Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3, line 12 reads “a coordinate zero point connected the vertical axis with the horizontal axis”. There is a grammatical error in this sentence. Examiner suggests rephrasing to “a coordinate zero point connecting the vertical axis with the horizontal axis”. Claim 3, line 14 reads “coordinate plane defining by the vertical axis and the horizontal axis”. There is a grammatical error in this sentence. Examiner suggests rephrasing to “coordinate plane defined by the vertical axis and the horizontal axis”. Appropriate correction is 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.
Claims 1. 5-7, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Itoh (US 20170274250 A1) in view of Oishi (WO 2005032664 A1) and Chiang (US 20180056111 A1).
Regarding claim 1, Itoh teaches a cardiopulmonary rehabilitation assistance system, including: a training unit (paragraph 0020 “a configuration of the ergometer, which is an example of the electric training apparatus according to the embodiment of the present invention”), including a ergometer configured for a user to ride (paragraph 0020 "An exercising person EX sits on a body ERGB of an ergometer ERG to rotate pedals 205") and being controllable to adjust a load intensity (paragraph 0052 "The exercise control unit 213 is configured to perform control for gradually increasing the load of the load motor 202”); a physiological biosignal-monitoring unit (the group of sensors in Figs. 1 and 2); and a control unit (Fig. 2 control device 20 and load motor control 10 are collectively a control unit), electrically connected with the ergometer (Fig. 4 where load control 213a is connected with control unit 21), controlling the ergometer to perform an assisted exercise program; wherein in the assisted exercise program, the ergometer adjusts the load intensity according to a predetermined resistance given protocol (claim 1 “the load of the load motor toward a set load upper limit value so that the detection result of the exercise physiological response value of the exercising person approaches a target exercise physiological response value set in advance”).
Itoh is silent on an exercise assistance unit, including an intake tube near the user and an oxygen supply module communicated with the intake tube and configured to supply oxygen to the intake tube and a control unit electrically connected with the oxygen supply module and controls the oxygen supply module to supply extra oxygen when a physiological parameter is out of a suggested range.
However, Oishi teaches an exercise assistance unit including an intake tube near the user (page 7 paragraph 4 “an oxygen mouse 933 extending from one head pad 932 via a hard tube”) and an oxygen supply module (Fig. 1 oxygen generating section 90) communicated with the intake tube and configured to supply oxygen to the intake tube (page 7 paragraph 4 “The oxygen mouse 933 is provided with an oxygen-enriched air ejection hole formed at a position facing the mouth of the exerciser, and the exerciser sucks the oxygen-enriched air ejected from the ejection hole") and a control unit electrically connected with the oxygen supply module and controls the oxygen supply module to supply extra oxygen when a physiological parameter is out of a suggested range (page 10 paragraph 9 "The oxygen supply instruction determination unit 140 detects the pulse from the pulse meter 300 in a state in which the oxygen on / off switch 65 6 is set to on (that is, in a state in which the oxygen enrichment device 91 is driven). It outputs a control signal for adjusting the driving state of the oxygen enrichment device 91 based on the signal. When the pulse rate detected by the pulse meter 300 exceeds a preset value, the oxygen enrichment is performed. Control signal to increase the driving state to the oxygen enrichment unit 91, while returning the pulse rate to the original state Signal is output").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Itoh to include an oxygen supply module with an intake tube that is electrically connected to a control unit. Including the oxygen supply module can make the exercise easier and decrease the burden on a user’s respiratory system, which is critical in the rehabilitation process (page 13 paragraph 3 “With appropriate fitness, it is possible to secure the required amount of exercise without burdening the respiratory function, which can contribute to both health promotion and physical fitness”). It would have been obvious to connect the oxygen supply to the control unit in a similar way in order to have an automatic control of the oxygen supply without requiring user input and use the sensor parameters to supply oxygen when needed.
Itoh is silent on a blood oxygen saturation sensor configured to measure a blood oxygen saturation of the user and control unit electrically connected to the sensor.
However, Chiang teaches a blood oxygen saturation sensor (paragraph 0043 "The physiology parameter for reflecting the body intensity or assisting to determine exercise intensity comprises: heart rate, respiratory rate, blood pressure, oxygen saturation, body temperature, electrocardiograph signals, or electromyogram signals”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Itoh to include a sensor configured to measure blood oxygen saturation. Blood oxygen saturation can provide more data to the control unit and user about the respiratory function of the user and the impact of the exercise on a person’s cardiovascular status without requiring more invasive evaluation techniques.
It would have been further obvious based on Itoh as modified by Oishi and Chiang that during the assisted exercise program, the control unit performs at least one of a training assistance program and an exercise safety program; in the training assistance program, the control unit controls the oxygen supply module to supply extra oxygen when the blood oxygen saturation is out of a suggested saturation range; and in the exercise safety program, the control unit controls the ergometer to reduce the load intensity or stop when the blood oxygen saturation is lower than a critical saturation value (Itoh, paragraph 0051 "The exercise control unit 213 is configured to control the exercise performed by the exercising person EX based on signals from the various sensors (SE1 to SE5)"; paragraph 0073 "The load control unit 213a is configured to perform load control so that a detection result of the exercise physiological response of the exercising person EX approaches a target exercise physiological response value set in advance"). It would have been obvious to supply the extra oxygen using the blood oxygen saturation measurement as a parameter as this measurement provides insights into a user’s respiratory function and is an indicator of potential oxygen deficiency. It also would have been obvious for the blood oxygen saturation to be one of the exercise physiological responses that the load control as this is an indicator of the burden of the exercise on the user’s lungs and would be important to monitor as it relates to the exercise intensity.
Regarding claim 5, modified Itoh teaches the system of claim 1.
Itoh further teaches further including an exercise safety detection unit, wherein the exercise safety detection unit includes a rotational speed sensor disposed on the ergometer and electrically connected with the control unit to detect a rotational speed of the ergometer (paragraph 0021 "an encoder SES, which is a pedaling rate detection unit mounted to the load motor 202 and configured to detect a rotation speed of the motor in order to obtain a pedaling rate of the pedals 205") and in the assisted exercise program, the predetermined resistance given protocol represents the load intensity of the ergometer at a plurality of exercise stages during an exercise period (paragraph 0056 "a warm-up load LT; [0057] a first load upper limit value LM1 after the warm up by the exercising person EX; and [0058] a set period T1 required until the post-warm-up load is increased to the first load upper limit value"; Itoh discloses a plurality of stages distinguished by different time periods and predetermined load limits that is analogous to the predetermined resistance given protocol).
Regarding claim 6, modified Itoh teaches the system of claim 5.
Itoh further teaches wherein each of the plurality of exercise stages corresponds to a preset rotational speed (paragraph 0061 “When warming up of a duration set in advance finishes at a time t1, the load of the load motor 202, namely, any one or a plurality of the load torque, the power, and the pedaling rate, is/are increased for the period T1 from the warm-up load to the first load upper limit value LM1”; paragraph 0061 discusses how the load of the motor is increased to preset limits in different stages and these loads can be increased by increasing the pedaling rate), in the exercise safety program, when the rotational speed sensor senses the rotational speed of the ergometer is lower than the preset rotational speed corresponding to one of the plurality of exercise stages being performed, the control unit controls the load intensity of the ergometer to remain unchanged or reduce in next one of the plurality of exercise stages (paragraph 0051 “The exercise control unit 213 is configured to control the exercise performed by the exercising person EX based on signals from the various sensors (SE1 to SE5)” where SE5 is the encoder to detect rotational speed; paragraph 0052 “The exercise control unit 213 is configured to perform control for gradually increasing the load of the load motor 202” therefore the exercise control unit can control the load intensity based on the rotational speed from SE5).
Regarding claim 7, modified Itoh teaches the system of claim 5.
Itoh further teaches wherein the control unit controls the load intensity of the ergometer to be gradually increased with the plurality of exercise stages in sequence during the exercise period (paragraph 0056 "a warm-up load LT; [0057] a first load upper limit value LM1 after the warm up by the exercising person EX; and [0058] a set period T1 required until the post-warm-up load is increased to the first load upper limit value"; the loads increase after each exercise stage).
Regarding claim 9, modified Itoh teaches the system of claim 1.
Itoh further teaches wherein the physiological biosignal-monitoring unit further includes a blood pressure sensor configured to measure a blood pressure of the user (paragraph 0024 "a blood pressure meter SE3, which is attached to an arm of the exercising person EX, and is configured to detect a blood pressure") and in the exercise safety program, the control unit controls the ergometer to reduce the load intensity or stop when the control unit determines that the user is in a blood pressure abnormal status according to the blood pressure measured by the blood pressure sensor (paragraph 0052 "The exercise control unit 213 is configured to perform control for gradually increasing the load of the load motor 202 toward a set load upper limit value so that an exercise physiological response value obtained based on the heart rate of the exercising person approaches a target exercise physiological response value"; paragraph 0091 "Further, blood pressure may be used as the exercise physiological response value of the exercising person. In this case, all of the features may be achieved by replacing the above-mentioned heart rate with the blood pressure").
Regarding claim 10, modified Itoh teaches the system of claim 1.
Modified Itoh is silent wherein the physiological biosignal-monitoring unit further includes an electrocardiogram (ECG) sensor configured to measure ECG signals of the user and in the exercise safety program, the control unit controls the ergometer to reduce the load intensity or stop when the control unit determines that the user is in a ECG abnormal status according to the ECG signals measured by the electrocardiogram sensor.
However, Chiang teaches an ECG sensor to measure ECG signals that communicate with a control unit (paragraph 0033 "The heart rate sensor 70 further comprises a sensing circuit (not shown) built in the handle assembly 40 and electrically connected to the metal plates 72. It is able to sense the electrocardiograph (ECG) signals and/or the electromyogram (EMG) signals of the user's hands via the metal plates 72 so as to detect the occurrence and frequency of the heartbeats of the user"; paragraph 0033 “The control unit 60 is electrically connected the heart rate sensor 70”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Itoh to include a sensor configured to measure ECG signals. The ECG signals can provide insights into a patient’s cardiac health and provides another way to monitor the user’s health and determine how a user’s heart is responding to the training. It would have been further obvious to use the ECG signals as a parameter in the control unit to adjust the load intensity as the control unit can use a variety of physiological response values and the ECG signals provide more specific load control based on a user’s heart health (Itoh, paragraph 0051 "The exercise control unit 213 is configured to control the exercise performed by the exercising person EX based on signals from the various sensors (SE1 to SE5)"; paragraph 0073 "The load control unit 213a is configured to perform load control so that a detection result of the exercise physiological response of the exercising person EX approaches a target exercise physiological response value set in advance").
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Itoh (US 20170274250 A1) in view of Oishi (WO 2005032664 A1) and Chiang (US 20180056111 A1) as applied to claim 1 and in further view of Sankai (US 20220118315 A1) and Evans (US 20200360690 A1).
Regarding claim 2, modified Itoh teaches the system of claim 1.
Modified Itoh is silent wherein the exercise assistance unit further includes an output tube near the user and the physiological biosignal-monitoring unit further includes a gas sensor configured to sense changes of a gas flow in the output tube.
However, Sankai teaches an output tube near the user (paragraph 0080 "a passage for making the subject's respiratory air flow through a mouthpiece 54 held between the subject's teeth") and a gas sensor configured to sense changes of a gas flow in the output tube (paragraph 0080 "a gas sensor 57 composed of a light-emitting unit 55 which emits infrared light to a passage for making the subject's respiratory air flow through a mouthpiece 54 held between the subject's teeth").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Itoh to include an output tube and gas sensor. The gas sensor measurements may be added to the control unit as a way to adjust the autonomous versus voluntary control of the exercise intensity (paragraph 0076 “a concentration of carbon dioxides contained in the subject's exhaled gas may be detected and the detection result may be added to the adjustments of the hybrid ratio of the voluntary control and the autonomous control”). It would have been obvious to include an output tube in order to create an area for the sensor to interface with the user’s expired air and create a pathway for the sensor to make physiological measurements.
Modified Itoh is silent wherein the exercise assistance unit further includes a positive pressure air supply module communicated with the intake tube and configured to supply gas to the intake tube.
However, Evans teaches a positive pressure air supply module (Fig. 2 where 1007 is an external respiratory support; paragraph 0143 “Systems herein may further comprise an external respiratory support device, such as a positive pressure respiratory device for moving gas into the lungs of the patient”) communicated with an intake tube and configured to supply gas to the intake tube (Fig. 2 shows external respiratory support 1007 being connected to a user intake tube).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Itoh to include a positive pressure air supply to supply gas to the intake tube. The positive pressure supply can enhance the efficiency of a user’s respiration (paragraph 0098 “In some embodiments, this delivery of positive pressure ventilation and neuromuscular stimulation may enhance the efficiency of the respiratory cycle”). It can also balance the gas levels and gas flow in a user’s lungs (paragraph 0143 “The controller may optimize the delivery of positive pressure from the positive pressure respiratory device and/or the stimulation energy from the respiratory muscle stimulator to balance the gas level and flow in the various regions of the patient's lungs during a respiratory cycle”).
Claims 8 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Itoh (US 20170274250 A1) in view of Oishi (WO 2005032664 A1) and Chiang (US 20180056111 A1) as applied to claim 5 and in further view of Shimada (WO 2016203664 A1).
Regarding claim 8, modified Itoh teaches the system of claim 8.
Itoh further teaches further including a display unit disposed on the ergometer (paragraph 0031 “As in an example illustrated in FIG. 3, the touch panel monitor 22 includes a parameter display area 22a configured to display various parameters”).
Modified Itoh is silent wherein the control unit controls the display unit to display a low-speed prompt when the rotational speed sensor senses the rotational speed of the ergometer is lower than corresponding one of said preset rotational speeds.
However, Shimada teaches wherein the control unit controls the display unit (page 7 paragraph 2 “the control device unit 136 controls the electric device 120 and the touch panel 131”) to display a low-speed prompt when the rotational speed sensor senses the rotational speed of the ergometer is lower than corresponding one of said preset rotational speeds (page 7 paragraph 2 "On the touch panel 131, when the speed at which the user pedals the pedal 111 is too fast, it is displayed that the speed is too fast, and when the speed at which the user strokes the pedal 111 is too slow, it is displayed that the speed is too slow").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Itoh so the control unit controls the display to display a message when the rotational speed is low. This allows the control unit to communicate with the user and allows the user to adjust their speed to produce the desired physiological output (page 7 paragraph 2 “The user adjusts the speed of pedaling 111 with reference to these displays, and feels the speed of pedaling appropriate pedal 111”).
Regarding claim 12, modified Itoh teaches the system of claim 1.
Modified Itoh is silent wherein the training unit further includes a stop switch electrically connected with the control unit, and the control unit controls the ergometer to stop when the stop switch is triggered.
However, Shimada teaches a stop switch electrically connected with the control unit, and the control unit controls the ergometer to stop when the stop switch is triggered (page 3 paragraph 6 “On the touch panel 131, the rotation speed of the pedal 111, various input buttons, such as an emergency stop button”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the product of Itoh to include a stop switch that stops the ergometer. This allows the user a way to control the ergometer in an emergency and allows the user to maintain their own safety during use.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Itoh (US 20170274250 A1) in view of Oishi (WO 2005032664 A1) and Chiang (US 20180056111 A1) as applied to claim 1 and in further view of Zhang (US 20160051847 A1).
Regarding claim 11, modified Itoh teaches the system of claim 1.
Modified Itoh is silent on further including a humidification unit, wherein the humidification unit is configured to supply a water vapor with a constant temperature to the intake tube.
However, Zhang teaches a humidification unit, wherein the humidification unit is configured to supply a water vapor with a constant temperature to the intake tube (paragraph 0053 "The oxygen-rich air having the pressure difference that flows into the humidifying box 123 is humidified by the humidifying box 123 and filtered for output to the exerciser or an air collection tank").
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Itoh to include a humidification unit. Humidifying the intake gas can make the inhaled gas more like natural air and therefore making the inspiration of the gas more comfortable and natural without drying out a user’s respiratory system.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Itoh (US 20170274250 A1) in view of Oishi (WO 2005032664 A1) and Chiang (US 20180056111 A1) as applied to claim 1 and in further view of Zitvogel (US 20200269122 A1).
Regarding claim 13, modified Itoh teaches the system of claim 1.
Modified Itoh is silent on further including a wearable device, wherein the wearable device is communicated with the control unit and configured to display a virtual image.
However, Zitvogel teaches a wearable device (Fig. 1, reference 1.7), wherein the wearable device is communicated with the control unit (paragraph 0066 “the virtual reality headset 1.7 also transmits movement information to the virtual environment generator 1.6. This information relates to the head movements made by the user and is integrated into the movement information received by the control computer 1.5 for the generation of the virtual environment”) and configured to display a virtual image (paragraph 0070 “The virtual reality headset is typically a three-dimensional viewing headset equipped with headphones. The images generated are therefore typically three-dimensional images comprising an image intended for each of the user's eyes”).
Thus, it would have been obvious to one having ordinary skill in the art before the effective filing
date of the claimed invention to have modified the product of Itoh to include a wearable device that displays a virtual image. The wearable device can make using the device more enjoyable and entertaining for the user, which encourages the user to consistently use the device (paragraph 0005 “Coupled with a mechanical system for practicing sports, virtual reality makes it possible to simulate the sporting activity in a virtual environment which can, for example, simulate an outdoor activity. Thus, the activity is made more entertaining and enjoyable than an activity in a fixed indoor environment”).
Allowable Subject Matter
Claims 3 and 4 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the closest prior art of record is Aoki (US 20210137467 A1) and Hisahara (WO 2021010150 A1) which both disclose different charts analyzing respiratory function. The prior art does teach charts with flow rate on the vertical axis, total flow on the horizontal axis, a zero point on the axis connection and a curve on the first quadrant of the coordinate plan. However, the art does not teach the chart analysis performed by the control unit, specifically the rectangular ratio, and how the ratio is sued to modulate the positive pressure air supply. Although the art does analyze the data on the chart, it would not have been obvious to analyze the exhalation chart with these specific limitations.
Regarding claim 4, the closest prior art of record is Zhang (WO 2009129739 A1) which teaches a medicinal supply that can be inserted into an oxygen supply tube. However, since claim 4 is dependent on claim 3, and requires the use of the rectangular ratio to adjust the medicine being supplied to the user. It would not have been obvious to use a rectangular ratio to control the medicine supplied to the user and therefore claim 4 is objected to.
Conclusion
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/AKHIL A JAYAN/Examiner, Art Unit 3785
/VICTORIA MURPHY/Primary Patent Examiner, Art Unit 3785