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 .
Response to Arguments
Applicant’s arguments with respect to claims 1-16, 20 and 22 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. As detailed in infra rejections: claims 1-4, 7, 11, 15, 20 and 22 are rejected over Sheng in further view of AlMohimeed in further view of Dieterich; claim 8 is rejected over Sheng in further view of AlMohimeed in further view of Dieterich; claim 9 is rejected over Sheng in further view of AlMohimeed in further view of Dieterich; claim 10 is rejected over Sheng in further view of AlMohimeed in further view of Dieterich; claims 5-6, 12-14, and 16 are rejected over Sheng in further view of AlMohimeed in further view of Dieterich in further view of Sharma.
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 (i.e., changing from AIA to pre-AIA ) 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-4, 7, 11, 15, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Sheng et al. (“Quantitative assessment of changes in muscle contractility due to fatigue during NMES: An ultrasound imaging approach” 2019), hereinafter “Sheng,” in further view of AlMohimeed et al. (“Ultrasound measurement of skeletal muscle contractile parameters using flexible and wearable single-element ultrasonic sensor” June 2020), hereinafter “AlMohimeed,” in further view of Dieterich et al. (“M-mode ultrasound used to detect the onset of dep muscle activity” 2015), hereinafter “Dieterich.”
Regarding claim 1, Sheng discloses an analysis system (NMES and ultrasound analysis apparatus/system, Figs. 1 and 2), comprising:
an electric stimulus device that applies an electric stimulus formed by short pulses to a muscle (stimulator and electrodes apply an electrical stimulus formed by short pulses to a muscle, P.835, ¶4-5, Figs.1 and 2);
an ultrasonic wave pulse echo device that transmits ultrasonic waves to the muscle and receives reflected ultrasonic waves (ultrasonic transducer transmits ultrasonic waves to the muscle and receives reflected ultrasonic waves, P.835, ¶4, Figs. 1 and 2); and
a processing circuitry that analyzes a contraction characteristic of the muscle at a time of a single contraction response of the muscle in response to one short pulse of the electric stimulus based on the reflected ultrasonic waves (personal computer analyzes the strain/deformation/displacement of the muscle at a time of a single contraction response of the muscle to the electric stimulus based on the reflected ultrasonic waves, P.833, ¶4 – P.835, ¶1, P.836, ¶3, Figs. 2 and 4-7; the electric stimulus is formed by the short pulse with a particular pulse frequency, P.835, ¶4-5, Fig. 2)
the processing circuitry further designates an analysis region of the reflected ultrasonic waves (personal computer locates a region of interest (ROI) in the acquired ultrasound image, P.833, ¶2, P.835, ¶2-4, P.837, ¶1, Figs. 1-2, 4-7) and analyzes the contraction characteristic of the analysis region (personal computer analyzes the strain/deformation/displacement of the muscle at a time of a single contraction response of the muscle to the electric stimulus based on the reflected ultrasonic waves, P.833, ¶4 – P.835, ¶1, P.836, ¶3, Figs. 2 and 4-7).
However, Sheng does not appear to disclose the contraction characteristic of the muscle comprises a time response of the muscle from contraction to relaxation.
However, in the same field of endeavor of combined electrical muscle stimulation and ultrasound analysis, AlMohimeed teaches a processing circuitry that analyzes a contraction characteristic of the muscle at a time of a single contraction response of the muscle in response to one short pulse of the electric stimulus based on the acquired ultrasonic waves, wherein the contraction characteristic of the muscle comprises a time response of the muscle from contraction to relaxation (contraction characteristic of the muscle comprises a time response of the muscle from contraction to complete relaxation in response to electrical muscle stimulation at 2 or 4 Hz based on acquired ultrasonic waves, Abstract, P.6, ¶3 – P.8, ¶1, P.8, ¶3 -P.10, P.10, ¶2 – P.12, ¶3; see also Figs. 2-6 and 8-9 and Table 1; analysis is performed using a digital acquisition system and a personal computer, P. 7, ¶1 – P.8, ¶2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied AlMohimeed’s known technique of using an electrical stimulus pulse frequency of 2 or 4 Hz to evaluate the contraction characteristic of the muscle including contraction and relaxation to Sheng’s known apparatus of using an electrical stimulus pulse frequency to evaluate the contraction characteristic of the muscle to achieve the predictable result that evaluating multiple frequencies along the FI-EMS frequency curve between 2 Hz and 10 Hz, including 2 Hz and 4Hz, that correspond to different levels of contraction from non-tetanic to partially fused tetanic contraction allows for assessment of the degree of muscle fatigue and/or the evaluation of muscle fiber type and fiber composition ratio. See, e.g., AlMohimeed, P.12, ¶3-4.
However, Sheng in further view of AlMohimeed does not appear to teach the reflected ultrasonic waves comprise reflection of a boundary surface of the muscle, and the processing circuitry designates the analysis region comprising an M-mode image showing a range of a motion of the boundary surface of the muscle according to the motion of the boundary surface of the muscle.
However, in the same field of endeavor of M-mode muscle motion analysis, Dieterich teaches the reflected ultrasonic waves comprise reflection of a boundary surface of the muscle (M-mode ultrasound waves are reflected from an interface surface of the muscle, P.225, ¶2, P.225, ¶4 – P.226, ¶1, P.226, ¶6 – P.227, ¶1, Figs. 1, 2b, and 4), and the processing circuitry designates the analysis region comprising an M-mode image showing a range of a motion of the boundary surface of the muscle according to the motion of the boundary surface of the muscle (LabView software application executed by a processor to determine a zone/region/depth of analysis from an M-mode image showing a motion/displacement of the interface surface of the muscle, P.225, ¶2, P.225, ¶4 – P.226, ¶1, P.226, ¶6 – P.227, ¶1, Figs. 1, 2b, and 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Dieterich’s known technique of using M-mode imaging to determine a zone/region/depth of analysis showing a motion/displacement of the interface surface of the muscle to Sheng in further view of AlMohimeed’s known apparatus using ultrasound imaging to analyze the displacement/motion of the muscle layer using reflected ultrasound waves to achieve the predictable result that using M-mode imaging to analyze muscle displacement/motion provides for non-invasive assessment of deep muscle activity. See, e.g., Dieterich, Abstract.
Regarding claim 2, Sheng discloses the electric stimulus is formed by the short pulses with a particular repetition frequency (the electric stimulus is formed by the short pulse with a particular pulse frequency, P.835, ¶4-5, Fig. 2).
Regarding claim 3, Sheng discloses the processing circuitry calculates a feature amount indicating the contraction characteristic (personal computer calculates the strain/deformation/displacement amount indicating the strain/deformation/displacement resulting from the contraction, P.833, ¶4 – P.835, ¶1, P.836, ¶3, Figs. 2 and 4-7).
Regarding claim 4, Sheng discloses the processing circuitry calculates, as the feature amount, a half-width of a peak corresponding to the single contraction in a waveform that represents the single contraction response of the muscle (personal computer calculates, as the strain/deformation/displacement amount, the rising period towards the maximum value segment corresponding to a single contraction cycle in a waveform that represents the single contraction response of the muscle, P.836, ¶3).
Regarding claim 7, Sheng discloses a repetition period of the short pulses is shifted by a particular time from an integer multiple of a transmission repetition period of the ultrasonic waves transmitted by the ultrasonic wave pulse echo device, and the particular time is shorter than the transmission repetition period of the ultrasonic waves (a pulse frequency of the short pulses is shifted by a particular time from an integer multiple of the transmission pulse repetition frequency of the ultrasonic waves transmitted by the ultrasonic transducer, and the particular time is shorter than the transmission pulse repetition frequency of the ultrasonic waves, P.835, ¶4-P.836, ¶2, Fig. 2), and
the processing circuitry estimates a displacement of a muscle boundary of the single contraction response by sampling the displacement of the muscle boundary detected by the ultrasonic waves in a time frame of each period of the short pulses and overlapping the displacements of the muscle boundary in a plurality of time frames into one time frame (personal computer estimates a displacement of a muscle boundary of the single contraction response by sampling the displacement of the muscle boundary detected by the ultrasonic waves in a time frame of each period of the short pulses and summing the displacements of the muscle boundary in a plurality of time frames into one time frame, P.834, ¶2 – P.835, ¶835).
Regarding claim 11, Sheng discloses the processing circuitry calculates a feature amount indicating the contraction characteristic (personal computer calculates the strain/deformation/displacement amount indicating the strain/deformation/displacement resulting from the contraction, P.833, ¶4 – P.835, ¶1, P.836, ¶3, Figs. 2 and 4-7).
Regarding claim 15, Sheng discloses a repetition period of the short pulses is shifted by a particular time from an integer multiple of a transmission repetition period of the ultrasonic waves transmitted by the ultrasonic wave pulse echo device, and the particular time is shorter than the transmission repetition period of the ultrasonic waves (a pulse frequency of the short pulses is shifted by a particular time from an integer multiple of the transmission pulse repetition frequency of the ultrasonic waves transmitted by the ultrasonic transducer, and the particular time is shorter than the transmission pulse repetition frequency of the ultrasonic waves, P.835, ¶4-P.836, ¶2, Fig. 2), and
the processing circuitry estimates a displacement of a muscle boundary of the single contraction response by sampling the displacement of the muscle boundary detected by the ultrasonic waves in a time frame of each period of the short pulses and overlapping the displacements of the muscle boundary in a plurality of time frames into one time frame (personal computer estimates a displacement of a muscle boundary of the single contraction response by sampling the displacement of the muscle boundary detected by the ultrasonic waves in a time frame of each period of the short pulses and summing the displacements of the muscle boundary in a plurality of time frames into one time frame, P.834, ¶2 – P.835, ¶835).
Regarding claim 20, Sheng discloses the ultrasonic waves that is transmitted comprises ultrasonic waves for imaging (B-mode ultrasound images from transmitted and reflected ultrasound waves, P.834, ¶3, P. 835, ¶4, Figs. 1-2, 4-7), and the processing circuitry sets a frame rate of the ultrasonic waves for imaging (B-mode ultrasound image frame rate, P.834, ¶3, P.835, ¶4, P.836, ¶2).
However, Sheng does not appear to disclose the ultrasonic waves that is transmitted comprises ultrasonic waves for motion detection, and the processing circuitry sets a repetition frequency of the ultrasonic waves for motion detection.
However, in the same field of endeavor of M-mode muscle motion analysis, Dieterich teaches the ultrasonic waves that is transmitted comprises ultrasonic waves for motion detection (M-mode ultrasound is transmitted into the tissue for reflection from an interface surface of the muscle and the M-mode image shows a motion/displacement of the interface surface of the muscle, P.225, ¶2, P.225, ¶4 – P.226, ¶1, P.226, ¶6 – P.227, ¶1, Figs. 1, 2b, and 4), and the processing circuitry sets a repetition frequency of the ultrasonic waves for motion detection (custom-programmed application executed by a processor sets a repetition frequency of the ultrasonic waves for M-mode imaging of motion/displacement, P.226, ¶2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Dieterich’s known technique of using M-mode imaging to determine a zone/region/depth of analysis showing a motion/displacement of the interface surface of the muscle to Sheng in further view of AlMohimeed’s known apparatus using ultrasound imaging to analyze the displacement/motion of the muscle layer using reflected ultrasound waves to achieve the predictable result that using M-mode imaging to analyze muscle displacement/motion provides for non-invasive assessment of deep muscle activity. See, e.g., Dieterich, Abstract.
Regarding claim 22, Sheng discloses the processing circuitry sets a transmission frequency band for imaging (B-mode or plane wave imaging with a 5MHz center frequency and a sampling frequency of 20MHz, P.835, ¶4).
However, Sheng does not appear to disclose a transmission frequency band for motion detection different from the transmission frequency band for imaging.
However, in the same field of endeavor of M-mode muscle motion analysis, Dieterich teaches a transmission frequency band for motion detection different from the transmission frequency band for imaging as disclosed by Sheng (M-mode with a 7.5-10 MHz transmission frequency band, P.226, ¶2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Dieterich’s known technique of using M-mode imaging to determine a zone/region/depth of analysis showing a motion/displacement of the interface surface of the muscle to Sheng in further view of AlMohimeed’s known apparatus using ultrasound imaging to analyze the displacement/motion of the muscle layer using reflected ultrasound waves to achieve the predictable result that using M-mode imaging to analyze muscle displacement/motion provides for non-invasive assessment of deep muscle activity. See, e.g., Dieterich, Abstract.
Claim 8 is rejected under 35 U.S.C.103 as being unpatentable over Sheng in further view of AlMohimeed in further view of Dieterich.
Regarding claim 8, Sheng discloses an analysis method (NMES and ultrasound analysis methodology, P.832, ¶1), comprising:
applying an electric stimulus formed by short pulses to a muscle (stimulator and electrodes apply an electrical stimulus formed by short pulses to a muscle, P.835, ¶4-5, Figs.1 and 2),
transmitting ultrasonic waves to the muscle to receive reflected ultrasonic waves (ultrasonic transducer transmits ultrasonic waves to the muscle and receives reflected ultrasonic waves, P.835, ¶4, Figs. 1 and 2), and
based on the reflected ultrasonic waves, analyzing a contraction characteristic of the muscle at a time of a single contraction response of the muscle in response to one short pulse of the electric stimulus (personal computer analyzes the strain/deformation/displacement of the muscle at a time of a single contraction response of the muscle to the electric stimulus based on the reflected ultrasonic waves, P.833, ¶4 – P.835, ¶1, P.836, ¶3, Figs. 2 and 4-7; the electric stimulus is formed by the short pulse with a particular pulse frequency, P.835, ¶4-5, Fig. 2), and
designating an analysis region of the reflected ultrasonic waves (locate a region of interest (ROI) in the acquired ultrasound image, P.833, ¶2, P.835, ¶2-4, P.837, ¶1, Figs. 1-2, 4-7) and analyzing the contraction characteristic of the analysis region (analyze the strain/deformation/displacement of the muscle at a time of a single contraction response of the muscle to the electric stimulus based on the reflected ultrasonic waves, P.833, ¶4 – P.835, ¶1, P.836, ¶3, Figs. 2 and 4-7).
However, Sheng does not appear to disclose the contraction characteristic of the muscle comprises a time response of the muscle from contraction to relaxation.
However, in the same field of endeavor of combined electrical muscle stimulation and ultrasound analysis, AlMohimeed teaches based on the acquired ultrasonic waves, analyzing a contraction characteristic of the muscle at a time of a single contraction response of the muscle in response to one short pulse of the electric stimulus, wherein the contraction characteristic of the muscle comprises a time response of the muscle from contraction to relaxation (contraction characteristic of the muscle comprises a time response of the muscle from contraction to complete relaxation in response to electrical muscle stimulation at 2 or 4 Hz based on acquired ultrasonic waves, Abstract, P.6, ¶3 – P.8, ¶1, P.8, ¶3 -P.10, P.10, ¶2 – P.12, ¶3; see also Figs. 2-6 and 8-9 and Table 1; analysis is performed using a digital acquisition system and a personal computer, P. 7, ¶1 – P.8, ¶2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied AlMohimeed’s known technique of using an electrical stimulus pulse frequency of 2 or 4 Hz to evaluate the contraction characteristic of the muscle including contraction and relaxation to Sheng’s known process of using an electrical stimulus pulse frequency to evaluate the contraction characteristic of the muscle to achieve the predictable result that evaluating multiple frequencies along the FI-EMS frequency curve between 2 Hz and 10 Hz, including 2 Hz and 4Hz, that correspond to different levels of contraction from non-tetanic to partially fused tetanic contraction allows for assessment of the degree of muscle fatigue and/or the evaluation of muscle fiber type and fiber composition ratio. See, e.g., AlMohimeed, P.12, ¶3-4.
However, Sheng in further view of AlMohimeed does not appear to teach the reflected ultrasonic waves comprise reflection of a boundary surface of the muscle, and the analysis region comprising an M-mode image showing a range of a motion of the boundary surface of the muscle is designated according to the motion of the boundary surface of the muscle.
However, in the same field of endeavor of M-mode muscle motion analysis, Dieterich teaches the reflected ultrasonic waves comprise reflection of a boundary surface of the muscle (M-mode ultrasound waves are reflected from an interface surface of the muscle, P.225, ¶2, P.225, ¶4 – P.226, ¶1, P.226, ¶6 – P.227, ¶1, Figs. 1, 2b, and 4), and the analysis region comprising an M-mode image showing a range of a motion of the boundary surface of the muscle is designated according to the motion of the boundary surface of the muscle (LabView software application executed by a processor to determine a zone/region/depth of analysis from an M-mode image showing a motion/displacement of the interface surface of the muscle, P.225, ¶2, P.225, ¶4 – P.226, ¶1, P.226, ¶6 – P.227, ¶1, Figs. 1, 2b, and 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Dieterich’s known technique of using M-mode imaging to determine a zone/region/depth of analysis showing a motion/displacement of the interface surface of the muscle to Sheng in further view of AlMohimeed’s known process using ultrasound imaging to analyze the displacement/motion of the muscle layer using reflected ultrasound waves to achieve the predictable result that using M-mode imaging to analyze muscle displacement/motion provides for non-invasive assessment of deep muscle activity. See, e.g., Dieterich, Abstract.
Claim 9 is rejected under 35 U.S.C.103 as being unpatentable over Sheng in further view of AlMohimeed in further view of Dieterich.
Regarding claim 9, Sheng discloses an analysis device (NMES and ultrasound analysis apparatus/system, Figs. 1 and 2), comprising a hardware processing circuitry (personal computer, Fig. 2) programmed to at least:
analyze a contraction characteristic of a muscle at a time of a single contraction response of the muscle (personal computer analyzes the strain/deformation/displacement of the muscle at a time of a single contraction response of the muscle to the electric stimulus based on the reflected ultrasonic waves, P.833, ¶4 – P.835, ¶1, P.836, ¶3, Figs. 2 and 4-7) in response to one short pulse of an electric stimulus formed by short pulse applied to the muscle (stimulator and electrodes apply an electrical stimulus formed by short pulses to a muscle, P.835, ¶4-5, Figs.1 and 2; the electric stimulus is formed by the short pulse with a particular pulse frequency, P.835, ¶4-5, Fig. 2) based on ultrasonic waves transmitted to the muscle and reflected (ultrasonic transducer transmits ultrasonic waves to the muscle and receives reflected ultrasonic waves, P.835, ¶4, Figs. 1 and 2), and
designate an analysis region of the ultrasonic waves that are reflected (locate a region of interest (ROI) in the acquired ultrasound image, P.833, ¶2, P.835, ¶2-4, P.837, ¶1, Figs. 1-2, 4-7) and analyze the contraction characteristic of the analysis region (analyze the strain/deformation/displacement of the muscle at a time of a single contraction response of the muscle to the electric stimulus based on the reflected ultrasonic waves, P.833, ¶4 – P.835, ¶1, P.836, ¶3, Figs. 2 and 4-7).
However, Sheng does not appear to disclose the contraction characteristic of the muscle comprises a time response of the muscle from contraction to relaxation.
However, in the same field of endeavor of combined electrical muscle stimulation and ultrasound analysis, AlMohimeed teaches an analysis device, comprising a hardware processing circuitry programmed to at least: analyze a contraction characteristic of the muscle at a time of a single contraction response of the muscle in response to one short pulse of the electric stimulus based on ultrasonic waves transmitted to the muscle and acquired, wherein the contraction characteristic of the muscle comprises a time response of the muscle from contraction to relaxation (contraction characteristic of the muscle comprises a time response of the muscle from contraction to complete relaxation in response to electrical muscle stimulation at 2 or 4 Hz based on acquired ultrasonic waves from ultrasound wave transmission, Abstract, P.6, ¶3 – P.8, ¶1, P.8, ¶3 -P.10, P.10, ¶2 – P.12, ¶3; see also Figs. 2-6 and 8-9 and Table 1; analysis is performed using a digital acquisition system and a personal computer, P. 7, ¶1 – P.8, ¶2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied AlMohimeed’s known technique of using an electrical stimulus pulse frequency of 2 or 4 Hz to evaluate the contraction characteristic of the muscle including contraction and relaxation to Sheng’s known apparatus of using an electrical stimulus pulse frequency to evaluate the contraction characteristic of the muscle to achieve the predictable result that evaluating multiple frequencies along the FI-EMS frequency curve between 2 Hz and 10 Hz, including 2 Hz and 4Hz, that correspond to different levels of contraction from non-tetanic to partially fused tetanic contraction allows for assessment of the degree of muscle fatigue and/or the evaluation of muscle fiber type and fiber composition ratio. See, e.g., AlMohimeed, P.12, ¶3-4.
However, Sheng in further view of AlMohimeed does not appear to teach the ultrasonic waves that are reflected comprise reflection of a boundary surface of the muscle, and the analysis region comprising an M-mode image showing a range of a motion of the boundary surface of the muscle is designated according to the motion of the boundary surface of the muscle.
However, in the same field of endeavor of M-mode muscle motion analysis, Dieterich teaches the ultrasonic waves that are reflected comprise reflection of a boundary surface of the muscle (M-mode ultrasound waves are reflected from an interface surface of the muscle, P.225, ¶2, P.225, ¶4 – P.226, ¶1, P.226, ¶6 – P.227, ¶1, Figs. 1, 2b, and 4), and the analysis region comprising an M-mode image showing a range of a motion of the boundary surface of the muscle is designated according to the motion of the boundary surface of the muscle (LabView software application executed by a processor to determine a zone/region/depth of analysis from an M-mode image showing a motion/displacement of the interface surface of the muscle, P.225, ¶2, P.225, ¶4 – P.226, ¶1, P.226, ¶6 – P.227, ¶1, Figs. 1, 2b, and 4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Dieterich’s known technique of using M-mode imaging to determine a zone/region/depth of analysis showing a motion/displacement of the interface surface of the muscle to Sheng in further view of AlMohimeed’s known apparatus using ultrasound imaging to analyze the displacement/motion of the muscle layer using reflected ultrasound waves to achieve the predictable result that using M-mode imaging to analyze muscle displacement/motion provides for non-invasive assessment of deep muscle activity. See, e.g., Dieterich, Abstract.
Claim 10 is rejected under 35 U.S.C.103 as being unpatentable over Sheng in further view of AlMohimeed in further view of Dieterich
Regarding claim 10, Sheng discloses a computer-readable recording medium storing an analysis program, causing a computer to operate as an analysis device (personal computer of the NMES and ultrasound analysis apparatus/system, Fig. 2) to analyze a contraction characteristic of a muscle at a time of a single contraction response of the muscle (personal computer analyzes the strain/deformation/displacement of the muscle at a time of a single contraction response of the muscle to the electric stimulus based on the reflected ultrasonic waves, P.833, ¶4 – P.835, ¶1, P.836, ¶3, Figs. 2 and 4-7) in response to one short pulse of an electric stimulus formed by short pulse applied to the muscle (stimulator and electrodes apply an electrical stimulus formed by short pulses to a muscle, P.835, ¶4-5, Figs.1 and 2; the electric stimulus is formed by the short pulse with a particular pulse frequency, P.835, ¶4-5, Fig. 2) based on ultrasonic waves transmitted to the muscle and reflected (ultrasonic transducer transmits ultrasonic waves to the muscle and receives reflected ultrasonic waves, P.835, ¶4, Figs. 1 and 2), and
designate an analysis region of the ultrasonic waves that are reflected (locate a region of interest (ROI) in the acquired ultrasound image, P.833, ¶2, P.835, ¶2-4, P.837, ¶1, Figs. 1-2, 4-7) and analyze the contraction characteristic of the analysis region (analyze the strain/deformation/displacement of the muscle at a time of a single contraction response of the muscle to the electric stimulus based on the reflected ultrasonic waves, P.833, ¶4 – P.835, ¶1, P.836, ¶3, Figs. 2 and 4-7).
However, Sheng does not appear to disclose the contraction characteristic of the muscle comprises a time response of the muscle from contraction to relaxation.
However, in the same field of endeavor of combined electrical muscle stimulation and ultrasound analysis, AlMohimeed teaches causing a computer to operate as an analysis device to analyze a contraction characteristic of the muscle at a time of a single contraction response of the muscle in response to one short pulse of an electric stimulus based on ultrasonic waves transmitted to the muscle and acquired, wherein the contraction characteristic of the muscle comprises a time response of the muscle from contraction to relaxation (contraction characteristic of the muscle comprises a time response of the muscle from contraction to complete relaxation in response to electrical muscle stimulation at 2 or 4 Hz based on acquired ultrasonic waves from ultrasound wave transmission, Abstract, P.6, ¶3 – P.8, ¶1, P.8, ¶3 -P.10, P.10, ¶2 – P.12, ¶3; see also Figs. 2-6 and 8-9 and Table 1; analysis is performed using a digital acquisition system and a personal computer, P. 7, ¶1 – P.8, ¶2).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied AlMohimeed’s known technique of using an electrical stimulus pulse frequency of 2 or 4 Hz to evaluate the contraction characteristic of the muscle including contraction and relaxation to Sheng’s known apparatus of using an electrical stimulus pulse frequency to evaluate the contraction characteristic of the muscle to achieve the predictable result that evaluating multiple frequencies along the FI-EMS frequency curve between 2 Hz and 10 Hz, including 2 Hz and 4Hz, that correspond to different levels of contraction from non-tetanic to partially fused tetanic contraction allows for assessment of the degree of muscle fatigue and/or the evaluation of muscle fiber type and fiber composition ratio. See, e.g., AlMohimeed, P.12, ¶3-4.
However, Sheng in further view of AlMohimeed does not appear to teach the ultrasonic waves that are reflected comprise reflection of a boundary surface of the muscle (M-mode ultrasound waves are reflected from an interface surface of the muscle, P.225, ¶2, P.225, ¶4 – P.226, ¶1, P.226, ¶6 – P.227, ¶1, Figs. 1, 2b, and 4), and the analysis region comprising an M-mode image showing a range of a motion of the boundary surface of the muscle is designated according to the motion of the boundary surface of the muscle (LabView software application executed by a processor to determine a zone/region/depth of analysis from an M-mode image showing a motion/displacement of the interface surface of the muscle, P.225, ¶2, P.225, ¶4 – P.226, ¶1, P.226, ¶6 – P.227, ¶1, Figs. 1, 2b, and 4).
However, in the same field of endeavor of M-mode muscle motion analysis, Dieterich teaches the ultrasonic waves that are reflected comprise reflection of a boundary surface of the muscle, and the analysis region comprising an M-mode image showing a range of a motion of the boundary surface of the muscle is designated according to the motion of the boundary surface of the muscle.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Dieterich’s known technique of using M-mode imaging to determine a zone/region/depth of analysis showing a motion/displacement of the interface surface of the muscle to Sheng in further view of AlMohimeed’s known process using ultrasound imaging to analyze the displacement/motion of the muscle layer using reflected ultrasound waves to achieve the predictable result that using M-mode imaging to analyze muscle displacement/motion provides for non-invasive assessment of deep muscle activity. See, e.g., Dieterich, Abstract.
Claims 5-6, 12-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Sheng in further view of AlMohimeed in further view of Dieterich as applied to claims 1, 2, 3, or 4, respectively, above, and further in view of Sharma et al. (“A non-linear control method to compensate for muscle fatigue during neuromuscular electrical stimulation” 2017), hereinafter “Sharma.”
Regarding claim 5, while Sheng discloses controlling a magnitude of the electrical stimulus (stimulator controls the stimulation amplitude, P.835, ¶4-5, Fig. 2), Sheng does not appear to disclose a computer that controls a magnitude of the electrical stimulus in response to a magnitude of the single contraction of the muscle.
However, in the same field of endeavor of neuromuscular electrical stimulation, Sharma teaches discloses a computer that controls a magnitude of the electrical stimulus in response to a magnitude of the single contraction muscle (a NMES feedback controller that controls the stimulation magnitude (voltage, current, or pulse-width modulation) of the electrical stimulus in response to a magnitude of the single contraction of the muscle, P.2, ¶6, P.3, ¶5, P.5, ¶6, P.6, ¶1-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Sharma’s known technique of providing for an electric stimulation feedback controller to modulate the amplitude of the stimulation to reach saturation to Sheng in further view of AlMohimeed in further view of Dieterich’s known apparatus for providing an electric stimulation controller to modulate the amplitude of stimulation to achieve the predictable result that the feedback controller accounts for an uncertain non-linear muscle model and bounded non-linear disturbances. See, e.g., Sharma, P.1.
Regarding claim 6, while Sheng discloses controlling a magnitude of the electrical stimulus (stimulator controls the stimulation amplitude, P.835, ¶4-5, Fig. 2), Sheng does not appear to disclose the computer increases the electric stimulus until the single contraction response of the muscle is saturated.
However, in the same field of endeavor of neuromuscular electrical stimulation, Sharma teaches the computer increases the electric stimulus until the single contraction response of the muscle is saturated (the NMES feedback controller increases the electric stimulus until the single contraction response of the muscle is saturated, P.2, ¶6, P.3, ¶5, P.5, ¶6, P.6, ¶1-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Sharma’s known technique of providing for an electric stimulation feedback controller to modulate the amplitude of the stimulation to reach saturation to Sharma’s known apparatus for providing an electric stimulation controller to modulate the amplitude of stimulation to achieve the predictable result that the feedback controller accounts for an uncertain non-linear muscle model and bounded non-linear disturbances. See, e.g., Sharma, P.1.
Regarding claim 12, while Sheng discloses controlling a magnitude of the electrical stimulus (stimulator controls the stimulation amplitude, P.835, ¶4-5, Fig. 2), Sheng does not appear to disclose a computer that controls a magnitude of the electrical stimulus in response to a magnitude of the single contraction of the muscle.
However, in the same field of endeavor of neuromuscular electrical stimulation, Sharma teaches discloses a computer that controls a magnitude of the electrical stimulus in response to a magnitude of the single contraction muscle (a NMES feedback controller that controls the stimulation magnitude (voltage, current, or pulse-width modulation) of the electrical stimulus in response to a magnitude of the single contraction of the muscle, P.2, ¶6, P.3, ¶5, P.5, ¶6, P.6, ¶1-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Sharma’s known technique of providing for an electric stimulation feedback controller to modulate the amplitude of the stimulation to reach saturation to Sharma’s known apparatus for providing an electric stimulation controller to modulate the amplitude of stimulation to achieve the predictable result that the feedback controller accounts for an uncertain non-linear muscle model and bounded non-linear disturbances. See, e.g., Sharma, P.1.
Regarding claim 13, while Sheng discloses controlling a magnitude of the electrical stimulus (stimulator controls the stimulation amplitude, P.835, ¶4-5, Fig. 2), Sheng does not appear to disclose a computer that controls a magnitude of the electrical stimulus in response to a magnitude of the single contraction of the muscle.
However, in the same field of endeavor of neuromuscular electrical stimulation, Sharma teaches discloses a computer that controls a magnitude of the electrical stimulus in response to a magnitude of the single contraction muscle (a NMES feedback controller that controls the stimulation magnitude (voltage, current, or pulse-width modulation) of the electrical stimulus in response to a magnitude of the single contraction of the muscle, P.2, ¶6, P.3, ¶5, P.5, ¶6, P.6, ¶1-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Sharma’s known technique of providing for an electric stimulation feedback controller to modulate the amplitude of the stimulation to reach saturation to Sharma’s known apparatus for providing an electric stimulation controller to modulate the amplitude of stimulation to achieve the predictable result that the feedback controller accounts for an uncertain non-linear muscle model and bounded non-linear disturbances. See, e.g., Sharma, P.1.
Regarding claim 14, while Sheng discloses controlling a magnitude of the electrical stimulus (stimulator controls the stimulation amplitude, P.835, ¶4-5, Fig. 2), Sheng does not appear to disclose a computer that controls a magnitude of the electrical stimulus in response to a magnitude of the single contraction of the muscle.
However, in the same field of endeavor of neuromuscular electrical stimulation, Sharma teaches discloses a computer that controls a magnitude of the electrical stimulus in response to a magnitude of the single contraction muscle (a NMES feedback controller that controls the stimulation magnitude (voltage, current, or pulse-width modulation) of the electrical stimulus in response to a magnitude of the single contraction of the muscle, P.2, ¶6, P.3, ¶5, P.5, ¶6, P.6, ¶1-5).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have applied Sharma’s known technique of providing for an electric stimulation feedback controller to modulate the amplitude of the stimulation to reach saturation to Sharma’s known apparatus for providing an electric stimulation controller to modulate the amplitude of stimulation to achieve the predictable result that the feedback controller accounts for an uncertain non-linear muscle model and bounded non-linear disturbances. See, e.g., Sharma, P.1.
Regarding claim 16, Sheng discloses a repetition period of the short pulses is shifted by a particular time from an integer multiple of a transmission repetition period of the ultrasonic waves transmitted by the ultrasonic wave pulse echo device, and the particular time is shorter than the transmission repetition period of the ultrasonic waves (a pulse frequency of the short pulses is shifted by a particular time from an integer multiple of the transmission pulse repetition frequency of the ultrasonic waves transmitted by the ultrasonic transducer, and the particular time is shorter than the transmission pulse repetition frequency of the ultrasonic waves, P.835, ¶4-P.836, ¶2, Fig. 2), and
the processing circuitry estimates a displacement of a muscle boundary of the single contraction response by sampling the displacement of the muscle boundary detected by the ultrasonic waves in a time frame of each period of the short pulses and overlapping the displacements of the muscle boundary in a plurality of time frames into one time frame (personal computer estimates a displacement of a muscle boundary of the single contraction response by sampling the displacement of the muscle boundary detected by the ultrasonic waves in a time frame of each period of the short pulses and summing the displacements of the muscle boundary in a plurality of time frames into one time frame, P.834, ¶2 – P.835, ¶835).
Allowable Subject Matter
Claims 21 and 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Silver et al. (“An ultrasonic technique for imaging of tissue motion due to muscle contraction” 2009) discloses a system and method using an electrical stimulator and a B-mode imaging ultrasound transmitter and receiver to evaluate muscle contractile properties using short electrical pulses, and a M-mode imaging ultrasound transmitter and receiver to evaluate muscle motion at muscle boundaries.
Vasseljen et al. ("Muscle activity onset in the lumbar multifidus muscle recorded simultaneously by ultrasound imaging and intramuscular electromyography” 2006) discloses a system and method using a M-mode imaging ultrasound transmitter and receiver to evaluate muscle motion at muscle boundaries by determining a depth range in the muscle tissue movement information.
Mannion et al. (“A new method for the noninvasive determination of abdominal muscle feedforward activity based on tissue velocity information from tissue Doppler imaging” 2008) discloses a system and method using a M-mode imaging ultrasound transmitter and receiver to evaluate muscle motion at muscle boundaries by determining a depth range in the muscle tissue movement information.
Dieterich et al. ("Separate assessment of gluteus medius and minimus: B-mode or M-mode ultrasound?” 2014) discloses a system and method using M-mode imaging ultrasound transmitter and receiver to evaluate muscle motion at muscle boundaries by determining a depth range in the muscle tissue movement information.
Huang (“Effect of ultrasonic probe movement on tissue displacement measurements for muscle monitoring” 2013) discloses a system and method using an ultrasound transmitter and receiver to evaluate muscle motion at muscle boundaries by determining a depth range in the muscle tissue movement information.
Dietrich et al. (“Muscle thickness measurements to estimate gluteus medius and minimus activity levels” 2014) discloses a system and method using M-mode imaging ultrasound transmitter and receiver to evaluate muscle motion at muscle boundaries.
Witte et al. (High resolution ultrasound imaging of skeletal muscle dynamics and effects of fatigue” 2004) discloses a system and method using M-mode imaging ultrasound transmitter and receiver to evaluate muscle motion at muscle boundaries and muscle contractile properties using short electrical pulses.
AlMohimeed et al. (“Flexible and wearable ultrasonic sensor for assessment of skeletal muscle contractile properties” 2019) discloses a system and method using an electrical stimulator and an ultrasound transmitter and receiver to evaluate muscle contractile properties using short electrical pulses allowing for complete relaxation of the muscle following contraction.
Huang et al. (“Estimation of wrist flexion angle from muscle thickness changes measured by a flexible ultrasonic sensor” 2016) discloses a system and method using an electrical stimulator and an ultrasound transceiver to evaluate muscle contractile properties using short electrical pulses allowing for complete relaxation of the muscle following contraction.
Turkistani et al. (“Continuous monitoring of muscle thickness changes during isometric contraction using a wearable ultrasonic sensor” 2013) discloses a system and method using an electrical stimulator and an ultrasound transceiver to evaluate muscle contractile properties using short electrical pulses allowing for complete relaxation of the muscle following contraction.
Huang et al. (“Ultrasonic monitoring of skeletal muscle response to electrical stimulation of peripheral nerve” 2014) discloses a system and method using an electrical stimulator and an ultrasound transceiver to evaluate muscle contractile properties using short electrical pulses allowing for complete relaxation of the muscle following contraction.
Deffieux et al. (“Ultrafast imaging of in vivo muscle contraction using ultrasound” 2006) discloses a system and method using an electrical stimulator and an ultrasound transceiver to evaluate muscle contractile properties using short electrical pulses allowing for complete relaxation of the muscle following contraction.
AlMohimeed et al. (“Development of wearable and flexible ultrasonic sensor for skeletal muscle monitoring” 2013) discloses a system and method using an electrical stimulator and an ultrasound transmitter and receiver to evaluate muscle contractile properties using short electrical pulses allowing for complete relaxation of the muscle following contraction.
Tous-Fajardo et al. (“Inter-rater reliability of muscle contractile property measurements using non-invasive tensiomyography” 2010) discloses a system and method using an electrical stimulator and an ultrasound transceiver to evaluate muscle contractile properties using short electrical pulses allowing for complete relaxation of the muscle following contraction.
Loram et al. (“Use of ultrasound to make noninvasive in vivo measurement of continuous changes in human muscle contractile length” 2006) discloses a system and method using an electrical stimulator and an ultrasound transceiver to evaluate muscle contractile properties using short electrical pulses allowing for complete relaxation of the muscle following contraction.
Qiu et al. (“Sonomyography analysis on thickness of skeletal muscle during dynamic contraction induced by neuromuscular electrical stimulation: a pilot study” 2017) discloses a system and method using an electrical stimulator and an ultrasound transceiver to evaluate muscle contractile properties using short electrical pulses allowing for complete relaxation of the muscle following contraction.
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.
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/J.M./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798