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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, drawn to a method of monitoring gait quality of an individual, in the reply filed on 5/27/26 is acknowledged.
Claims 9-19 (now canceled) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/27/26.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The accompanying information disclosure statement (IDS) submission(s) is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Objections
Claim 8 is objected to because of the following informalities: the positive recitation of “wherein spatiotemporal metrics” in line 1 should apparently read “wherein the spatiotemporal metrics”, or the like. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-8 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.
The term “smart insoles” in claim 1 is a relative term which renders the claim indefinite. The term “smart insoles” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The scope of the claim is indeterminate with respect to what may be explicitly, implicitly, inherently, and/or implicitly required and/or excluded for the scope of the claimed invention and/or the degree or to what degree the insoles are required to be “smart”. Depending claims 2-8 inherit and do not remedy the indefiniteness.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more, wherein the abstract idea comprises a mental process.
For independent claim 1, the claim(s) recite(s) a process of training a model comprising an artificial neural network, using the model to identify ambulatory data, segmenting the data, analyzing the segments related only to ambulatory activity to characterize a gait event with spatiotemporal metrics, classifying the spatiotemporal metrics to produce a score, computing a change in score from previous, and providing a notification of improvement or degradation of gait quality based on the change.
As broadly as claimed these steps may be reasonably considered as the judicial exception of a mental process performable within the human mind, including by observation, evaluation, judgement and opinion forming, or by a human using pen and paper (see MPEP 2106.04(a)(2) subsection III). For example, at least, these limitations are nothing more than a trained medical professional capturing ambulatory data, printing it out, and using the data to mentally extract, segment, classify, and/or learn from data features to determine a change in gait quality of an individual.
This judicial exception is not integrated into a practical application because the process steps as broadly as claimed are not tied to nor required to be performed, executed, or programmed on a special purpose computer. Further, the judicial exception is not even required to be performed on or tied to a mere generic processing device, controller, or the like. The positive recitation of “at least one artificial neural network” may fairly and reasonably be interpreted to merely include a trained medical professional’s mental process of analyzing ambulation data and/or metrics.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the preliminary step(s) of data gathering from insole sensors is/are well-known, routine and conventional amounting to insignificant data gathering as pre-solution activity.
Depending claims 2-8 inherit and do not remedy the non-statutory deficiency noted above. Despite further specifying steps relating to the sensor data, the model(s), specifics of the measured individual, and spatiotemporal metric grouping(s), these steps do not integrate into a practical application nor do they add additional elements amounting to significantly more than the abstract idea.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chatzaki et al. (5/20/25 IDS NPL Cite No 27: "Chatzaki C, Skaramagkas V, Tachos N, Christodoulakis G, Maniadi E, Kefalopoulou Z, et al. The Smart-Insole Dataset: Gait Analysis Using Wearable Sensors with a Focus on Elderly and Parkinson's Patients. Sensors. 2021 Apr 16;21(8):1-22.", and hereinafter Chatzaki).
For claim 1, Chatzaki discloses a method for monitoring gait quality of an individual (Figs 1-9) (Tbls 1-9) (Pgs 1-22), comprising the steps of inter alia:
training one or more human activity recognition (HAR) models, each HAR model comprising at least one artificial neural network (ANN) trained on a general or phenotype-specific population (Tables 2 and 5) (Section 2 The Smart-Insole Dataset, pgs 2-9, especially Section 2.4 Smart Insole Dataset Annotation);
using the one or more HAR models to identify one or more ambulatory activities in sensor data (Table 2) (Section 2 The Smart-Insole Dataset, pgs 2-9) measured by one or more sensors from a pair of smart insoles worn by the individual (Fig 2);
segmenting said data into one or more segments in accordance with the identified ambulatory activities (Table 2) (Section 2 The Smart-Insole Dataset, pgs 2-9);
analyzing, via a gait detection algorithm, segments only related to an ambulatory activity to characterize a gait event with one or more spatiotemporal metrics (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results);
classifying, via one or more machine learning algorithms, the spatiotemporal metrics to produce a gait quality composite index (CI) score (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results);
computing a change between the CI score relative to a previously produced CI score (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results); and
provide a notification of an improvement or degradation in said gait quality based on said change (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results).
For claim 2, Chatzaki discloses the method of claim 1, wherein the sensor data comprises pressure data acquired by one or more pressure sensors (Fig 2) (Pgs 1-4), and tri-axial inertial measurement unit data acquired by one or more inertial measurement units (IMU) (Fig 2) (Pgs 1-4).
For claim 3, Chatzaki discloses the method of claim 1, wherein the ANN of each HAR model comprises four-fully connected dense layers with rectified linear unit activation functions for non-linear transformation (Table 5) (Section 2.4 Smart Insole Dataset Annotation).
For claim 4, Chatzaki discloses the method of claim 1, wherein said phenotype-specific population comprises at least one of: healthy people, or people with a designated disease affecting gait (Table 2).
For claim 5, Chatzaki discloses the method of claim 4, wherein said people with a designated disease affecting gait include at least one of: people with multiple sclerosis (PwMS) or people with Parkinson's disease (PwPD) (Table 2).
For claim 6, Chatzaki discloses the method of claim 1, wherein the one or more machine learning models comprise at least one support vector machines (SVMs) (Table 5) (Section 2.4 Smart Insole Dataset Annotation).
For claim 7, Chatzaki discloses the method of claim 1, wherein the spatiotemporal metrics are grouped, before said classifying, into four categories: core, pace, percentage, and asymmetry (Tables 6-9) (Figs 5-9).
For claim 8, Chatzaki discloses the method of claim 7, wherein spatiotemporal metrics grouped into said asymmetry category comprises at least one of: a stride time/length/velocity asymmetry, stance time/percent asymmetry, swing time/percent asymmetry, single support time/percent asymmetry or double support time/percent asymmetry (Tables 6-9) (Figs 5-9).
Conclusion
The cited prior art made of record on the accompanying PTO-892 and not relied upon is considered pertinent to applicant's disclosure, relating to means for providing gait evaluation of an individual based on sensed gait parameters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey G. Hoekstra whose telephone number is (571)272-7232. The examiner can normally be reached Monday through Thursday from 5am-3pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A. Marmor II can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jeffrey G. Hoekstra
Primary Examiner
Art Unit 3791
/JEFFREY G. HOEKSTRA/ Primary Examiner, Art Unit 3791
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