Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks , filed 10/27/2025, with respect to the rejection(s) of claim(s) 1-2, 9-12, and 14-15 under 35 USC 103 WIP Publication No. WO2020046142 to McDaid in view of U.S. Patent No. US8058823B2 to Horst et al. (hereinafter, Horst). have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
with respect to the rejection(s) of Claims 4, 13, and 20 rejected under 35 U.S.C. 103 as being unpatentable over McDaid, in view of Horst as applied to Claims 1-2 and 14 above, and further in view of U.S. PG Pub No. US 20050273022 A1 to Diaz et al. (hereinafter, Diaz). have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
The references do not reasonably teach the limitations of claim 1 and 14 including 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 of the first and second supports so as to rotate about the joint; Nor do the references teach 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.
However, upon further consideration, a new ground(s) of rejection is made in view of Thorsteinsson et al.(7578799).
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, 9-12, 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 claims 1 and 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 claims 2 and 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.
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, 13, and 20 are 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 Claims 1-2 and 14 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) teaches the invention as claimed above in claim 2. However, Thorsteinsson et al.(7578799) as modified by Horst et al. (8058823) 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 claims 13 and 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.
Horst et al.( 9889058) teaches an orthosis includes a first portion and a second portion configured to attach on opposite sides of a joint. An actuator is configured to apply a force between the first and second portions. The actuator includes a first spool and a second spool rotatably mounted to the first portion.
Sverrisson et al.(9387096) teaches methods and systems are used for monitoring a global position or location of a prosthetic or orthotic device and to provide feedback control of the device. Certain methods may employ remote transmitting devices and receivers to recognize when a prosthetic or orthotic device user is in a moving vehicle and, therefore, initiate automatic shut-off, driving mode, or relaxed mode. Other methods may employ remote transmitting devices and receivers to identify the global position of the prosthetic or orthotic device, compare the global position to a stored terrain mapped database and output feedback control instructions and/or alerts to the prosthetic or orthotic device based at least in part on the stored terrain mapping information.
Auberger et al.( 9022965) teaches a knee orthosis and a method for controlling a knee orthosis including a thigh structure having a fastening structure to be fixed to a thigh, a lower leg structure which is pivotally coupled to the thigh rail using a joint mechanism and has a fastening structure to be fixed to a lower leg as well as a foot piece for supporting a foot, and an actuator device between the thigh structure and the lower leg structure.
Clausen(9017418) teaches Geomagnetic methods and systems are used for monitoring the directionality of a prosthetic or orthotic device. Certain methods may include measuring multiple data points over a particular time interval to identify orientation information with respect to a prosthetic or orthotic device and/or used in the real-time control of the prosthetic or orthotic device. In certain examples, multiple points may be further compared with stored orientation data associated with predefined unsafe gait patterns. Control instructions and/or alerts based on the geomagnetic measurements can then be generated for the prosthetic or orthotic device, such as if the orientation data information matches one of the predefined unsafe gait patterns.
Herr(8870967) teaches Artificial limbs and joints that behave like biological limbs and joints employ a synthetic actuator which consumes negligible power when exerting zero force, consumes negligible power when outputting force at constant length (isometric) and while performing dissipative, nonconservative work, is capable of independently engaging flexion and extension tendon-like, series springs, is capable of independently varying joint position and stiffness, and exploits series elasticity for mechanical power amplification.
Hartman(US20130085531) teaches an apparatus (1) for treating a body part (5) of a patient (3) is provided. The apparatus comprises a support (7) for at least partially supporting and holding the body part and a manipulator (11) connected to the support for supporting and maneuvering the support. The manipulator comprises a parallel linkage device (13) comprising a plurality of hingedly interconnected linear actuators (19). The parallel linkage device (11) comprises at least one hinge (21) comprising a, preferably resilient, tendon joint (61). Further, a method, a storage medium and a piece of headgear are provided. [0028] To record at least part of a maneuvering sequence or a trajectory, the apparatus may be configured for storing a plurality of the determined spatial positions and orientations of the first and second portions relative to each other in a memory. Further, time stamps corresponding to at least some of the determined spatial positions and orientations may be stored for providing velocity and acceleration information.
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