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
The amendment filed 01/02/2026 has been entered. Claims 1, 4, 7-8, 11, 14-15, 18, 21, 23, 27-28 and 31-38 remain pending in the application.
Response to Arguments
Applicant’s arguments, filed 01/02/2026, with respect to the rejections of the claims under 101 have been fully considered and are not persuasive.
Applicant argues (pages 12-15)
Applicant respectfully traverses the rejection and asserts that the invention provides an improvement in computer-related technology as well as an improvement to at least the field of medical diagnosis utilizing machine learning models, more specifically, assessing gait as it relates to Parkinson's disease by providing a uniform method of assessing the gait associated with a walking user by training one or more machine learning models to access the gait of the walking user as opposed to the current state of the art which suffers from the subjectivity of medical professionals.
The August 4th Memo regarding Subject Matter Eligibility provided instructive guidance with respect to patent eligible claims under the Step 2A Prong Two, the Improvements Consideration which states that an Examiner can conclude that claims are eligible in Step 2A Prong Two by finding that a claim reflects an improvement to the functioning of a computer or to another technical field, integrating a recited judicial exception into a practical application of the exception. More specifically, the Memo states that the "examiner is reminded to consult the specification to determine whether the disclosed invention improves technology or a technical field and evaluate the claim to ensure it reflects the disclosed improvement" and goes on to further clarify that "the claim itself does not need to explicitly recite the improvement described in the specification."
As described throughout the specification, specifically [0025], [0032], [0036], and [0041] Applicant's invention is focused on the improvement of the unreliability and inconsistency of trained clinicians in assigning a Posture Instability and Gait Disturbance (PIGD) score as part of the Parkinson's disease rating scale (UPDRS). The present invention leverages the one or more machine learning models to automatically infer the walking user's PIGD score based on training data and data corresponding to a walking user collected from a plurality of inertial sensors. In fact, the improvements of Applicant's invention over the prior art are clearly detailed in paragraph [0041] of the specification, which states in relevant part that the "gait assessor 134 utilizes the gait assessor models 132 to determine a PIGD predication and Real/Fake assessment, which provide feedback to the generator and discriminator gait assessor models 132. The gait assessor 134 uses this feedback to more accurately train the gait assessor models 132 with each additional iteration through the GAN training method." These improvements are depicted in the graph of the results of the gait assessor versus the PIGD score predictions of a Convolutional Neural Network (CNN) in FIG.6. As stated in paragraph [0042] of the specification the "confidence value of PIGD score predictions using the GAN method of FIG. 4-5 is 0.90129, which is higher than the confidence value of PIGD score predictions using Convolutional Neural Networks (CNN), which is 0.87703" clearly illustrating the improvement of Applicant's invention. As described throughout the specification, this invention addresses the poor consistency and highly subjective nature of gait assessments by understanding the "correlation between each of the one or more training data features and the one or more gait classifications" and applying a weighting in the training of the one or more models based on the data feature correlations
These improvements are clearly embodied by the claim limitations and are thus patent eligible under Step 2A Prong Two and more specifically, MPEP 2106.05(a). Specifically, the extracting limitations, the training limitation, and the assessing limitations of independent claim 1 above. These claim limitations directly tie the claims to the improvements described throughout the specification, in particular the paragraphs cited above, which describe the improvements to the technological field of medical diagnosis utilizing machine learning models and this recite a practical application of the exception alleged by the Office Action.
Therefore, for at least the above reasons, Applicant respectfully requests that the rejection under 35 U.S.C. § 101 be reconsidered and withdrawn.
In response
The claim invention is related to a technical field of “determining gait of a user for health assessment” using one or more machine learning models.
Since the process of “determining gait of a user” is based on observations, evaluations, judgments or opinion that are performable in the human mind or with the aid of pencil and paper, the claim recites an abstract idea. While the applicant argues that “the invention provides an improvement to at least the field of medical diagnosis utilizing machine learning models”, this statement itself makes clear that any alleged improvement is in the abstract idea itself. An improvement to the abstract idea is not consider an improvement on the functioning of a computer or to any other technology or technical field.
The Applicant argues that the invention provides a uniform method of assessing the gait such as using “the one or more machine learning models to automatically infer the walking user's PIGD score based on training data and data corresponding to a walking user collected from a plurality of inertial sensors”, and the PIGD score (among others) is used to accurately train the gait assessor for assessing a gait of the user. However, it can be seen that the claim only recites using generic computer components (machine learning models) to generate the abstract idea (determine gait of a user) based on certain data (PIGD score for example), thus, the solution of “determining gait of a user” is the improvement on the abstract idea, which, as mentioned above, is not the improvement in the computer technology field.
Further, the claim limitations do not show an improvement to the functioning of a computer. The claim does not recite how the machine learning model is trained or operated to implement the process such that the machine learning model is improved. For example, when a computer analyzing data in such a way to improve the computer function or to save computer resource then it is an improvement to the functioning of the computer, but if merely use of machine learning model to perform the determining is no different that reciting that the method is performed on a computer ("using a computer or other machinery as a tool"), an additional element which by MPEP 2106.05 (f) cannot integrate the abstract idea into a practical application nor provide significantly more than the abstract idea itself.
Therefore, even when considering the additional elements in combination, the claim as a whole does not integrate the recited exception into a practical application.
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, 4, 7-8, 11, 14-15, 18, 21, 23, 27-28 and 31-38 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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites a method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 1):
The limitation of “processing the training data …”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “processing” in the context of this claim encompasses the user analyzing the received data.
Similarly, the limitation of “extracting the one or more training data features from the training data …”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “extracting” in the context of this claim encompasses the user selects certain feature(s) from the received data to process, wherein, the extracting is based on the relationship between the two set of data.
Similarly, the limitation of “the one or more training data features are weighted based on the correlation between each of the one or more training data features and the one or more gait classifications of the training data”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “weight” in the context of this claim encompasses the user assigns the scores to the received data based on the relationship between the two set of data.
Similarly, the limitation of “extracting one or more features from the data corresponding to the walking user”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “extracting” in the context of this claim encompasses the user selects certain feature(s) from the data associated with the patient’s movement such as acceleration, small step, etc.,
Similarly, the limitation of “assessing a gait of the walking user”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “assessing” in the context of this claim encompasses the user determining the gait of the patient based on the extracted/selected features.
Similarly, the limitation of “updating electronic health records of the walking user with the user PIGD score”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “updating” in the context of this claim encompasses the user changing a patient record based on some new data values.
If a claim, under the broadest reasonable interpretation covers concepts that can be performed in the human mind, or by a human using a pen and paper, including observation, evaluation, judgment, or opinion, it will be considered as falling within the "mental processes" grouping of abstract idea.
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of “models” and “generative adversarial nets”. The additional elements are recited at a high-level of generality (i.e., as a generic device performing the generic computer functions) such that they amount no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The additional elements of “receiving training data”, “collecting data corresponding to a walking user” amount to insignificant extra-solution activities of data gathering, which do not amount to significantly more than the abstract idea (MPEP 2106.05(g)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
The additional elements of “wherein the training data is comprised of one or more gait classifications”, “processing … by removing turning data and applying a Fast Fourier Transform (FFT) to each time series of the training data, wherein the turning data is identified based on at least, one or more of, a lack of velocity, a decreased acceleration, or an increase in gyroscopic motion”, “wherein each of the one or more training data features are extracted based on a correlation between each of the one or more training data features and the one or more gait classifications of the training data”, “wherein the one or more ON/OFF Loss values are indicative of whether the PIGD score on an individual in an OFF state is higher than the PIGD score of the individual in an ON state”, “wherein the data collected includes at least data received from one or more inertial sensors and data received from a user registration”, “wherein at least one of the plurality of inertial sensors is positioned on a lower back of the walking user, and wherein the data received from the plurality of inertial sensors are utilized in generating a graph of acceleration over time representing a motion of the walking user”, “extracting one or more features … by applying the FTT to each time series of the data corresponding to the walking user” and “wherein one or more modified models are utilized for future gait assessments of future users” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
The additional elements of “one or more resulting FTT amplitudes are stored as one or more training data features” amount to insignificant extra-solution activity of data storage. As described in MPEP 2106.05(g), limitations that amount to merely adding insignificant extra-solution activity to a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.
The additional elements of “notifying the walking user and a physician of the walking user of the gait assessed for the walking user” amounts to an extra solution activity because it is a mere nominal or tangential addition to the claim, amounting to mere data output (see MPEP 2106.05(g)).
The claim recites the additional elements of “training one or more models using generative adversarial nets based on the one or more training data features, one or more Postural Instability and Gait Disturbance (PIGD) scores, and one or more ON/OFF Loss Values”, “applying the one or more models to the one or more features extracted from the data corresponding to the walking user to determine a user PIGD score” and “modifying the one or more models utilizing the data corresponding to the walking user, the gait assessed for the walking user, and the user PIGD score as new training data”. These limitations are recited at a high-level of generality (i.e., as a generic device performing the generic computer functions of training and assessing) such that they amount no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “models” and “generative adversarial nets” to perform the “assessing” step amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The additional elements of “receiving training data”, “collecting data corresponding to a walking user” are recited at a high level of generality and amount to insignificant extra-solution activity related to mere data gathering (MPEP 2106.05(g)). The courts have found limitations directed to receiving information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”).
The additional elements of “wherein the training data is comprised of one or more gait classifications”, “processing … by removing turning data and applying a Fast Fourier Transform (FFT) to each time series of the training data, wherein the turning data is identified based on at least, one or more of, a lack of velocity, a decreased acceleration, or an increase in gyroscopic motion”, “wherein the one or more ON/OFF Loss values are indicative of whether the PIGD score on an individual in an OFF state is higher than the PIGD score of the individual in an ON state”, “wherein the data collected includes at least data received from one or more inertial sensors and data received from a user registration”, “wherein at least one of the plurality of inertial sensors is positioned on a lower back of the walking user, and wherein the data received from the plurality of inertial sensors are utilized in generating a graph of acceleration over time representing a motion of the walking user”, “extracting one or more features … by applying the FTT to each time series of the data corresponding to the walking user” and “wherein one or more modified models are utilized for future gait assessments of future users” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
The additional element of " one or more resulting FTT amplitudes are stored as features" is recited at a high level of generality and amounts to insignificant extra-solution activity of storing data. The courts have found limitations directed to storing information, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), "electronic record keeping," and "storing and retrieving information in memory").
the additional elements of “notifying the walking user and a physician of the walking user of the gait assessed for the walking user” amount to extra solution activity because it is a mere nominal or tangential addition to the claim, amounting to mere data output (see MPEP 2106.05(g)). The courts have similarly found limitations directed to displaying a result, recited at a high level of generality, to be well-understood, routine, and conventional. See (MPEP 2106.05(d)(II), "presenting offers and gathering statistics.", “determining an estimated outcome and setting a price”).
The additional elements of “training one or more models using generative adversarial nets based on the one or more training data features, one or more Postural Instability and Gait Disturbance (PIGD) scores, and one or more ON/OFF Loss Values”, “applying the one or more models to the one or more features extracted from the data corresponding to the walking user to determine a user PIGD score” and “modifying the one or more models utilizing the data corresponding to the walking user, the gait assessed for the walking user, and the user PIGD score as new training data” amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites a method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of “wherein the generative adversarial nets are utilized in generating additional training data, wherein the additional training data includes unlabeled walking examples derived from the training data received” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “wherein the generative adversarial nets are utilized in generating additional training data, wherein the additional training data includes unlabeled walking examples derived from the training data received” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites a method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of “wherein the one or more training data features and the one or more features corresponding to the walking user include features selected from a group comprising tremors, slowness of movement, muscular rigidity, gait speed, stride length, toe off angle, strike angle, trunk coronal range of motion, and body symmetry” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “wherein the one or more training data features and the one or more features corresponding to the walking user include features selected from a group comprising tremors, slowness of movement, muscular rigidity, gait speed, stride length, toe off angle, strike angle, trunk coronal range of motion, and body symmetry” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites a computer program product which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 1):
The limitation of “processing the training data …”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “processing” in the context of this claim encompasses the user analyzing the received data.
Similarly, the limitation of “extracting the one or more training data features from the training data …”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “extracting” in the context of this claim encompasses the user selects certain feature(s) from the received data to process, wherein, the extracting is based on the relationship between the two set of data.
Similarly, the limitation of “the one or more training data features are weighted based on the correlation between each of the one or more training data features and the one or more gait classifications of the training data”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “weight” in the context of this claim encompasses the user assigns the scores to the received data based on the relationship between the two set of data.
Similarly, the limitation of “extracting one or more features from the data corresponding to the walking user”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “extracting” in the context of this claim encompasses the user selects certain feature(s) from the data associated with the patient’s movement such as acceleration, small step, etc.,
Similarly, the limitation of “assessing a gait of the walking user”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “assessing” in the context of this claim encompasses the user determining the gait of the patient based on the extracted/selected features.
Similarly, the limitation of “updating electronic health records of the walking user with the user PIGD score”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “updating” in the context of this claim encompasses the user changing a patient record based on some new data values.
If a claim, under the broadest reasonable interpretation covers concepts that can be performed in the human mind, or by a human using a pen and paper, including observation, evaluation, judgment, or opinion, it will be considered as falling within the "mental processes" grouping of abstract idea.
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of “A computer program product”, “one or more non-transitory computer-readable storage media”, “models” and “generative adversarial nets”. The additional elements are recited at a high-level of generality (i.e., as a generic device performing the generic computer functions) such that they amount no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The additional elements of “receiving training data”, “collecting data corresponding to a walking user” amount to insignificant extra-solution activities of data gathering, which do not amount to significantly more than the abstract idea (MPEP 2106.05(g)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
The additional elements of “wherein the training data is comprised of one or more gait classifications”, “processing … by removing turning data and applying a Fast Fourier Transform (FFT) to each time series of the training data, wherein the turning data is identified based on at least, one or more of, a lack of velocity, a decreased acceleration, or an increase in gyroscopic motion”, “wherein each of the one or more training data features are extracted based on a correlation between each of the one or more training data features and the one or more gait classifications of the training data”, “wherein the one or more ON/OFF Loss values are indicative of whether the PIGD score on an individual in an OFF state is higher than the PIGD score of the individual in an ON state”, “wherein the data collected includes at least data received from one or more inertial sensors and data received from a user registration”, “wherein at least one of the plurality of inertial sensors is positioned on a lower back of the walking user, and wherein the data received from the plurality of inertial sensors are utilized in generating a graph of acceleration over time representing a motion of the walking user”, “extracting one or more features … by applying the FTT to each time series of the data corresponding to the walking user” and “wherein one or more modified models are utilized for future gait assessments of future users” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
The additional elements of “one or more resulting FTT amplitudes are stored as one or more training data features” amount to insignificant extra-solution activity of data storage. As described in MPEP 2106.05(g), limitations that amount to merely adding insignificant extra-solution activity to a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.
The additional elements of “notifying the walking user and a physician of the walking user of the gait assessed for the walking user” amounts to an extra solution activity because it is a mere nominal or tangential addition to the claim, amounting to mere data output (see MPEP 2106.05(g)).
The claim recites the additional elements of “training one or more models using generative adversarial nets based on the one or more training data features, one or more Postural Instability and Gait Disturbance (PIGD) scores, and one or more ON/OFF Loss Values”, “applying the one or more models to the one or more features extracted from the data corresponding to the walking user to determine a user PIGD score” and “modifying the one or more models utilizing the data corresponding to the walking user, the gait assessed for the walking user, and the user PIGD score as new training data”. These limitations are recited at a high-level of generality (i.e., as a generic device performing the generic computer functions of training and assessing) such that they amount no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “A computer program product”, “one or more non-transitory computer-readable storage media”, “models” and “generative adversarial nets” to perform the “assessing” step amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The additional elements of “receiving training data”, “collecting data corresponding to a walking user” are recited at a high level of generality and amount to insignificant extra-solution activity related to mere data gathering (MPEP 2106.05(g)). The courts have found limitations directed to receiving information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”).
The additional elements of “wherein the training data is comprised of one or more gait classifications”, “processing … by removing turning data and applying a Fast Fourier Transform (FFT) to each time series of the training data, wherein the turning data is identified based on at least, one or more of, a lack of velocity, a decreased acceleration, or an increase in gyroscopic motion”, “wherein the one or more ON/OFF Loss values are indicative of whether the PIGD score on an individual in an OFF state is higher than the PIGD score of the individual in an ON state”, “wherein the data collected includes at least data received from one or more inertial sensors and data received from a user registration”, “wherein at least one of the plurality of inertial sensors is positioned on a lower back of the walking user, and wherein the data received from the plurality of inertial sensors are utilized in generating a graph of acceleration over time representing a motion of the walking user”, “extracting one or more features … by applying the FTT to each time series of the data corresponding to the walking user” and “wherein one or more modified models are utilized for future gait assessments of future users” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
The additional element of " one or more resulting FTT amplitudes are stored as features" is recited at a high level of generality and amounts to insignificant extra-solution activity of storing data. The courts have found limitations directed to storing information, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), "electronic record keeping," and "storing and retrieving information in memory").
the additional elements of “notifying the walking user and a physician of the walking user of the gait assessed for the walking user” amount to extra solution activity because it is a mere nominal or tangential addition to the claim, amounting to mere data output (see MPEP 2106.05(g)). The courts have similarly found limitations directed to displaying a result, recited at a high level of generality, to be well-understood, routine, and conventional. See (MPEP 2106.05(d)(II), "presenting offers and gathering statistics.", “determining an estimated outcome and setting a price”).
The additional elements of “training one or more models using generative adversarial nets based on the one or more training data features, one or more Postural Instability and Gait Disturbance (PIGD) scores, and one or more ON/OFF Loss Values”, “applying the one or more models to the one or more features extracted from the data corresponding to the walking user to determine a user PIGD score” and “modifying the one or more models utilizing the data corresponding to the walking user, the gait assessed for the walking user, and the user PIGD score as new training data” amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claim 11 is being rejected by the same reason as of claim 4, since these claims recite the same limitations.
Claim 14 is being rejected by the same reason as of claim 7, since these claims recite the same limitations.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites a computer system which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 1):
The limitation of “processing the training data …”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “processing” in the context of this claim encompasses the user analyzing the received data.
Similarly, the limitation of “extracting the one or more training data features from the training data …”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “extracting” in the context of this claim encompasses the user selects certain feature(s) from the received data to process, wherein, the extracting is based on the relationship between the two set of data.
Similarly, the limitation of “the one or more training data features are weighted based on the correlation between each of the one or more training data features and the one or more gait classifications of the training data”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “weight” in the context of this claim encompasses the user assigns the scores to the received data based on the relationship between the two set of data.
Similarly, the limitation of “extracting one or more features from the data corresponding to the walking user”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “extracting” in the context of this claim encompasses the user selects certain feature(s) from the data associated with the patient’s movement such as acceleration, small step, etc.,
Similarly, the limitation of “assessing a gait of the walking user”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “assessing” in the context of this claim encompasses the user determining the gait of the patient based on the extracted/selected features.
Similarly, the limitation of “updating electronic health records of the walking user with the user PIGD score”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “updating” in the context of this claim encompasses the user changing a patient record based on some new data values.
If a claim, under the broadest reasonable interpretation covers concepts that can be performed in the human mind, or by a human using a pen and paper, including observation, evaluation, judgment, or opinion, it will be considered as falling within the "mental processes" grouping of abstract idea.
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of “A computer system”, “one or more computer processors”, “one or more computer-readable storage media”, “models” and “generative adversarial nets”. The additional elements are recited at a high-level of generality (i.e., as a generic device performing the generic computer functions) such that they amount no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The additional elements of “receiving training data”, “collecting data corresponding to a walking user” amount to insignificant extra-solution activities of data gathering, which do not amount to significantly more than the abstract idea (MPEP 2106.05(g)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
The additional elements of “wherein the training data is comprised of one or more gait classifications”, “processing … by removing turning data and applying a Fast Fourier Transform (FFT) to each time series of the training data, wherein the turning data is identified based on at least, one or more of, a lack of velocity, a decreased acceleration, or an increase in gyroscopic motion”, “wherein each of the one or more training data features are extracted based on a correlation between each of the one or more training data features and the one or more gait classifications of the training data”, “wherein the one or more ON/OFF Loss values are indicative of whether the PIGD score on an individual in an OFF state is higher than the PIGD score of the individual in an ON state”, “wherein the data collected includes at least data received from one or more inertial sensors and data received from a user registration”, “wherein at least one of the plurality of inertial sensors is positioned on a lower back of the walking user, and wherein the data received from the plurality of inertial sensors are utilized in generating a graph of acceleration over time representing a motion of the walking user”, “extracting one or more features … by applying the FTT to each time series of the data corresponding to the walking user” and “wherein one or more modified models are utilized for future gait assessments of future users” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
The additional elements of “one or more resulting FTT amplitudes are stored as one or more training data features” amount to insignificant extra-solution activity of data storage. As described in MPEP 2106.05(g), limitations that amount to merely adding insignificant extra-solution activity to a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.
The additional elements of “notifying the walking user and a physician of the walking user of the gait assessed for the walking user” amounts to an extra solution activity because it is a mere nominal or tangential addition to the claim, amounting to mere data output (see MPEP 2106.05(g)).
The claim recites the additional elements of “training one or more models using generative adversarial nets based on the one or more training data features, one or more Postural Instability and Gait Disturbance (PIGD) scores, and one or more ON/OFF Loss Values”, “applying the one or more models to the one or more features extracted from the data corresponding to the walking user to determine a user PIGD score” and “modifying the one or more models utilizing the data corresponding to the walking user, the gait assessed for the walking user, and the user PIGD score as new training data”. These limitations are recited at a high-level of generality (i.e., as a generic device performing the generic computer functions of training and assessing) such that they amount no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “A computer system”, “one or more computer processors”, “one or more computer-readable storage media”, “models” and “generative adversarial nets” to perform the “assessing” step amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The additional elements of “receiving training data”, “collecting data corresponding to a walking user” are recited at a high level of generality and amount to insignificant extra-solution activity related to mere data gathering (MPEP 2106.05(g)). The courts have found limitations directed to receiving information electronically, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), “receiving or transmitting data over a network”).
The additional elements of “wherein the training data is comprised of one or more gait classifications”, “processing … by removing turning data and applying a Fast Fourier Transform (FFT) to each time series of the training data, wherein the turning data is identified based on at least, one or more of, a lack of velocity, a decreased acceleration, or an increase in gyroscopic motion”, “wherein the one or more ON/OFF Loss values are indicative of whether the PIGD score on an individual in an OFF state is higher than the PIGD score of the individual in an ON state”, “wherein the data collected includes at least data received from one or more inertial sensors and data received from a user registration”, “wherein at least one of the plurality of inertial sensors is positioned on a lower back of the walking user, and wherein the data received from the plurality of inertial sensors are utilized in generating a graph of acceleration over time representing a motion of the walking user”, “extracting one or more features … by applying the FTT to each time series of the data corresponding to the walking user” and “wherein one or more modified models are utilized for future gait assessments of future users” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
The additional element of " one or more resulting FTT amplitudes are stored as features" is recited at a high level of generality and amounts to insignificant extra-solution activity of storing data. The courts have found limitations directed to storing information, recited at a high level of generality, to be well-understood, routine, and conventional (see MPEP 2106.05(d)(II), "electronic record keeping," and "storing and retrieving information in memory").
the additional elements of “notifying the walking user and a physician of the walking user of the gait assessed for the walking user” amount to extra solution activity because it is a mere nominal or tangential addition to the claim, amounting to mere data output (see MPEP 2106.05(g)). The courts have similarly found limitations directed to displaying a result, recited at a high level of generality, to be well-understood, routine, and conventional. See (MPEP 2106.05(d)(II), "presenting offers and gathering statistics.", “determining an estimated outcome and setting a price”).
The additional elements of “training one or more models using generative adversarial nets based on the one or more training data features, one or more Postural Instability and Gait Disturbance (PIGD) scores, and one or more ON/OFF Loss Values”, “applying the one or more models to the one or more features extracted from the data corresponding to the walking user to determine a user PIGD score” and “modifying the one or more models utilizing the data corresponding to the walking user, the gait assessed for the walking user, and the user PIGD score as new training data” amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claim 18 is being rejected by the same reason as of claim 4, since these claims recite the same limitations.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites a method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional element of “applying a band filter to the training data and the data corresponding to the walking user to remove high frequency noise and an effect of gravity”. This limitation is recited at high level of generality i.e., as a generic device performing the generic computer functions of remove) such that they amount no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “applying a band filter to the training data and the data corresponding to the walking user to remove high frequency noise and an effect of gravity” amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claim 23 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites a method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 1):
The limitation of “adjusting the one or more models utilized in assessing the gait of the walking user based on whether the discriminator correctly discriminates between the additional training data and the training data”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “adjusting” in the context of this claim encompasses the user using some other methods or data to determine the gait of the patient.
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of “discriminating between the additional training data and the training data using a discriminator”. This limitation is recited at a high-level of generality (i.e., as a generic device performing the generic computer functions of discriminating) such that they amount no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “discriminating between the additional training data and the training data using a discriminator” amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claim 27 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites a method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of “wherein the one or more training data features and the one or more features corresponding to the walking user include features selected from a group comprising tremors, slowness of movement, muscular rigidity, gait speed, stride length, toe off angle, strike angle, trunk coronal range of motion, and body symmetry” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “wherein the one or more training data features and the one or more features corresponding to the walking user include features selected from a group comprising tremors, slowness of movement, muscular rigidity, gait speed, stride length, toe off angle, strike angle, trunk coronal range of motion, and body symmetry” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 28 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of “generating additional training data using the generative adversarial nets” and “retraining the one or more models”. These limitations are recited at a high-level of generality (i.e., as a generic device performing the generic computer functions of generating) such that it amounts to no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
The claim recites the additional elements of “wherein the additional training data includes unlabeled walking examples derived from the training data received” and “retraining the one or more models based on a PIGD score prediction and whether a discriminator correctly discriminates between the additional training data and the training data received” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “generating additional training data using generative adversarial nets” amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claim recites the additional elements of “wherein the additional training data includes unlabeled walking examples derived from the training data received” and “retraining the one or more models based on a PIGD score prediction and whether a discriminator correctly discriminates between the additional training data and the training data received” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 31 is being rejected by the same reason as of claim 21, since these claims recite the same limitations.
Claim 32 is being rejected by the same reason as of claim 23, since these claims recite the same limitations.
Claim 33 is being rejected by the same reason as of claim 27, since these claims recite the same limitations.
Claim 34 is being rejected by the same reason as of claim 28, since these claims recite the same limitations.
Claim 35 is being rejected by the same reason as of claim 21, since these claims recite the same limitations.
Claim 36 is being rejected by the same reason as of claim 23, since these claims recite the same limitations.
Claim 37 is being rejected by the same reason as of claim 27, since these claims recite the same limitations.
Claim 38 is being rejected by the same reason as of claim 28, since these claims recite the same limitations.
Allowable Subject Matter
Claims 1, 4, 7-8, 11, 14-15, 18, 21, 23, 27-28 and 31-38 would be allowable if rewritten so that the 101 rejections above were overcome.
The claims were previously indicated as having allowable subject matter, the examiner has performed an updated search, but no prior art references are found to teach or suggest, individually or in combination the limitations as reciting in the independent claims as a whole, especially limitations (among others) “processing the training data by removing turning data and applying a Fast Fourier Transform (FFT) to each time series of the training data, wherein the turning data is identified based on at least, one or more of, a lack of velocity, a decreased acceleration, or an increase in gyroscopic motion, and wherein one or more resulting FTT amplitudes are stored as features;
extracting one or more training data features from the training data;
training one or more models based on the one or more training data features”.
Therefore, the combination of features is considered to be allowable.
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Kording et al. (US Patent 9,872,637) describes a method for determining movement of a patient based on sensor data.
Sales et al. (US Pub 2018/0206775) describes a method for analyzing information from the sensors to identify one or more conditions associated with the individual.
Conclusion
THIS ACTION IS MADE FINAL. 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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/TRI T NGUYEN/Examiner, Art Unit 2128
/OMAR F FERNANDEZ RIVAS/Supervisory Patent Examiner, Art Unit 2128
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