6, 14, 16, 17, 22, 25, 26, and 28 have been amended. Claims 1, 4, 6, 14, 16, and 17 have been amended to overcome the claim objections and claim 25 has been amended to overcome the 35 U.S.C. 101 rejection directed to non-statutory subject matter set forth in the Non-Final Office Action mailed on 16 December 2025.
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, 2, 4, 6-10, 14-17, 20-23, 25, 26, 28, and 29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
STEP 1
Regarding claim 1, the claim recites a series of steps or acts, including recording the subject performing a plurality of tasks. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of
wherein at least one of the plurality of tasks requires the subject to interact with the device by touching the device;
wherein at least one of the plurality of tasks requires the subject to manipulate the device;
assessing neuromuscular disease;
determining one or more parameters from the recorded touch interactions and the recorded background monitoring of the computing device; and
comparing the determined parameters for each task with predetermined parameters
set forth a judicial exception. The steps of interacting with the device and manipulating the device describe a concept of organizing human activity. The steps of assessing, determining, and comparing describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to Organizing Human Activity and a Mental Process, which are Abstract Ideas.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites aggregating the compared parameters to obtain an assessment score for the subject, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The aggregating of the compared parameters to obtain the assessment score does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the aggregated compared parameters to obtain the assessment score, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of recording the subject performing a plurality of tasks on a device, including recording touch interactions with the device using one or more sensors of the device, including recording movement of the device using one or more sensors of the device; wherein at least one task of the plurality of tasks comprises background monitoring of the device, obtained via sensor outputs not resulting directly from performance of a task presented to the subject via a user interface of the device. Recording data (subject performing plurality of tasks, touch interactions, movement) and obtaining data (background monitoring, sensor outputs not resulting directly from performance of a task) is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the recording and obtaining steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
The same rationale applies to claims 25 and 26.
Regarding claim 26, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited device comprising a touch screen and one or more sensors are generic sensors configured to perform pre-solutional data gathering activity and the one or more processors is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claim. Claims 2, 7-10, 15, 20, 21 and 21 recite steps that add to the pre-solution activity of data gathering as the claims generally add to what data is being gathered. Claims 4, 6, 14, 16, 17 recite steps that add to the Abstract Idea as the claims recite steps of organizing human activity. Claims 22, 28, and 29 recite steps that add to the Abstract Idea as the claims recite step mental processing steps. Claim 23 recite an additional element that does not integrate the judicial exception into a practical application. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 2, 4, 6-10, 14-17, 20-23, 25, 26, 28, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et al. ‘915 (US Pub No. 2019/0200915 – previously cited) in view of Najafi et al. ‘148 (US Pub No. 2021/0290148, provisional date 18 September 2016).
Regarding claim 1, Baker et al. ‘915 teaches a method for assessing neuromuscular disease in a subject using a handheld or wearable computing device ([0178]; “a computer-implemented test evaluating fine motoric capabilities (fine motoric assessments), in particular, hand motor functions and, in particular, the touchscreen-based “Draw a Shape” and “Squeeze a Shape” tests”), the method comprising:
recording the subject performing a plurality of tasks on a device ([0179]; “…perform or acquire data from fine motoric assessments, and in particular, Hand Motor Function Tests”), wherein at least one of the plurality of tasks requires the subject to interact with the device by touching the device, including recording touch interactions with the device using one or more sensors of the device, and wherein at least one of the plurality of tasks requires the subject to manipulate the device, including recording movement of the device using one or more sensors of the device ([0184]; “The patients are instructed to hold the mobile device in the untested hand and draw on a touchscreen of the mobile device 6 pre-written alternating shapes of increasing complexity (linear, rectangular, circular, sinusoidal, and spiral; vide infra) with the second finger of the tested hand “as fast and as accurately as possible” within a maximum time of for instance 30 seconds.”);
wherein at least one task of the plurality of tasks futher comprises background monitoring of the device, obtained via sensor outputs not resulting directly from performance of a task presented to the subject via a user interface of the device specifically for assessing neuromuscular disease ([0231]; “the dataset of activity measurements may be obtained from a passive monitoring of all or a predetermined subset of activities of a subject performed during a certain time window, e.g., during daily routine. These measurements allow for assessing a subject's quality of life, fatigue, mental state and/or mood. In this context, passive monitoring may include continuous measurements of gait, the amount of movement in daily routines in general, e.g., frequency and/or velocity of walking, the types of movement in daily routines, e.g., amount, ability and/or velocity to stand up/sit down, stand still and balance, general mobility in daily living as indicated by, e.g., visiting more or fewer locations, changes in moving behavior as indicated by, e.g., changes in types of locations visited.”);
determining one or more parameters from the recorded touch interactions and the recorded background monitoring of the computing device ([0304]); and
comparing the determined parameters for each task with predetermined parameters ([0313]-[0314]).
Baker et al. ‘915 teaches all of the elements of the current invention as mentioned above except for aggregating the compared parameters to obtain an assessment score for the subject.
Najafi et al. ‘148 teaches comparing parameters extracted from a instrumented trail-making task (iTMT) platform to assess movement. iTMT is combined with other measurements to increase the accuracy of the assessment of each independent subcomponent of iTMT such as such as visual search, scanning, speed of processing, mental flexibility, and/or executive functions. In some embodiments, iTMT is used as an exercise program to enhance cognitive-motor performance ([0007]).
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 method of Baker et al. ‘915 to include aggregating the compared parameters to obtain an assessment score for the subject as Najafi et al. ‘148 teaches that this will aid in increasing the accuracy of the assessment and enhance cognitive-motor performance.
Regarding claim 2, Baker et al. ‘915 teaches wherein the plurality of tasks further includes a task presented to the subject via a user interface of the device (Figs. 1A-3C).
Regarding claim 4, Baker et al. ‘915 teaches wherein at least one of the plurality of tasks further comprises repeatedly touching a single target ([0184]; “The patient has maximum two attempts to successfully complete each of the 6 shapes.” The two attempts are interpreted as “repeatedly touching.”).
Regarding claim 6, Baker et al. ‘915 teaches wherein one of the plurality of tasks further comprises typing a character string ([0164]-[0168]; “cluster of symbols”).
Regarding claim 7, Baker et al. ‘915 teaches wherein the one or more parameters include indicators of interaction speed ([0349]) and/or accuracy ([0216]).
Regarding claim 8, Baker et al. ‘915 teaches wherein for a task requiring the subject to touch the device the one or more parameters include one or more of: a rate of touch interactions, variation in the rate of the touch interactions over time, and time taken for the subject to complete the task ([0195]; “overall and first attempt completion rate for each 6 individual shapes based on multiple testing within a certain period of time”).
Regarding claim 9, Baker et al. ‘915 teaches wherein for a task requiring the subject to touch the device the one or more parameters include indicators for interaction accuracy ([0184], [0216], [0230]).
Regarding claim 10, Baker et al. ‘915 teaches wherein the one or more parameters include one or more of: accuracy of the touch interactions ([0184], [0216], [0230]), variation in the accuracy of the touch interactions over time, total number of errors by the subject ([0108]), rate of errors by the subject ([0109]-[0114]), time for the subject to make a predetermined number of errors.
Regarding claim 14, Baker et al. ‘915 teaches wherein one of the plurality of tasks further includes holding the device in a predefined way for a predefined duration ([0184]; “The patients are instructed to hold the mobile device in the untested hand…”).
Regarding claim 15, Baker et al. ‘915 teaches wherein for a task requiring the subject to manipulate the device the one or more parameters include one or more of: positional deviation from a predetermined position over time ([0231]; “changes in moving behavior”), rotational deviation from a predetermined orientation over time, oscillation frequency, variation in oscillation frequency over time, oscillation magnitude, and variation in oscillation magnitude over time.
Regarding claim 16, Baker et al. ‘915 teaches wherein one of the plurality of tasks further comprises moving the device in a predefined way ([0234], [0249]).
Regarding claim 17, Baker et al. ‘915 teaches wherein one of the plurality of tasks further comprises walking with the device ([0231]), wherein the one or more parameters include one or more of: stride frequency, variation in stride frequency over time ([0234]; “increase in step duration and asymmetry and less periodic strides and steps”), stride length ([0234]; “decrease of stride and step length”), variation in stride length over time, stride width, variation in stride over time.
Regarding claim 20, Baker et al. ‘915 teaches wherein one or more of the plurality of tests is performed bilaterally; and the one or more determined parameters includes differences between parameters for each side ([0453], [0466]).
Regarding claim 21, Baker et al. ‘915 teaches wherein the predetermined parameters include one or more of: a baseline for the subject, a baseline for a predetermined population group, a baseline for a predetermined clinical group ([0041], [0169]-[0178], [0231]-[0232]).
Regarding claim 22, Baker et al. ‘915 teaches wherein the assessment score indicates the severity and progression of neurological disease symptoms in the subject ([0280]-[0281]).
Regarding claim 23, Baker et al. ‘915 teaches wherein the neuromuscular disease is a degenerative neuromuscular disease comprising deterioration of dexterity ([0046]).
Regarding claim 25, Baker et al. ‘915, as modified by Najafi et al. ‘148, teaches a non-transitory computer-readable medium storing a computer program that when executed on a handheld or wearable computing device configured to perform the claimed steps, as the subject matter of claim 25 is analogous to the subject matter of claim 1.
Regarding claim 26, Baker et al. ‘915, as modified by Najafi et al. ‘148, teaches a system for assessing neuromuscular disease in a subject, as the subject matter of claim 26 is analogous to the subject matter of claim 1.
Regarding claim 28, Baker et al. ‘915 teaches wherein the assessment score indicates the severity of neurological disease in the subject ([0280]-[0281]).
Regarding claim 29, Baker et al. ‘915 teaches wherein the assessment score is determined by applying different weightings to the determined parameters and the predetermined parameters based on the neurological disease ([0185]-[0201], [0288]).
Response to Arguments
Applicant argues that the combination of active touch-based tasks, device manipulation tasks, passive background monitoring, and the aggregation step provides a complete technical pipeline that produces a concrete, quantifiable output – an assessment score for the subject. However, the active touch-based tasks, device manipulation tasks, and passive background monitoring are abstract ideas. It is noted that section 2106.05(a) II. of the MPEP states that “…it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology.” Furthermore, the aggregating step merely outputs a data point (assessment score). There is no recitation as to how the mere output of data would provide a technical improvement or transform the system. Furthermore, section 2106.05(h) of the MPEP states that “limiting the abstract idea of collecting information, analyzing it, and displaying certain results of the collection and analysis to data related to the electric power grid, because limiting application of the abstract idea to power-grid monitoring is simply an attempt to limit the use of the abstract idea to a particular technological environment, Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354, 119 USPQ2d 1739, 1742 (Fed. Cir. 2016).” As such, the 35 U.S.C. 101 rejection has been maintained.
Applicant’s arguments with respect to the 35 U.S.C. 102(a)(1) rejection have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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