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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/07/2026 has been entered.
Response to Arguments
Rejection Under 101
Applicant's arguments filed 01/07/2026 have been fully considered.
Applicant argues that the claims recite limitations in the amended claim that cannot be practically performed in the human mind.
In response to Applicant’s argument, the recited elements at issue can be classified to fall under the mathematical relationships and organizing human activity groupings. See the rejection below for further clarification.
The claims recite drawing on a touchscreen which cannot be done in the mind.
In response to Applicant’s argument, this limitation is considered an additional element and not part of the abstract idea. Specifically, this is insignificant extrasolution activity. See below for further information.
The claim recites determination and comparison of multiple performance parameters to predict the TMS of a subject and identify the severity of the disease and is not something that can be done mentally.
In response to Applicant’s argument, as discussed below the use of the algorithms to compare the performance parameters is part of the mathematical abstract idea. See below.
The claims recite elements that impose meaningful limits on the abstract idea such as using a mobile device with a touchscreen for the draw test, comparing parameters with a comparison algorithm and training data using partial least-squares analysis with the performance parameters, and providing therapy against HD in response to the predicted TMS and identified severity. As detailed in the specification tests on the mobile device are more efficient for patients and the draw test can help to select more efficient treatments based on the status of the patient. Therefore, the claims recite a practical application.
In response to Applicant’s arguments, the use of the mobile device with a touch screen amounts to invoking the use of computers as tools to carry out the abstract idea. The draw test is also considered an additional element that amounts to insignificant extrasolution activity, such as, performing a test on a patient to gather input. The use of the algorithm and training with partial least squares is math and falls under the abstract idea grouping of mathematical concepts. See below for further clarifications.
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, 14-21 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, 15-21 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:
obtaining from said subject using a mobile device a dataset of measurements of central motor function capabilities during predetermined activity performed by the subject, wherein the mobile device comprises a touchscreen and said predetermined activity comprises drawing on the touchscreen one or more shape 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 but for the recitation of generic computer components. That is, other that reciting a mobile device, a sensor, a data processing device, a processor, a database, software, nothing in the claim element precludes the step from practically being performed in the mind. For example, but for a mobile device, a sensor, a data processing device, a processor, a database, software, the limitations in the context of this claim encompass 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, the limitations in the context of this claim encompass a mathematical relationship 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, 16-21 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:
obtaining from said subject using 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 during predetermined activity performed by the subject, wherein the mobile device comprises a touchscreen and said predetermined activity comprises drawing on the touchscreen one or more shape 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)) and (merely insignificant extrasolution activity steps as noted below, see MPEP 2106.05(g))
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, mobile device with a touchscreen, 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))
add insignificant extra-solution activity to the abstract idea (such as recitation of drawing on the touchscreen one or more shape selected from the group consisting of linear, rectangular, circular, sinusoidal, spiral shapes, and combinations thereof amounts to insignificant extrasolution activity, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claim 3, 9, 16-21 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea, and claims 3-5, 9, 16-21 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 and add insignificant extra-solution activity to the abstract idea. 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, mobile device with a touchscreen, 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).
adding insignificant extrasolution activity to the abstract idea, for example mere data gathering, selecting a particular data source or type of data to be manipulated, and/or insignificant application. The following represent examples that courts have identified as insignificant extrasolution activities (e.g. see MPEP 2106.05(g)): drawing on the touchscreen one or more shape selected from the group consisting of linear, rectangular, circular, sinusoidal, spiral shapes, and combinations thereof, (e.g., performing clinical tests on individuals to obtain input, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989)).
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, 14-15 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
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/AMANDA R. COVINGTON/Examiner, Art Unit 3686
/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686