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 1 is objected to because of the following informalities: the phrase “the direction” in lines 25-26 should be amended to read –the initial direction--. 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 1-4 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 recites the limitation "the subject" in line 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the wobble" in line 23. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the upper body" in line 23. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the body frame" in line 25. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the initial direction" in line 25. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the cross product" in line 26. There is insufficient antecedent basis for this limitation in the claim.
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
STEP 1: claim 1 recites a system to determine quantitative gait score and claim 5 recites a series of steps or acts to determine quantitative gait score the claims are directed to a process and a product. Thus, which are ones of the statutory categories of invention.
STEP 2A PRONG ONE: The claim(s) recite(s) specific limitations/method steps of: output signals indicative of movement of the subject along one or any combination of an x-axis, a y-axis, and a z-axis; output signals indicative of variations in position of the subject in a space defined by the x-axis, the y-axis, and the z-axis; output signals indicative of angular velocity of the subject around one or any combination of the x-axis, the y-axis, and the z-axis; receive the output signals and analyse the signals to determine the quantitative gait score for the subject from any combination of the gait metric, wherein the WORM Score measures the wobble of the upper body of the subject as measured from a single-point inertial measurement unit (IMU) with a chest-based attachment with the body frame x-axis aligned with the initial direction of walk, the z-axis aligned with the direction of measured acceleration due to gravity, and the y-axis calculated as the cross product of the z-axis and the x-axis. And claim 5 recite the method steps obtaining the gait velocity, step length asymmetry and step time asymmetry for the subject; assigning a score to each of the gait velocity, step length asymmetry and step time asymmetry.
This limitation recites a mental process and/or mathematical concept, because the claimed limitation describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). For example, a caregiver can receive the measurements from the accelerometer, magnetometer and gyroscope and calculate the WORM score and/or obtain the gait velocity using mathematical formulas. Thus, the claims are drawn to a Mental Process and/or mathematical concept, which is an Abstract Idea. Examiner also notes that nothing from the claims suggests that the limitations cannot be practically performed by a human or using simple pen/paper.
STEP 2A PRONG TWO: This judicial exception is not integrated into a practical application because claim 1 recites the combination of additional elements/method steps of: A) accelerometer, B) magnetometer, C) gyroscope and D) processor. And claim 5 does not recite any additional elements/method steps.
Accordingly, the combination of the additional element/step A-C does not integrate the exception into a practical application of the exception because the use of inertial sensors is merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering (see MPEP 2106.05(g)).
Element D does not integrate the exception into a practical application of the exception because the use of a controller/processor amounts to merely using a computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Accordingly, each of the additional elements or a combination of the additional elements do not integrate the abstract idea into a practical application as they fail to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
STEP 2B: Claim 1 does/do not include additional structural elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements, such as, A) accelerometer, B) magnetometer, C) gyroscope and D) processor. And claim 5 does not recite any additional elements/method steps.
The combination of elements A-C of inertial sensors does not amount to significantly more than the judicial exception because the use of inertial sensors is merely adding insignificant extra-solution activity to the judicial exception, e.g. using those elements for mere data gathering (see MPEP 2106.05(g)). Furthermore, the elements A-C are well-understood, routine, and conventional, as is evidenced by Guimaraes et al (WO 2018/127506 A1), Wen et al (US 2020/0170515 A1), Wang et al (US 2017/0273601 A1), which all show inertial sensors and a processor as claimed in claim 1 evidencing that these elements are well-understood, route, and conventional in the art.
Element D does not amount to significantly more than the judicial exception because adding a controller/processor is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g. a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine, and conventional activities previously known in the industry (see MPEP 2106.05(d)II).
Accordingly, the additional elements individual or in co do not integrate the abstract idea into a practical application as they fail to recite additional element(s) 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.
When viewed alone or in combination, the limitations of claims 1-18 merely instruct the practitioner to implement the concept of collecting data with routine, conventional activity specified at a high level of generality in a particular technological environment. The inventive concept cannot be furnished by the abstract idea; instead, the application must provide something inventive, beyond mere “well-understood, routine, conventional activity” (Genetic Technologies Limited v. Merial L.L.C.). The additional elements of independent claims when viewed alone or as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea and does not amount to significantly more than the abstract idea itself. In other words, this claim merely applies an abstract idea to a computer and does not (i) improve the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
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.
Claim(s) 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guimaraes et al (WO 2018/127506 A1).
As to claim 5, Guimaraes discloses a method for determining a quantitative gait score for a subject (determining fall risk value from gait parameters, Abstract, Figs. la-lc, 2-15; a fall sensor (4); fall risk value (10)/(12); a risk calculator (6)), the method comprising:
a) obtaining a gait velocity and daily step count for the subject, assigning a first numerical value to a walking speed, assigning a second numerical value to the daily step count and summing the first and second numerical values to provide the quantitative gait score; wherein if the walking speed is above a threshold walking speed, the first numerical value is a first maximum numerical value; or if the walking speed is below the threshold walking speed, the walking speed is divided by the threshold walking speed to provide a product, and the product is multiplied by the maximum numerical value to provide the first numerical value; and wherein if the daily step count is above a threshold step count, the second numerical value is a second maximum numerical value; or if the daily step count is below the threshold daily step count, the daily step count is divided by the threshold daily step count to provide a second product and the second product is multiplied by the second maximum numerical value to provide the second numerical value; or
b) obtaining a step cadence and stride length for the subject and assigning a first numerical value to the step cadence, assigning a second numerical value to the stride length and summing the first and second numerical values to provide the quantitative gait score; wherein if the step cadence is below a first threshold cadence, the first numerical value is a first minimum numerical value; or if the step cadence is above a second threshold cadence, the first numerical value is a first maximum numerical value; or if the step cadence is between the first and second threshold cadences, the first threshold step cadence is subtracted from the step cadence and the difference between the step cadence and the first threshold step cadence is the first numerical value; and wherein if the stride length is below a first threshold stride length, the second numerical value is a second minimum numerical value; or if the stride-length is above a second threshold stride length, the second numerical value is a second maximum numerical value; or if the stride-length is between the first and second threshold stride-lengths, the second numerical value is calculated by multiplying the stride-length by a value equal to the value of the second threshold stride-length to provide a product and then subtracting half of the value from the product to provide the second numerical value; or
c) obtaining the gait velocity, step length asymmetry and step time asymmetry for the subject (processor 26b determines fall risk value based on gait velocity, step length (p. 8, ln. 20-22), gait speed variability ("Unusual/higher acceleration" - p. 8, n, 20-30, "set of parameters 14", p. 9, In. 4 -p. 13, In. 21);
assigning a score to each of the gait velocity, step length asymmetry and step time asymmetry (measured value of each fall risk factor, such as, gait velocity, step length, gait speed variability ("Unusual/higher acceleration) (p. 8, ln. 20-22, p. 9, In. 4 -p. 13, In. 21, fig.1c and fig.5), and
summing the scores (summing fall risk factors as in equation 2 in fig.5, "a first risk value" (10) "a second risk value" (12) and "motion 8", p.8-p.10, p. 12, ln.12-p. 13, In. 6, all fall risk factors are summed in risk factor calculator 6, fig.1c, 2b).
Response to Arguments
Applicant’s arguments with respect to claim objections, 112 rejections, double patenting rejection and 102 rejection for claim 1 have been fully considered and are persuasive. The claim objections, 112 rejections, double patenting rejection and 102 rejection for claim 1 have been withdrawn.
Applicant's arguments filed regarding 101 for claims 1 and 5 have been fully considered but they are not persuasive, because claims 1 and 5 recite a mental recites and/or mathematical concept that can be performed by a human, or using simple pen/paper. The claims only recite obtaining signals from different inertial sensors and calculating WORM score and/or gait velocity. The claims does not recite additional elements or a combination of the additional elements do not integrate the abstract idea into a practical application as they fail to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception.
Applicant's arguments filed regarding Guimaraes does not disclose the percentile-based CMOS scoring methodology of amended claim 5 (see arguments page 12) have been fully considered but they are not persuasive, because claim 5 is not amended, claim 5 filed on 09/28/2026 (see arguments pages 3-5) recite the same limitations as claim 5 filed on 02/23/2024, and since there are no arguments regarding the applied art for the previous presented claim 5 limitations, the same art rejection is applied therein to current claim 5.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAY A ABOUELELA whose telephone number is (571)270-7917. The examiner can normally be reached 8-5.
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
