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 Amendment
Applicant’s Response filed 5/8/2026 is acknowledged. However the response appears to be non-compliant.
Applicant appears to have amended claim 1 to include new language, Claim 14 appears to be “Previously Presented” , Claims 3 and 16 have been canceled, and claims 5-8 and 17-19 have been withdrawn.
Amended claim 1 (5/8/26): 1. (Currently amended) A medical device for assessing and/or rehabilitating a human joint of an extremity, the device comprising:
a) a joint brace comprising a first support for coupling to an upper part of the extremity, a second support for coupling to a lower part of the extremity, and a rotatable joint connecting the first and second supports;
b) a linear actuator coupled to the first and second supports, the linear actuator including a motor configured for actively moving one or more of the first and second supports so as to rotate about the joint;
c) one or more sensors located at or near the joint, wherein the one or more sensors are configured for making angle measurements between the first and second supports and for recording movement data regarding the first and second supports and for collecting rehabilitation exercise data including a number of repetitions and a number of sets associated with movement of the extremity; and
d) a computing device communicatively coupled to the one or more sensors, the computing device configured for receiving and storing the angle measurements, the and the rehabilitation exercise data, determining rehabilitation compliance metrics based on the rehabilitation exercise data and the data and the rehabilitation exercise data via a radio transmitter communicatively coupled to the computing device.
However, Newly amended claim 1 and claim 14 do not appear to include the amendments made to the claims on 10/27/2025.
In the amendment on 10/27/25 claim 1 was amended to include the following language:
1. (Currently amended) A medical device for assessing and/or rehabilitating a human joint of an extremity, the device comprising:
a) a joint brace comprising a first support for coupling to an upper part of the extremity, a second support for coupling to a lower part of the extremity, and a rotatable joint connecting the first and second supports;
b) a mechanical device comprising a linear actuator hingedly coupled to the first and second supports at an off-axis angle such that a line of action of the linear actuator is not collinear with a longitudinal axis of either the first or second supports, the linear actuator including a motor configured for applying force-loaded extension and retraction
c) one or more sensors located at or near the joint, wherein the one or more sensors are configured for making angle measurements between the first and second supports and for recording movement data regarding the first and second supports; and
d) a computing device communicatively coupled to the one or more sensors, the computing device configured for receiving and storing the angle measurements and the movement data and for transmitting the angle measurements and the movement data via a radio transmitter communicatively coupled to the computing device, the device further comprising an internal clock operatively associated with the computing device and configured to measure the angle measurements and the movement data relative to time so as to generate time-stamped records of the angle measurements and the movement data.
In the amendment on 10/27/25 claim 14 was amended to include the following language:
14. (Currently amended) A medical device for assessing and/or rehabilitating a human joint of an extremity, the device comprising: a) a joint brace comprising a first support for coupling to an upper part of the extremity, a second support for coupling to a lower part of the extremity, and a rotatable joint connecting the first and second supports; and b) a mechanical device comprising a linear actuator hingedly coupled to the first and second supports at an off-axis angle such that a line of action of the linear actuator is not collinear with a longitudinal axis of either the first or second supports, the linear actuator including a motor configured for applying force-loaded extension and retraction
However, None of the language from the claim amendments dated 10/27/25 appear to be included in the claim amendments dated 5/8/26 nor are there any indication the language from the 10/27/26 amendment intended to be deleted ( strikethrough).
In a conversation with the Attorney of record, Mark Terry, on May 19, 2026, Applicants intended on including the language of the previous amendment( amendment dated 10/27/25) as well as the newly added subject matter from the amendment filed on 5/8/26 into claim 1.
Regarding independent Claim 14, prosecution will proceed to include only the subject matter added in the amendment dated 10/27/25.
Prosecution will continue on the claims as follows:
Regarding claim 1: 1. (Currently amended) A medical device for assessing and/or rehabilitating a human joint of an extremity, the device comprising:
a) a joint brace comprising a first support for coupling to an upper part of the extremity, a second support for coupling to a lower part of the extremity, and a rotatable joint connecting the first and second supports;
b) a linear actuator coupled to the first and second supports, the linear actuator including a motor configured for actively moving one or more of the first and second supports so as to rotate about the joint; a mechanical device comprising a linear actuator hingedly coupled to the first and second supports at an off-axis angle such that a line of action of the linear actuator is not collinear with a longitudinal axis of either the first or second supports, the linear actuator including a motor configured for applying force-loaded extension and retraction actively moving one or more of the first and second supports so as to rotate about the joint;
c) one or more sensors located at or near the joint, wherein the one or more sensors are configured for making angle measurements between the first and second supports and for recording movement data regarding the first and second supports and for collecting rehabilitation exercise data including a number of repetitions and a number of sets associated with movement of the extremity; and
d) a computing device communicatively coupled to the one or more sensors, the computing device configured for receiving and storing the angle measurements, the and the rehabilitation exercise data, determining rehabilitation compliance metrics based on the rehabilitation exercise data and the data and the rehabilitation exercise data via a radio transmitter communicatively coupled to the computing device. The device further comprising an internal clock operatively associated with the computing device and configured to measure the angle measurements and the movement data relative to time so as to generate time-stamped records of the angle measurements and the movement data.
Regarding claim 14:
14. (Currently amended) A medical device for assessing and/or rehabilitating a human joint of an extremity, the device comprising:
a) a joint brace comprising a first support for coupling to an upper part of the extremity, a second support for coupling to a lower part of the extremity, and a rotatable joint connecting the first and second supports; and
b) a mechanical device comprising a linear actuator hingedly coupled to the first and second supports at an off-axis angle such that a line of action of the linear actuator is not collinear with a longitudinal axis of either the first or second supports, the linear actuator including a motor configured for applying force-loaded extension and retraction
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks , filed 5/8/2026, with respect to the rejection(s) of claim(s) 1-2, 9-12, and 14-15 under 35 USC 103 Thorsteinsson(US7578799) in view of U.S. Patent No. US8058823B2 to Horst et al. (hereinafter, Horst). have been fully considered and are not persuasive.
Applicant’s arguments with respect Thorsteinsson(US7578799) in view of Horst et al. (US8058823B2) as they pertain to the newly added limitations are mute in view of the new grounds of rejection incorporating Wiedenhoefer et al.( US 20160302721).
Applicant’s arguments regarding a lack of explicit or implicit motivation to combine Thorsteinsson(US7578799) in view of Horst et al. (US8058823B2) are respectfully not persuasive.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case , Claims 1 and 14 are directed to a medical device for assessing and/or rehabilitating a human joint of an extremity including a joint brace a mechanical actuator in claim 14 and further including sensors and a computing device for receiving sensor data from the brace in claim 1.
Thorsteinsson(US7578799) is also directed to an orthotic brace and an intelligent knee, ankle, and foot orthosis(KAFO) for biomechanical evaluation and functional compensation of joint disorders. This intelligent system comprises multiple sensors, such as pressure sensors, strain gauges, angular sensors, angular velocity sensors, and ground reaction force sensors. Other sensor types may also be included. The information from these sensors is gathered in, and evaluated by, a control unit that in turn controls a set of actuators that activate the KAFO to assist the user. The control function is based on recognizing phases of the gait cycle and responding to strategic needs in the gait cycle to assist the user to maintain "normal" gait cycle.
Horst et al. (US8058823B2) is directed to an actuator system for extending and flexing a joint where Motors and actuators are used in a wide variety of applications. Many applications, including robotics and active orthotics, which require characteristics similar to human muscles. The characteristics include the ability to deliver high force at a relatively low speed and to allow free-movement when power is removed, thereby allowing a limb to swing freely during portions of the movement cycle.
Both Thorsteinsson(US7578799) and Horst et al. (US8058823B2) deal with active orthotics with active actuators which certainly can be used for assessing and/or rehabilitating a human joint of an extremity.
As set forth in the office action, Thorsteinsson(US7578799) simply does not set forth where the active actuator includes a motor. One of ordinary skill in the art looking at active orthotics would look to other active orthotics to merely substitute one active actuator for another active orthotic having a motor to improve or enhance the performance of the orthotic actuator. Again as noted above, motivation to combine may be found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Applicant’s argument regarding improper combination that would change the principle operation of Thorsteinsson(US7578799) and that “modifying Thorsteinsson to incorporate Applicant's claimed rehabilitation compliance monitoring functionality would fundamentally alter Thorsteinsson's intended operation and purpose.” is found unpersuasive.
Applicant is reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Furthermore applicant’s specification paragraph 5 of the background it is stated that “[0005] Generally, a joint brace, such as a hinged immobilizer knee brace, is used for postoperative management and rehabilitation after an event such as a cruciate and collateral ligament injury, repair, or reconstruction. Joint braces are used for fractures, dislocations, and realignment procedures and both post-injury and as preventive injury protection in indications that would benefit from structural support or a controlled and limited movement of the joint.”
Thorsteinsson(US7578799) is directed to an orthotic brace, and more particularly to an intelligent knee, ankle, and foot orthosis for biomechanical evaluation (which includes assessing or evaluating) and functional compensation of joint disorders. The intelligent knee, ankle, and foot orthosis (KAFO) incorporates both passive and active components in an orthotic frame to compensate for muscle weakness during walking, standing, and other activities(interpreted to include exercising), to support a user and to assist the user in approximating or achieving a normal gait.
The point of rehabilitation is the treatment of physical disabilities to which Thorsteinsson(US7578799) is also directed. The intelligent system of Thorsteinsson(US7578799) comprises an orthotic brace, a linear actuator, with multiple sensors, such as pressure sensors, strain gauges, angular sensors, angular velocity sensors, and ground reaction force sensors. Other sensor types may also be included. The information from these sensors is gathered in, and evaluated by, a control unit(computing device) that in turn controls a set of actuators that activate the Orthotic to assist the user. The control function is based on recognizing phases of the gait cycle and responding to strategic needs in the gait cycle to assist the user to maintain "normal" gait cycle.(which is considered to be rehabilitative).
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.
Claim(s) 1,2 and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thorsteinsson et al.(7578799) in view of Horst et al. (8058823) and further in view of Wiedenhoefer et al.( US 20160302721) .
Regarding claim 1, Thorsteinsson et al.(7578799) teaches an orthotic frame has proximal and distal frame members joined by a knee joint, and a foot support joined by an ankle joint to a distal end of the distal frame. A knee actuator connected between the proximal and distal frame members has a selective stiffness allowing selection of a relatively rigid stiffness during stance and a relatively flexible stiffness during swing. As can be seen in Figure 1, the knee actuator(300) is hingedly connected and at an off-axis to the main supports. Figure 1, further shows upper(110) and lower supports(120) connected at a rotating knee joint (200). Figure 1 also teaches in paragraphs (37)-(38), Pelotte carriers (150) and straps (152) to attach the orthotic to the upper leg and lower leg. The stiffness of the knee actuator is selected according to the gait cycle, either mechanically according to dorsal flexion of the ankle joint or electronically according to gait cycle phases recognized based on read sensor data. An ambulatory unit gathers data from sensors located on the orthotic frame. Sensor data may be provided to a base unit for diagnostic and biomechanical evaluation, or evaluated by the ambulatory unit to control active components of the orthotic frame according to the recognized gait cycle phases for functional compensation. Paragraph (22) , the Orthotic is instrumented with a multiple purpose sensor set, which enables measurement of physical variables related to comfort (pressure and strain), kinematics (sagittal plane angles of the knee and ankle joints, rotational velocities of the shank and foot segments, and foot accelerations, for example), and knee joint and actuator status. Paragraph (23) Information gathered by the sensor set is used for monitoring purposes and for control of active components of the Orthotic. The gathered information may be employed to determine or recognize certain aspects or phases of the gait cycle, and to drive active components of the mechanical orthotic frame to provide assistance at relevant times during the gait cycle. For example, active actuators may help in assisting a patient with muscular weaknesses, such as a patient with weak quadriceps, in regaining functionality. Paragraphs (24)-(25), (24) This intelligent system comprises multiple sensors, such as pressure sensors, strain gauges, angular sensors, angular velocity sensors, and ground reaction force sensors. Other sensor types may also be included. The information from these sensors is gathered in, and evaluated by, a control unit that in turn controls a set of actuators that activate the Orthotic to assist the user. The control function is based on recognizing phases of the gait cycle and responding to strategic needs in the gait cycle to assist the user to maintain "normal" gait cycle. (25) The sensors and actuators are strategically placed about or near the knee joint, the ankle joint, or at other relevant locations of the mechanical orthotic to provide the relevant information and perform the required assistance during gait. Paragraph (109) Referring to FIG. 9, the ambulatory unit 900 comprises generally conventional control hardware architecture. Such a control hardware architecture typically comprises a microprocessor 910 connected by a bus 990 to an area of main memory 920, comprising both read only memory (ROM) 922, and random access memory (RAM) 924. Paragraphs (110) – (111), (110) The microprocessor 910 may be in communication, via bus 990, with a storage device 930 such as a disk storage device or a removable media memory device such as a removable memory card or the like. Input/output devices 940, 950 are included to provide an interface to the sensors and actuators of the Orthotic 10. Paragraph (111), A communication interface 960 is provided for communication between the ambulatory unit 900 and the base unit 1000. The communication interface 960 may be a wireless interface, employing an RF, infra-red (IR), or other wireless communication medium. Alternatively, the communication interface 960 may be wired, using a cable in connection with the base unit 1000. Note also Figure 1, Paragraphs (112)-(113), (140) set forth real-time control and sampling rates for real-time functions and sampling for later analysis. The examiner interprets the real-time sampling of data for and sampling of data for later analysis would include time relevant data as is known and would be needed in order to analyze the data at a later time. Note also figures 11A and 11B show and are set forth in paragraph (117) Data collected during trials of sitting down and standing up activities are shown in FIGS. 11A and 11B. Each figure shows measured data from a single transition (between standing to sitting, and vice versa). The data is shown with respect to time which is indicative of time stamped data. Note also claims 21-22.
Thorsteinsson et al.(7578799) does teach in paragraph (49) the knee actuator 300 may be an active device that applies a torque to orthotic frame 100 about the knee joint 200 to cause a desired flexion of the orthotic frame 100 at the knee joint 200. Paragraph (23) Information gathered by the sensor set is used for monitoring purposes and for control of active components of the Orthotic. The gathered information may be employed to determine or recognize certain aspects or phases of the gait cycle, and to drive active components of the mechanical orthotic frame to provide assistance at relevant times during the gait cycle. For example, active actuators may help in assisting a patient with muscular weaknesses, such as a patient with weak quadriceps, in regaining functionality.
Thorsteinsson et al.(7578799) does not specifically teach where the active actuator includes a motor.
Horst et al. (8058823) is directed to an actuator system for extending and flexing a joint where Motors and actuators are used in a wide variety of applications. Many applications, including robotics and active orthotics, which require characteristics similar to human muscles. The characteristics include the ability to deliver high force at a relatively low speed and to allow free-movement when power is removed, thereby allowing a limb to swing freely during portions of the movement cycle. Horst et al. (8058823) further teaches a linear actuator coupled to the first and second supports (Figure 1 depicts actuator system 100 connected to first supports on upper extremity and second support on the lower extremity; Column 2, lines 13-18, the actuator system 100 of the preferred embodiments for extending and flexing a joint 110 of a user includes a multi-motor assembly 120 for providing a rotational output, a rotary-to-linear mechanism 150 for converting the rotational output from the multi-motor assembly 120 into a linear motion; Examiner notes actuator system converting rotational output into linear motion as a linear actuator), the linear actuator including a motor (Figure 1 depicts multi-motor assembly with motors 128 and 134) configured for actively moving one or more of the first and second supports so as to rotate about the joint (Column 2, lines 13-18, the actuator system 100 of the preferred embodiments for extending and flexing a joint 110 of a user includes a multi-motor assembly 120 for providing a rotational output, a rotary-to-linear mechanism 150 for converting the rotational output from the multi-motor assembly 120 into a linear motion that ultimately extends and flexes the joint, Examiner notes flexion and extension of a joint as rotational movement about a joint and linear motion from the rotary-to-linear mechanism extending and flexing the joint as active movement);
Both Thorsteinsson(US7578799) and Horst et al. (US8058823B2) deal with active orthotics with active actuators which certainly can be used for assessing and/or rehabilitating a human joint of an extremity.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thorsteinsson et al.(7578799) to incorporate the teachings of Horst et al. (8058823) by substituting the actuator of Thorsteinsson et al.(7578799) with the linear actuator and motor of Horst et al. (8058823) and connecting it to the first and second supports. Doing so would allow for the ability to deliver high force at low speeds and would allow free movement when power is removed (Column 1, lines 16-17, The characteristics include the ability to deliver high force at a relatively low speed and to allow free-movement when power is removed).
Thorsteinsson(US7578799) as modified by Horst et al. (US8058823B2) does not specifically teach where the computing device is configured for collecting rehabilitation exercise data including a number of repetitions and a number of sets associated with movement of the extremity and the rehabilitation exercise data, determining rehabilitation compliance metrics based on the rehabilitation exercise data.
Wiedenhoefer et al.( US 20160302721) teaches system for monitoring a joint of a patient includes multiple sensors to be disposed near a joint and to measure or observe actions or physical quantities associated with the joint; and at least one communications module coupled to the sensors to receive data from the sensors and to transmit sensor information to an external device. In some embodiments, the sensors are implantable near the joint. In other embodiments, the sensors are disposed in a sensor module that is positioned adjacent the skin of the patient near the joint. [0037] The system may also provide alerts if patient tissue becomes inflamed or if the effectiveness of, or compliance to, rehabilitation therapy is insufficient. [0052] The one or more sensors 102 can be used to measure, monitor, or otherwise observe one or more aspects of the orthopedic device, surrounding tissue, or patient activity, or the like. The following are examples of observations or measurements that can be made or interpreted using one or more of the sensors: number of steps, repetitions of an exercise, repetitions of joint movement (e.g., joint pivoting), type of exercise being performed, or other actions; stability, or lack thereof; flexion angle or range of motion; rate of motion; [0053] The following provides further details on some of these measurements or observations. One or more sensors (for example, accelerometers, gyroscopes, magnetometers, proximity sensors, or the like) may count steps or repetitions of an exercise or number of joint movements or other actions experienced by the sensor, and may be utilized to determine what type of exercise or movement is occurring. This can be used, for example, to monitor patient activity, monitor compliance with exercise therapy, or monitor possible signs of pain or other conditions that may hinder or aid rehabilitation. The sensor data may also be used to monitor changes in activity or trends in activity. [0064] a sensor to measure number of steps or movement of the joint may be continuous, and a sensor to measure range of motion may be activated manually by the sensor module, patient device, or clinician device when the patient performs rehabilitation exercises. [0067] The proximity sensor 302a, 302b may also be used to observe or determine, for example, number of steps, number of joint movements, or exercise repetitions.
Therefore, It would have been obvious to one of ordinary skill in the art at the time of the invention to include in the device of Thorsteinsson(US7578799) as modified by Horst et al. (US8058823B2) where the computing device is configured for collecting rehabilitation exercise data including a number of repetitions and a number of sets associated with movement of the extremity and the rehabilitation exercise data, determining rehabilitation compliance metrics based on the rehabilitation exercise data as taught by Wiedenhoefer et al.( US 20160302721) for better diagnostic and biomechanical evaluation and functional compensation of joint disorders and enhanced monitoring of various parameters that provide a basis for tracking activities of the user which can be helpful in assessment and follow-up of the user.
Regarding claim 2, Thorsteinsson et al.(7578799) teaches wherein the first support is a cylindrical brace that surrounds at least a portion of the upper part of the extremity and wherein the second support is a cylindrical brace that surrounds at least a portion of the lower part of the extremity. Note Figure 1, further shows upper(110) and lower supports(120) connected at a rotating knee joint (200). Figure 1 also teaches in paragraphs (37)-(38), Pelotte carriers (150) and straps (152) to attach the orthotic to the upper leg and lower leg.
Regarding claims 9-12, Thorsteinsson et al.(7578799) teaches wherein the one or more sensors includes a rotary position sensor and wherein the one or more sensors include an inertial measurement unit, wherein the movement data includes position, distance, speed, and acceleration, and wherein the movement data includes a spline path of one or more movements performed by a user. Note Figure 1, paragraph (22) wherein the orthotic is instrumented with a multiple purpose sensor set, which enables measurement of physical variables related to comfort (pressure and strain), kinematics (sagittal plane angles of the knee and ankle joints, rotational velocities of the shank and foot segments, and foot accelerations, for example), and knee joint and actuator status. Note also figures 11-16.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Thorsteinsson et al.(7578799) in view of Horst et al. (8058823) and Wiedenhoefer et al.( US 20160302721) as applied to Claims 1 and 2 above, and further in view of U.S. PG Pub No. US 20050273022 A1 to Diaz et al.(20050273022).
Regarding claim 4, Thorsteinsson et al.(7578799) as modified by Horst et al. (8058823) and Wiedenhoefer et al.( US 20160302721) teaches the invention as claimed above in claim 2. However, Thorsteinsson et al.(7578799) as modified by Horst et al. (8058823) and Wiedenhoefer et al.( US 20160302721) does not teach the linear actuator being conductively coupled to a battery.
However, Diaz teaches a linear actuator (Figure 8, linear actuator 63) conductively coupled to a battery (Paragraph [0070], the controller 67 and/or linear actuator 63 may include a battery pack).
Thorsteinsson et al.(7578799) and Diaz et al.(20050273022) are both considered to be analogous to the claimed invention because they are in the same field of joint brace rehabilitation devices. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thorsteinsson et al.(7578799) to incorporate the teachings of Diaz et al.(20050273022) by providing a battery conductively coupled to the linear actuator. Doing so would power the controlling components of the medial device, as recognized by Diaz et al.(20050273022) (Paragraph [0010], It is yet another objective of this invention to provide a portable, lightweight, low voltage, high torque motor and controller supplied power by either battery operation or connected to an electrical grid).
Regarding claim 13, Thorsteinsson et al.(7578799) as modified by Horst et al. (8058823) and Wiedenhoefer et al.( US 20160302721) teaches the invention as disclosed above in Claim 1 including a foot support(130) as seen in figure 1 of Thorsteinsson et al.(7578799). However Thorsteinsson et al.(7578799) as modified by Horst et al. (8058823) and Wiedenhoefer et al.( US 20160302721) does not teach the device further comprising at least one wheel coupled to a distal end of the second support, the at least one wheel configured to rotate on an axle and roll along a surface while bearing weight of said extremity.
Diaz et al.(20050273022) teaches a medical device of claim 1 (Figure 1, modular therapy device 10), comprising at least one wheel coupled to a distal end of the second support (Figure 7, Paragraph [0072], set of wheels 53, 54, one at each end of the axle 52), the at least one wheel configured to rotate on an axle (Figure 7, axle 52) and roll along a surface while bearing weight of said extremity (Figure 8, Paragraph [0073], the wheels 53, 54 are in contact with a supporting surface, such as the floor, so that the wheels move across the surface in response to the actuation of the linear actuator, the examiner notes the actuation of the medical device as implying bearing weight of the extremity surrounded by the brace).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thorsteinsson et al.(7578799) to incorporate the teachings of Diaz et al.(20050273022) by providing one or more wheels configured to rotate on an axle and roll along a surface while bearing weight of an extremity surrounded by the brace. Doing so would enable the use of the medical device in a variety of positions and settings for versatility of support, as recognized by Diaz et al.(20050273022) (Paragraph [0013], It is a still further objective of this invention to provide a CPM device, with wheeled heel supports that allows the CPM to be used in a sitting position, as in riding along the floor, or with limited control by the patient while sitting in a bed, the examiner notes the use of the medical device as implying bearing weight of the extremity surrounded by the brace).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thorsteinsson et al.(7578799) in view of Horst et al. (8058823).
Regarding claim 14, Thorsteinsson et al.(7578799) teaches an orthotic frame has proximal and distal frame members joined by a knee joint, and a foot support joined by an ankle joint to a distal end of the distal frame. A knee actuator connected between the proximal and distal frame members has a selective stiffness allowing selection of a relatively rigid stiffness during stance and a relatively flexible stiffness during swing. As can be seen in Figure 1, the knee actuator(300) is hingedly connected and at an off-axis to the main supports. Figure 1, further shows upper(110) and lower supports(120) connected at a rotating knee joint (200). Figure 1 also teaches in paragraphs (37)-(38), Pelotte carriers (150) and straps (152) to attach the orthotic to the upper leg and lower leg. The stiffness of the knee actuator is selected according to the gait cycle, either mechanically according to dorsal flexion of the ankle joint or electronically according to gait cycle phases recognized based on read sensor data. An ambulatory unit gathers data from sensors located on the orthotic frame. Sensor data may be provided to a base unit for diagnostic and biomechanical evaluation, or evaluated by the ambulatory unit to control active components of the orthotic frame according to the recognized gait cycle phases for functional compensation. Paragraph (22) , the Orthotic is instrumented with a multiple purpose sensor set, which enables measurement of physical variables related to comfort (pressure and strain), kinematics (sagittal plane angles of the knee and ankle joints, rotational velocities of the shank and foot segments, and foot accelerations, for example), and knee joint and actuator status. Paragraph (23) Information gathered by the sensor set is used for monitoring purposes and for control of active components of the Orthotic. The gathered information may be employed to determine or recognize certain aspects or phases of the gait cycle, and to drive active components of the mechanical orthotic frame to provide assistance at relevant times during the gait cycle. For example, active actuators may help in assisting a patient with muscular weaknesses, such as a patient with weak quadriceps, in regaining functionality. Paragraphs (24)-(25), (24) This intelligent system comprises multiple sensors, such as pressure sensors, strain gauges, angular sensors, angular velocity sensors, and ground reaction force sensors. Other sensor types may also be included. The information from these sensors is gathered in, and evaluated by, a control unit that in turn controls a set of actuators that activate the Orthotic to assist the user. The control function is based on recognizing phases of the gait cycle and responding to strategic needs in the gait cycle to assist the user to maintain "normal" gait cycle. (25) The sensors and actuators are strategically placed about or near the knee joint, the ankle joint, or at other relevant locations of the mechanical orthotic to provide the relevant information and perform the required assistance during gait. Paragraph (109) Referring to FIG. 9, the ambulatory unit 900 comprises generally conventional control hardware architecture. Such a control hardware architecture typically comprises a microprocessor 910 connected by a bus 990 to an area of main memory 920, comprising both read only memory (ROM) 922, and random access memory (RAM) 924. Paragraphs (110) – (111), (110) The microprocessor 910 may be in communication, via bus 990, with a storage device 930 such as a disk storage device or a removable media memory device such as a removable memory card or the like. Input/output devices 940, 950 are included to provide an interface to the sensors and actuators of the Orthotic 10. Paragraph (111), A communication interface 960 is provided for communication between the ambulatory unit 900 and the base unit 1000. The communication interface 960 may be a wireless interface, employing an RF, infra-red (IR), or other wireless communication medium. Alternatively, the communication interface 960 may be wired, using a cable in connection with the base unit 1000. Note also Figure 1, Paragraphs (112)-(113), (140) set forth real-time control and sampling rates for real-time functions and sampling for later analysis. The examiner interprets the real-time sampling of data for and sampling of data for later analysis would include time relevant data as is known and would be needed in order to analyze the data at a later time. Note also figures 11A and 11B show and are set forth in paragraph (117) Data collected during trials of sitting down and standing up activities are shown in FIGS. 11A and 11B. Each figure shows measured data from a single transition (between standing to sitting, and vice versa). The data is shown with respect to time which is indicative of time stamped data. Note also claims 21-22.
Thorsteinsson et al.(7578799) does teach in paragraph (49) the knee actuator 300 may be an active device that applies a torque to orthotic frame 100 about the knee joint 200 to cause a desired flexion of the orthotic frame 100 at the knee joint 200. Paragraph (23) Information gathered by the sensor set is used for monitoring purposes and for control of active components of the Orthotic. The gathered information may be employed to determine or recognize certain aspects or phases of the gait cycle, and to drive active components of the mechanical orthotic frame to provide assistance at relevant times during the gait cycle. For example, active actuators may help in assisting a patient with muscular weaknesses, such as a patient with weak quadriceps, in regaining functionality.
Thorsteinsson et al.(7578799) does not specifically teach where the active actuator includes a motor.
Horst et al. (8058823) teaches a linear actuator coupled to the first and second supports (Figure 1 depicts actuator system 100 connected to first supports on upper extremity and second support on the lower extremity; Column 2, lines 13-18, the actuator system 100 of the preferred embodiments for extending and flexing a joint 110 of a user includes a multi-motor assembly 120 for providing a rotational output, a rotary-to-linear mechanism 150 for converting the rotational output from the multi-motor assembly 120 into a linear motion; Examiner notes actuator system converting rotational output into linear motion as a linear actuator), the linear actuator including a motor (Figure 1 depicts multi-motor assembly with motors 128 and 134) configured for actively moving one or more of the first and second supports so as to rotate about the joint (Column 2, lines 13-18, the actuator system 100 of the preferred embodiments for extending and flexing a joint 110 of a user includes a multi-motor assembly 120 for providing a rotational output, a rotary-to-linear mechanism 150 for converting the rotational output from the multi-motor assembly 120 into a linear motion that ultimately extends and flexes the joint, Examiner notes flexion and extension of a joint as rotational movement about a joint and linear motion from the rotary-to-linear mechanism extending and flexing the joint as active movement);
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thorsteinsson et al.(7578799) to incorporate the teachings of Horst et al. (8058823) by substituting the actuator of Thorsteinsson et al.(7578799) with the linear actuator and motor of Horst et al. (8058823) and connecting it to the first and second supports. Doing so would allow for the ability to deliver high force at low speeds and would allow free movement when power is removed (Column 1, lines 16-17, The characteristics include the ability to deliver high force at a relatively low speed and to allow free-movement when power is removed).
Regarding claim 15, Thorsteinsson et al.(7578799) teaches wherein the first support is a cylindrical brace that surrounds at least a portion of the upper part of the extremity and wherein the second support is a cylindrical brace that surrounds at least a portion of the lower part of the extremity. Note Figure 1, further shows upper(110) and lower supports(120) connected at a rotating knee joint (200). Figure 1 also teaches in paragraphs (37)-(38), Pelotte carriers (150) and straps (152) to attach the orthotic to the upper leg and lower leg.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Thorsteinsson et al.(7578799) in view of Horst et al. (8058823) as applied to Claim 14 above, and further in view of U.S. PG Pub No. US 20050273022 A1 to Diaz et al.(20050273022).
Regarding claim 20, Thorsteinsson et al.(7578799) as modified by Horst et al. (8058823) teaches the invention as disclosed above in Claims 1 and 14 including a foot support(130) as seen in figure 1 of Thorsteinsson et al.(7578799). However Thorsteinsson et al.(7578799) as modified by Horst et al. (8058823) does not teach the device further comprising at least one wheel coupled to a distal end of the second support, the at least one wheel configured to rotate on an axle and roll along a surface while bearing weight of said extremity.
Diaz et al.(20050273022) teaches a medical device of claim 1 (Figure 1, modular therapy device 10), comprising at least one wheel coupled to a distal end of the second support (Figure 7, Paragraph [0072], set of wheels 53, 54, one at each end of the axle 52), the at least one wheel configured to rotate on an axle (Figure 7, axle 52) and roll along a surface while bearing weight of said extremity (Figure 8, Paragraph [0073], the wheels 53, 54 are in contact with a supporting surface, such as the floor, so that the wheels move across the surface in response to the actuation of the linear actuator, the examiner notes the actuation of the medical device as implying bearing weight of the extremity surrounded by the brace).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Thorsteinsson et al.(7578799) to incorporate the teachings of Diaz et al.(20050273022) by providing one or more wheels configured to rotate on an axle and roll along a surface while bearing weight of an extremity surrounded by the brace. Doing so would enable the use of the medical device in a variety of positions and settings for versatility of support, as recognized by Diaz et al.(20050273022) (Paragraph [0013], It is a still further objective of this invention to provide a CPM device, with wheeled heel supports that allows the CPM to be used in a sitting position, as in riding along the floor, or with limited control by the patient while sitting in a bed, the examiner notes the use of the medical device as implying bearing weight of the extremity surrounded by the brace).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
LEE et al.( US 20190209101) teaches a method of analyzing tele-rehabilitation which includes calculating a completion rate of the number of times of performance, indicating how much a user achieves a designated number of times of performance of a first rehabilitation exercise, based on the designated number of times of performance of the first rehabilitation exercise, and the number of times of the first rehabilitation exercise actually performed by the user, by an apparatus for analyzing tele-rehabilitation, calculating a variation coefficient indicating whether the first rehabilitation exercise is regularly and repeatedly performed, based on a performance time consumed at each time while the user repeatedly performs the first rehabilitation exercise, by the apparatus for analyzing tele-rehabilitation, and generating a result of analysis indicating a result obtained as the user performs the first rehabilitation exercise, based on the completion rate of the number of times of performance and the variation coefficient, by the apparatus for analyzing tele-rehabilitation.
Gillis(US 2020006) teaches a knee rehabilitation system includes a plurality of compressible resistance members, a knee garment, and a resistance member receptable. [0006] a rehabilitation method is provided. The rehabilitation method may include [0007] (i) receiving, by one or more processors collectively, from a resistance sensor connected to an exercise device, sensory data indicative of a one repetition maximum resistance measured by the resistance sensor; and [0008] after (i), one or more iterations of: [0009] a) receiving, from the resistance sensor, sensory data indicative of a resistance measured by the resistance sensor, and [0010] b) in response to determining that the resistance exceeds a lower threshold resistance percentage of the one repetition maximum resistance, either registering a successful repetition or starting an isometric-interval timer. 0124] In some embodiments, transmitter 268 includes (or is in communication with) a pressure sensor 276 positioned to sense an internal pressure of compressible resistance member 176. This allows transmitter 268 to send resistance member information 272 including pressure readings taken during exercise. This can allow a user or a third party (e.g. physician, physiotherapist, or insurance provider) to monitor progress and/or compliance with a prescribed rehabilitation program.
KOSAKA et al.( US 20210362005) teaches method and system for signal processing rehabilitation exercise signals. The method comprises the step of receiving a first and a second motion signals associated with movements of a body part, wherein the motion signals comprise temporal data of the movements. [0002] Physical rehabilitation usually involves the treatment of an individual by exercises. Various data are collected during the exercises using sensors attached to the individual and the data collected at different rehabilitation sessions can be analyzed to measure the progress of the individual over a period of time. [0050] In an embodiment, the motion signals and the EMGs are sent to the system 102 by the motion sensor 108 and electromyography 110 respectively. In order to assess muscle recovery, at least two sets of motion and EMGs are sent to the system 102 for signal processing. These sets of signals are typically recorded a period of time apart (e.g. a week or a month apart) and are associated with the same rehabilitation exercise (e.g. the flexion exercise of a limb).
Applicant’s amendment necessitated the new grounds of rejection. Therefore THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN L CASLER whose telephone number is (571)272-4956. The examiner can normally be reached M-Th 6:30 to 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor can be reached at (571)272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIAN L CASLER/Primary Examiner, Art Unit 3791
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