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 .
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15 recites “triggering output of the toe off when the total signal is lower than a predetermined toe off threshold;” however, the antecedent basis for “the toe off” appears only in the preamble. Examiner recommends amendment to recite “a toe off” or “toe off” or suitable language.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15, 24, and dependent claims thereof are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Re. Claim 15: Claim 15 recites the limitation “the calibration phase.” There is insufficient antecedent basis for this limitation in the claim.
Re. Claim 24: Claim 24 recites “dynamic response of sensing cell.” It is unclear if Applicant intends to refer to the response of plural sensing cells or merely the response from a single sensing cell. Applicant’s Paragraph 0025 does not aid in providing clarity because it repeats claim language without further clarification. Paragraph 0026 further obfuscates the intention of the claim because it describes measuring the dynamic response of plural sensing cells, but then refers to a singular sensing cell in the recitation “since it modifies the response of the sensing cell.” It is unclear whether calibration requires measurement of a response of a single sensing cell or multiple sensing cells.
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 15-28 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 quality of sleep of subject, 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 (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 16-22 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 softwar 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).”
Thus, the processor is generically described such that it appears to be directed to no more than a general purpose computer. 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.”
Accordingly, in light of Applicant’s specification, the claimed terms interpretable as a processor are reasonably construed as a generic computing device.
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 16-22, 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 ore 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 15, 19, and 23-28 are rejected under 35 U.S.C. 103 as being unpatentable over:
Chang et al. (US 20190336040 A1) (hereinafter – Chang) in view of
Crema et al. (US 20230157578 A1) (disclosed by Applicant) (hereinafter – Crema).
Re. Claim 15: Chang teaches a method for determining toe off with an insole comprising a controller and a plurality of sensing cells (Fig. 2: sensor 200 includes multiple detection areas; Fig. 1: sensor 200 is in communication with controller 300”),
the method comprising:
identifying a discharge period (Paragraph 0039: “When no obvious pressure is detected within the rear foot detection area 240 (i.e., the detection unit 241 shown in FIG. 2) and the pressure detected within the forefoot detection area 210 decreases to no obvious pressure, the status determining unit 310 is configured to determine the step status 20 to be at the toe-off status 24”),
during the discharge period:
collecting by the controller a measured signal from each sensing cell (see previous citation – implies detection from each sensing cell since entire areas are checked for pressure signals).
Chang does not teach the invention outputting by the controller, for each sensing cell:
the signal if said signal is larger than or equal to a predetermined cell calibration threshold,
a null output if said signal is lower than said predetermined cell calibration threshold.
Crema teaches analogous art in the technology of insole sensing systems (Paragraph 0002). Crema further teaches the invention wherein which determines, for each sensing cell:
the signal if said signal is larger than or equal to a predetermined cell calibration threshold (Examiner is interpreting “outputting” as presently claimed to be equivalent to identifying a subset of data to analyze at a future processing step; Paragraph 0020: “…storing the calibrated data in the memory unit and/or send the calibrated data to a computing device if calibrated data are greater than at least one threshold value…;” Paragraph 0037: “Advantageously, for each condition of use the at least one threshold value takes into account the “minimum value” emitted by each sensing unit during a threshold calibration period at which the sensing unit is considered active at the use condition”),
a null output if said signal is lower than said predetermined cell calibration threshold (Paragraph 0022: “If the calibrated values are lower than the at least one threshold value then they are discarded and not saved or transmitted”),
It would have been obvious to one having skill in the art before the effective filing date to have modified Chang to include providing a calibration phase and determining calibration thresholds for sensing cell signals as taught by Crema, the motivation being that doing so saves memory and/or to reduce the quantity of exchanged data and, therefore, increases the responsiveness of the method of the invention (Paragraph 0022).
Chang as modified by Crema further teaches the invention computing, from the overall output signals, a total signal of the sensing cells
(Paragraph 0039: “… pressure components are detected within the forefoot detection area 210, the rear foot detection area 240, the detection area of the inner side of the foot 220, and the detection area of the outer side foot 230 (i.e., the detection units 211, 212, 221, 222, 231, 232, 241 shown in FIG. 2)…;” see processing thereafter involving analysis of each of these areas, implying evaluation of a total, such as determination of a swinging phase requiring detection of signals from all areas),
and triggering output of the toe off when the total signal is lower than a predetermined toe off threshold (Examiner is interpreting “triggering output” as equivalent to carrying out the computer-implemented step which produces a determination of toe-off status; Paragraph 0039: “…the pressure detected within the forefoot detection area 210 decreases to no obvious pressure, the status determining unit 310 is configured to determine the step status 20 to be at the toe-off status 24. Regarding “obvious or non-obvious”, it can be compared with at least one critical value. When a pressure value is greater than the at least one critical value, it is determined to be obvious. When the pressure value is less than the at least one critical value, it is determined to be non-obvious;” alternatively, see Fig. 1: status signal outputting unit 320, in light of Paragraph 0047: “The status signal outputting unit 320 is configured to transmit signals of the step status 20 to the output module 500…;” see Paragraph 0039: toe-off status is a step status),
wherein the discharge period is a time period when a load applied on the sensing cells is decreasing (Paragraph 0039: “… pressure detected within the forefoot detection area 210 decreases to no obvious pressure, the status determining unit 310 is configured to determine the step status 20 to be at the toe-off status 24”) 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 (Paragraphs 0040, 0045: calibration process involves determination of offload and onload thresholds).
Re. Claim 19: Chang as modified by Crema teaches the invention according to claim 15. Chang further teaches the invention
Re. Claim 19: Chang as modified by Crema teaches the invention according to claim 15. Chang further teaches the invention further comprising, before identifying a discharge period, determining heel strike comprising:
collecting by the controller a measured signal from each sensing cell (Paragraph 0039: detection of pressure components from each sensor of each area),
computing a total signal from the collected signals (Paragraph 0039: detection of pressure at particular parts includes identification of lack of signal at others, thus identifying a total signal), and
triggering the determination of a heel strike when the total signal exceeds a predetermined heel strike threshold (Paragraph 0039: “When the obvious pressure is only detected within the rear foot detection area 240 (i.e., the detection unit 241 shown in FIG. 2), the status determining unit 310 is configured to determine the step status 20 to be at the heel-strike status 21… Regarding “obvious or non-obvious”, it can be compared with at least one critical value. When a pressure value is greater than the at least one critical value, it is determined to be obvious. When the pressure value is less than the at least one critical value, it is determined to be non-obvious”).
Re. Claim 23: Chang as modified by Crema teaches the invention according to claim 15. Chang further teaches the invention wherein at least one sensing cell is
a capacitive pressure cell or
a force sensing cell (Paragraph 0009: “The sensor including a plurality of detection units is disposed on a bottom of the shoe body, and each of the detection units is configured to detect a pressure generated by a foot on the bottom of the shoe body;” Examiner notes that a pressure is a measurement of force over area).
Re. Claim 24: Chang as modified by Crema teaches the invention according to claim 15. Crema teaches analysis of patterns of loading and unloading the foot (Paragraph 0014). Crema further teaches a calibration which considers an onload conditions (Paragraph 0033: “…the condition in which the user is in contact with the at least one sensing unit and exerts a pressure on the at least one sensing unit and is still or is moving and performing a task like for example walking, running, jumping, etc.”) as well as an offload condition (Paragraph 0035: “…the portion of the body and/or of a human prosthesis does not exert any pressure”). Determination of what may be an onload or offload threshold (Paragraph 0040, 0045) between these two conditions necessarily requires enacting a activity during calibration in which a load is decreasing at some point (e.g., during walking, running, jumping, etc.). However, Crema does not teach such a calibration phase specifically having a load which decreases from its maximum value to zero in 0.12 to 0.7 seconds.
However, such a load and its variation over time is dependent on the activity itself, whereby Crema’s recitation of various known activities may provide a load which decrease in the requisite time span. For instance, referring to Applicant’s Fig. 1, a walking activity possesses a time span in P1 which produces a maximum load that decreases to zero within 0.12 to 0.7 seconds. Should it not, a slightly faster walking activity may encompass the claimed duration range for how quickly a load decreases from its maximum value.
Re. Claim 25: Chang as modified by Crema teaches the invention according to claim 15. Chang further teaches the invention wherein the sensing cells are distributed along the surface of the insole (Fig. 2).
Re. Claim 26: Chang as modified by Crema teaches the invention according to claim 15. Chang further teaches the invention wherein at least one of the sensing cells is located in the toe part of the insole (Fig. 2).
Re. Claim 27: Chang as modified by Crema teaches the invention according to claim 15. Chang further teaches the invention wherein at least one of the sensing cells is located in the heel part of the insole (Fig. 2).
Re. Claim 28: Chang as modified by Crema teaches the invention according to claim 15. Chang further teaches a non-volatile computer storage medium comprising instructions which, when the program is executed by a controller, cause the controller to carry out the method for determining toe off according to claim 15 (Paragraph 0046: “The status determining unit 310 and the algorithm may be implemented by a programmable logic device, a logic circuit, or a processor/controller with a firmware or software.”).
Claims 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over:
Chang et al. (US 20190336040 A1) (hereinafter – Chang) in view of
Crema et al. (US 20230157578 A1) (disclosed by Applicant) (hereinafter – Crema) in further view of
Lidstone et al., Electronic measurement of plantar contact area during walking using an adaptive thresholding method for Medilogic® pressure-measuring insoles, The Foot, Volume 39, 2019, Pages 1-10, ISSN 0958-2592, https://doi.org/10.1016/j.foot.2019.01.009. (https://www.sciencedirect.com/science/article/pii/S0958259218300993) (disclosed by Applicant) (hereinafter – Lidstone).
Re. Claims 16 and 20: Chang as modified by Crema teaches the invention according to claim 15, but does not teach wherein
the predetermined toe off threshold corresponds to a force ranging between 5 and 40N (as required by claim 16); or
the predetermined heel strike threshold corresponds to a force ranging between 5 and 40N (as required by claim 20).
Lidstone teaches analogous art in the technology of analyzing pressure-measuring insole data (Title; Abstract). Lidstone further teaches the invention wherein the predetermined toe off threshold corresponds to a force ranging between 5 and 40N (Fig. 6: threshold for determining toe-off status may be 40 N; threshold for determining heel contact status may be 40 N).
It would have been obvious to one having skill in the art before the effective filing date to have modified Chang as modified by Crema to utilize a threshold of 40 N for both toe-off and heel-strike determination as taught by Lidstone, the motivation being that Chang teaches comparison to a “critical value” for determining toe-off events (Chang, Paragraph 0039), but does not provide an example of said value, and Lidstone teaches that a suitable value for determining toe-off and heel-strike status from insole sensor data is 40 N.
Examiner’s Note
Claims 17 and 18 are not provided with prior art rejections. The closest prior art of record does not teach:
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.
While Chang identifies periods when the load applied to sensing cells is globally decreasing (i.e., the definition of a discharge period as per Applicant’s Paragraph 0054), Chang does not identify the beginning of a discharge period; additionally, such a determination does not appear to be pertinent to the calculations of Chang.
Claim 18 is dependent upon claim 17, and inherits limitations identified above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/ Primary Examiner, Art Unit 3791