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 .
Status of Claims
Claims 1-8,10-17,19-20,22 and 49-50 are pending.
This communication is in response to the communication filed February 11, 2026.
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 1-8,10-17,19-20,22 and 49-50 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite systems, apparatuses, and methods for predicting motor function scores, which are statutory categories of inventions.
Specifically, the independent claims, taking claim 1 as exemplary, recite obtaining input data comprising a temporal trajectory of an indicator metabolite compound for the subject, the temporal trajectory of the indicator metabolite compound comprising, for each of one or more time points, a respective value for the indicator metabolite compound for the subject at the respective time point; obtaining a plurality of first model parameters of a prediction model; determining a predicted temporal trajectory of the motor function score using the input data, the determining comprising: for each of the one or more time points after a baseline time point, determining a respective predicted value for a change in the motor function score from a baseline value at the respective time point using the prediction model based at least on (i) the input data and (ii) the first model parameters, wherein the prediction model includes a non-linear functional term of a change of the respective value for the indicator metabolite compound at the respective time point from a baseline value; and outputting data characterizing the predicted temporal trajectory of the motor function score. The dependent claims recite limitations directed to further explaining the parameters, determining predicted values, non-liner functional terms, indicator metabolites, and obtaining temporal trajectory.
The claim limitations directed to predicting a motor function score, determining a predicted temporal trajectory, and the various functions are interpreted as being grouped within the “mental processes” grouping of abstract ideas, because they involve making various calculations that may be performed either mentally or manually by a person skilled in the art. The totality of the limitations are interpreted as being directed to “certain methods of organizing human activity” grouping of abstract ideas, because the claims recite a series of steps for collecting patient or health data, analyzing it, and outputting the results of the collection and analysis as predictions for a patient motor function. See MPEP 2106.04. The claims are interpreted to recite concepts relating to tracking or organizing patient information. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. Integration into a practical application requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. Here, the additional elements of the claims include computers, storage devices, computer-readable storage media.
The claims merely use the additional elements as tools to perform abstract ideas and generally link the use of a judicial exception to a particular technological environment. The use of the additional elements as tools to implement the abstract idea and generally to link the use of the abstract idea to a particular technological environment does not render the claim patent eligible, because it requires no more than a computer performing functions that correspond to acts required to carry out the abstract idea. Specifically, the computers may include storage devices and computer-readable storage media. The computer functions to input, output, process, and store data (p. 21-25). Moreover, a computer can be embedded in another device, e.g., a mobile telephone, a personal digital assistant (PDA), a mobile audio or video player, a game console, a Global Positioning System (GPS) receiver, or a portable storage device, e.g., a universal serial bus (USB) flash drive (p. 22).
The additional elements do not show an improvement to the functioning of a computer or to any other technology, rather the additional elements perform general computing functions and do not indicate how the particular combination improves any technology or provides a technical solution to a technical problem. See Apple v. Ameranth, 842 F.3d 1229, 1240 (Fed. Cir. 2016). The additional elements do not use the exception to affect a particular treatment or prophylaxis for a disease, do not apply the exception using particular machines, and do not effect a transformation or reduction of a particular article to a different state or thing, rather the computer elements are generally stated as to their structure and function and are only used to make predictions instead of directly providing specific treatment or prophylaxis. Therefore, the additional elements do not impose any meaningful limits on practicing the abstract idea and the additional limitations are not indicative of materializing into a practical application. Accordingly, the claim is directed to an abstract idea.
Generic computer elements recited as performing generic computer functions that are well-understood, routine, or conventional activities amount to no more than implementing the abstract idea with a computerized system (Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network and performing repetitive calculations); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."); See MPEP 2106.05(d) and July 2015 Update: Section IV). Here, the claim limitations directed to predicting a motor function score, determining a predicted temporal trajectory, and the various functions are similar to performing repetitive calculations.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the steps of the claims amount to no more than using computer related devices to automate or implement the abstract idea for predicting motor function scores.
The use of a computer or processor to merely automate or implement the abstract idea cannot provide significantly more than the abstract idea itself. (See MPEP 2106.05(f) where mere instructions to apply an exception does not render an abstract idea patent eligible). There is no indication that the additional limitations alone or in combination improves the functioning of a computer or any other technology, improves another technology or technical field, or effects a transformation or reduction of a particular article to a different state or thing. Therefore, the claims are not patent eligible.
In conclusion, the claims are directed to the abstract idea for predicting motor function scores. The claims do not provide an inventive concept, because the claims do not recite additional elements or a combination of elements that amount to significantly more than the judicial exception of the claims. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and the collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an order combination, the claims are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 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.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-4, 8, 10-17, 19-20, and 49-50 are rejected under 35 U.S.C. 103 as being unpatentable over Mano (IDS reference) in view of McNair US11335461.
As per claim 1, Mano teaches
A…method for predicting a motor function score measuring one or more motor functions of a subject, the method comprising: (Mano abstract teaches biomarkers reflecting the severity and possibly predicting the deterioration of motor functions.)
obtaining input data comprising a temporal trajectory of an indicator metabolite compound for the subject, the temporal trajectory of the indicator metabolite compound comprising, for each of one or more time points, a respective value for the indicator metabolite compound for the subject at the respective time point; (Mano abstract, p. 692, col. 2)
obtaining a plurality of first model parameters of a prediction model; (Mano tables 3-5, p. 695, col 2.)
determining a predicted temporal trajectory of the motor function score using the input data, the determining comprising: for each of the one or more time points after a baseline time point, determining a respective predicted value for a change in the motor function score from a baseline value at the respective time point using the prediction model based at least on (i) the input data and (ii) the first model parameters, wherein the prediction model includes a…functional term of a change of the respective value for the indicator metabolite compound at the respective time point from a baseline value; and outputting data characterizing the predicted temporal trajectory of the motor function score (Mano fig. 2, tables 3-5, p. 695, col 2. teaches clinical scales and measures of motor function also showed a significant increase during various periods. During the follow up period, urinary 8-OHdG levels increased and were correlated with each measure of motor function at all time points examined. Investigation of whether the change in the levels reflects the degree of disease progression. The percentage of change from baseline was used to analyze each parameter. At baseline correlation with the changes of 6MWT during 24 months, suggesting that the intensity of oxidative stress at baseline is associated with the prognosis for ambulatory capacity.).
Mano does not specifically teach the following limitations met by Y, computers and non-linear functional term (McNair abstract, claim 6, col. 17, lines 11-38 teaches computer for diagnostic and decision support. Examples of post-processing steps include but are not limited of the following: optimal categorization determinations, scaling techniques (linear and non-linear), transformations (linear and non-linear), and probability estimations (such as logit or probit equations).)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Mano to use computers and non-linear functions as taught by McNair with the motivation to improve healthcare outcomes for people with Pompe disease (McNair col. 1). Many patients may go years undiagnosed or, alternatively, are mis-diagnosed and are treated for many years on the basis of an incorrect diagnosis. Such erroneous misdiagnosis-based treatments or non-treatments are ineffective or even unsafe and impair the health of the patient or lead to needless progression of the disease or irreversible loss of body function.
As per claim 2, Mano and McNair teach all the limitations of claim 1 and further teach wherein the prediction model is a non-linear random coefficient model that comprises one or more random parameters (McNair abstract, claim 6, col. 17, lines 11-38).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Mano to use non-linear functions or models as taught by McNair with the motivation to improve healthcare outcomes for people with Pompe disease (McNair col. 1).
As per claim 3, Mano and McNair teach all the limitations of claim 2 and further teach wherein a rate of change parameter in the non-linear functional term is one of the random parameters (McNair abstract, claim 6, col. 9, lines 55-65).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Mano to use a rate of change parameter in the non-linear functional term as taught by McNair with the motivation to improve healthcare outcomes for people with Pompe disease (McNair col. 1).
As per claim 4, Mano and McNair teach all the limitations of claim 2 and further teach wherein determining the respective predicted value comprises: for each of the one or more random parameters, selecting a respective value for the respective random parameter from a respective pre-defined distribution; wherein the predicted value is determined based on the respective values selected for the one or more random parameters (McNair col. 15, lines 15-35).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Mano to selecting a respective value for the respective random parameter from a respective pre-defined distribution as taught by McNair with the motivation to improve healthcare outcomes for people with Pompe disease (McNair col. 1).
As per claim 8, Mano and McNair teach all the limitations of claim 1 and further teach wherein the motor function score is a Gross Motor Function Measure (GMFM) score or a Quality of Upper Extremity Skills Test (QMFT) score (Mano results).
As per claim 12, Mano and McNair teach all the limitations of claim 1 and further teach wherein the input data further comprises (i) one or more demographic attributes of the subject, (ii) one or more clinical diagnosis for the subject, or (iii) a treatment history of the subject (Mano methods).
As per claim 13, Mano and McNair teach all the limitations of claim 1 and further teach wherein the respective predicted value is determined further based on (i) the baseline score for the subject and (ii) a median baseline score obtained for a population of subjects (Mano data analysis).
As per claim 14, Mano and McNair teach all the limitations of claim 1 and further teach wherein the predicted value is determined further based on (i) an age of diagnosis of the subject and (ii) a median age of diagnosis obtained for a population of subjects (Mano methods, results).
As per claim 15, Mano and McNair teach all the limitations of claim 1 and further teach wherein the respective predicted value is determined further based on a median baseline value for the indicator metabolite compound obtained for a population of subjects (Mano abstract, methods).
As per claim 16, Mano and McNair teach all the limitations of claim 1 and further teach wherein the subject is a subject that has been diagnosed with a particular disease that affects motor functions (Mano abstract, methods).
As per claim 17, Mano and McNair teach all the limitations of claim 16 and further teach wherein the particular disease is Infantile- onset Pompe disease (IOPD) or Late-onset Pompe disease (LOPD) (McNair abstract).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Mano to use methods for IOPD or LOPD as taught by McNair with the motivation to improve healthcare outcomes for people with Pompe disease (McNair col. 1).
As per claim 19, Mano and McNair teach all the limitations of claim 16 and further teach wherein the subject is under an enzyme replacement therapy for Pompe disease (McNair col 4-5, 20-21).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Mano to use subjects under an enzyme replacement therapy for Pompe disease as taught by McNair with the motivation to improve healthcare outcomes for people with Pompe disease (McNair col. 1).
As per claim 20, Mano and McNair teach all the limitations of claim 19 and further teach wherein the therapy is an alpha-glucosidase replacement therapy or an avalglucosidase alfa replacement therapy (McNair col 4-5, 20-21).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Mano to use subjects under an enzyme replacement therapy for Pompe disease as taught by McNair with the motivation to improve healthcare outcomes for people with Pompe disease (McNair col. 1).
As per claims 49-50, see claim 1 rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAY M. PATEL whose telephone number is (571)272-6793 and email is jay.patel2@uspto.gov. The examiner can normally be reached on Monday-Friday 8AM-4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H. Choi can be reached on (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAY M. PATEL/Primary Examiner, Art Unit 3686
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