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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/02/26 and 06/28/24 have been considered by the examiner.
Amendment Entered
In response to the amendment filed on July 6, 2026, amended claims 1, 2, 4, 5, 7, and 9-12 have been entered. Claim 6 has been cancelled
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under U.S.C. 101 have been fully considered, but were not persuasive. Examiner argues that nothing from the claims, accompanying specification, and/or drawings suggest that the method steps cannot be practically performed mentally, or using pen/paper. Applicant argues the invention is not an abstract idea. Examiner notes that although the claims include an accelerometer, processor, etc., no physical aspect of the device mentioned in the claims is novel. The claims merely recite data gathering/outputting steps. Applicant further argues the claims integrate into a practical application. Examiner notes that according to MPEP 2106.04(d)(2), the practical application consists of administering a specific medication in response to the collected data. Alternately, a practical application would consist of incorporating additional structure to the device. Lastly, Applicant argues the invention is significantly more based on the additional elements. Examiner notes the components of the invention are all well known in the art and conventional. Therefore, as currently claimed, the invention is not an improvement in technology. Accordingly, Examiner maintains that the identified judicial exception recites a mathematical equation and mental process that is not integrated into a practical application. As such, the 35 USC 101 rejections are maintained. Examiner notes that incorporating a particular treatment based on the results or more structure to the claims would help move prosecution forward. Please see corresponding rejection heading below for more detailed analysis.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered and were not persuasive.
Applicant argues Byun does not teach a two-model structure. Examiner notes that Byun teaches the use of separate models based on specific gait parameters [fig. 2; pg. 6, par. 2]. Therefore, this equates to a two-model structure, when taking into consideration broadest reasonable interpretation.
Applicant also argues Park refers to a roll-angle as merely an intermediate, pre-processing parameter and not a direct input factor. Examiner disagrees and notes that Park teaches the roll angle is used to generate a matrix [par. 7, 34], which is further used to determine walking speed estimation [par. 7], indicating the roll angle is used as an input factor. Therefore, Park teaches the developing of the gait speed estimation model comprises: a first model that performs linear regression analysis comprising roll angle, when taking into consideration broadest reasonable interpretation.
Applicant further argues Soltani does not teach the claimed second model, which “classifies the subjects into a plurality of subgroups based on normalized step length (NSL), and performs the linear regression analysis for each subgroup.”. Examiner notes that Soltani teaches personalized step length models [pg. 660: col. 2, par. 2], which examiner interprets as each being in an individual subgroup. Additionally, Soltani teaches a linear approach to model the step length [pg. 662: col. 1, par. 5]. Therefore, this equates to classifying the subjects into a plurality of subgroups based on normalized step length (NSL), and performs the linear regression analysis for each subgroup, when taking into consideration broadest reasonable interpretation.
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 1-5 and 7-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a method of estimating a gait speed, the method comprising: determining N subjects for gait speed measurement and obtaining personal data of the subjects. Thus, the claim is directed to a process, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
determining N subjects for gait speed measurement and obtaining personal data of the subjects
developing a gait speed estimation model having a plurality of gait factors based on the measured gait data,
calculating gait speeds of the subjects using the gait speed estimation model
wherein the developing of the gait speed estimation model comprises: a first model that performs linear regression analysis comprising a roll angle, a yaw angle, and a body weight as gait factors; and a second model that classifies the subjects into a plurality of subgroups based on normalized step length (NSL), and performs the linear regression analysis for each subgroup
These limitations set forth a judicial exception. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites performing, using an accelerometer worn on a center of body mass of each of the subjects, a clinical assessment and a gait assessment, based on the clinical assessment data, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The assessments do not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the clinical assessments, nor does the method use a particular machine to perform the Abstract Idea. Additionally, claims 4 and 5 recite a gait measurement device and an accelerometer is an inertial measurement unit (IMU) attached to waist of each of the subjects with a predetermined adhesive material. The additional elements do not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the additional elements.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of:
obtaining data regarding a result of performing a clinical assessment on the subjects
obtaining measured gait data by performing a gait assessment on the subjects;
an accelerometer worn on a center of body mass of each of the subjects
The providing and recording steps are well-understood, routine and conventional activities for those in the field of medical diagnostics. Further, the providing and recording steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Additionally, regarding claim 11, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited estimation device is a generic estimation and configured to perform pre-solutional data gathering activity, the interface is configured to perform insignificant extra-solution activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application
Dependent claims 2, 3, and 7-10 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-5 and 7-12 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Byun (“Walking-speed estimation using a single inertial measurement unit for the older adults.” PLoS one 14.12 (2019): e0227075.) and in further view of Park (U.S. Patent Application Document 2020/0149894) and Soltani (“Real-world gait speed estimation using wrist sensor: A personalized approach." IEEE journal of biomedical and health informatics 24.3 (2019): 658-668)
Regarding claim 1, Byun teaches a method of estimating a gait speed [pg. 1, 2, Abstract], the method comprising: determining N subjects for gait speed measurement and obtaining personal data of the subjects [pg. 10: par. 3]; obtaining clinical assessment data regarding a result of performing a clinical assessment on the subjects [pg. 3: par. 4]; obtaining measured gait data by performing, using an accelerometer worn on a center of body mass of each of the subjects [pg. 4: par. 2] a gait assessment on the subjects based on the clinical assessment data [pg. 3: par. 6]; and developing a gait speed estimation model having a plurality of gait factors based on the measured gait data [pg. 4: par. 4], and calculating gait speeds of the subjects using the gait speed estimation mode [pg. 4: par. 4], wherein the developing of the gait speed estimation model comprises: a first model that performs linear regression analysis comprising, yaw angle, and body weight as gait factors [pg. 4: par. 3, 4]; and a second model that classifies the subjects into a plurality of subgroups, and performs the linear regression analysis for each subgroup [fig. 2; Examiner notes fig. 2 shows the use of separate models based on specific gait parameters]
However, Byun does not teach the developing of the gait speed estimation model comprises: a first model that performs linear regression analysis comprising roll angle
Park teaches the developing of the gait speed estimation model comprises: a first model that performs linear regression analysis comprising roll angle [par. 7, 23, 51, 52]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Byun, to incorporate the developing of the gait speed estimation model comprises: a first model that performs linear regression analysis comprising roll angle, for determining the rotation matrix, as evidence by Park [par. 51]
However, Byun does not teach a second model that classifies the subjects into a plurality of subgroups based on normalized step length (NSL)
Soltani teaches a second model that classifies the subjects into a plurality of subgroups based on normalized step length (NSL) [fig. 5; pg. 660: col. 2, par. 2, pg. 662: col. 1, par. 5]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Byun, to incorporate a second model that classifies the subjects into a plurality of subgroups based on normalized step length (NSL), for allowing for a linear model, as it requires less training, as evidence by Soltani [pg. 662: col. 1, par. 5]
Regarding claim 2, Byun further teaches the determining of the N subjects comprises determining, as the N subjects, people in a population after excluding those who have diseases that is likely to affect a gait or whose scores of a performance-oriented mobility assessment are less than a preset score [pg. 3: par. 4]
Regarding claim 3, Byun further teaches the clinical assessment is to diagnose mental disorders according to pre-established diagnostic criteria, determine global severity of cognitive disorders, and evaluate gait and balance abilities by using Performance Oriented Mobility Assessment (POMA) [pg. 3: par. 4]
Regarding claim 4, Byun further teaches the obtaining of the measured gait data comprises obtaining gait characteristic values of each of the subjects by using the accelerometer attached to the center of body weight and an existing gait measurement device [pg. 3: par. 6]
Regarding claim 5, Byun further teaches the accelerometer is an inertial measurement unit (IMU) [pg. 3: par. 6] attached to waist of each of the subjects with a predetermined adhesive material [pg. 4: par. 2], and is a device capable of measuring three-axis acceleration [pg. 3: par. 6]
Regarding claim 8, Byun further teaches statistically analyzing the gait speed estimation model which is developed [Table 5; pg. 10: par. 2]
Regarding claim 9, Byun further teaches calculating a gait speed of each of the subjects for gait speed estimation by using the gait speed estimation model which is developed [fig. 2; pg. 6: par. 2]
Regarding claim 10, Byun further teaches the calculating of the gait speed comprises obtaining data regarding an age, a weight, and a foot length of each of the subjects for gait speed estimation by receiving an input, obtaining a cadence, a vertical height displacement (VHD), and a yaw angle from an inertial measurement unit (IMU), and calculating the gait speed by substituting obtained values into the gait speed estimation model [pg. 4: par. 4; Examiner notes cadence, VHD and inertial measurements are obtained to be used in a gait estimation model]
However, Byun does not teach obtaining a roll angle
Park teaches obtaining a roll angle [par. 7, 23, 51, 52]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Byun, to incorporate obtaining a roll angle, for determining the rotation matrix, as evidence by Park [par. 51]
Regarding claim 11, Byun teaches a device for estimating a gait speed [pg. 1, 2, Abstract], the device comprising: a processor; a memory [pg. 4: par. 1, pg. 5: par. 3]; wherein the processor is configured to determine N subjects for gait speed measurement and obtain personal data of the subjects [pg. 10: par. 3]; perform a clinical assessment on the subjects [pg. 3: par. 4]; obtain measured gait data by performing, using an accelerometer worn on a center of body mass of each of the subjects [pg. 4: par. 2], a gait assessment on the subjects [pg. 3: par. 6]; develop a gait speed estimation model having a plurality of gait factors based on the measured gait data [pg. 4: par. 4], calculate gait speeds of the subjects using the gait speed estimation model, [pg. 4: par. 4] wherein the developing of the gait speed estimation model comprises: a first model that performs linear regression analysis comprising, yaw angle, and body weight as gait factors [pg. 4: par. 3, 4]; and a second model that classifies the subjects into a plurality of subgroups, and performs the linear regression analysis for each subgroup [fig. 2; Examiner notes fig. 2 shows the use of separate models based on specific gait parameters]
However, Byun does not teach the developing of the gait speed estimation model comprises: a first model that performs linear regression analysis comprising roll angle
Park teaches the developing of the gait speed estimation model comprises: a first model that performs linear regression analysis comprising roll angle [par. 7, 23, 51, 52]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Byun, to incorporate the developing of the gait speed estimation model comprises: a first model that performs linear regression analysis comprising roll angle, for determining the rotation matrix, as evidence by Park [par. 51]
However, Byun does not teach a second model that classifies the subjects into a plurality of subgroups based on normalized step length (NSL)
Soltani teaches a second model that classifies the subjects into a plurality of subgroups based on normalized step length (NSL) [fig. 5; pg. 660: col. 2, par. 2, pg. 662: col. 1, par. 5]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Byun, to incorporate a second model that classifies the subjects into a plurality of subgroups based on normalized step length (NSL), for allowing for a linear model, as it requires less training, as evidence by Soltani [pg. 662: col. 1, par. 5]
Regarding claim 12, Byun further teaches a computer-readable recording medium having recorded thereon a program for causing a computer to execute the method of claim 1 [pg. 4: par. 1, pg. 5: par. 3]
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Byun, Park, and Soltani and in further view of Chang (U.S. Patent Application Document 2019/0283247)
Regarding claim 7, Byun, Park and Soltani teach a method of estimating a gait speed
Soltani teaches an equation for calculating step length [pg. 662: col. 1, par. 3-5]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Byun and Park, to incorporate an equation for calculating step length, for allowing for a linear model, as it requires less training, as evidence by Soltani [pg. 662: col. 1, par. 5]
However, Byun, Park and Soltani do not teach a coefficient of leg bending, and an angular displacement
Chang teaches a coefficient of leg bending, and an angular displacement for calculating gait biomechanical parameters [par. 235]
Although Chang does not explicitly teach the equation claimed, it would be obvious to one having ordinary skill in the art when the invention was filed since Chang also suggests the use of all the components in the equation to determine a gait biomechanical parameter [232, 235]. Therefore, incorporating the claimed equation to calculate the gait parameter of step length would only involve routine skill in the art.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8 AM - 5 PM.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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