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 .
Election/Restrictions
Claims 19-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups II-III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 11th, 2025.
Applicant’s election without traverse of Group I (Claims 1-18) and Species V (Figures 8A-8C) in the reply filed on November 11th, 2025 is acknowledged.
Claim Objections
Claims 16-17 are objected to because of the following informalities:
Claim 16 recites “ECG system” in line 1, but should read “electrocardiogram (ECG) system”
Claim 16 recites “the signal-measuring electrode” in lines 1-2, but should read “the at least one signal-measuring electrode”
Claim 17 recites “EMG system” in line 1, but should read “electromyography (EMG) system”
Claim 17 recites “the signal-measuring electrode” in lines 1-2, but should read “the at least one signal-measuring electrode”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 9-11, and 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites “at least one of” in line 2. Further in line 3, Claim 3 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if both limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 9 recites “the conductor is comprised by” in line 1. It is unclear as to whether the Applicant meant to recite “the conductor comprises” instead, or if “comprised by” is meant to refer to a different meaning. Clarification is requested.
Claim 10 recites the limitation "the stretchable cable" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites “a patient” in line 2. It is unclear as to whether this limitation is referring to the previously introduced “patient” from Claim 1, or a separate element.
Claim 15 recites “a signal determined therefrom” in line 3. It is unclear as to whether this limitation is referring to the previously introduced “signal determined therefrom” from line 2 of Claim 15, or a separate element.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cha (U.S. Publication No. 2018/0098735).
Regarding Claim 1, Cha discloses a system for characterizing fluids in a tissue located in a portion of a patient (Body composition measurement using clamp electrodes; Abstract), comprising:
an impedance system comprising at least one current-injecting electrode configured to inject an electrical current into the portion of the patient (two current electrodes and two voltage electrodes are used to obtain impedance (or an electrical resistance value) for a body portion. For example, a current electrode pad and a voltage electrode pad are attached to or contacting a hand of a subject. Another current electrode and another voltage electrode are attached to or contacting a foot of the same subject; [0106]; Referring to FIGS. 4, 10 and 11, in order to analyze body compositions of a subject body, electrical measurements are first performed on the subject using the electrical measurement system 50; [0136]), and at least one signal-measuring electrode configured to measure an impedance signal affected by the injected electrical current and an amount of the fluids (While supplying electric current between the hand and the foot via the two current electrodes, a voltage difference or voltage drop between the hand and the foot via the two voltage electrodes is measured; [0106]; After clamping the clamp electrode apparatuses on the limbs of the subject body and connecting the electrodes of the clamp electrode apparatus to the terminals of the measurement system, the electrical measurement is performed by connecting the terminals to a current source 60 and a voltage measuring circuit 70 using the switching circuit 80; [0136]), wherein the system comprises an alignment feature that during use is aligned on the portion using a marking on the portion (the opening or channel 118 is used to place the clamp electrode apparatus 100 at a target location on a limb in reference with a reference mark…the clamp electrode apparatus 100 is arranged such that the reference mark is placed within the channel 118; [0120-0127]; An opening 322 is formed at the center of the integrated upper clamp body 312 of the clamp…the clamp electrode apparatus 400 or 500 is clamped at a specific position by aligning the opening 422 or 522 with a mark; [0155-0156]); and
a processing system configured to receive the impedance signal from the impedance system (the measurement system 50 may further have one or more processors and one or more memories, one or more storages, a display, a printer, etc. The memory stores one or more programs for controlling various devices or circuits included in the measurement system 50. Such programs can further process data and analyze body compositions; [0133]), or a signal determined therefrom, and then process it to determine a parameter related to the degree of fluids in the tissue (The amount of the applied current and the obtained voltage difference are processed to compute a value, which represents the impedance of a body portion extending from the hand to the foot via arm, trunk and leg; [0106]; impedances of body portions can be calculated using the voltage drops obtained in the first and second measurement settings…the impedance of an ankle can be used for body composition analysis; [0144-0145]).
Regarding Claim 2, Cha discloses wherein the alignment feature is one of an opening, optically transparent area, notch, or cut-out area configured to be disposed above the marking (the opening or channel 118 is used to place the clamp electrode apparatus 100 at a target location on a limb in reference with a reference mark…the clamp electrode apparatus 100 is arranged such that the reference mark is placed within the channel 118; [0120-0127]; An opening 322 is formed at the center of the integrated upper clamp body 312 of the clamp…the clamp electrode apparatus 400 or 500 is clamped at a specific position by aligning the opening 422 or 522 with a mark; [0155-0156]).
Regarding Claim 3, Cha discloses wherein the opening, optically transparent area, notch, or cut-out area is configured to allow the marking to be visualized when at least one of the current-injecting electrode and the signal-measuring electrode is attached to the portion (the clamp electrode apparatus 100 is arranged such that the reference mark is placed within the channel 118…a user can check if the reference mark is being located in the channel. When the reference mark is misaligned with respect to the channel, the user can move the clamp electrode apparatus and adjust the position or orientation of the clamp electrode apparatus such that the reference mark is located within the channel; [0121-0122]).
Regarding Claim 4, Cha discloses wherein the alignment feature is a component configured to contact the patient proximal to the marking (the clamp electrode apparatus 100 is arranged such that the reference mark is placed within the channel 118. For example, when clamping a wrist, the clamp electrode apparatus 100 is located and grips the wrist such that an ulnar head of the wrist is placed within the opening or channel 118. When clamping an ankle, the clamp electrode apparatus 100 is located and grips the ankle such that a malleolus of the ankle is placed within the opening or channel 118…use of the channel and the reference mark allows the clamp electrode apparatus to grip the same location of the limb with or without ignorable or tolerable errors; [0122]).
Regarding Claim 5, Cha discloses wherein the impedance system comprises two current-injecting electrodes and two signal-measuring electrodes (Two current electrodes and two voltage electrodes are used to obtain impedance (or an electrical resistance value) for a body portion. For example, a current electrode pad and a voltage electrode pad are attached to or contacting a hand of a subject. Another current electrode and another voltage electrode are attached to or contacting a foot of the same subject. While supplying electric current between the hand and the foot via the two current electrodes, a voltage difference or voltage drop between the hand and the foot via the two voltage electrodes is measured; [0106]).
Regarding Claim 6, Cha discloses wherein the impedance system comprises two electrode patches, with each electrode patch comprising one current-injecting electrode and one signal-measuring electrode (the clamp electrode apparatus 100 has a first electrode 122, a second electrode 152, a third electrode 124 and a fourth electrode 154. In the illustrated embodiments, electrode pads are attached to inside the first and second clamps to provide the first to fourth electrodes 122, 152, 124 and 154. Specifically, the first electrode 122 is attached to the upper clamp body 112 of the first clamp 110, and the third electrode 124 is attached to the lower clamp body 114 of the first clamp 110. The second electrode 162 is attached to the upper clamp body 152 of the second clamp 150, and the fourth electrode 164 is attached to the lower clamp body 154 of the second clamp 150. In some embodiments, the electrodes are embedded in the upper lower bodies of the first and second clamps; [0128-0129]; Figures 7-9).
Regarding Claim 7, Cha discloses an electrical cable connecting the two electrode patches (In embodiments, referring to FIG. 4, each of the electrodes may be connected to a terminal of the measurement system 50 using wires or cables. When measuring, all four electrodes may be connected to the terminals of the measurement system 50; [0130]).
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 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.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Cha in view of Nebuya (U.S. Publication No. 2016/0235334).
Regarding Claim 8, Cha fails to teach wherein the electrical cable further comprises a conductor characterized by a resistance that changes with mechanical strain.
In a similar technical field, Nebuya teaches a length measurement device, length measurement method, program, shape estimation device, and body fat percentage measurement device (Abstract),
wherein the electrical cable further comprises a conductor characterized by a resistance that changes with mechanical strain (the tape portion 10 of the length measurement device 1 according to the third embodiment is configured such that a plurality of strain gauges 140, 141, . . . 14 m (m is an integer of 1 or greater) which are an aspect of a curvature sensor are periodically arrayed at a constant interval B along a longitudinal direction. Each of the strain gauges 140, 141, . . . is a sensor that outputs a detection signal according to the degree of strain (bending) which is given to itself; [0184-0185]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the strain gauge teachings of Nebuya into the invention of Cha in order to obtain a detection signal according to the degree of strain (bending) (Nebuya [0185]).
Regarding Claim 9, Cha fails to teach wherein the conductor is comprised by a strain gauge.
In a similar technical field, Nebuya teaches a length measurement device, length measurement method, program, shape estimation device, and body fat percentage measurement device (Abstract), wherein the conductor is comprised by a strain gauge (strain gauges 140, 141, . . . 14 m (m is an integer of 1 or greater); [0184]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the strain gauge teachings of Nebuya into the invention of Cha in order to obtain a detection signal according to the degree of strain (bending) (Nebuya [0185]).
Regarding Claim 10, Cha fails to teach wherein the conductor is in electrical contact with a distance-measuring component that generates a signal related to a degree that the stretchable cable stretches.
In a similar technical field, Nebuya teaches a length measurement device, length measurement method, program, shape estimation device, and body fat percentage measurement device (Abstract),
wherein the conductor is in electrical contact with a distance-measuring component that generates a signal related to a degree that the stretchable cable stretches (“strain gauges” (strain gauges 140, 141, . . . ) which are periodically arrayed on the tape portion 10, but the “strain gauge” is nothing more than an aspect of a “curvature sensor” for acquiring curvature data at a position where each of the strain gauges is arrayed…specifically, the curvature sensor according to the another embodiment is configured such that two strain gauges and resistive elements having a well-known resistance value are electrically connected to each other so as to form a bridge circuit. In this manner, during the generation of a change in temperature or tensile and compressive stress, these error factors influence two strain gauges, and a change in the same characteristics and a change in resistance values in association therewith are caused on the both; [0201-0202]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the distance-measuring component teachings of Nebuya into the invention of Cha in order to accurately estimate the length based on curvature data acquired from the strain gauge (Nebuya [0201]).
Regarding Claim 11, Cha fails to teach wherein the distance-measuring component comprises a capacitor characterized by a capacitance value that changes with the degree that the stretchable cable stretches.
In a similar technical field, Nebuya teaches a length measurement device, length measurement method, program, shape estimation device, and body fat percentage measurement device (Abstract), wherein the distance-measuring component comprises a capacitor characterized by a capacitance value that changes with the degree that the stretchable cable stretches (the circuit shown in FIG. 4 may be configured such that various elements (such as resistive elements and capacitors) for impedance matching, and amplifiers or filters for improving the accuracy of detection are appropriately arrayed; [0077]; according to the length measurement device 1 of the modified example shown in FIG. 9, the electrode pads 100 a, 100 b, . . . are arrayed in a zigzag. Thereby, for example, when the electrical impedance between the electrode pads 101 a and 101 b shown in FIG. 9 is acquired, capacitive coupling between the electrode pad 100 b and the electrode pad 102 a adjacent to each other is reduced, and thus it is possible to keep the influence thereof to a minimum; [0122-0124]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the capacitor teachings of Nebuya into the invention of Cha in order to improve the accuracy of detection (Nebuya [0077]).
Claims 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Cha in view of Dhillon et al (U.S. Publication No. 2020/0352510).
Regarding Claim 12, Cha fails to teach an optical system comprising a light source and a photodetector.
In a similar technical field, Dhillon teaches a patch-based physiological sensor (Abstract), further comprising an optical system comprising a light source and a photodetector (The optical sensor 36 features an optical system 60 that includes an array of photodetectors 62, arranged in a circular pattern, that surround a LED 61 that emits radiation in the red and infrared spectral regions. During a measurement, sequentially emitted red and infrared radiation from the LED 61 irradiates and reflects off underlying tissue in the patient's chest, and is detected by the array of photodetectors 62; [0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the ECG teachings of Dhillon into the invention of Cha in order to enable processing of PPG waveforms, which can yield multiple parameters such as heart rate (HR), heart rate variability (HRV), respiration rate (RR), pulse oximetry (SpO2), blood pressure (BP), stroke volume (SV), cardiac output (CO), and parameters related to thoracic impedance, such as thoracic fluid content (FLUIDS) (Dhillon [0003]).
Regarding Claim 13, Cha fails to teach wherein the light source is configured to irradiate the tissue located in the portion of a patient.
In a similar technical field, Dhillon teaches a patch-based physiological sensor (Abstract), wherein the light source is configured to irradiate the tissue located in the portion of a patient (The optical sensor 36 features an optical system 60 that includes an array of photodetectors 62, arranged in a circular pattern, that surround a LED 61 that emits radiation in the red and infrared spectral regions. During a measurement, sequentially emitted red and infrared radiation from the LED 61 irradiates and reflects off underlying tissue in the patient's chest, and is detected by the array of photodetectors 62; [0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the ECG teachings of Dhillon into the invention of Cha in order to enable processing of PPG waveforms, which can yield multiple parameters such as heart rate (HR), heart rate variability (HRV), respiration rate (RR), pulse oximetry (SpO2), blood pressure (BP), stroke volume (SV), cardiac output (CO), and parameters related to thoracic impedance, such as thoracic fluid content (FLUIDS) (Dhillon [0003]).
Regarding Claim 14, Cha fails to teach wherein the photodetector is configured to detect radiation from the light source after it irradiates the tissue and, in response, generate a radiation-induced signal.
In a similar technical field, Dhillon teaches a patch-based physiological sensor (Abstract), wherein the photodetector is configured to detect radiation from the light source after it irradiates the tissue and, in response, generate a radiation-induced signal (The detected radiation is modulated by blood flowing through capillary beds in the underlying tissue. Processing the reflected radiation with electronics in the central sensing/electronics module 30 results in PPG waveforms corresponding to the red and infrared radiation, which as described below are used to determine BP and SpO2; [0087-0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the radiation teachings of Dhillon into the invention of Cha in order to enable processing of the reflected radiation in different spectral ranges to generate analog red-PPG and infrared-PPG waveforms (Dhillon [0013]).
Regarding Claim 15, Cha fails to teach wherein the processing system is further configured to receive the radiation-induced signal, or a signal determined therefrom, and process it along with the impedance signal or a signal determined therefrom to determine the parameter related to the degree of fluids in the tissue in the portion of the patient.
In a similar technical field, Dhillon teaches a patch-based physiological sensor (Abstract), wherein the processing system is further configured to receive the radiation-induced signal, or a signal determined therefrom, and process it along with the impedance signal or a signal determined therefrom to determine the parameter related to the degree of fluids in the tissue in the portion of the patient (The detected radiation is modulated by blood flowing through capillary beds in the underlying tissue. Processing the reflected radiation with electronics in the central sensing/electronics module 30 results in PPG waveforms corresponding to the red and infrared radiation; [0087-0089]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the radiation teachings of Dhillon into the invention of Cha in order to enable processing of the reflected radiation in different spectral ranges to generate analog red-PPG and infrared-PPG waveforms (Dhillon [0013]).
Regarding Claim 16, Cha fails to teach an ECG system in electrical contact with the signal- measuring electrode and configured to measure an ECG waveform.
In a similar technical field, Dhillon teaches a patch-based physiological sensor (Abstract), further comprising an ECG system in electrical contact with the signal- measuring electrode and configured to measure an ECG waveform (In light of the disclosure herein, disclosure herein, and without limiting the scope of the invention in any way, in a first aspect of the present disclosure, which may be combined with any other aspect listed herein unless specified otherwise, a sensor for measuring…an electrocardiogram (ECG) waveform from a patient's chest includes a housing configured to be located on the patient's chest…the sensor includes a set of electrodes that attach the optical sensor and the digital microphone to the patient's chest, with the set of electrodes connected to an ECG sensor configured to measure the ECG waveform; [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the ECG teachings of Dhillon into the invention of Cha in order to enable processing of ECG waveforms, which can yield multiple parameters such as heart rate (HR), heart rate variability (HRV), respiration rate (RR), pulse oximetry (SpO2), blood pressure (BP), stroke volume (SV), cardiac output (CO), and parameters related to thoracic impedance, such as thoracic fluid content (FLUIDS) (Dhillon [0003]).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Cha in view of Kim et al (U.S. Publication No. 2016/0147367).
Regarding Claim 17, Cha fails to teach an EMG system in electrical contact with the signal- measuring electrode and configured to measure EMG signals from muscle neurons in the patient.
In a similar technical field, Kim teaches an apparatus and method for measuring biosignals (Abstract), further comprising an EMG system in electrical contact with the signal-measuring electrode and configured to measure EMG signals from muscle neurons in the patient (Biosignals are any signals detected from a human body and include bioelectric signals, bio-impedance signals, or the like. The bioelectric signals may be in a current or voltage form, the current or voltage being generated by muscle cells or neurons. For example, electrocardiogram (ECG) signals, electromyogram (EMG) signals, electroencephalogram (EEG) signals, etc. are the bioelectric signals; [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the teachings of Kim into the invention of Cha in order to incorporate bioelectric signals such as electromyogram (EMG) signals, in order to obtain more information concerning body composition, blood volume, blood distribution, or the like (Kim [0060]).
Regarding Claim 18, although Cha discloses measuring body composition, Cha fails to specifically disclose wherein the processing system is further configured to process the EMG signals to determine adipose tissue concentration corresponding to the patient.
In a similar technical field, Kim teaches an apparatus and method for measuring biosignals (Abstract), wherein the processing system is further configured to process the EMG signals to determine adipose tissue concentration corresponding to the patient (electromyogram (EMG) signals, electroencephalogram (EEG) signals, etc. are the bioelectric signals. The bio-impedance signals are based on a voltage drop occurring due to an impedance of tissues, which is generated when a predetermined level of current flows in the tissues. The bio-impedance signals may include information concerning body composition...body fat may be measured by using the bio-impedance signals; [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the teachings of Kim into the invention of Cha in order to incorporate bioelectric signals such as electromyogram (EMG) signals, in order to obtain more information concerning body composition, specifically body fat (Kim [0060]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791