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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “bioimpedance measurement system 300” [Applicant’s Specification ¶¶0042, 0046]; “computing device 200” [Applicant’s Specification ¶0044].
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 11 and 13 is/are objected to because of the following informalities:
Claim 11 should read “upon determining mid-activity changes in the portion of the body using DFBIA during the dynamic activity” [lines 3-4], based on the language of claim 10, from which claim 11 depends.
Claim 13 should read “a thigh of [[a]] the user” [lines 1-2].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 3, 19-20, and those dependent therefrom is/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.
Claims 3 and 19 each recite “wherein the first frequency is about 5kHz and the second frequency is about 100kHz” [lines 1-2 in each claim]. The term “about” is a relative term which renders the claim indefinite. The term “about” 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.
Claim 20 recites the limitation “wherein the controller is further configured to determine, based at least in part on the measured bioimpedances at the first and second times, a change in a biomechanical property of the portion of the body of the user between the first time and the second time, by calculating a muscle fatigue score” [lines 1-4, see emphasized portion], which is considered indefinite, as claim 17 [from which claim 20 depends from] recites “a controller configured to assess musculoskeletal health of the portion of the body of the user according to the method of claim 1” [line 7-8], such that the controller of claim 17 is configured to perform the determining step of claim 1 [lines 6-8], which defines “a change in a biomechanical property of the portion of the body of the user between the first time and the second time” [lines 7-8 of claim 1]. As such, it is unclear whether “a change in a biomechanical property of the portion of the body of the user between the first time and the second time” as recited in claim 20 is meant to define a new or separate change in the biomechanical property; or whether “a change in a biomechanical property of the portion of the body of the user between the first time and the second time” as recited in claim 20 is meant to further limit the previously defined change in the biomechanical property of claim 1 [the Examiner notes that claims 22 and 26 recite language that further limit the biomechanical property of claim 1]. For examination purposes, the Examiner has interpreted the indefinite limitation of claim 20 to further limit the previously defined change in the biomechanical property of claim 1.
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.
Claim(s) 1-6, 10-13, 15, 17-22, and 26-28 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Representative claim(s) 1 [representing all independent claims] recite(s):
A method of assessing musculoskeletal health comprising:
measuring a bioimpedance across a portion of a body of a user at a first time;
measuring the bioimpedance across the portion of the body of the user at a second time; and
determining, based at least in part on the measured bioimpedances at the first and second times, a change in a biomechanical property of the portion of the body of the user between the first time and the second time.
(Emphasis added: abstract idea, additional element)
Step 2A Prong 1
Representative claim(s) 1 recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper:
“determining, based at least in part on the measured bioimpedances at the first and second times, a change in a biomechanical property of the portion of the body of the user between the first time and the second time” – may be performed by merely observing at least a limited amount of known or previously collected data and drawing mental conclusions therefrom under no particular time constraints [Applicant’s Specification ¶0050]
If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extra-solutionary activity (and otherwise generic computer elements) then the claim falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Step 2A Prong 1 of the Mayo framework as set forth in the 2019 PEG.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) [i.e., “determining, based at least in part on the measured bioimpedances at the first and second times, a change in a biomechanical property of the portion of the body of the user between the first time and the second time”] to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts [Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)]. The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
The dependent claims merely include limitations that either further define the abstract idea [e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process] and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data [Int. Ventures v. Cap One Financial], collecting information, analyzing it, and displaying certain results of the collection and analysis [Electric Power Group], collection, storage, and recognition of data [Smart Systems Innovations].
Step 2A Prong 2
The judicial exception is not integrated into a practical application.
Representative claim 1 only recites additional elements of extra-solutionary activity – in particular, extra-solution activity [data gathering as a necessary precursor for mental analyses] – without further sufficient detail that would tie the abstract portions of the claim into a specific practical application (2019 PEG p. 55 – the instant claim, for example does not tie into a particular machine, a sufficiently particular form of data or signal collection – via the claimed extra-solution activity, or a sufficiently particular form of display or computing architecture/structure).
Dependent claim(s) 4-6, 10, 20-22 merely add detail to the abstract portions of the claim but do not otherwise encompass any additional elements which tie the claim(s) into a particular application/integration [the dependent claim(s) recite generic ‘units’ or ‘steps’ which encompass mere computer instructions to carry out an otherwise wholly abstract idea].
Dependent claim(s) 26 encounter substantially the same issues as the independent claim(s) from which they depend in that they encompass further generic extra-solutionary activity [generic data gathering] and/or generic computer elements [storage, memory per se].
Accordingly, the claim(s) are not integrated into a practical application under Step 2A Prong 2.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Independent claims 1 as individual wholes fail to amount to significantly more than the judicial exception at Step 2B. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of extra-solutionary activity [i.e., data gathering as a necessary precursor for mental analyses] and generic computer elements cannot amount to significantly more than an abstract idea [MPEP § 2106.05(f)] and is further considered to merely implement an abstract idea on a generic computer [MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality].
For the independent claim portions and dependent claims which provide additional elements of extra-solutionary data gathering, MPEP § 2106.05(g) establishes that mere data gathering for determining a result does not amount to significantly more. The extra-solutionary activity of processor steps [acquiring signals, etc.] as presently recited, cannot provide an inventive concept which amounts to significantly more than the recited abstract idea.
For the independent claims as well as the dependent claims merely reciting generic computer elements and functions [controller recited at a high level of generality and corresponding functions therein], MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality.
Accordingly, the generic computer elements and corresponding functions, as presently limited, cannot provide an inventive concept since they fall under a generic structure and/or function that does not add a meaningful additional feature to the judicial exception(s) of the claim(s).
Claim 2 recites “applying, with a wearable system, a first electrical current across the portion of the body of the user at a first frequency” and “applying, with the wearable system, a first electrical current across the portion of the body of the user at a second frequency”, wherein claim 3 recites “wherein the first frequency is about 5kHz and the second frequency is about 100kHz”; claim 11 and claim 17 [similarly] recite “wherein the wearable system comprises a bioimpedance measurement system comprising: a first pair of electrodes positioned proximate a first end of the portion of the body of the user; a second pair of electrodes positioned proximate a second end of the portion of the body of the user; and a controller configured to measure a bioimpedance between the first and second pairs of electrodes” and claim 17 further recites “measure the bioimpedance between the first and second pairs of electrodes at the first time; and measure the bioimpedance between the first and second pairs of electrodes at the second time”, wherein claim 13 recites “wherein the first pair of electrodes are positioned on a thigh of a user at a position above a midpoint of the length of the femur”; wherein claims 18-19 and 28 are considered to recite similar subject matter to claims 2-3 and 13. Such a “wearable system” is considered well-understood, routine, and conventional, as known by at least:
Rutkove (US-20170007151-A1) [Multi-frequency EIM can be performed by varying the frequency of the alternating current applied to the muscle of group of muscles. For example the frequency that is applied may be in the range between about 1 kHz and about 20 MHz, but embodiments are not limited to this particular frequency range, as any other suitable frequency range can be used. The alternating current can be injected via one set of surface electrodes (referred to as current-injecting electrodes), and the resulting voltage patterns can be recorded via a second set of surface electrodes (referred to as voltage-recording electrodes). Based on the measurement of the injected current's magnitude, an impedance instrument can convert the voltage signals into a resistance (R) and reactance (X), for each applied frequency (Rutkove ¶0062); In some embodiments, an electrode array may have a size suitable for assessing a particular region of a body… Though, the electrode array may be designed to be disposable, meaning that the electrode array may be attached to the body of the EIM probe so that the array may be easily removed (Rutkove ¶0082)]
Skrabal (US-20150374256-A1) [Also the patient's fluid equilibrium can be identified excellently with the above arrangement… by the proximal leg electrodes 4 and the distal leg electrodes 5… In each of those individual segments, the alternating current resistance (impedance) or, respectively, the effective resistance (resistance) and the reactive impedance (reactance) of the individual body sections is analyzed at several frequencies, possibly also a full frequency sweep, and the ECW, the TBW and hence also the ICW, especially also the ratio ECW/TBW or ECW/ICW, is analyzed therefrom. An analysis of the segments at at least two frequencies of, e.g, between 1 Hz and 10 Hz, e.g., 5 Hz, on the one hand, and at frequencies higher than 100 Hz, e.g., also of 400 or, respectively, 800 Hz, on the other hand, or also via a frequency sweep, has proved to be particularly useful, since, in this way, the ratio of the extra- to the intracellular fluid can be determined, which is independent of the dimensions of the examined segment (Skrabal ¶0029, Fig. 1); The ratio of ECW to TBW is determined from the ratio of the base impedance (fundamental impedance) at a low frequency between, theoretically, 0 KHz (determined from the Cole-Cole plot) and, e.g., 10 kHz, e.g., 5 kHz, and a higher frequency (e.g., more than 100 kHz up to, theoretically, ∞ kHz, also determined via the Cole-Cole plot, e.g., 400 kHz). Discrete frequencies, e.g., in the range of 5 KHz and about 400 kHz, are likewise very sufficient for calculating the ratio ECW/TBW or ECW/ICW. It is known that the intracellular water (ICW) is determined from the difference between total body water (TBW) and extracellular water (ECW) (Skrabal ¶0071)]
Maceachern (US-20150272501-A1) [In some cases, the plurality of electrical signals can include skin impedance signals or bio-impedance signals… The phase of the received signal may also be compared across differing frequencies (Maceachern ¶0159); Bio-impedance signals can be acquired by measuring signals using a tetrapolar electrode configuration. A signal can be injected into the user's body using a first electrode pair (e.g. 406A and 406B). The signal received by a second electrode pair (e.g. 4060 and 406D) can be measured. A comparison of the injected signal to the received signal can be used to determine bio-impedance for the user (Maceachern ¶0160); In some cases, the electrode pairs can be positioned at far apart locations on the user skin surface, such as cross-body or at opposite ends of a limb such that skin conduction in negligible. This may also provide an indication of the user's bio-impedance that is more representative of the hydration levels throughout the user's body, rather than in a localized region (Maceachern ¶0161, Fig. 2B); To acquire both the bio-impedance signal and the skin impedance signal, a similar process can be used. In each case, an AC injection signal can be generated, e.g. a 50 kHz signal (Maceachern ¶00162)]
Claim 12 and claim 27 [similarly] recite “wherein the bioimpedance measurement system further comprises an inertial measurement unit configured to measure one or more kinematic properties of the portion of the body of the user”. Such an “inertial measurement unit” is considered well-understood, routine, and conventional, as known by at least:
Strausser (US-20150045703-A1) [Inertial measurement units (IMUs) could be coupled to the leg support 212. An inertial measurement unit is generally composed of an accelerometer and a gyroscope and sometimes a magnetometer as well; in many modern sensors these devices are MEMS (Mico electromechanical systems) that have measurement in all three orthogonal axes on one or more microchips. The behavior of IMUs is well understood in the art (IMUs being used for applications from missile guidance to robotics to cell phones to hobbyist toys); they typically provide measurement of angular orientation with respect to gravity, as well as measurement of angular velocity with respect to earth and linear acceleration, all in three axes (Strausser ¶0025)]
Examiner’s Note Regarding Particular Treatment or Prophylaxis: Claim(s) 11 recites subject matter regarding “upon determining mid-activity changes in the portion of the body DFBIA during the dynamic activity, reporting at least one of: an indication representative of delayed onset muscle soreness (DOMS); or an indication representative of muscle tissue damage” [lines 3-6] and claim(s) 26 recites subject matter regarding “generate an output instructing the user to limit use of the portion of the body of the user based on the change in the biomechanical property”, which the Examiner notes is not considered to be a particular treatment or prophylaxis, as none of the identified claims positively recite or include language that is considered to be a particular treatment or prophylaxis as an additional element to integrate the judicial exception into a practical application or allow the identified claims to amount to significantly more than the judicial exception [MPEP § 2106.04(d)(2)].
Accordingly, the claim(s) as whole(s) fail amount to significantly more than the judicial exception under Step 2B.
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) 1-2, 4, 6, 15, 17-18, 20, 22, and 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Inan (US-20180289313-A1, cited by Applicant).
Regarding claim 1, Inan teaches
A method of assessing musculoskeletal health comprising:
measuring a bioimpedance across a portion of a body of a user at a first time [FIG. 6(a) is a block diagram of a bioimpedance measurement system according to an exemplary embodiment of the present invention. E1-E4 represent the electrodes that interface to the body. The signals i(t) and q(t) relate to the static (slowly varying on the order of hours to days) component and the signals) Δi(t) and Δq(t) relate to the dynamic component of the knee impedance. A(t) is used to monitor the amplitude of the current (i.sub.body(t) passing through the knee joint (Inan ¶0197, Figs. 6A, 8); Similarly, for the EBI measurements, measurement repeatability and variability in the resistance and reactance measurements across the recording time have been used as an index of quality (Inan ¶0336); measurements of… EBI, and joint angle baseball players, for example (5 pitchers, and 5 infielders), will be obtained. The measurements will be obtained at three time points throughout the season (to assess cumulative “wear-and-tear” on the joints). At each time point, sensor data will be measured (a) before, (b) immediately after, (c) 24 hours after, and (d) 48 hours after an exhaustive pitching session (to assess acute effects of a fatiguing workout on the joints, and delayed onset inflammatory effects such as edema) (Inan ¶0338)];
measuring the bioimpedance across the portion of the body of the user at a second time [Inan ¶¶0197, 0336, 0338, Figs. 6A, 8]; and
determining, based at least in part on the measured bioimpedances at the first and second times, a change in a biomechanical property of the portion of the body of the user between the first time and the second time [The present invention makes use of bioimpedance measurements to monitor the amount of swelling and the blood flow rate at the joint. To measure changes in slow-varying fluid volume and fast-varying blood flow rate, the bioimpedance hardware outputs both static and dynamic components of the joint bioimpedance, which has a resistive and reactive component (Inan ¶0043); In an exemplary embodiment related to assessing overuse of the joint, vector EBI measurements are taken from the joint using a tetrapolar electrode configuration before, after, and/or at different intervals during, the training session or competition. Changes in the resistive and/or reactive components of the EBI measurements are quantified… These changes in EBI characteristics are then outputted to the user as a score indicative of joint swelling/tissue damage (Inan ¶0289)].
Regarding claim 2, Inan teaches
The method of claim 1, wherein measuring the bioimpedances comprises:
measuring the bioimpedance at the first time while applying, with a wearable system, a first electrical current across the portion of the body of the user at a first frequency [The bioimpedance measurements are done by delivering current to the joint site through the electrodes, which are in quadripolar configuration to reduce the effect of electrode-skin interface impedance and measuring the potential difference across the joint through amplification and phase-sensitive detection stages. The static and dynamic components are later separated by a filter stage at the output. The injected current magnitude is below a safety threshold that does not create damage at the measurement site, and its frequency is such that it can propagate through both intra and extra-cellular fluids (Inan ¶0044); The circuit excites the body with a sine wave current at f.sub.0=50 kHz, a frequency that enables current to flow through both extracellular and intracellular fluid paths and therefore is widely used in single-frequency bioimpedance analysis systems (Inan ¶0227), wherein as disclosed in ¶0197 and depicted in Fig. 6A and 8, the application is by a wearable system]; and
measuring the bioimpedance at the second time while applying, with the wearable system, a first electrical current across the portion of the body of the user at a second frequency [Inan ¶¶0044, 0197, Figs. 6A, 8; wherein any frequency can be considered to read on a second frequency, including the same frequency as the first frequency].
Regarding claim 4, Inan teaches
The method of claim 2, wherein the biomechanical property is selected from a group consisting of pain and muscle fatigue [The data analytics efforts will then have two focuses: (1) using unsupervised machine learning (i.e., graph mining) to facilitate clustering of the measured data to determine which signals, and features of signals, provide the best capability in detecting fatigue and “wear-and-tear” (cumulative throughout the season, incorporating metrics such as the number of pitches throughout the season) for the joints (Inan ¶0340)]].
Regarding claim 6, Inan teaches
The method of claim 1, wherein the biomechanical property is selected from a group consisting of muscle fatigue [Inan ¶0340], muscle damage, muscle torque, and muscle recovery [while EBI can detect extremely small differences in tissue edema due to heating and/or cooling the limb. These have been applied these measures to discriminate healthy from injured knees and quantify post-surgery recovery (Inan ¶0333)].
Regarding claim 15, Inan teaches
The method of claim 1, wherein the method does not comprise measuring an acoustic characteristic of the portion of the body of the user [Inan ¶0033, wherein the measuring of an acoustic characteristic is considered to be optional and not required].
Regarding claim 17, Inan teaches
A system for assessing musculoskeletal health comprising:
a first pair of electrodes configured to be positioned proximate a first end of a portion of a body of a user [Inan ¶¶0044, 0197, Figs. 6A, 8];
a second pair of electrodes configured to be positioned proximate a second end of the portion of the body of the user [Inan ¶¶0044, 0197, Figs. 6A, 8]; and
a controller configured to assess musculoskeletal health of the portion of the body of the user according to the method of claim 1 [See § 102 rejection of claim 1 above; Inan ¶¶0197, 0336, 0338, Figs. 6A, 8];
wherein the controller is further configured to:
measure the bioimpedance between the first and second pairs of electrodes at the first time [Inan ¶¶0197, 0336, 0338, Figs. 6A, 8]; and
measure the bioimpedance between the first and second pairs of electrodes at the second time [Inan ¶¶0197, 0336, 0338, Figs. 6A, 8].
Regarding claim 18, Inan teaches
The system of claim 17, wherein the controller is further configured to measure the bioimpedance between the first and second pairs of electrodes at each of the first and second times by:
measuring the bioimpedance between the first and second pairs of electrodes while applying a first electrical current to the first and second pairs of electrodes at a first frequency [Inan ¶¶0044, 0197, Figs. 6A, 8]; and
measuring the bioimpedance between the first and second pairs of electrodes while applying a first electrical current to the first and second pairs of electrodes at a second frequency [Inan ¶¶0044, 0197, Figs. 6A, 8; wherein any frequency can be considered to read on a second frequency, including the same frequency as the first frequency].
Regarding claim 20, Inan teaches
The system of claim 18, wherein the controller is further configured to determine, based at least in part on the measured bioimpedances at the first and second times, a change in a biomechanical property of the portion of the body of the user between the first time and the second time, by calculating a muscle fatigue score [Inan ¶0340].
Regarding claim 22, Inan teaches
The system of claim 17, wherein the biomechanical property is selected from a group consisting of muscle fatigue, muscle damage, muscle torque, and muscle recovery [Inan ¶¶0333, 0340].
Regarding claim 27, Inan teaches
The system of claim 17 further comprising an inertial measurement unit configured to measure one or more kinematic properties of the portion of the body of the user [Inan ¶0033, 0049, 0150].
Regarding claim 28, Inan teaches
The system of claim 17, wherein at least one of:
the first pair of electrodes are configured to be positioned on a thigh of the user at a position above a midpoint of the length of the femur, and wherein the second pair of electrodes are configured to be positioned below a knee of the user;
the portion of the body of the user comprises the user's knee and at least a portion of one or more muscles of the user above and below the knee [Inan ¶¶0197, 0336, 0338, Figs. 6A, 8]; or
the system does not include a sensor for measuring an acoustic characteristic of the portion of the body of the user [Inan ¶0033, wherein the measuring of an acoustic characteristic is considered to be optional and not required].
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 3, 5, 10-12, 19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inan, as applied to claims 2, 4, 18, and 20 above, in view of Rutkove (US-20170007151-A1).
Regarding claim 3, Inan teaches
The method of claim 2.
However, while Inan discloses wherein the determining is based on bioimpedance characteristics [Changes in the resistive and/or reactive components of the EBI measurements are quantified. Simultaneously obtained inertial measures such as joint angle and body posture/position are taken to ensure that the physical conditions of the user during the EBI measurements were the same for each usage. These changes in EBI characteristics are then outputted to the user as a score indicative of joint swelling/tissue damage (Inan ¶0289)], Inan fails to explicitly disclose wherein the first frequency is about 5kHz and the second frequency is about 100kHz.
Rutkove discloses methods and systems for performing bioimpedance measurements to measure muscle status, wherein Rutkove discloses measuring bioimpedance while applying different frequencies [Some embodiments relate to methods and devices for multi-frequency EIM, which involves performing measurements at least two different frequencies of electrical signals. Because the electrical parameters of a muscle can be dependent on the frequency of an alternating current applied to a muscle, measurements of the muscle impedance for a plurality of frequencies can be utilized to facilitate diagnosis of muscle condition, and to differentiate between normal and abnormal muscle tissue. In some embodiments, multi-frequency measurements may reduce the impact of subcutaneous fat on the muscle health measurements by taking a ratio or difference of measurements at two frequencies in order to provide a more accurate measure of muscle status. In some embodiments, impedance measurements performed over several frequencies may be fit to an impedance model in order to assist in identifying intra-cellular and cellular characteristics such as muscle fiber size, muscle type (e.g., type 1, type 2), and number of mitochondria. By identifying such intra-cellular and cellular characteristics, an assessment and prediction of exercise skill sets (e.g., long-distance, sprinting) well-suited for the muscle may be determined (Rutkove ¶0061); Multi-frequency EIM can be performed by varying the frequency of the alternating current applied to the muscle of group of muscles. For example the frequency that is applied may be in the range between about 1 kHz and about 20 MHz, but embodiments are not limited to this particular frequency range, as any other suitable frequency range can be used (Rutkove ¶0062)]. Rutkove further discloses that the frequency of the electrical current applied is a result effective variable [the range of frequencies over which EIM measurements are performed may be selected in order to identify particular cellular components. Identification of intracellular components may include performing EIM measurements at frequencies above 1 MHz in order to effectively penetrate the cell membrane (Rutkove ¶0071); The phase value for muscle peaks at a lower frequency than the phase value for fat. Frequencies may be selected for impedance measurements with more significant contributions from fat or muscle (Rutkove ¶0108)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Inan to employ wherein the second frequency is different from the first frequency, so as to enable characterization of different muscle parameters. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Inan in view of Rutkove to employ wherein the first frequency is about 5kHz and the second frequency is about 100kHz, as this modification would amount to a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 5, Inan teaches
The method of claim 4, wherein the biomechanical property is muscle fatigue [Inan ¶0340].
However, while Inan discloses determining a difference between measured bioimpedances at the first time and the second time [Inan ¶¶0043, 0289], Inan fails to explicitly disclose wherein determining comprises calculating a muscle fatigue score based on a difference between a ratio of the bioimpedances at the first and second frequencies at the first time and the second time.
Rutkove discloses calculating muscle condition at an instant in time by determining a ratio of bioimpedances at a first frequency and a second frequency [At some frequencies, muscle and/or fat may dominate an EIM measurement. As an example, FIG. 8 illustrates the frequency dependence of phase impedance measurements on muscle and fat. The phase value for muscle peaks at a lower frequency than the phase value for fat. Frequencies may be selected for impedance measurements with more significant contributions from fat or muscle. In some embodiments, the two frequencies may be at approximately 50 kHz and approximately 200 kHz, and a ratio or difference of impedance values may be calculated at these two frequencies. In some embodiments, the frequency ratio may include a numerator based on an approximate peak in the reactance as a function of frequency and denominator based on a frequency higher than the frequency associated with the approximate peak in the reactance. By comparing phase values taken at two frequency values, such as by taking a ratio or difference of the two values, may provide an approach to remove the impact of fat on interpretation of EIM measurements. Reducing the impact of fat on EIM measurements can be advantageous while tracking the progress of a disease and/or effectiveness of a treatment of a disease, since some therapies, such as corticosteroids, may alter subcutaneous fat. In addition, reducing the impact of fat on EIM measurements can assess an exercise routine by determining if an individual's muscle condition and/or quality is improved and if the individual is losing fat from the exercise routine (Rutkove ¶0108)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Inan to employ wherein determining comprises calculating a muscle fatigue score based on a difference between a ratio of the bioimpedances at the first and second frequencies at the first time and the second time, so as to remove the impact of dominant characteristics in bioimpedance measurements in order to allow for analysis of underlying characteristics.
Regarding claim 10, Inan teaches
The method of claim 2, wherein:
measuring the bioimpedances comprises measuring the bioimpedances of the portion of the body of the user during dynamic activity of the portion of the body [Inan ¶0289].
However, Inan fails to explicitly disclose wherein determining uses dual-frequency electrical bioimpedance analyses (DFBIA).
Rutkove discloses measuring bioimpedance while applying different frequencies [Rutkove ¶¶0061-0062, 0071, 0108].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Inan to employ wherein determining uses dual-frequency electrical bioimpedance analyses (DFBIA), so as to enable characterization of different muscle parameters.
Regarding claim 11, Inan in view of Rutkove teaches
The method of claim 10 further comprising:
upon determining mid-activity changes in the portion of the body DFBIA during the dynamic activity [See § 103 modification of claim 10 above; Inan ¶0289; Rutkove ¶¶0061-0062], reporting at least one of:
an indication representative of delayed onset muscle soreness (DOMS); or
an indication representative of muscle tissue damage [Inan ¶0340];
wherein the wearable system comprises a bioimpedance measurement system comprising:
a first pair of electrodes positioned proximate a first end of the portion of the body of the user [Inan ¶¶0044, 0197, Figs. 6A, 8];
a second pair of electrodes positioned proximate a second end of the portion of the body of the user [Inan ¶¶0044, 0197, Figs. 6A, 8]; and
a controller configured to measure a bioimpedance between the first and second pairs of electrodes [Inan ¶¶0197, 0336, 0338, Figs. 6A, 8].
Regarding claim 12, Inan in view of Rutkove teaches
The method of claim 11, wherein the bioimpedance measurement system further comprises an inertial measurement unit configured to measure one or more kinematic properties of the portion of the body of the user [In an exemplary embodiment, the present invention can combine at least two of the following sensing modalities: joint acoustical emissions, electrical bioimpedance, and inertial measures. At least two of these modalities can be fused together in a wearable system that the user wears for some period of time, during which the present invention learns the characteristics of the measured signals for that particular user using, for example, machine learning algorithms (Inan ¶0033); Since bioimpedance measurements are greatly impacted by motion artifacts, subject position, electromagnetic interference and voltage fluctuations of the skin electrode interference, an innovative solution is needed to provide consistency that measurements should be taken when subject is still in a given position and in the absence of electromagnetic interference and skin electrode interface related fluctuations (such as an electrode losing contact with the skin). The present invention can provide a solution by presenting inertial measurement units along with the dynamic resistance (impedance plethysmography) signals that are used together to decide if the user is in an acceptable position for bioimpedance measurements to be taken or not (Inan ¶0049); Lastly, two wireless inertial measurement units (IMUS) (MTW-38A70G20, Xsens, Enschede, The Netherlands), which contained three-axis accelerometer, gyroscope, and magnetometer as well as built-in sensor fusion outputs, were positioned on the lateral sides of the thigh and shank (Inan ¶0150)].
Regarding claim 19, Inan teaches
The system of claim 18.
However, while Inan discloses wherein the determining is based on bioimpedance characteristics [Inan ¶0289], Inan fails to explicitly disclose wherein the first frequency is about 5kHz and the second frequency is about 100kHz.
Rutkove discloses methods and systems for performing bioimpedance measurements to measure muscle status, wherein Rutkove discloses measuring bioimpedance while applying different frequencies [Rutkove ¶¶0061-0062)]. Rutkove further discloses that the frequency of the electrical current applied is a result effective variable [Rutkove ¶¶0071, 0108].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Inan to employ wherein the second frequency is different from the first frequency, so as to enable characterization of different muscle parameters. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Inan in view of Rutkove to employ wherein the first frequency is about 5kHz and the second frequency is about 100kHz, as this modification would amount to a matter of routine optimization, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 21, Inan teaches
The system of claim 20.
However, while Inan discloses determining a difference between measured bioimpedances at the first time and the second time [Inan ¶¶0043, 0289], Inan fails to explicitly disclose wherein the muscle fatigue score is based on a difference between a ratio of the bioimpedances at the first and second frequencies at the first time and the second time.
Rutkove discloses measuring bioimpedance while applying different frequencies [Rutkove ¶¶0061-0062)], wherein Rutkove further discloses calculating muscle condition at an instant in time by determining a ratio of bioimpedances at a first frequency and a second frequency [Rutkove ¶0108].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Inan to employ wherein the second frequency is different from the first frequency, so as to enable characterization of different muscle parameters. It would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Inan to employ wherein the muscle fatigue score is based on a difference between a ratio of the bioimpedances at the first and second frequencies at the first time and the second time, so as to remove the impact of dominant characteristics in bioimpedance measurements in order to allow for analysis of underlying characteristics.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inan in view of Rutkove, as applied to claim 11 above, in further view of Skrabal (US-20150374256-A1).
Regarding claim 13, Inan in view of Rutkove teaches
The method of claim 11.
However, Inan in view of Rutkove fails to explicitly disclose wherein the first pair of electrodes are positioned on a thigh of a user at a position above a midpoint of the length of the femur; and wherein the second pair of electrodes are positioned below a knee of the user.
Skrabal discloses methods and systems for measuring bioimpedance across a portion of a leg between electrodes positioned on a thigh of a user at a position above a midpoint of the length of the femur and positioned below a knee of the user [As mentioned earlier, the introduction of the current for the impedance measurement occurs in this case advantageously via one or both arm electrodes 6 and/or via the neck electrode 3, on the one hand, and either via one or both proximal leg electrodes 4 and/or else via the one or two distal leg electrodes 5 (either suction, adhesive, band or clamping electrodes) on the left and right legs, on the other hand, on the site where they are also used for the ECG leads. For separately examining the fluid or, respectively, the fluid shift in the two legs, the legs can be examined separately or jointly by an interconnection or separation in the multiplexer 2, or, respectively, the total impedance of the left and right legs can, also in this case, be calculated without an interconnection (Skrabal ¶0027, Fig. 1), wherein as depicted in Skrabal Fig. 1, the proximal leg electrodes 4 are depicted as being proximal to the user’s hips and are thus considered to be at a position above a midpoint of the length of the femur, and wherein distal leg electrodes are depicted as being proximal to the user’s ankles and are thus considered to be below a knee of the user].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Inan in view of Rutkove to employ wherein the first pair of electrodes are positioned on a thigh of a user at a position above a midpoint of the length of the femur; and wherein the second pair of electrodes are positioned below a knee of the user, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [enable measuring of bioimpedance across a portion of the leg of the user] [MPEP § 2143(I)(D)].
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inan, as applied to claim 17 above, in view of Maceachern (US-20150272501-A1).
Regarding claim 26, Inan teaches
The system of claim 17.
However, while Inan discloses quantifying risk of injury of the portion of the body measured [This will allow the data analytics efforts to both focus on pre-injury (prediction) and post-injury (rehabilitation status) quantification of joint health/risk (Inan ¶0339)], in particular overuse injury [using supervised machine learning (i.e., support vector machines) to provide preliminary approaches for quantifying the risk of acute overuse injury throughout the season (Inan ¶0340)], Inan fails to explicitly disclose wherein the controller is further configured to generate an output instructing the user to limit use of the portion of the body of the user based on the change in the biomechanical property.
Maceachern discloses systems and methods for measuring bioimpedance across a portion of a user’s body [In some cases, the plurality of electrical signals can include skin impedance signals or bio-impedance signals… The phase of the received signal may also be compared across differing frequencies (Maceachern ¶0159); Bio-impedance signals can be acquired by measuring signals using a tetrapolar electrode configuration. A signal can be injected into the user's body using a first electrode pair (e.g. 406A and 406B). The signal received by a second electrode pair (e.g. 4060 and 406D) can be measured. A comparison of the injected signal to the received signal can be used to determine bio-impedance for the user (Maceachern ¶0160)], wherein Maceachern discloses generating an output instructing the user to limit use of relevant portions of the user’s body based on measurement trends [The various biometric features and metrics determined for a user may be analyzed to identify trends and alert users to those trends. This may enable users to adjust the activities they are performing, or how they are performing activities in response to the trends. For instance, the signal amplitude and frequency content of acquired EMG signals may be analyzed over time to identify muscle growth or muscle efficiency trends. Similarly, muscle coordination (the sequence in which an individual's muscles are operating) may be analyzed to provide recommendations to improve individual performance. Muscle balance (cross-body) may be tracked and recommendations may be provided to users to adjust their training if muscles appear to be unbalanced. The various biometric features and metrics may also be analyzed to identify an injury risk trend, provide feedback to a user indicating a potential risk of injury, and provide recommendations to avoid the potential risk of injury (Maceachern ¶0053); Muscle fatigue may be tracked and a fatigue alert may be provided to the user when a fatigue trend is identified. A fatigue alert may be used to prevent overtraining (Maceachern ¶0054)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Inan to employ wherein the controller is further configured to generate an output instructing the user to limit use of the portion of the body of the user based on the change in the biomechanical property, so as to allow the user to avoid potential risk of injury.
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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