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 .
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyung (U.S 2016/0143800 A1)
Regarding claim 16, Hyung discloses a method of controlling a wearable device performed by the wearable device (Abstract, Claim 1), the method comprising:
determining whether a walking state of a user of the wearable device is a normal state based on test movement information of the user obtained through test walking (Paragraph 0034, 0036, 0087, 0093, 0102-0103, 0109; A reference gait model may be generated according to the body information detected compared to a desired/predetermined body model; The assistive forces are generated to adjust the gait when the user deviates from the desired gait model; also see Paragraph 0084 regarding determination of a muscle being in an abnormal state according to poor bilateral symmetry/poor gait);
determining first correction torque information based on the test movement information, when the walking state is not the normal state (Paragraph 0102-0103, 0087 and 0093, 0097; A corrective torque is applied to drive the user towards normal gate and thus is applied when the walking state deviates from the normal/when the walking state is not the normal state), wherein the first correction torque information comprises a control signal for at least one of a drive module (Paragraph 0075, 0177-0179; Controller 140, which may include one or multiple processors, determines the assistive torque to be provided via the drive module 120), each of drive module a motor and/or circuitry (Paragraph 0075, 0177-0179, the controller drives the actuator and thus comprises connective circuitry); and
outputting a first correction torque corresponding to the first correction torque information through at least one of the drive module (Paragraph 0075, 0177-0179, the controller drives the actuator/drive module and thus outputs any determined correction torque).
Regarding claim 18, Hyung discloses the device of claim 16.
Hyung further discloses wherein the determining whether the walking state of the user is the normal state comprises: determining whether the walking state of the user is the normal state at least by comparing a test movement range obtained based on the test movement information and a preset reference movement range (Paragraph 0097, 0115; The corrective torque profile is delivered to the user to prompt them into a normal gait and thus is based on the comparison/difference between the measured gait range and the optimal/desired/reference gait movement range; Additionally, muscles are determined to be within normal range according to bilateral symmetry and poor gait and thus is based on comparison between the measured test gait range and the preset/baseline/optimal/reference gait range).
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.
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 1-6, 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Hyung (U.S 2016/0143800 A1) in view of Angold (U.S 2011/0166489 A1).
Regarding claim 1, Hyung discloses a wearable device (Abstract, Claim 1), comprising:
a base body, comprising a housing, configured to be disposed proximate to a waist portion of a user (Fig. 1A-B; Walking assistance apparatus 100 and housing of IMU sensor 130, includes a housing/main body portion around the waist of the user);
a waist support frame and a leg support frame configured to support at least a portion of the body of the user (Fig. 1; The device includes left and right hip plates/supports and leg supports which project from sensor portion 120/driving portion 110);
a thigh fastener configured to attach the leg support frame to a thigh of the user (see Fig. 1A-B, the leg support frame is connected to the user via a fastening band/loop about the thigh);
an inertial measurement unit (IMU), comprising circuitry, disposed in the base body (Fig. 1B and Paragraph 0069, 0073; IMU sensor 130 is disposed in the housing of the base body along with controller 140);
a drive module, comprising a motor and/or circuitry, configured to generate a torque to be applied to a leg of the user (driving portion 110, see Fig. 1 and Paragraph 0069-0071, 0075; The driving portion provides torque to the legs/hips to assist the user; Controller 140 controls the output signals and modulation of the torque);
an angle sensor configured to measure a rotation angle of the leg support frame (Paragraph 0018-0019, 0071; Sensor portion 120 may measure hip joint angle with respect to the legs to determine the torque to be applied); and
a control module comprising at least one processor configured to control at least part of the wearable device (Paragraph 0075, 0177-0179; Controller 140, which may include one or multiple processors, determines the assistive torque to be provided).
Hyung is silent regarding wherein the leg support frame comprises: a first partial leg support frame connected to the drive module; a second partial leg support frame connected to the thigh fastener; a hinge configured to connect the first partial leg support frame and the second partial leg support frame; and an additional drive module, comprising an actuator and/or circuitry, configured to control a movement of the second partial leg support frame with respect to the first partial leg support frame.
However, Angold teaches wherein the leg support frame comprises a first partial leg support frame connected to the drive module, a second partial leg support frame connected to the leg fastener, a hinge configured to connect the first partial leg support frame and the second partial leg support frame (see Fig. 2 and Paragraphs 0035-0036; The leg frame includes a first leg support frame, thigh link 101, which is connected to the first drive module 106 to the hip link 102; A second leg support frame, shank link 104, is connected to the thigh link via orthotic hinge joint 105; also Paragraph 0035 describes use of straps to affix the orthotic to the wearer); and an additional drive module, comprising an actuator and/or circuitry, configured to control a movement of the second partial leg support frame with respect to the first partial leg support frame (see Fig. 2 and Paragraph 0036; A linear actuator 112 may drive torque about the knee to provide the assistive/adaptive movement).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of XXXXX to have included multiple partial leg support frames connected to the hip drive module and leg fastener and to include an additional drive module to control movement of said partial leg support frames, such as that taught by Angold, in order to produce additional torque about the multiple joints of the leg and thus better compensate for, or assist, the user’s motion during use (Paragraph 0036).
Regarding claim 2, Hyung discloses the device of claim 1.
Hyung is silent regarding specifically wherein a battery configured to supply power to the wearable device.
However, Angold further teaches wherein batteries may provide the power necessary to drive the controller and torque generators of the device (Paragraph 0036).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Hyung to include batteries to supply power to the device, such as that taught by Angold, in order to use known and routine power sources suitable for driving actuators and controllers of assistive orthotic devices (Paragraph 0036).
Regarding claim 3, Hyung discloses the device of claim 1.
Hyung further discloses a communication module, comprising communication circuitry, configured to perform short-range wireless communication with an external device (Paragraph 0109, 0126, 0166 and Fig. 10-11; The device may have a communication module that can communicate with external devices to allow remote extraction of assisting torque profiles and transmission of optimal assistive profiles; also see Paragraph 0025/0112 regarding wireless receiving of gait models or profiles from an external server).
Regarding claim 4, Hyung discloses the device of claim 1.
Hyung is silent regarding wherein the leg support frame further comprises: an additional angle sensor configured to measure an angle between the first partial leg support frame and the second partial leg support frame.
However, Hyung teaches use of an angle sensor about/in proximity to the actuator to determine the torque to be applied based on the measured joint angle at a point in the gait cycle (Paragraph 0018-0019, 0071; Sensor portion 120 may measure hip joint angle with respect to the legs to determine the torque to be applied).
Angold also teaches use of a second actuator about the knee/lower leg to further drive the joints and provide corrective or assistive torque (Paragraph 0036).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have included a second angle sensor to measure the angle between the first and second partial leg support frames, such as that taught by Hyung and Angold, in order to also determine the assistive torque to be applied at the knee between the thigh/shank portions based on the sensed angle (Paragraph 0018-0019, 0071 of Hyung), and to provide assistive force according to the knee joint angle as is done for the hip (Paragraph 0036 of Angold).
Regarding claim 5, Hyung discloses the device of claim 1.
Angold further teaches wherein the additional drive module comprises a linear actuator (see Fig. 2 and Paragraph 0039; Linear actuators 110/112 are used to drive the hip/knee joints and are advantageous for providing more constant torque over the range of motion and to increase the range of motion where non-zero torque can be applied).
Regarding claim 6, Hyung discloses the device of claim 1.
Hyung further discloses wherein the at least one processor is configured to perform: an operation determining whether a walking state of the user is a normal state based on test movement information of the user obtained through test walking (Paragraph 0034, 0036, 0087, 0093, 0102-0103, 0109; A reference gait model may be generated according to the body information detected compared to a desired/predetermined body model; The assistive forces are generated to adjust the gait when the user deviates from the desired gait model; also see Paragraph 0084 regarding determination of a muscle being in an abnormal state according to poor bilateral symmetry/poor gait); an operation determining first correction torque information based on the test movement information when the walking state is not the normal state, wherein the first correction torque information comprises a control signal for at least one of the drive module or the additional drive module (see Paragraph 0097, 0115; A first assistive torque profile may be determined to prompt the user into a normal gait); and an operation outputting a first correction torque corresponding to the first correction torque information through at least one of the drive module or the additional drive module (Paragraph 0097, 0115; The corrective torque profile is delivered to the user to prompt them into a normal gait; This step is merely a driving of the determined corrective torque profile and thus is done in use).
Regarding claim 11, Hyung discloses the device of claim 6.
Hyung further discloses wherein the operation determining whether the walking state of the user is the normal state comprises: determining whether the walking state of the user is the normal state at least by comparing a test movement range obtained based on the test movement information and a preset reference movement range (Paragraph 0097, also see Paragraph 0084, muscle usage data ranges and bilateral symmetry ranges are used to determine if a muscle is in a normal state; Outside of these ranges, a muscle may be determined to be in an abnormal state).
Regarding claim 12, Hyung discloses the device of claim 11.
Hyung further discloses wherein the operation determining whether the walking state of the user is the normal state at least by comparing the test movement range obtained based on the test movement information and the preset reference movement range comprises: calculating a difference between the test movement range and the reference movement range (Paragraph 0084, 0097; The muscle usage data and bilateral symmetry ranges are determined and a difference between the two allows for determination of a muscle as ‘abnormal’ and thus out of the range when the difference is calculated/determined); and determining that the walking state of the user is not the normal state, in response to the difference between the test movement range and the reference movement range exceeding a preset first threshold value (Paragraph 0084, 0097; A muscle is only determined as abnormal when compared to a normal operating range and thus the muscle must exceed/drop below a particular threshold in order to be denoted as ‘abnormal’; In other words, the detection of an abnormal muscle necessarily involves the evaluation of a difference between the problem muscle and the normal baseline range).
Regarding claim 13, Hyung discloses the device of claim 11.
Hyung further discloses wherein the operation determining the first correction torque information based on the test movement information when the walking state is not the normal state comprises: determining the first correction torque information based on a difference between the test movement range and the preset reference movement range (Paragraph 0097, 0115; The corrective torque profile is delivered to the user to prompt them into a normal gait and thus is based on the comparison/difference between the measured gait range and the optimal/desired/reference gait movement range).
Claims 7-9 rejected under 35 U.S.C. 103 as being unpatentable over Hyung (U.S 2016/0143800 A1) in view of Angold (U.S 2011/0166489 A1), as applied to claims 1 and 6, in further view of Lamb (U.S 2020/0375836 A1).
Regarding claim 7, Hyung discloses the device of claim 6.
Hyung further discloses obtaining the test movement information when the wearable device is normally worn on the body of the user (Paragraph 0034, 0036, 0087, 0093, 0102-0103, 0109; The test movement information which is compared to the reference/desired gait is obtained when the wearable device is normally worn on the body; It is assumed that the device is operated when properly worn as this is the base case; Alternatively, the body information will still be collected after fixing and normally donning the device).
Hyung is silent regarding wherein the at least one processor is configured to further perform: an operation determining whether the wearable device is normally worn on the body of the user.
However, Lamb teaches wherein an operation carried out by the processor determines whether the wearable device is normally worn on the body of the user (Paragraph 0062-0063; Determination is made after test actuation of the device if the displacement angles are beyond a certain threshold which is indicative of improper fit; also see Paragraph 0067 regarding detection of lack of contact between a portion of the device and the user; Sensors may detect strap tension or coupler tension).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Hyung to have included the processor determining normal adornment of the device on the body, such as that taught by Lamb, in order to limit use of the device until a subsequent fit is made and ensure safety of the user (Paragraph 0062, where power/actuation/ROM is limited when the device is determined to be improperly fitted).
Regarding claim 8, Hyung discloses the device of claim 7.
Hyung further discloses wherein the test movement information comprises test pelvic movement information of the user obtained through the IMU (see Paragraph 0073 and 0119; The IMU sensor may provide the angle/angular velocity of the hip joint to determine the corrective torque based on the measured user data compared to the reference/desired gait model).
Regarding claim 9, Hyung discloses the device of claim 7.
Hyung further discloses wherein the test movement information comprises straight leg movement information of the user obtained through the angle sensor (see Paragraph 0073 and 0119; The IMU sensor may provide the angle/angular velocity of the hip joint to determine the corrective torque based on the measured user data compared to the reference/desired gait model; It is noted that the sensor will collect data through all phases of the gait cycle, to include ‘straight leg movement’ when the hip angles are at a maximum; Additionally, such angles are used to determine the degree of torque, where the torque is minimized when the hip angles are at a maximum and the legs are relatively straight, such as in Fig. 1A).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hyung (U.S 2016/0143800 A1) in view of Angold (U.S 2011/0166489 A1) and Lamb (U.S 2020/0375836 A1), as applied to claims 1 and 6-7, in further view of Choi (U.S 2020/0179216 A1).
Regarding claim 10, Hyung discloses the device of claim 7.
Hyung further teaches wherein the test movement information comprises lateral leg angles (Paragraph 0097, 0115, the determination of abnormal muscles from normal movement/muscles is based on bilateral symmetry of the gait).
Hyung is silent regarding specifically wherein the test movement information comprises lateral leg movement information of the user obtained through an additional angle sensor configured to measure an angle between the first partial leg support frame and the second partial leg support frame of the leg support frame.
However, Choi teaches wherein gait correction can include adjusting lateral leg movement information of the user from the angle measured between the first partial leg support frame and the second partial leg support frame of the leg support frame (see Fig. 10-11 and Paragraph 0095; Lateral angles of about the knee may be adjusted through applied torque via about the thigh support frame and lower leg/shank support frame; The correction of lateral angles of the legs can prevent bone-on-bone contact in the knee).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Hyung to have included monitoring and adjusting the lateral angles of the legs through the leg support frames, such as that taught by Hyung and Choi, in order to further correct posture/gait and prevent joint wear (Paragraph 0095 of Choi) and to adjust the gait to be bilaterally symmetric (Paragraph 0097 of Hyung).
Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hyung (U.S 2016/0143800 A1) in view of Angold (U.S 2011/0166489 A1), as applied to claims 1 and 6, in further view of Lerner (U.S 2019/0344434 A1).
Regarding claim 15, Hyung discloses the device of claim 6.
Hyung is silent regarding executing a preset muscular strength-assisting exercise program to assist a muscular strength of the user, when the walking state is the normal state.
However, Lerner teaches an exoskeleton rehabilitation device in which resistance is increased when the user has increased performance metrics and is near-normal gait (Paragraph 0101; As a user improves their mobility or strength the resistance may be increased; Thus, as the gait/mobility approaches normal, or is determined to be normal, the resistance will increase to continually strengthen the muscles).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Hyung to have included executing a present strength-assisting exercise program when the walking state is approaching/at normal state, such as that taught by Lerner, in order to reduce assistance and increase muscle strength as the user improves (Paragraph 0101).
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hyung (U.S 2016/0143800 A1), as applied to claim 16, in view of Lamb (U.S 2020/0375836 A1).
Regarding claim 17, Hyung discloses the device of claim 16.
Hyung further discloses obtaining the test movement information when the wearable device is normally worn on the body of the user (Paragraph 0034, 0036, 0087, 0093, 0102-0103, 0109; The test movement information which is compared to the reference/desired gait is obtained when the wearable device is normally worn on the body; It is assumed that the device is operated when properly worn as this is the base case; Alternatively, the body information will still be collected after fixing and normally donning the device).
Hyung is silent regarding wherein the at least one processor is configured to further perform: an operation determining whether the wearable device is normally worn on the body of the user.
However, Lamb teaches wherein an operation carried out by the processor determines whether the wearable device is normally worn on the body of the user (Paragraph 0062-0063; Determination is made after test actuation of the device if the displacement angles are beyond a certain threshold which is indicative of improper fit; also see Paragraph 0067 regarding detection of lack of contact between a portion of the device and the user; Sensors may detect strap tension or coupler tension).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Hyung to have included the processor determining normal adornment of the device on the body, such as that taught by Lamb, in order to limit use of the device until a subsequent fit is made and ensure safety of the user (Paragraph 0062, where power/actuation/ROM is limited when the device is determined to be improperly fitted).
Claims 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hyung (U.S 2016/0143800 A1), as applied to claim 16, in view of Lerner (U.S 2019/0344434 A1).
Regarding claim 20, Hyung discloses the device of claim 16.
Hyung is silent regarding executing a preset muscular strength-assisting exercise program to assist a muscular strength of the user, when the walking state is the normal state.
However, Lerner teaches an exoskeleton rehabilitation device in which resistance is increased when the user has increased performance metrics and is near-normal gait (Paragraph 0101; As a user improves their mobility or strength the resistance may be increased; Thus, as the gait/mobility approaches normal, or is determined to be normal, the resistance will increase to continually strengthen the muscles).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Hyung to have included executing a present strength-assisting exercise program when the walking state is approaching/at normal state, such as that taught by Lerner, in order to reduce assistance and increase muscle strength as the user improves (Paragraph 0101).
Allowable Subject Matter
Claims 14 and 19 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 14, the closest prior art is Hyung (U.S 2016/0143800 A1) and Hirata (U.S 2012/0095373 A1) and Agrawal (U.S 2017/0027803 A1) and Kim (U.S 2018/0146890 A1) and Riener (U.S 2019/0343707 A1) and Dalley (U.S 11,642,272 B2) and Jang (U.S 2016/0029928 A1) and Lim (U.S 2016/0101515 A1).
None of the prior art teaches or suggests the limitations of claim 14. In particular none of the prior art executes or enables a preset muscular strength regimen/routine in response to a difference between the first compensated/corrected movement range and the rest movement range being with a threshold value. The prior art generally teaches estimation of a gait cycle and its variation from a normal/reference/optimal cycle and prompts compensatory actuation to drive the cycle closer to the target cycle. Additionally, the prior art generally teaches weaning the user off the powered assistance and increases resistance as the user gets closer to the ideal/normal gait, which can generally be considered a ‘muscular strength-assisting exercise program’. However, none of the prior art teaches that this program is enacted based on a comparison between the first corrected movement range and the test movement range being with a particular threshold value. To do so would require substantial hindsight reasoning and arbitrary reconstruction of the devices of the prior art to arrive at the claims as currently filed.
Similar arguments can be made for claim 19.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS WILLIAM GREIG whose telephone number is (571)272-5378. The examiner can normally be reached Monday - Thursday: 7:30AM - 5:00PM.
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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