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 .
Terminal Disclaimer
The terminal disclaimer filed on 22 July 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US 12,133,726 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Response to Amendment
The amendment filed 22 July 2026 has been entered. Claim(s) 16-35 remain pending in the application. Applicant’s terminal disclaimer and amendments to the claims have overcome each and every objection to the claims and each and every rejection under 35 U.S.C. 112(b) and double patenting previously set forth in the Office Action mailed 22 April 2026.
A second non-final office action is provided in light of new grounds of rejection under 35 U.S.C. 101 being applied to claim 27 and its dependents which are not necessitated by the amendment.
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.
Utilizing the two step process adopted by the Supreme Court (Alice Corp vs CLS Bank Int'l, US
Supreme Court, 110 USPQ2d 1976 (2014) and the recent 101 guideline Federal Register Vol. 84, No., Jan
2019)), determination of the subject matter eligibility under the 35 U.S.C. 101 is as follows: Specifically, the Step 1 requires claim belongs to one of the four statutory categories (process, machine, manufacture, or composition of matter). If Step 1 is satisfied, then in the first part of Step 2A (Prong One), identification of any judicial recognized exceptions in the claim is made. If any limitation in the claim is identified as judicial recognized exception, then in the second part of Step 2A (Prong Two), determination is made whether the identified judicial exception is being integrated into practical application. If the identified judicial exception is not integrated into a practical application, then in Step 2B, the claim is further evaluated to see if the additional elements, individually and in combination provide "inventive concept" that would amount to significantly more than the judicial exception. If the element and combination of elements do not amount to significantly more than the judicial recognized exception itself, then the claim is ineligible under the 35 U.S.C. 101.
Claims 16-35 are rejected under 35 U.S.C. 101.
Claims 16, 34, and 35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. The claim recite(s) "identifying one or more directional components of the signal, the one or more directional components including a medio-lateral component and an antero-posterior component, and the one or more directional components being independent of an orientation of the one or more sensors on the subject; determining a wavelet transform of the one or more directional components of the signal; validating the medio-lateral component and the antero-posterior component of the signal; upon validating the medio-lateral component and the antero-posterior component of the signal, determining, based at least on one or more derivatives of the wavelet transform, one or more gait features of the gait activity of the subject; and determining, based at least on the one or more gait features, at least one of a diagnosis, a progression, and a treatment response for a neurological dysfunction". This judicial exception is not integrated into a practical application and the claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claims 16, 34, and 35 each satisfies Step 1, namely the claim is directed to one of the four statutory classes, machine or process. Following Step 2A Prong one, any judicial exceptions are identified in the claims. In claims 16, 34, and 35, the limitations "identifying one or more directional components of the signal, the one or more directional components including a medio-lateral component and an antero-posterior component, and the one or more directional components being independent of an orientation of the one or more sensors on the subject; determining a wavelet transform of the one or more directional components of the signal; validating the medio-lateral component and the antero-posterior component of the signal; upon validating the medio-lateral component and the antero-posterior component of the signal, determining, based at least on one or more derivatives of the wavelet transform, one or more gait features of the gait activity of the subject; and determining, based at least on the one or more gait features, at least one of a diagnosis, a progression, and a treatment response for a neurological dysfunction" are abstract ideas as they are directed to a mental process as each of these steps may be performed alone or with the aid of pen and paper using mathematical transforms on data received from sensors and then making human judgments based on the mathematically transformed data, where the current claim language does not require any particular transformations of data which would not be practically performed in the human mind even if cumbersome or requiring significant time to perform and where the claim similarly has no requirement for any particular timeliness of the calculations and determinations being performed. With the identification of an abstract idea, the next phase is to proceed Step 2A, Prong Two, wherewith additional elements and taken as a whole, evaluation occurs of whether the identified abstract idea is integrated into a practical application.
In Step 2A, Prong Two, the claim does not recite any additional elements or evidence that amounts to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements ”at least one data processor; and at least one memory storing instructions, which when executed by the at least one data processor, result in operations comprising: receiving, from one or more sensors located on a subject, a signal representative of a gait activity of the subject”. However, these components may be seen as the use of well-understood, routine, or conventional elements to perform a non-mental process in order to gather data for the mental process step, much like the example given in MPEP 2106.04(d)(2)(c), such that these limitations are extra-solution activity and thus do not integrate the judicial exception into a practical application. The receiving step leads to the final limitation of “determin[ing]” such that the end result of use of the system is only the generic determined “at least one of a diagnosis, a progression, a treatment, and a treatment response for a neurological dysfunction” which may be any generic output, or no output at all as the claim limitation fails to affirmatively recite an action that effects a particular treatment or prophylaxis on the basis of this determination. As the determination is not defined as requiring any further action, such as a form of prophylaxis or treatment or an improvement to a computer or other technology, the claim limitations constitute mere generation of data, in this case a signal representative of a gait activity of the subject, which is a necessary precursor for all uses of the recited exception such that the claim does not integrate the judicial exception into any practical application (see MPEP2106.04(d)(2)(c)). It is further noted that no particular prophylaxis or treatment has been recited (see MPEP2106.04(d)(2)(a)). Under the broadest reasonable interpretation, the claim elements are recited with a high level of generality (as written, each claimed operation of the at least one data processor may be performed by a person in an undefined manner including identifying directional components and gait features visually or by hand and performing a determination mentally) that there are no meaningful limitations to the abstract idea. Consequently, with the identified abstract idea not being integrated into a practical application, the next step is Step 2B, evaluating whether the additional elements provide "inventive concept" that would amount to significantly more than the abstract idea.
In Step 2B, claims 16, 34, and 35 do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Besides the abstract idea, the claim recites the additional elements ”at least one data processor; and at least one memory storing instructions, which when executed by the at least one data processor, result in operations comprising: receiving, from one or more sensors located on a subject, a signal representative of a gait activity of the subject”. The limitation constitutes extra-solution activity to the judicial exception, which does not amount to an inventive concept when the activity is well-understood, routine, or conventional, and are thus not indicative of integration into a practical application. The claim limitation constitutes adding a generic processor, memory, and sensor, which McDaid (US 20210315488 A1) describes as well-understood, routine or conventional in its description of “the memory may be of any suitable means known in the art, capable of storing information in a manner accessible by the processors, including a computer-readable medium, or any other medium that stores data that may be read with the aid of an electronic device. The processors may be any suitable device known to a person skilled in the art” (Paragraph 0061) and “objective measures such as electrogoniometers, optical motion capture and wearable sensor networks—typically including a plurality of inertial measurement units (IMUs)—are known for determining both limb kinematics (describing motion of the limb or a joint thereof) and kinetics (describing moments and loads associated with motion of the limb or joint thereof)” (Paragraph 0005, 0020). Regarding “at least one data processor; and at least one memory storing instructions, which when executed by the at least one data processor, result in operations”, the limitation amounts to nothing more than an instruction to apply the abstract idea using a generic computer, which does not render an abstract idea eligible. The steps performed by the at least one data processor are, as claimed, capable of being performed in the human mind similar to the examples given in MPEP 2106.04(a)(2)(III)(A)-(C), wherein it is described that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’ where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind” recites a mental process and that claims which merely use a computer as a tool to perform a mental process are not eligible when “there is nothing in the claims themselves that foreclose them from being performed by a human, mentally or with pen and paper” such as “mental processes of parsing and comparing data” when the steps are recited at a high level of generality and a computer is used merely as a tool to perform the processes. As discussed above with respect to integration of the abstract idea into a practical application, the present elements amount to no more than mere indications to apply the exception.
In Summary, claims 16, 34, and 35 recites abstract idea without being integrated into a practical application, and does not provide additional elements that would amount to significantly more. As such, taken as a whole, the claim and is ineligible under the 35 U.S.C. 101.
Claims 17-33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in this case an abstract idea, without significantly more. As each of these claims depends from claim 16, which was rejected under 35 U.S.C. 101 in paragraph 10 of this action, these claims must be evaluated on whether they sufficiently add to the practical application of claim 16, or comprise significantly more than the limitations of claim 16.
The claim element of claim 16 of a system is recited with a high level of generality (as written, the actions of the at least one data processor may be carried out by a person alone or with a generic computer in any undefined manner). The various calculations and determinations performed in claims 17-33 serve as further steps of mere data gathering or abstract ideas which require no particular timeliness which would preclude the steps from being performed in the human mind alone or aided by pen and paper, including additional data processing steps of filtering and validating which may be performed as basic mathematical processes and mental processes of identification, classification, and determination which may be performed as judgments, such that the claimed limitations of claims 17-33 cannot provide a practical application or provide meaningful limitations to the abstract idea of claim 16.
Response to Arguments
Applicant's arguments filed 22 July 2026 have been fully considered but they are not persuasive.
While the applicant argues that the claimed invention recites an improvement in a computer or other technology through the included validation steps, the argument is not presently persuasive.
As the current claim language requires no particular timeliness or calculations which cannot be practically performed in the human mind, the validation steps may additionally be seen as being directed toward a mental process. Under the Mayo/Alice framework, a claim directed to a newly discovered abstract idea cannot rely on the novelty of that discovery for the inventive concept necessary for patent eligibility; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity.” Mayo, 132 S. Ct. at 1294; see also Myriad, 133 S. Ct. at 2117; Ariosa, 788 F.3d at 1379. As the additional elements of the claimed invention relate to a generic processor, memory, and sensor which are well-understood, routine, or conventional activity in the art of gait detection, these elements fail to integrate the judicial exception into a practical application of an improvement in the functioning of a computer or other technology.
Conclusion
The prior art fails to provide any teaching or suggestion of “determining, based at least on one or more derivatives of the wavelet transform, one or more gait features of the gait activity of the subject”. Tietsche (“Robust Step Detection from Different Waist-Worn Sensor Positions: Implications for Clinical Studies”) provides no particular teachings related to either determining derivatives of the wavelet transform or of determining toe-off events. Escamilla-Nunez (“Derivative Based Gait Event Detection Algorithm Using Unfiltered Accelerometer Signals”), in analogous art of gait monitoring, discusses the determination of heel-strike and toe-off events using a gait signal. However, it relates a determination of these events using maximum local peaks (rather than a minimum) of the direct gait signal rather than any derivative of a wavelet transform. Nathan (US 20170188895 A1) in the same field of endeavor of body motion recognition and analysis, provides some teachings of wavelet transforms of a motion signal (Paragraph 0055, 0236) and some teachings of determining derivatives of a motion sensor signal (Paragraph 0053, 0057, 0059, 0249) but does not disclose determining derivatives of a wavelet transform or using these derivatives to determine one or more gait features of the gait activity. Barrey (US 6895341 B2) in the same field of endeavor of a method of analyzing human locomotion, teaches determining a wavelet transform of a gait signal (Fig. 9-10 and 12) and determining a derivative of a gait signal (Fig. 14), but does not teach or suggest determining a derivative of a wavelet transform of a gait signal.
Regarding claims 27-29, the prior art of the record additionally fails to provide any teaching or suggestion of “wherein the validating the medio-lateral component and the antero-posterior component of identified for each signal block includes determining a medio-lateral autocorrelation of the medio-lateral component and an antero-posterior autocorrelation of the antero-posterior component, and validating, based at least on the medio-lateral autocorrelation and the antero-posterior autocorrelation, the medio-lateral component and the antero-posterior component identified for each signal block” or “validating the medio-lateral component and the antero-posterior component of a signal block as correctly identified based at least on (i) the antero-posterior autocorrelation showing a first positive peak while the medio-lateral autocorrelation is showing a first negative peak, or (ii) a first peak of the antero-posterior autocorrelation having a highest absolute value where the first peak the antero-posterior autocorrelation and that of the medio-lateral autocorrelation are negative”. Tietsche discusses determining autocorrelations for the medio-lateral component and the antero-posterior component (see above in this action), but fails to discuss any means of validating these components using the determined autocorrelations. Kelly (US 20210389159 A1), in analogous art of determining movement information of a user using one or more sensors (Abstract, paragraph 0009) teaches aligning each directional component with an axis (Paragraph 0015, 0052, 0066), performing an autocorrelation of each directional component of the sensor data (Paragraph 0072) which may result in the switching of axes (Paragraph 0073), but fails to specifically teach that this switching of axes constitutes a validation of the axes, nor does it teach any validation of the axes using particular peaks of the autocorrelations.
Conclusion
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/ANNA ROBERTS/ Examiner, Art Unit 3791
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