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 Arguments
Rejection Under 101
Applicant's arguments filed 06/02/2026 have been fully considered.
Applicant argues that the amended claims recite limitations that impose meaningful limits on the claims, directed to a specific ordered combination, that goes beyond merely using a computer as a tool.
In response to Applicant’s argument, the argument is directed to the amendment and is therefore moot. However, as discussed below in the rejection, the additional elements, recited at a high level of generality and for their intended purpose, amount to nothing more than merely applying the abstract idea in a computer environment.
Applicant argues with regards to the limitations being significant and imposing meaningful limits on the claim that the amended claim limitations are not nominally or tangentially related but rather define the motor function assessment itself. The parameters are integrally related to the touchscreen interactions from the subject during the distal motor function test.
In response to Applicant’s argument, the argument is directed to the amendment and is therefore moot. However, as discussed below, the amendments, but for the computer components, have been understood to recite an abstract idea. As noted by the Applicant and recited in the amended claims, the limitations recite to “define the motor function assessment” and thus this limitation now falls under the abstract idea.
Applicant argues that the amended claims require specific touchscreen interaction for the subject and therefore the mathematical concepts cannot be broadly applied to data obtained by any other means.
In response to Applicant’s argument, the argument is directed to the amendment and is therefore moot. However, as discussed below, the recited elements for determine and compare the parameters can be classified to fall under the mathematical relationships and organizing human activity groupings. See the rejection below for further clarification.
Applicant argues that the In re Grams case cited for amounting to insignificant extrasolution activity is not analogous to the claimed invention.
In response to Applicant’s argument, the argument is directed to the amendment and is therefore moot. However, as noted by the Applicant (see above) and recited in the amended claims, the limitations recite to “define the motor function assessment” and thus this limitation now falls under the abstract idea.
Applicant argues that the claims recite a practical application by reciting touchscreen-based drawing activity (i.e., "generating" step (a)) that constrains how the dataset is produced and enables capture of movement trajectory information reflective of neurological function.
In response to Applicant’s argument, the argument is directed to the amendment and is therefore moot. However, as noted by the Applicant (see above) and recited in the amended claims, the limitations recite to “define the motor function assessment” and thus this limitation now falls under the abstract idea. Additionally, as discussed below in the rejection, the additional elements amount to nothing more than merely applying the abstract idea in a computer environment.
Applicant argues that the additional elements amount to significantly more that judicial exception. The ordered combination is not routine or conventional.
In response to Applicant’s argument, as discussed below in the rejection, the additional elements, recited at a high level of generality and for their intended purpose, amount to nothing more than merely applying the abstract idea in a computer environment. The amended limitations defining the touchscreen test is part of the abstract idea and not an additional element.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3-5, 9, 11-12, 14-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Step 1 of the Alice/Mayo Test
Claims 1, 3-5, 9, 15-23 are drawn to a method, which is within the four statutory categories (i.e. process). Claim 11 is drawn to a mobile device, which is within the four statutory categories (i.e., apparatus). Claim 12 is drawn to a system, which is within the four statutory categories (i.e., apparatus). Claim 14 is drawn to a mobile and data processing device, which is within the four statutory categories (i.e., apparatus).
Step 2A of the Alice/Mayo Test - Prong One
The independent claim 1 (and substantially similar with claims 11, 12, 14, 15) recites:
A computer-implemented method for predicting a total motor score (TMS) in a subject suffering from Huntington's disease (HD) comprising the steps of:
generating, via a processor of a mobile device, a dataset of measurements of central motor function capabilities of the subject during predetermined activity based on a distal motor function test performed by the subject on a touchscreen of the mobile device, wherein the distal motor function test comprises the subject providing touch gestures to trace one or more designated shapes displayed on the touchscreen, wherein the one or more designated shapes are selected from the group consisting of linear, rectangular, circular, sinusoidal, spiral shapes, and combinations thereof;
determining at least two performance parameters from the dataset of measurements of central motor function capabilities from said subject, wherein the at least two performances parameters are derived from the dataset by an automated algorithm tangibly embedded on a data processing device, and wherein the at least two performance parameters are selected from the group consisting of a coefficient of variation in drawing velocity of a spiral shape, a maximum hausdorff distance between a drawn and reference shape, and number of waypoints hit divided by time taken to complete a square shape;
comparing by an automated comparison algorithm implemented on the data processing device the determined at least two performance parameters to a reference obtained from a computer-implemented regression model generated on training data using partial least-squares (PLS) analysis with the at least two performance parameters; and
predicting the TMS of the subject based on said comparison to identify severity of Huntington’s disease in the subject.
These underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the management of personal behavior or interactions (i.e., following rules or instructions) but for the recitation of generic computer components. For example, but for a mobile device, a sensor, a data processing device, a processor, a database, software, processor of mobile device, touchscreen of mobile device, the limitations in the context of this claim encompass following rules or instructions for evaluating a patient’s risk and severity for Huntington’s disease and providing a suggested therapy for the patient (claim 15). If a claim limitation, under its broadest reasonable interpretation, covers the management of personal behavior or interactions but for the recitation of generic computer components, then the limitations fall within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a).
Additionally, these underlined elements recite an abstract idea that can be categorized, under its broadest reasonable interpretation, to cover the mathematical relationships but for the recitation of generic computer components. For example, but for a mobile device, a sensor, a data processing device, a processor, a database, software, processor of mobile device, touchscreen of mobile device, the limitations in the context of this claim encompass a mathematical relationship by using algorithm models to determine and compare the parameters for predictions to determine a patient’s severity of their Huntington’s disease. If a claim limitation, under its broadest reasonable interpretation, covers mathematical relationships, but for the recitation of generic computer components, then it falls within the “Mathematical Concepts” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. See MPEP § 2106.04(a).
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 3-5, 9, 16-23 reciting particular aspects of predicting the total motor score and disease severity).
Step 2A of the Alice/Mayo Test - Prong Two
The independent claim 1 (and substantially similar with claims 11, 12, 14, 15) recites:
A computer-implemented method for predicting a total motor score (TMS) in a subject suffering from Huntington's disease (HD) comprising the steps of:
generating, via a processor of a mobile device, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) a dataset of measurements of central motor function capabilities of the subject during predetermined activity based on a distal motor function test performed by the subject on a touchscreen of the mobile device, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) wherein the distal motor function test comprises the subject providing touch gestures to trace one or more designated shapes displayed on the touchscreen, wherein the one or more designated shapes are selected from the group consisting of linear, rectangular, circular, sinusoidal, spiral shapes, and combinations thereof; (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f))
determining at least two performance parameters from the dataset of measurements of central motor function capabilities from said subject, wherein the at least two performances parameters are derived from the dataset by an automated algorithm tangibly embedded on a data processing device, (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) and wherein the at least two performance parameters are selected from the group consisting of a coefficient of variation in drawing velocity of a spiral shape, a maximum hausdorff distance between a drawn and reference shape, and number of waypoints hit divided by time taken to complete a square shape;
comparing by an automated comparison algorithm implemented on the data processing device (merely invokes use of computer and other machinery as a tool as noted below, see MPEP 2106.05(f)) the determined at least two performance parameters to a reference obtained from a computer-implemented regression model generated on training data using partial least-squares (PLS) analysis with the at least two performance parameters; and
predicting the TMS of the subject based on said comparison to identify severity of Huntington’s disease in the subject.
The judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations, which:
amount to mere instructions to apply an exception (such as recitations a mobile device, a sensor, a data processing device, a processor, a database, software, processor of mobile device, touchscreen of mobile device, thereby invoking computers as a tool to perform the abstract idea, see applicant’s specification pgs. 5, 9, 13-14, 20-21, 24, see MPEP 2106.05(f))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claim 4-5, 9, 16-23 recite additional limitations which amount to furthering the abstract idea; claim 3, 9, 16-23 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea, and claims 3-5, 9, 16-23 additional limitations which generally link the abstract idea to a particular technological environment or field of use). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B of the Alice/Mayo Test for Claims
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception. Additionally, the additional elements, other than the abstract idea per se, amount to no more than elements which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as using a mobile device, a sensor, a data processing device, a processor, a database, software, processor of mobile device, touchscreen of mobile device, e.g., Applicant’s spec describes the computer system with it being well-understood, routine, and conventional because it describes in a manner that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such elements to satisfy 112a. (See Applicant’s Spec. pgs. 5, 9, 13-14, 20-21, 24); a mobile device, a sensor, a data processing device, a processor, a database, software, mobile device with a touchscreen, e.g., merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions, Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2358-59, 110 USPQ2d 1976, 1983-84 (2014).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea, and are generally linking the abstract idea to a particular field of environment. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, the claims are not patent eligible, and are rejected under 35 U.S.C. § 101.
Subject Matter Free of Prior Art
Claims 1, 3-5, 9, 11-12, 14-23 are free of prior art over Baker et al. (WO 2018/050763) in view of Drake et al. (US 2021/0174958). The prior art references, or reasonable combination thereof, could not be found to disclose, or suggest all of the limitations found in the independent claims. The closest prior art is Baker et al. (WO 2018/050763), which teaches a method for assessing a cognition and movement disease or disorder in a subject suspected to suffer therefrom comprising determining cognition and fine motoric activity parameters from datasets. Drake et al. (US 2021/0174958) teaches using machine learning for analyzing multiple analytes and classifying the sample. The references taken solely, or in combination, fail to provide the required limitations, and modification of any complementary combination of the references of record would be impermissible hindsight and not provide any advantages over their present application. The dependent claims are also free of prior art due to their corresponding dependency of the independent 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.
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686 /RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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