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 July 11, 2026 has been entered. Claims 15, 16 and 18-28 are pending. Claim 17 is cancelled.
Applicant’s amendments obviate claim objections to claim 15 previously presented.
Applicant’s amendments obviate rejections to claims 15 and 24 under 35 U.S.C. 112(b) previously presented.
Applicant’s amendments incorporate limitations of cancelled claim 17 (which does not possess a prior art rejection) into independent claim 15. Thus, each prior art rejection has been withdrawn.
Applicant’s amendments and argument are not sufficient to overcome the rejection to the claims under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed June 11, 2026 with respect to the rejection of the claims under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Regarding Applicant’s argument:
“Under Step 2A, Prong 1, claim 15 is not properly characterized as a mental process. The claim does not recite steps that can practically be performed in the human mind. The claimed method requires an insole worn by a user and having a plurality of sensing cells that measure physical load applied to the sole of the foot during gait. The controller collects measured signals from each sensing cell, computes total signals at different instants, compares temporally separated total signals to detect the beginning of a discharge period, applies predetermined cell calibration thresholds on a cell-by-cell basis during that discharge period, replaces sub-threshold residual sensor outputs with null outputs, computes a corrected total signal from the overall outputs, and triggers toe off when that corrected total signal falls below a predetermined toe off threshold. These operations are tied to physical sensor measurements acquired over time from a wearable insole during a gait cycle, and they address the behavior of the sensing cells during unloading. A person could not, as a practical matter, mentally collect and process time-varying measured signals from a plurality of insole sensing cells during gait, determine the beginning of the discharge period from current and preceding total signals, and apply cell-specific calibration thresholds to correct latency-induced sensor outputs in the manner now claimed.”
Applicant appears to repeat steps which appear to be no more than data-gathering and processing thereof, and thereafter alleges that the claimed limitations could not be performed mentally or by pen-and-paper practice without further support as to why such steps could not be practically performed as an abstract mental process carried out by generic computer processors. Collecting measured signals from each sensing cell is an observation of gathered data; computing a total therefrom is a simple summation; comparing different totals is a simple evaluation of two sums; applying thresholds and replacing sensor outputs with nulls is akin to the mental concept of data selection with rules; triggering toe off is understood as reaching a determination of the toe leaving the ground based on the aforementioned actions. The requirement that the actions “correct latency-induced sensor outputs” is not claimed. Should Applicant be argue that the actions could not be performed within requisite timeframes, carrying out the evaluation data analysis steps by computer allows for steps to be performed at significantly faster rates than the human mind could produce; however, such an increase in speed in data processing is not material to the patent eligibility of the abstract idea. See Bancorps: “Indeed, humans routinely processed large amounts of data by hand before the advent of computers. As our reviewing court has explained, “the fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter. Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012).””
Regarding Applicant’s argument “The Office Action characterizes the claims as ascertaining and processing data to assess quality of sleep.”
Examiner has corrected this error. See updated rejection under 35 U.S.C. 101.
Regarding Applicant’s argument “The claimed sensor-signal processing is therefore not a generic evaluation of human information, but a specific technique for detecting a biomechanical gait event from physical load measurements produced by an insole.”
The technique is abstract – see arguments above and updated rejection under 35 U.S.C. 101.
Regarding Applicant’s argument:
“Nor is the claim directed merely to comparing values to thresholds in the abstract. The claimed thresholds have a specific technological role in correcting the physical behavior of the sensing cells. The specification explains that dielectric materials used in sensing cells are subject to latency, also called elastic recovery, during pressure decay, so that a sensing cell can still measure a positive signal when the applied pressure is null. See paragraphs [0004] and [0071]. That latency produces a time delay and a loss of precision in determining toe off. Id. Claim 15 addresses that technical problem by using predetermined cell calibration thresholds determined for each sensing cell during an unloading phase, specifically as the signal measured by that sensing cell when the applied load becomes null. The controller then uses those cell-specific thresholds during the discharge period to output the measured signal only when it is at least the corresponding threshold and otherwise output a null output. This is not a disembodied mental comparison. Rather, it is a specific correction of residual sensor signals caused by latency of the sensing cells.”
Applicant’s identification of predetermined cell calibration thresholds requires no more than observation of the sensing cells’ load values at various stride phases, and identifying the load value at which an applied load is zero. Identifying which sensing cells are selected to be null based on comparison of their performance in a previous phase is an abstract process of observation, whereby evaluation thereafter to determine thresholds for further analysis steps is solely abstract.
Regarding Applicant’s argument:
“Under Step 2A, Prong 2, even if any portion of claim 15 were considered to recite an abstract idea, the claim as a whole integrates any such idea into a practical application. The claim applies the alleged comparison and computation steps in a concrete wearable sensing system to improve toe off detection. The claimed insole and sensing cells are not merely a nominal data source appended to an abstract calculation. They are the physical components whose measured load signals are processed, whose latency problem is corrected, and whose corrected outputs are used to determine the gait event. The claimed controller does not simply receive generic data and display a result; it performs a particular sequence of operations on physical sensor signals during a detected discharge period of the gait cycle. The specification provides ample technical context for this practical application. It explains that known toe off detection methods using sensing cells are not satisfactory because sensor latency during pressure decay causes delayed signal decay and therefore imprecision in detecting when the foot no longer contacts the ground.”
The claims are directed to observation and analysis of data from a known form of sensor (an insole with a plurality of sensor cells), carried out by generic computer components. The identified judicial exception includes every evaluation step recited in the claim, including the identification of a predetermined cell calibration threshold. That is, Applicant fails to identify claim limitations which are additional to the abstract process which are sufficient to integrate the judicial exception into a practical application. As per MPEP 2106.04: “For a claim reciting a judicial exception to be eligible, the additional elements (if any) in the claim must “transform the nature of the claim” into a patent-eligible application of the judicial exception, Alice Corp., 573 U.S. at 217, 110 USPQ2d at 1981, either at Prong Two or in Step 2B. If there are no additional elements in the claim, then it cannot be eligible.”
Applicant’s arguments directed to Step 2B (i.e., repeating claim steps of abstract evaluation) can be responded to with Examiner’s response above. No additional elements are recited which provide significantly more than carrying out the claimed abstract process via generic components on data gathered from a well-understood, routine, and conventional sensor.
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 15-17, 18-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of the claims recites steps or instructions for ascertaining and processing data to assess toe off using insole sensing cells, which is grouped as a mental process. Accordingly, each of the claims recites an abstract idea.
Independent claim 15 recites:
an insole comprising a controller and a plurality of sensing cells (evaluation, judgement, or observation, additional element),
the method comprising: identifying a discharge period by collecting by the controller a measured signal from each sensing cell, computing a total signal from the measured signals, comparing the total signal and a total signal computed at a preceding instant, and triggering the determination, from this comparison, of the beginning of the discharge period when the total signal computed at the preceding instant is larger than the total signal (evaluation, judgement, or observation),
during the discharge period: collecting by the controller a measured signal from each sensing cell (data-gathering, additional element),
outputting by the controller, for each sensing cell:
the signal if said signal is larger than or equal to a predetermined cell calibration threshold (evaluation, judgement, or observation),
a null output if said signal is lower than said predetermined cell calibration threshold (evaluation, judgement, or observation),
computing, from the overall output signals, a total signal of the sensing cells (evaluation, judgement, or evaluation, additional element),
and triggering output of the toe off when the total signal is lower than a predetermined toe off threshold (extra-solution activity, evaluation, judgement, or observation),
wherein the discharge period is a time period when a load applied on the sensing cells is decreasing (details of evaluation, judgement, or observation)
and wherein the predetermined cell calibration thresholds are values determined during the calibration phase for each sensing cell as the signal measured by said sensing cell when an applied load becomes null during an unloading phase (details of evaluation, judgement, or observation).
As indicated above, the independent claim recites at least one step or instruction grouped as a mental process. Therefore, each of the independent claims recites an abstract idea. Each limitation, aside from language reciting a generic computer components, can be grouped as a mental process (see italicized portions above), and is addressed as follows:
Examiner first notes that the term “outputting” is not provided with an element which receives the output; thus, interpretation of “outputting” encompasses a processor passing the result of an evaluation to another data-processing step.
The limitation of outputting… the signal if said signal is larger than or equal to a predetermined cell calibration threshold encompasses an individual observing gathered sensor data and identifying which signals are larger than or equal to a threshold prior to another later judgement step.
The limitation of outputting… a null output if said signal is lower than said predetermined cell calibration threshold encompasses an individual observing gathered sensor data and identifying which signals are smaller than a threshold, and providing a null element in a list prior to another later judgement step.
The limitation of computing… a total signal encompasses an individual performing any type evaluation which could be considered as representative of a combination of all output signals (e.g., summation, integration, multiplication, etc.).
The limitation of triggering an output of the toe off when the total signal is lower than a predetermined toe off threshold is merely an extra-solution activity of output (to a non-descript receiver of the output) after an evaluation of whether a total signal is less than a threshold is completed.
The limitation of wherein the discharge period is a time period when a load applied on the sensing cells is decreasing is merely further detail defining what may be evaluated as a discharge period in the prior identification step.
The limitation of wherein the predetermined cell calibration thresholds are values determined during the calibration phase for each sensing cell as the signal measured by said sensing cell when an applied load becomes null during an unloading phase is merely further detail regarding what a predetermined cell calibration threshold may be in the prior evaluation step requiring comparison of a signal to a predetermined cell calibration threshold.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) (i.e., evaluation of relative to thresholds, identification of total signal, etc.) to derive a conclusion based on input of medical data, which corresponds to concepts identified as abstract ideas by the courts, such as in Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989). The concept of the recited steps above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
The dependent claims merely include limitations that either further define the abstract idea (e.g., particular steps which are entirely embodied in the mental process), limitations relating to the data gathered or additional elements therefor and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data (Int. Ventures v. Cap One Financial), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), collection, storage, and recognition of data (Smart Systems Innovations).
Step 2A, Prong 2
The above-identified abstract idea is not integrated into a practical application because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use.
More specifically:
Independent claim 15 recites the additional elements of:
an insole comprising a controller and a plurality of sensing cells.
The above combination of elements can be interpretable as an insole comprising sensing cells in communication with a controller. That is, the insole comprising… a plurality of sensing cells is reasonably interpretable as a sensor in communication with a controller. Such additional elements are generically recited elements which do not improve the functioning of a computer or any other technology or technical field. The claim recites merely acquiring data from a sensor (insole comprising… a plurality of sensing cells), having no operative connection to the controller besides communication of obtained data, which amounts to insignificant, extra-solution activity in the form of mere data gathering and does not constitute an integration into a practical application. Although the sensors may imply particular structure, their use in the mental process is merely extra-solution. See MPEP 2106.05(b).III:
“Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted)”
The controller is recited at a high-level of generality (i.e., as a generic processors and memory performing a generic computer function of performing calculations and storing data, respectively) such that it amounts no more than mere instructions to apply the exception using a generic computer component.
Thus, such additional elements do not serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified generically recited elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea is not integrated into a practical application.
Moreover, the above-identified abstract idea is not integrated into a practical application under because the claimed method and system merely implements the above-identified abstract idea using rules (e.g., computer instructions) executed by a computer (e.g., controller as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract ideas identified above in the independent claims (and their respective dependent claims) are not integrated into a practical application.
Dependent claims 16, 18-22, and 24 are additional steps related to either the abstract idea or details of extra-solution data-gathering.
Dependent claims 23 and 25-27 are directed to structural details of the sensing cell and insoles; however, such additional details are merely directed to the data-gathering component.
Dependent claim 28 recites generic computer components for carrying out the method of claim 15.
Accordingly, the claims are each directed to an abstract idea.
Step 2B
None of the claims include additional elements that, when viewed as a whole, are sufficient to amount to significantly more than the abstract idea for at least the following reasons:
Independent claim 1 recites:
an insole comprising a controller and a plurality of sensing cells.
As per Applicant’s Paragraph 0050, a generically-recited controller is described as follows:
“The controller 15 may include a processor. The expression "processor" should not be construed to be restricted to hardware capable of executing15 software and refers in a general way to a processing device, which can for example include a computer, a microprocessor, an integrated circuit, or a programmable logic device (PLD).”
Accordingly, in light of Applicant’s specification, the claimed terms interpretable as a processor are reasonably construed as a generic computing device. Thus, such an additional element does not amount to significantly more than the judicial exception.
The concept of an insole comprising a controller and a plurality of sensing cells is known from at least:
Gazdag et al. (US 20170188950 A1) – Paragraph 0006: “Recently there have been some entries into the market for shoe insoles that use micro-sensors. Moticon has a wired version of a micro-sensor enabled insole which tracks pressure and Sensoria has a micro-sensor enabled sock which tracks pressure. There are also several diagnostic shoe insoles that connect through wires to large power and data interpretation pieces (usually strapped to the leg) that are sold commercially to physical fitness and physician's offices.”
Lu et al. (US 20190175107 A1) – Paragraph 0002: “The internet of things (IoT) is a network of physical devices, vehicles, buildings and other items—embedded with electronics, software, sensors, actuators, and network connectivity that enable these objects to collect and exchange data, often without user input. IoT devices are sometimes referred to as smart devices. Lately, some advances have been made in developing smart insoles for use in shoes. Conventional smart insole solutions, however, rely primarily on force and/or pressure mapping using force sensing elements;” see also, Paragraph 0013 regarding conventional force sensing systems; Examiner notes that analysis of such force sensing elements are understood to utilize software and associated hardware.
Jo et al. (US 20240230434 A1) – Paragraph 0004 :” One example conventional plantar pressure sensor has a slippery surface interface on the sensing insole due to the use of dielectric film, which limits the sensor's capability to simulate the actual interaction between the foot and the interface inside the shoe. The contact points between the dielectric film and the foot displace relative to each other, which can be a safety issue during intense movements. The dielectric film on the insole is stiff, such that the edge of the plastic sensing pad becomes flexed and creates abnormal peak pressures. The example conventional plantar pressure sensor has a bulky and heavy data collector unit that is required to be mounted around each ankle of a user. The user also wears a data transmitter around the waist to tether between the data collector unit and software on a remote computer. The example conventional plantar pressure sensor restricts natural movements of the wearer, such as foot rotation or a change in center of mass. The example conventional plantar pressure sensor uses resistive pressure sensing approaches, which are based on deformation of the soft conductive material, in particular conductive ink between two polymer films. Deforming the material for pressure sensing decreases repeatability and reliability.”
Zanotto et al. (US 20250344966 A1) – Paragraph 0038: “Insoles instrumented with inertial (IMU) and force (FSR) sensors capture raw gait data (time-series) from the wearer in real-life or controlled environments. These sensors, which are known in the art, are discussed, for instance, in the aforementioned patent publications which have been incorporated by reference hereinabove. Data are stored in the onboard data-logger at a selectable rate 333-500 Hz and a phone App is used to control the recording process. Raw data from L/R insoles are synchronized within millisecond accuracy using BLE “connect events” and “Reference Broadcast Synchronization.” External instrumentation (e.g., lab equipment or wearable sensors) can also be synchronized through the phone app or an auxiliary wireless “sync box.” Machine-learning (ML) inference models are applied to data extracted from the insoles, to compute spatiotemporal and kinetic gait parameters with high accuracy and precision.”
Avni et al. (US 6273863 B1) – Col. 1, line 54 – Col. 2, line 10: “However, several devices are known in the prior art that assist the therapist and patient in determining how much weight is being applied to a patient's lower extremity and include external limb overload warning devices that warn the patient of an overload or an underload in the amount of pressure placed on the leg. For example, Schmidt et al. describe in U.S. Pat. No. 5,619,186 a foot weight alarm device including a foot-shaped insole device including resistive force sensors that fits inside the patient's shoe to warn the patient when the patient is putting too little or too much weight on a limited weight bearing foot. The foot weight alarm device also includes a shoe pouch which laces in the shoe, a foot weight alarm unit which fits in the shoe pouch and contains electronics that connects to the insole device, a data cable that is used by a health care professional to program the foot weight alarm unit, and a foot weight alarm calibration system used by the health care professional to program the foot weight alarm unit. The foot weight alarm unit measures the forces on each insole's sensors to compute the total force, and when the total force is below the target value, a low tone is produced by the foot weight alarm unit, while in the target zone a high tone is produced and above the target zone a two-tone warble is produced to inform the patient to take weight off the limb.”
Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear from the claims themselves and the specification that these limitations require no improved computer resources and merely utilize already available computers with their already available basic functions to use as tools in executing the claimed process.
Dependent claims 23 and 25-27 are directed to structural details of the sensing cell and insoles; however, each additional structural limitation is also known from the cited references above, and are considered merely well-understood, routine, and conventional structural elements.
Dependent claims 16, 18-22, 24, and 28 are merely recites steps which further define the abstract idea, data/data-processing steps, or generic computer elements for carrying out the abstract idea. Examiner notes that the dependent claims recite limitations which are extra-solution or part of the abstract idea itself do not constitute significantly more. See MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
The recitation of the above-identified additional limitations in the claims amount to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
For at least the above reasons, the claims are directed to applying an abstract idea on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. In other words, none of the claims provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in the independent claims do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment (processing of sensor data). That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, the claims merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself, or (ii) provide a technical solution to a problem in a technical field.
Therefore, none of the claims amounts to significantly more than the abstract idea itself.
Accordingly, the claims are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JUSTIN XU/ Primary Examiner, Art Unit 3791
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