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 the process of evaluating a user’s gait, in the reply filed on 4/8/26 is acknowledged.
Claims 14-20 (now cancelled) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 4/8/26.
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 and Third-Party Submission
The accompanying information disclosure statement (IDS) and Third-Party submission(s) is/are in compliance with the provisions of 37 CFR 1.97 and 35 U.S.C. 122(e). 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 6 is objected to because of the following informalities: the positive recitation of “the one or more sensor types” should apparently read “the one or more types of sensors” for consistency and antecedent. 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 1-13 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.
Claim 1 positively recites “via one or more algorithms” in line 7. Claim 1 also positively recites “via one or more algorithms” in line 12. The scope of the claim is indeterminate with respect to if the line 12 recitation is lacking antecedent basis, i.e. if “via the one or more algorithms” was intended to be recited, and/or if the instead the algorithms are independent and distinct. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention because it is ambiguous which and how many “one or more algorithms” may and/or may not be required or excluded explicitly, implicitly, inherently, or inferentially from the scope of the claim. Depending claims 2-13 inherit and do not remedy the indefiniteness.
Claim 4, depending directly from claim 1, positively recites “via one or more algorithms” in lines 1-2, suffering similar and escalating the indefiniteness as set forth hereinabove. Depending claim 5 inherits and does not remedy the indefiniteness.
Claim 7 positively recites the limitation "the parameters" in line 1. There is insufficient antecedent basis for this limitation in the claim. In the interest of compact prosecution, the examiner respectfully notes Applicant may have intended to positively recite “the gait parameters” consistent with claim 1.
Claim 8 positively recites the limitation "said gait metrics" in line 2. There is insufficient antecedent basis for this limitation in the claim. Depending claim 10 inherits and does not remedy the indefiniteness.
The term “recommendations for improvements” in claim 10 is a relative term which renders the claim indefinite. The term “improvements” 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. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention because it is ambiguous what may and/or may not be required or excluded explicitly, implicitly, inherently, or inferentially from the scope of the claim to be considered “improvements” and/or to what degree of “improvement” may be necessary.
Claim 11 positively recites the limitation "a patient’s" in line 3. The scope of the claim is indeterminate with respect to the relationship between and/or amongst “a patient” and “a user”. Consistent with the disclosure it appears they may be only the same, but per the antecedent they appear distinct. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention because it is ambiguous what may and/or may not be required or excluded explicitly, implicitly, inherently, or inferentially from the scope of the claim to be considered “a patient” in addition to “the user”.
Claim 11 positively recites the limitation "the patient’s gait" in line 4. The scope of the claim is indeterminate with respect to the relationship between and/or amongst “the patient’s gait” and “the user’s gait”. Consistent with the disclosure it appears they may be only the same, but per the antecedent they appear distinct. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention because it is ambiguous what may and/or may not be required or excluded explicitly, implicitly, inherently, or inferentially from the scope of the claim to be considered “the patient’s gait”.
Claim 12 positively recites the limitation "the individual " in line 3. The scope of the claim is indeterminate with respect to the relationship between and/or amongst “the individual” and “the user”. Consistent with the disclosure it appears they may be only the same, but per the antecedent they appear distinct. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention because it is ambiguous what may and/or may not be required or excluded explicitly, implicitly, inherently, or inferentially from the scope of the claim to be considered “the individual” in addition to “the user”.
The term “immediately following an injury” in claim 12 is a relative term which renders the claim indefinite. The term “immediately” 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. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention because there are infinite possibilities and it is ambiguous what may and/or may not be required or excluded explicitly, implicitly, inherently, or inferentially from the scope of the claim to be considered “immediately” and/or what degree of “immediate”-ness may be necessary.
The term “an effectiveness” in claim 12 is a relative term which renders the claim indefinite. The term “effectiveness” 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. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention because it is ambiguous what may and/or may not be required or excluded explicitly, implicitly, inherently, or inferentially from the scope of the claim to be considered “effectiveness” and/or to what degree of “effectiveness” may be necessary.
The term “optimized” in claim 13 is a relative term which renders the claim indefinite. The term “optimized” 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. In light of the instant Specification one of ordinary skill in the art would not be apprised of the metes and bounds of the claimed invention because it is ambiguous what may and/or may not be required or excluded explicitly, implicitly, inherently, or inferentially from the scope of the claim to be considered “optimized” and/or to what degree of “optimization” may be necessary.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7 and 8 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7, depending directly from claim 1, recites “…the (gait) parameters comprise gait metrics from…” while claim 1 recites “…processing the gait-related segmented data, via one or more algorithms stored in the memory of the computing device, to determine one or more of: gait patterns associated with the segmented data; gait parameters associated with the segmented data; gait phenotypes associated with the segmented data…”.
Similarly, claim 8, depending directly from claim 1, recites “…the gait patterns comprise a gait signature…” while claim 1 recites “…processing the gait-related segmented data, via one or more algorithms stored in the memory of the computing device, to determine one or more of: gait patterns associated with the segmented data; gait parameters associated with the segmented data; gait phenotypes associated with the segmented data…”.
Claims 7 and 8 fail to further limit claim 1 in multiple instances when the “one or more” determined and processed gait-related segmented data are not the referenced gait patterns or gait parameters from claim 1. For example at least, claims 7 and 8 fail to further limit claim 1 when the processed gait-related segmented data is determined with only gait phenotypes.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chatzaki et al. (6/27/24 IDS NPL Cite No 14: “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 computer implemented method for evaluating a user's gait (Figs 1-9) (Tbls 1-9) (Pgs 1-22), the method comprising inter alia:
receiving, by a computing device having a memory and a processor (Section 2 The Smart-Insole Dataset, pgs 2-9), from a pair of smart insoles (Fig 2) communicatively coupled to the computing device and worn by the user, data measured by one or more types of sensors (Fig 2);
segmenting, by the processor of the computing device, the data into gait-related segmented data processor (Table 2) (Section 2 The Smart-Insole Dataset, pgs 2-9) comprising one or more of: gait cycle segmentation or activity type (Table 2) (Section 2 The Smart-Insole Dataset, pgs 2-9);
processing the gait-related segmented data (Tables 3-5) (Section 2.4 Smart Insole Datset Annotation), via one or more algorithms stored in the memory of the computing device, to determine one or more of: gait patterns associated with the segmented data (Tables 3-5) (Section 2.4 Smart Insole Datset Annotation); gait parameters associated with the segmented data; (Tables 3-5) (Section 2.4 Smart Insole Datset Annotation) gait phenotypes associated with the segmented data (Tables 3-5) (Section 2.4 Smart Insole Datset Annotation);
calculating, via one or more algorithms a composite gait quality score (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results), based on a combination and interaction of at least two of: the segmented data, the gait patterns, the gait parameters, and the gait phenotypes (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results).
For claim 2, Chatzaki discloses the computer implemented method of claim 1, further comprising: displaying, on a graphical user interface of a user device communicatively coupled to the computing device, the composite gait quality score (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results).
For claim 3, Chatzaki disclises the computer implemented method of claim 2, wherein the graphical user interface (Page 19) comprises one or more of: a clinician portal and a patient smart phone app; wherein the clinician portal and patient app are further configured to receive raw and processed patient data from the system (Page 19).
For claim 4, Chatzaki discloses the computer implemented method of claim 1, wherein determining, via one or more algorithms a composite movement quality score, further comprises: training a support vector machine (SVM), of the one or more algorithms, to classify walking data associated with a plurality of participants in one or more groups (Table 5) (Section 2.4 Smart Insole Datset Annotation).
For claim 5, Chatzaki discloses the computer implemented method of claim 4, wherein training the SVM comprises a feature selection step to remove redundant features and identify one or more designated metrics for evaluating gait in a specific patient population (Table 5) (Section 2.4 Smart Insole Datset Annotation).
For claim 6, Chatzaki discloses the computer implemented method of claim 1, wherein the one or more sensor types comprise at least one of: an accelerometer, a gyroscope, a magnetometer, a pressure sensor, and a temperature sensor (Fig 2) (Pgs 1-4).
For claim 7, Chatzaki discloses the computer implemented method of claim 1, wherein the parameters comprise gait metrics from said heel strike, foot on floor, heel raise and toe off data (Table 4).
For claim 8, Chatzaki discloses the computer implemented method of claim 1, wherein the gait patterns comprise a gait signature of the individual from said gait metrics (Tables 3-5) (Section 2.4 Smart Insole Datset Annotation).
For claim 9, Chatzaki discloses the computer implemented method of claim 1, wherein determining the composite gait quality score further comprises: determining a progression over time of the combination (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results) and interaction of at least two of: the segmented data, the gait patterns, the gait parameters, and the gait phenotypes (Pgs 18-19) (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results).
For claim 10, Chatzaki discloses the computer implemented method of claim 8, wherein determining the composite gait quality score further comprises: an assessment of the user's gait signature and recommendations for improvement (Pgs 18-19) (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results)s.
For claim 11, Chatzaki discloses the computer implemented method of claim 1, wherein determining the composite gait quality score further comprises: an assessment of a change in a patient’s neurological disease condition based on measured changes to the patient’s gait (Pgs 18-19) (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results).
For claim 12, Chatzaki discloses the computer implemented method of claim 1, wherein determining the composite gait quality score further comprises: determining a baseline objective walking quality score of the individual obtained prior to start of a rehabilitation program or immediately following an injury; determining, based on the identified changes in gait pattern, an effectiveness of said rehabilitation program (Pgs 18-19) (Tables 6-9) (Figs 5-9) (Equations 2-16) (Section 3 Gait Analysis Methodology and Section 4 Results).
For claim 13, Chatzaki discloses the computer-implemented method of claim 1, wherein said processing is optimized, by the processor, based on a type of assistive device being used by the user (Tables 3-5) (Section 2.4 Smart Insole Datset Annotation).
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 evaluating gait.
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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