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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/27/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “ground” in the last line should be amended to read –the ground--. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: the phrase “optionally” in line 2 should be cancelled, as it takes little and/or no patentable weight. Appropriate correction is required.
Claims 4 and 6 objected to because of the following informalities: the phrase “SMoS calculated from gait velocity and daily step count” in line 3 should be amended to read -- Simplified Mobility Score (SMoS) calculated from the gait velocity and the daily step count--. Appropriate correction is required.
Claims 4 and 6 objected to because of the following informalities: the phrase “iMoS calculated from step cadence and stride length” in line 4 should be amended to read --Immediate Mobility Score (iMoS) calculated from the step cadence and the stride length--. Appropriate correction is required.
Claims 4 and 6 objected to because of the following informalities: the phrase “Gsi calculated from gait velocity or gait velocity variation, step length asymmetry and step time asymmetry” in lines 5-7 should be amended to read -- Gait Stability Index (Gsi) calculated from the gait velocity or the gait velocity variation, the step length asymmetry and the step time asymmetry--. Appropriate correction is required.
Claims 4 and 6 objected to because of the following informalities: the phrase “a) daily step count; b) one or more of gait velocity, step length, stride length, and cadence; c) one or more of step length asymmetry, step time asymmetry, single support time variability; and d) walking orientation randomness metric (WORM Score)” in lines 7-13 should be amended to read -- a) the daily step count; b) the one or more of gait velocity, the step length, the stride length, and the cadence; c) the one or more of step length asymmetry, the step time asymmetry, the single support time variability; and d) the walking orientation randomness metric (WORM Score)--. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: the phrase “the threshold daily step count” in lines 16 and 17 should be amended to read –the threshold step count--. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the phrase “cadence” in line 2 should be amended to read –step cadence--. Appropriate correction is required.
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 recite 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: an accelerometer configured to output signals, a magnetometer configured to output; a gyroscope configured to output signals, wherein the y-axis being a horizontal axis to the ground directed laterally of the subject's body; and the z-axis is vertical axis to ground. 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, because the claimed limitation describes 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.
STEP 2A PRONG TWO: This judicial exception is not integrated into a practical application because claim 1 recite the combination of additional elements/method steps of: a processor configured to receive the output signals and analyze the signals to determine the quantitative gait score for the subject from any combination of the gait metrics. And claim 5 recite summing the scores.
Accordingly, this additional element/step does not integrate the abstract idea into a practical application because the claim limitations fail 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.
STEP 2B: The claim(s) 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 processor configured to receive the output signals and analyze the signals to determine the quantitative gait score for the subject from any combination of the gait metrics, and summing the scores, but do(es) not include additional elements that are sufficient to amount to significantly more than the judicial exception because these structural elements are generically claimed to enable the collection of data by performing the basic functions of: (i) receiving, processing, and providing/displaying data, and (ii) automating mental tasks. The courts have recognized these functions to be well‐understood, routine, and conventional functions when claimed in a merely generic manner. Merely adding hardware that performs “‘well understood, routine, conventional activities’ previously known to the industry” will not make claims patent-eligible (In re TLI Communications LLC). As such, the recitation of these additional limitations in claims 2-4 and 6-18 does not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment and represent insignificant extra-solution activity. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as a sensor and use of a processor does 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)). Thus, the claimed invention does not amount to significantly more than the Abstract Idea.
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 § 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.
Claims 17 and 18 recite the limitation “assigned to it” in line 2, this limitation is not defined by the claims, which renders the claims indefinite. One with ordinary skill in the art would not be able to know the claimed “it” refers to which parameter. The scope of the claim remains indeterminate because of the claimed “it”
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) 1-3 and 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 1, Guimaraes discloses a system for determining a quantitative gait score (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 system comprising:
a) an accelerometer configured to output signals indicative of movement of the subject along one or any combination of an x-axis, a y-axis, and a z-axis (accelerometer 24c, p.13, ln.8-15, p.19, ln.10-20, and 3-axial accelerometer, p.16, ln.10, fig.2b and 4);
b) a magnetometer configured to 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 (magnetometer 24d, p.13, ln.8-15, p.19, ln.10-20, fig.2b and 4);
c) a gyroscope configured to 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 (gyroscope 24a, p.13, ln.8-15, p.19, ln.10-20, fig.2b and 4); and
d) a processor (processor 26b, p.13, ln.8-15, p.19, ln.10-20, fig.2b and 4) configured to receive the output signals and analyze the signals to determine the quantitative gait score for the subject (processor 26b having a risk determiner 16 configured to receive the output and analyze the signals to determine for the subject one or any combination of gait metrics 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) from any combination of the gait metrics: i) daily step count; ii) step cadence; iii) step time; iv) step time asymmetry; v) step length; vi) stride length; vii) step length asymmetry; viii) single support time variability; ix) walking orientation randomness metric (WORM Score); and x) gait velocity or gait velocity variation;
wherein the x-axis is a horizontal axis to the ground directed forward of the subject's body; the y-axis being a horizontal axis to the ground directed laterally of the subject's body; and the z-axis is vertical axis to ground (p. 12, In. 12-p.13, In. 6, p. 13, In. 8, p.16, ln.10, p.19, ln.10-20, as best seen in fig.2b and 4).
As to claim 2, Guimaraes discloses the system, wherein the accelerometer, magnetometer, gyroscope, and optionally the processor are in a sensor unit adapted to be disposed on the subject (accelerometer 24c, magnetometer 24d, gyroscope 24 and processor 26b are all in one unit/device 20, wherein device 20 is a wearable device by the user, page 13 and page 15, as best seen in fig.2b, 4, 6 and 10).
As to claim 3, Guimaraes discloses the system, wherein the processor is configured to determine the quantitative gait score from any two or more-gait metrics i-x (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).
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).
Double Patenting
The statutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A non-statutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a non-statutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4 are provisionally rejected on the ground of statutory double patenting as being unpatentable over claims 1-8 of U.S pending application No. 18/578714. Although the claims at issue are not identical, they are not patentably distinct from each other because the U.S pending application and the instance application are claiming a common subject matter including: a system comprising: a) an accelerometer configured to output signals indicative of movement of the subject along one or any combination of an x-axis, a y-axis, and a z-axis b) a magnetometer configured to 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; and c) a gyroscope configured to 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; d) a processor configured to receive the output and analyze the signals to determine for the subject one or any combination of gait metrics: i. stride time; ii. stride time variability; iii. stride cadence; iv. step time asymmetry; v. stride length; vi. stride length variability; vii. stride length asymmetry; viii. gait velocity; ix. gait speed variability; and x. walking orientation randomness metric (WORM) wherein the x-axis is a horizontal axis to the ground directed forward of the subject's body; the y-axis being a horizontal axis to the ground directed laterally of the subject's body; and the z-axis is vertical axis to ground.
This is a provisional statutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
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/MAY A ABOUELELA/Primary Examiner, Art Unit 3791