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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
The amendments made to claims 1, 12, 16, 20, and 22 in the response filed on 6/27/2025 are acknowledged. Claims 1, 4-16, and 18-24 are still pending in the application and are examined below.
Response to Arguments
Applicant’s arguments, see page 8, filed on 6/27/2025, with respect to the objections of claims 1, 12, 16, and 20 have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant’s arguments, see page 8, filed on 6/27/2025, with respect to the rejection of claim 22 under 35 U.S.C 112 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see pages 8-18, filed on 6/27/2025, with respect to the rejection of claims 1, 12, 16, and 20 under 35 U.S.C 103 have been fully considered but they are not persuasive. Please see arguments below.
Applicant argues “Applicant respectfully notes that none of the cited references describes or suggests an orthosis as recited in the independent claims. Specifically, none of the cited references describes or suggests an orthosis for a lower limb having a foot part which has a sole for supporting a foot where the foot part is assigned at least one device, which is coupled to the control device, for varying a stiffness of the sole and the device for varying the stiffness of the sole comprises an actuator for rotating at least one element within the sole or displacing at least one element within the sole along a longitudinal extent of the sole in a direction of a toe end of the sole to a heel end of the sole to vary the stiffness of the sole as recited in claims 1, 12, 16, and 20”, “Piercy does not describe or suggest elements within the sole that are displaced along a longitudinal extent of the sole or rotated within the sole along its longitudinal axis to vary the stiffness of the sole. The Office asserts that the inflatable sole of Piercy is displaced when the actuator is inflated or deflated. Office Action at page 11. However, inflation and deflation of the sole does not displace or rotate any element within the sole, much less along its longitudinal axis”; however, examiner respectfully disagrees. Piercy et al. teaches analogous orthosis (figure 1, novel exoskeleton orthotic: paragraph 0010-0011) for a lower limb (the orthosis [figure 1] is for the ankle, foot, and ankle-foot interface: paragraph 0010-0011) having an analogous foot part (110 - figure 1, foot structure: paragraph 0016) which has an analogous sole for supporting a foot (the foot part has a sole for supporting a foot: paragraph 0016), where the analogous foot part (110) is assigned at least one device (320 - figure 3, a pneumatic system that inflates and/or deflates inflatable actuators with fluid: paragraph 0027) coupled to an analogous control device (330 - figure 3, the one device [320] is coupled to a control system: paragraph 0030-0032) for varying a stiffness of the analogous sole (the one device [320] varies the stiffness of the sole since it inflates and/or deflates the inflatable actuators within the sole, which dynamically adjusts the stiffness: paragraph 0012/0016/0029-0033); wherein the at least one device (320) for varying the stiffness of the analogous sole comprises an actuator (the one device [320] is an actuator because it initiates the inflation or deflation of the inflatable actuators that can be in the sole: paragraph 0012/0016/0029-0033) for rotating at least one element (140 - figure 3, an inflatable actuator: paragraph 0012/0029) within the sole along a longitudinal axis of the sole, or for displacing at least one element (140) within the analogous sole along the longitudinal axis of the analogous sole to vary the stiffness of the analogous sole (the element [140] can be placed within the sole of the foot to provide motive force by direct manipulation of the sole [displacement of the sole due to expansion/displacement of the element]; hence, the stiffness is dynamically adjustable via the actuator [320] and elements [140] within the sole: paragraph 0012/0016/0029-0033). When the one element [140] is inflated, the one element [140] expands [the term “expand” is defined as “to increase the size, volume, quantity, or scope of; enlarge” by https://www.thefreedictionary.com/expand]; this implies that the one element [140] is displaced from its original position [deflated state] to the expanded position [inflated state] in the x-axis and y-axis [paragraph 0027]. The difference in the length/height between the original and expanded position is the displacement along the longitudinal and lateral axis of the sole. Applicant also states “in a direction of a toe end of the sole to a heel end of the sole” in their argument, however, the element [140] can expand in size [x-axis and y-axis], which implies that it is displaced along the longitudinal and lateral axis of the sole. Furthermore, any displaced distance could be considered along the longitudinal axis of the sole due to the how the claim limitation was written).
Applicant argues “Thus, McDonnell does not describe or suggest an orthosis for a lower limb having a foot part which has a sole for supporting a foot where the foot part is assigned at least one device, which is coupled to the control device, for varying a stiffness of the sole and the device for varying the stiffness of the sole comprises an actuator for rotating or displacing at least one element within the sole to vary the stiffness of the sole as recited in claims 1, 12, 16, and 20”, “McDonnell does not disclose longitudinal displacement of an element to alter stiffness of the sole in any way—just use of an artificial muscle to rotate a toe part. There is no disclosure or suggestion that this rotation alters the stiffness of the sole”, and “We have failed to discover any teaching that activation of the artificial muscle system alters the stiffness of the upper frame or the stiffness of the lower frame. Indeed, from our reading of the reference, it is apparent that the toe part has no influence on the stiffness of either the lower frame or the upper frame”; however, examiner respectfully disagrees. McDonnel does teach an analogous foot part (12b - figure 14, a frame system that envelopes the user’s foot: paragraph 0040) is assigned at least one device (43b - figure 15, an actuator system: paragraph 0040) which is coupled to an analogous control device (48b - figure 14/15, a control system: paragraph 0040/0047) (figure 14/15, the one device [43b] is coupled to the control device [48b]: paragraph 0047/0049), for varying a stiffness of an analogous sole (16b/18b - figure 15, the upper [16b] and lower frame [18b] of the foot part [12b] that extends along the bottom of the user’s foot: paragraph 0040), wherein the device (43b) for varying the stiffness of the analogous sole (16b/18b) comprises an actuator (the device [43b] is an actuator system: paragraph 0040) for rotating at least one element within the analogous sole (16b/18b) along a longitudinal axis of the sole or for displacing at least one element (52 - figure 15, actuator strands made of fibers [58]: paragraph 0040/0047) within the analogous sole along the longitudinal axis of the analogous sole to vary the stiffness of the analogous sole (16b/18b) (figure 14/15, the one element [52] are within the sole [16b/18b] and are displaced along the longitudinal extent of the sole [due to the one element [52] increasing in length when exposed to a voltage potential]; additionally, the one element [52] is within the sole [16b/18b]: paragraph 0040/0047/0049) (figure 15, the control device [48b] communicates to the actuator [43b] to control the application/removal of a voltage potential, which increases/decreases the length of the one element [52] in the longitudinal axis of the sole and changes the stiffness of the sole [16b/18b] by raising the toe portion [15b - figure 15] and assisting the user to move their foot forward: paragraph 0047/0049/0056). When the one element (52) is not exposed to the voltage difference, there is no change in length, hence, no change in stiffness to assist with forward movement of the foot. However, when the one element (52) increases its length due to the exposure of a voltage potential, it is implied that the stiffness of the sole (16b/18b) is varied because it assists users to raise their toes and assist them in moving the foot forward (paragraph 0047). As a result, the part of the sole (16b/18b) with the toes has a different stiffness than the sole (16b/18b) with the rest of the foot, therefore, a variation in stiffness exists throughout the sole (16b/18b) when the actuators (43b) apply a voltage potential to the one element. Additionally, there are also other modes such as rehabilitation mode, where the first and second actuators (42/46) and actuators (43a/43b) extend and contract to cause pivoting the heel or raise the toe in a situation in which the user is not walking (e.g., when the user is inactive, resting, etc.) (paragraph 0057). Therefore, the sole (16b/18b) is varied in stiffness via the actuator (43) that displaces the one element (58) within the sole (16b/18b) along the longitudinal axis (one end of heel to one end of the toe).
Election/Restrictions
Newly submitted claim 24 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claim 21 and claim 22 recites one element comprising of disks or strips (figure 13) while claim 24 recites one element comprising at least one of a projection or bar on the element (figure 17).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits.
Accordingly, claim 24 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5-6, 8-10, 12-16, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kogler et al. (WO 2018175859 A1) in view of Piercy et al. (US 20160278948 A1).
Regarding claim 1, Kogler et al. discloses an orthosis for a lower limb (100 - see annotated figure 1 below, ankle-foot orthotic device: Paragraph 0051), having a foot part (C- see annotated figure 1 below, a foot part that is a part of the orthosis: Paragraph 0051) which has a sole (D - see annotated figure 1 below, a foot sole that goes under user’s foot) for supporting a foot (the sole [D] is under the wearer’s foot to provide support), and having at least one leg rail (A - see annotated figure 1 below, an adjustable stirrups: Paragraph 0061) which extends from said foot part (C) and which in a fitted state extends along a lower leg (see annotated figure 1 below, the leg rail [A] extends from the foot part [C] to the distal part of the leg when worn) and which has devices for at least one of supporting and fastening the leg rail (A) on the lower leg (examiner focused on the limitation “which has devices for at least fastening the leg rail on the lower leg”) (114 - see annotated figure 1 below, a closure/suspension feature to secure the orthosis device to the leg of a user: Paragraph 0061), wherein: the orthosis (100) is assigned at least one sensor (102a -102f - see annotated figure 1 below, sensors coupled to the orthosis [100]: Paragraph 0052) for detecting orthosis parameters (the sensor [102a - 102f] can sense force, pressure, torque, and more: Paragraph 0052-0054), wherein the at least one sensor (102a - 102f) is coupled to a control device (the sensors [102a - 102f] are collected and monitored by a remote device; the remote device can be a CPU, smartphone, or tablet: Paragraph 0056/0063).
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Annotated Figure 1: orthosis of Kogler et al.
However, Kogler et al. fails to disclose the foot part is assigned at least one device coupled to the control device for varying a stiffness of the sole; wherein the at least one device for varying the stiffness of the sole comprises an actuator for rotating at least one element within the sole along a longitudinal axis of the sole or for displacing at least one element within the sole along the longitudinal axis of the sole to vary the stiffness of the sole.
Piercy et al. teaches an analogous foot part (110 - figure 1, foot structure: paragraph 0016) is assigned at least one device (320 - figure 3, a pneumatic system that inflates and/or deflates inflatable actuators with fluid: paragraph 0027) coupled to an analogous control device (330 - figure 3, the one device [320] is coupled to a control system: paragraph 0030-0032) for varying a stiffness (for the purpose of compact prosecution, “stiffness” is determined by the leg rail and sole’s resistive ability to limit the user from moving in a specific direction) of an analogous sole (the one device [320] varies the stiffness of the sole since it inflates and/or deflates the inflatable actuators within the sole, which dynamically adjusts the stiffness: paragraph 0012/0016/0029-0033); wherein the at least one device (320) for varying the stiffness of the analogous sole comprises an actuator (the one device [320] is an actuator because it initiates the inflation or deflation of the inflatable actuators that can be in the sole: paragraph 0012/0016/0029-0033) for rotating at least one element (140 - figure 3, an inflatable actuator: paragraph 0012/0029) within the analogous sole along longitudinal axis of the sole or for displacing at least one element within the sole along the longitudinal axis of the analogous sole to vary the stiffness of the analogous sole (the element [140] can be placed within the sole of the foot to provide motive force by direct manipulation of the sole [displacement of the sole due to expansion/displacement of the element]; hence, the stiffness is dynamically adjustable via the actuator [320] and elements [140] within the sole: paragraph 0012/0016/0029-0033). When the one element [140] is inflated, the one element [140] expands [the term “expand” is defined as “to increase the size, volume, quantity, or scope of; enlarge” by https://www.thefreedictionary.com/expand]; this implies that the one element [140] is displaced from its original position [deflated state] to the expanded position [inflated state] in the x-axis and y-axis [paragraph 0027]. The difference in the length/height between the original and expanded position is the displacement along the longitudinal and lateral axis of the sole. Applicant also states “in a direction of a toe end of the sole to a heel end of the sole” in their argument, however, the element [140] can expand in size [x-axis and y-axis], which implies that it is displaced along the longitudinal and lateral axis of the sole. Furthermore, any displaced distance could be considered along the longitudinal axis of the sole due to the how the claim limitation was written).
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 provided the sole of Kogler et al. with a control device coupled to an actuator and elements [inflatable actuators] to vary the stiffness of the sole as taught by Piercy et al. in order to provide an orthosis that has an improved sole to provide a motive force by direct manipulation of the sole and also dynamically adjust the stiffness of the sole depending on user’s needs (paragraph 0012/0016/0029-0033, Piercy et al.).
Regarding claim 5, Kogler et al. in view of Piercy et al. discloses the invention as discussed in claim 1. Kogler et al. further discloses wherein the leg rail (A) is formed as a separate component (the leg rail [A] is a member that is coupled to the joint [B] of the user) and is arranged in articulated fashion on the foot part (C) (see annotated figure 1 above, the leg rail [A] is located at a position around the user’s ankle joint and at the side of the user’s foot: Paragraph 0061).
Regarding claim 6, Kogler et al. in view of Piercy et al. discloses the invention as discussed in claim 5. Kogler et al. further discloses wherein the leg rail (A) is assigned a drive (108 - see annotated figure 1 above, a motion resisting mechanism is coupled to the leg rail [A]; the motion resisting mechanism can be a spring to adjust the magnitude of restriction: Paragraph 0066) for setting the orientation relative to the foot part (the drive [108] can be configured to restrict movement of the ankle in the plantarflexion or dorsiflexion direction: paragraph 0057) and is assigned a fixing device (106 - figure 6, a reaction arm coupled to the motion resisting mechanism [108]; the leg rail [A] and fixing device is coupled via joint [B]: Paragraph 0060) for fixing the orientation relative to the foot part (C) (the reaction arm [106] is coupled to the motion resisting mechanism [108] and assists with the restriction of movement of the ankle. The motion resisting mechanism [18] can restrict movement [dorsiflexion or plantarflexion] of the ankle joint in at least one direction by tension/force; therefore, the orientation of the orthosis is fixed by the reaction arm [106] and motion resisting mechanism [108] depending on user needs: Paragraph 0031/0057-0059/0060/0067).
Regarding claim 8, Kogler et al. in view of Piercy et al. discloses the invention as discussed in claim 1. Kogler et al. further discloses wherein at least one sensor (102a - 102f) is arranged outside the orthosis (102a/102b/102c/102d/102e/102f - figure 1A, these sensors are coupled to the external portion of the orthosis [100]: Paragraph 0052).
Regarding claim 9, Kogler et al. in view of Piercy et al. discloses the invention as discussed in claim 1. Kogler et al. further discloses wherein the at least one sensor (102a - 102f) is in the form of force sensors, pressure sensors, acceleration sensors, gyroscopes and angle sensors (examiner focused on the limitation “where the at least one sensor is in the form of force sensors and acceleration sensors”) (the sensors [102a - 102f] can be many different sensors such as force sensors, accelerometers, and torque sensors: Paragraph 0052).
Regarding claim 10, Kogler et al. in view of Piercy et al. discloses the invention as discussed in claim 1. Kogler et al. further discloses wherein at least one of multiple devices are provided (figure 1C, the motion resisting mechanism [108 - see annotated figure 1 above] can have more than one spring mounted in parallel with each other: Paragraph 0057) for varying the stiffness (for the purpose of compact prosecution, “stiffness” is determined by the leg rail and sole’s resistive ability to limit the user from moving in a specific direction) of the sole (D) (figure 1C, with more than one spring mounted in parallel with each other, it provides resistance to ankle rotation in the plantarflexion and/or dorsiflexion position; these springs provide different amounts of force to the ankle joint, which in turn affects the stiffness of the sole [D] at different orientations: Paragraph 0057-0059/0069-72).
Regarding claim 12, Kogler et al. discloses a method for controlling an orthosis for a lower limb (100 - see annotated figure 1 above, ankle-foot orthotic device: Paragraph 0051), the orthosis comprises a foot part (C- see annotated figure 1 above, a foot part that is a part of the orthosis: Paragraph 0051) which has a sole (D - see annotated figure 1 above, a foot sole that goes under user’s foot) for supporting a foot (the sole [D] is under the wearer’s foot to provide support), and having at least one leg rail (A - see annotated figure 1 above, an adjustable stirrups: Paragraph 0061) which extends from said foot part (C) and which in a fitted state extends along a lower leg (see annotated figure 1 above, the leg rail [A] extends from the foot part [C] to the distal part of the leg when worn) and which has devices for at least one of supporting and fastening the leg rail on the lower leg (examiner focused on the limitation “which has devices for at least fastening the leg rail on the lower leg”) (114 - see annotated figure 1 above, a closure/suspension feature to secure the orthosis device to the leg of a user: Paragraph 0061), wherein: the orthosis (100) is assigned at least one sensor (102a -102f - see annotated figure 1 above, sensors coupled to the orthosis [100]: Paragraph 0052) for detecting orthosis parameters (the sensor [102a - 102f] can sense force, pressure, torque, and more: Paragraph 0052-0054); the at least one sensor (102a - 102f) is coupled to a control device (the sensors [102a - 102f] are collected and monitored by a remote device; the remote device can be a CPU, smartphone, or tablet: Paragraph 0056/0063), wherein the method comprises: varying the stiffness of at least one of the sole (D) in a manner dependent on sensor values that have been ascertained by means of the sensors arranged on the orthosis (the orthotic device can have sensors [102a/102f] for measuring the force applied to the ankle joint by the motion resisting mechanism [108), which in turn helps a clinician determine the necessary amount of force needed from the motion resisting mechanism [108] to apply to an user’s ankle joint [comprising of the foot part {C} and leg rail {A} of the device]; by changing the force from the motion resisting mechanism [108] depending on the user’s need, it affects the stiffness/resistance of the sole [D]: Paragraph 0057-0059/0061/0065-0066/0069-0072).
However, Kogler et al. fails to disclose the foot part is assigned at least one device coupled to the control device for varying a stiffness of the sole; wherein the at least one device for varying the stiffness of the sole comprises an actuator for rotating at least one element within the sole along a longitudinal axis of the sole or for displacing at least one element within the sole along the longitudinal axis of the sole to vary the stiffness of the sole.
Piercy et al. teaches an analogous foot part (110 - figure 1, foot structure: paragraph 0016) is assigned at least one device (320 - figure 3, a pneumatic system that inflates and/or deflates inflatable actuators with fluid: paragraph 0027) coupled to an analogous control device (330 - figure 3, the one device [320] is coupled to a control system: paragraph 0030-0032) for varying a stiffness (for the purpose of compact prosecution, “stiffness” is determined by the leg rail and sole’s resistive ability to limit the user from moving in a specific direction) of an analogous sole (the one device [320] varies the stiffness of the sole since it inflates and/or deflates the inflatable actuators within the sole, which dynamically adjusts the stiffness: paragraph 0012/0016/0029-0033); wherein the at least one device (320) for varying the stiffness of the analogous sole comprises an actuator (the one device [320] is an actuator because it initiates the inflation or deflation of the inflatable actuators that can be in the sole: paragraph 0012/0016/0029-0033) for rotating at least one element (140 - figure 3, an inflatable actuator: paragraph 0012/0029) within the analogous sole along a longitudinal axis of the sole or for displacing at least one element within the sole along the longitudinal axis of the analogous sole to vary the stiffness of the analogous sole (the element [140] can be placed within the sole of the foot to provide motive force by direct manipulation of the sole [displacement of the sole due to expansion/displacement of the element]; hence, the stiffness is dynamically adjustable via the actuator [320] and elements [140] within the sole: paragraph 0012/0016/0029-0033). When the one element [140] is inflated, the one element [140] expands [the term “expand” is defined as “to increase the size, volume, quantity, or scope of; enlarge” by https://www.thefreedictionary.com/expand]; this implies that the one element [140] is displaced from its original position [deflated state] to the expanded position [inflated state] in the x-axis and y-axis [paragraph 0027]. The difference in the length/height between the original and expanded position is the displacement along the longitudinal and lateral axis of the sole. Applicant also states “in a direction of a toe end of the sole to a heel end of the sole” in their argument, however, the element [140] can expand in size [x-axis and y-axis], which implies that it is displaced along the longitudinal and lateral axis of the sole. Furthermore, any displaced distance could be considered along the longitudinal axis of the sole due to the how the claim limitation was written).
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 provided the sole of Kogler et al. with a control device coupled to an actuator and elements [inflatable actuators] to vary the stiffness of the sole as taught by Piercy et al. in order to provide an orthosis that has an improved sole to provide a motive force by direct manipulation of the sole and also dynamically adjust the stiffness of the sole depending on user’s needs (paragraph 0012/0016/0029-0033, Piercy et al.).
Regarding claim 13, Kogler et al. in view of Piercy et al. discloses the method as discussed in claim 12. Kogler et al. further discloses wherein a starting value for a center of gravity position of a force action points on at least one of the sole (D) and an orientation of the leg rail (A) or of the sole in space is specified (examiner focused on the limitation “an orientation of the leg rail or of the sole in space is specified”) (the sensors [102a - 102f] can be in a form of accelerometers, which can sense orientation and positioning; hence the orientation of the leg rail [A] and sole [D] is specified during use. Other parameters the sensors [102a - 102f] can collect are foot-ground placement during a movement, range of motion of the ankle, and pressure applied to the orthosis [100]: Paragraph 0052- 0055) and, when the starting value is overshot by a specified amount, a variation of the stiffness (for the purpose of compact prosecution, “stiffness” is determined by the leg rail and sole’s resistive ability to limit the user from moving in a specific direction) of the sole (D) is performed in a manner dependent on the position (the sensors [102a - 102f] collect data indicative of a user’s response to a resistive force applied to the ankle joint by the motion resisting mechanism [108], which in turn, gives the clinician the ability to adjust the tension of the motion resisting mechanism [108] based on user’s response to force applied, movement, and position. By adjusting the tension based on user’s movement [walking] and position [plantarflexion or dorsiflexion direction], it results in a varied stiffness of the sole [D] depending on user needs: Paragraph 0052-0059), ascertained by means of the sensors (by having the sensors [102a - 102f] on the orthosis [100] collect data indicative of a user’s response to a resistive force applied to the joint, it allows the clinician to adjust the tension of the motion resisting mechanism [108], which provides an accurate measurement of the amount of stiffness required for the leg rail [A] and sole [D] to be fitted to the user in different movements [walking] and positions [plantarflexion or dorsiflexion direction]: Paragraph 0052-0059), of at least one of the force action point and on the orientation of at least one of the sole and of the leg rail in space (with the sensors [102a - 102f] and remote control working together to provide data to the clinician, the orientation of the sole [D] and leg rail [A] is affected by the tension of the motion resisting mechanism [108] during a movement [walking] or while in a certain position [plantarflexion or dorsiflexion direction]: Paragraph 0052-0059).
Regarding claim 14, Kogler et al. in view of Piercy et al. discloses the method as discussed in claim 12. Kogler et al. further discloses wherein the orientation of the leg rail (A) relative to the foot part (C) is varied in a manner dependent on the sensor (102a/102f) values (the motion resisting mechanism [108] can restrict movement of the ankle joint in at least one direction [dorsiflexion or plantarflexion] by tension/force. Therefore, the orientation of the leg rail [A] and foot part [C] are varied depending on the amount of tension [measured by sensors {102a/102f}] the motion resisting mechanism [108] has and what the user needs: Paragraph 0031/0057-0059/0065-0066/0069-0070).
Regarding claim 15, Kogler et al. in view of Piercy et al. discloses the method as discussed in claim 12. Kogler et al. further discloses wherein between the foot part (C) and the leg rail (A), there is arranged a joint (B) (the joint is located between the foot part [C] and leg rail [A] to connect them together) the rotational resistance of which is varied in a manner dependent on the detected orthosis parameters (the motion resisting mechanism [108] provides modular torsional stiffness or resistance to rotation at the joint to restrict movement of the ankle joint in at least one direction [dorsiflexion or plantarflexion]: Paragraph 0031/0057-0059/0065-0066/0069-0070).
Regarding claim 16, Kogler et al. discloses an orthosis for a lower limb (100 - see annotated figure 1 above, ankle-foot orthotic device: Paragraph 0051), the orthosis having: a foot part (C- see annotated figure 1 above, a foot part that is a part of the orthosis: Paragraph 0051) which has a sole (D - see annotated figure 1 above, a foot sole that goes under user’s foot) for supporting a foot (the sole [D] is under the wearer’s foot to provide support), and at least one leg rail (A - see annotated figure 1 above, an adjustable stirrups: Paragraph 0061) which extends from said foot part (C) and which in a fitted state extends along a lower leg (see annotated figure 1 above, the leg rail [A] extends from the foot part [C] to the distal part of the leg when worn) and which has devices for at least one of supporting and fastening the leg rail (A) on the lower leg (examiner focused on the limitation “which has devices for at least fastening the leg rail on the lower leg”) (114 - see annotated figure 1 above, a closure/suspension feature to secure the orthosis device to the leg of a user: Paragraph 0061); wherein the orthosis (100) further includes at least one sensor (102a -102f - see annotated figure 1 above, sensors coupled to the orthosis [100]: Paragraph 0052) for detecting orthosis parameters (the sensor [102a - 102f] can sense force, pressure, torque, and more: Paragraph 0052-0054), the at least one sensor (102a -102f) being coupled to a control device (the sensors [102a - 102f] are collected and monitored by a remote device; the remote device can be a CPU, smartphone, or tablet: Paragraph 0056/0063); wherein the at least one leg rail (A) is assigned at least one device (108 - see annotated figure 1 above, a motion resisting mechanism is coupled to the leg rail [A]; the motion resisting mechanism can be a spring to adjust the magnitude of restriction: Paragraph 0066) coupled to the control device (the control device and the motion resisting mechanism [108] is coupled via sensors [102a - 102f]: Paragraph 0056-0059) for varying a stiffness (for the purpose of compact prosecution, “stiffness” is determined by the leg rail and sole’s resistive ability to limit the user from moving in a specific direction) of the leg rail (A) (the leg rail’s [A] stiffness is determined by how much tension the motion resisting mechanism [108] has; the more tension the motion resisting mechanism has, the stiffer the leg rail [A] becomes which limits movement in a certain direction: Paragraph 0057-0059/0069-77), and wherein the leg rail (A) is assigned at least one of a drive for setting the orientation relative to the foot part and a fixing device for fixing the orientation relative to the foot part (examiner focused on the limitation “a fixing device for fixing the orientation relative to the foot part”) (106 - figure 6, a reaction arm coupled to the motion resisting mechanism [108]; the leg rail [A] and fixing device is coupled via joint [B]: Paragraph 0060).
However, Kogler et al. fails to disclose wherein the foot part is assigned a device which is coupled to the control device for varying a stiffness of the sole, wherein the device for varying the stiffness of the sole comprises an actuator for rotating at least one element within the sole along a longitudinal axis of the sole or for displacing at least one element within the sole along the longitudinal axis of the sole to vary the stiffness of the sole.
Piercy et al. teaches wherein an analogous foot part (110 - figure 1, foot structure: paragraph 0016) is assigned a device (320 - figure 3, a pneumatic system that inflates and/or deflates inflatable actuators with fluid: paragraph 0027), which is coupled to an analogous control device (330 - figure 3, the one device [320] is coupled to a control system: paragraph 0030-0032), for varying a stiffness (for the purpose of compact prosecution, “stiffness” is determined by the leg rail and sole’s resistive ability to limit the user from moving in a specific direction) of an analogous sole (the one device [320] varies the stiffness of the sole since it inflates and/or deflates the inflatable actuators within the sole, which dynamically adjusts the stiffness: paragraph 0012/0016/0029-0033), wherein the device (320) for varying the stiffness of the analogous sole comprises an actuator (the one device [320] is an actuator because it initiates the inflation or deflation of the inflatable actuators that can be in the sole: paragraph 0012/0016/0029-0033) for rotating at least one element (140 - figure 3, an inflatable actuator: paragraph 0012/0029) within the analogous sole along a longitudinal axis of the sole or for displacing at least one element within the sole along the longitudinal axis of the analogous sole to vary the stiffness of the analogous sole (the element [140] can be placed within the sole of the foot to provide motive force by direct manipulation of the sole [displacement of the sole due to expansion/displacement of the element]; hence, the stiffness is dynamically adjustable via the actuator [320] and elements [140] within the sole: paragraph 0012/0016/0029-0033). When the one element [140] is inflated, the one element [140] expands [the term “expand” is defined as “to increase the size, volume, quantity, or scope of; enlarge” by https://www.thefreedictionary.com/expand]; this implies that the one element [140] is displaced from its original position [deflated state] to the expanded position [inflated state] in the x-axis and y-axis [paragraph 0027]. The difference in the length/height between the original and expanded position is the displacement along the longitudinal and lateral axis of the sole. Applicant also states “in a direction of a toe end of the sole to a heel end of the sole” in their argument, however, the element [140] can expand in size [x-axis and y-axis], which implies that it is displaced along the longitudinal and lateral axis of the sole. Furthermore, any displaced distance could be considered along the longitudinal axis of the sole due to the how the claim limitation was written).
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 provided the sole of Kogler et al. with a control device coupled to an actuator and elements [inflatable actuators] to vary the stiffness of the sole as taught by Piercy et al. in order to provide an orthosis that has an improved sole to provide a motive force by direct manipulation of the sole and also dynamically adjust the stiffness of the sole depending on user’s needs (paragraph 0012/0016/0029-0033, Piercy et al.).
Regarding claim 18, Kogler et al. in view of Piercy et al. discloses the invention as discussed in claim 16. Kogler et al. further discloses wherein a joint (B - see annotated figure 1 above, a joint that connects the foot part [C] and leg rail [A]) is arranged between the leg rail (A) and the foot part (C), and the joint (B) is assigned at least one of a brake and a damper device (examiner focused on the limitation “a damper device”) (the motion resisting mechanism [108] can be a mechanical damper that produces a magnitude of restriction on the ankle joint; additionally, in different embodiments, it was disclosed that the motion resisting mechanism [108] can be in many positions including, but not limited to, the anterior, posterior, medial, or lateral side of the user, and positions in between which includes the area of where the joint [B] is: Paragraph 0066) which is coupled to the control device (the control device and the motion resisting mechanism [108] is coupled via sensors [102a - 102f]: Paragraph 0056-0059) and which is activated or deactivated in a manner dependent on the detected orthosis parameters (the motion resisting mechanism [108] functionality can be adjusted depending on the user’s need [activation begins when there is an increase in tension]; since the motion resisting mechanism [108] is coupled to the control device via sensors [102a - 102f], orthosis parameters are collected [such as force, torque, and pressure] and evaluated to adjust the tension of the motion resisting mechanism [108] to provide a stiffness better suited for a specific patient: Paragraph 0057- 0059).
Regarding claim 19, Kogler et al. in view of Piercy et al. discloses the invention as discussed in claim 1. Kogler et al. further discloses wherein the leg rail (A) is formed as a separate component (the leg rail [A] is a member that is coupled to the joint [B] of the user) and is arranged in articulated fashion on the foot part (C) (see annotated figure 1 above, the leg rail [A] is located at a position around the user’s ankle joint and at the side of the user’s foot: Paragraph 0061).
Regarding claim 20, Kogler et al. discloses An orthosis for a lower limb (100 - see annotated figure 1 above, ankle-foot orthotic device: Paragraph 0051), the orthosis having: a foot part (C- see annotated figure 1 above, a foot part that is a part of the orthosis: Paragraph 0051) which has a sole (D - see annotated figure 1 above, a foot sole that goes under user’s foot) for supporting a foot (the sole [D] is under the wearer’s foot to provide support) for supporting a foot (the sole [D] is under the wearer’s foot to provide support), and at least one leg rail (A - see annotated figure 1 above, an adjustable stirrups: Paragraph 0061) which extends from said foot part (C) and which in a fitted state extends along a lower leg (see annotated figure 1 above, the leg rail [A] extends from the foot part [C] to the distal part of the leg when worn) and which has devices for at least one of supporting and fastening the leg rail (A) on the lower leg (examiner focused on the limitation “which has devices for at least fastening the leg rail on the lower leg”) (114 - see annotated figure 1 above, a closure/suspension feature to secure the orthosis device to the leg of a user: Paragraph 0061); wherein the orthosis (100) further includes at least one sensor (102a -102f - see annotated figure 1 above, sensors coupled to the orthosis [100]: Paragraph 0052) for detecting orthosis parameters (the sensor [102a - 102f] can sense force, pressure, torque, and more: Paragraph 0052-0054), the at least one sensor (102a -102f) being coupled to a control device (the sensors [102a - 102f] are collected and monitored by a remote device; the remote device can be a CPU, smartphone, or tablet: Paragraph 0056/0063); wherein the at least one leg rail (A) is assigned at least one device (108 - see annotated figure 1 above, a motion resisting mechanism is coupled to the leg rail [A]; the motion resisting mechanism can be a spring to adjust the magnitude of restriction: Paragraph 0066) coupled to the control device (the control device and the motion resisting mechanism [108] is coupled via sensors [102a - 102f]: Paragraph 0056-0059) for varying a stiffness (for the purpose of compact prosecution, “stiffness” is determined by the leg rail and sole’s resistive ability to limit the user from moving in a specific direction) of the leg rail (A) (the leg rail’s [A] stiffness is determined by how much tension the motion resisting mechanism [108] has; the more tension the motion resisting mechanism has, the stiffer the leg rail [A] becomes which limits movement in a certain direction: Paragraph 0057-0059/0069-77)
However, Kogler et al. fails to disclose wherein the foot part is assigned at least one device coupled to the control device for varying a stiffness of the sole, wherein the at least one device for varying the stiffness of the sole comprises an actuator for rotating at least one element within the sole along a longitudinal axis of the sole or for displacing at least one element within the sole along the longitudinal axis of the sole to vary the stiffness of the sole.
Piercy et al. teaches wherein an analogous foot part (110 - figure 1, foot structure: paragraph 0016) is assigned at least one device (320 - figure 3, a pneumatic system that inflates and/or deflates inflatable actuators with fluid: paragraph 0027) coupled to an analogous control device (330 - figure 3, the one device [320] is coupled to a control system: paragraph 0030-0032) for varying a stiffness (for the purpose of compact prosecution, “stiffness” is determined by the leg rail and sole’s resistive ability to limit the user from moving in a specific direction) of an analogous sole (the one device [320] varies the stiffness of the sole since it inflates and/or deflates the inflatable actuators within the sole, which dynamically adjusts the stiffness: paragraph 0012/0016/0029-0033), wherein the at least one device (320) for varying the stiffness of the analogous sole comprises an actuator (the one device [320] is an actuator because it initiates the inflation or deflation of the inflatable actuators that can be in the sole: paragraph 0012/0016/0029-0033) for rotating at least one element (140 - figure 3, an inflatable actuator: paragraph 0012/0029) within the analogous sole along a longitudinal axis of the sole or for displacing at least one element within the sole along the longitudinal axis of the analogous sole to vary the stiffness of the analogous sole (the element [140] can be placed within the sole of the foot to provide motive force by direct manipulation of the sole [displacement of the sole due to expansion/displacement of the element]; hence, the stiffness is dynamically adjustable via the actuator [320] and elements [140] within the sole: paragraph 0012/0016/0029-0033). When the one element [140] is inflated, the one element [140] expands [the term “expand” is defined as “to increase the size, volume, quantity, or scope of; enlarge” by https://www.thefreedictionary.com/expand]; this implies that the one element [140] is displaced from its original position [deflated state] to the expanded position [inflated state] in the x-axis and y-axis [paragraph 0027]. The difference in the length/height between the original and expanded position is the displacement along the longitudinal and lateral axis of the sole. Applicant also states “in a direction of a toe end of the sole to a heel end of the sole” in their argument, however, the element [140] can expand in size [x-axis and y-axis], which implies that it is displaced along the longitudinal and lateral axis of the sole. Furthermore, any displaced distance could be considered along the longitudinal axis of the sole due to the how the claim limitation was written).
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 provided the sole of Kogler et al. with a control device coupled to an actuator and elements [inflatable actuators] to vary the stiffness of the sole as taught by Piercy et al. in order to provide an orthosis that has an improved sole to provide a motive force by direct manipulation of the sole and also dynamically adjust the stiffness of the sole depending on user’s needs (paragraph 0012/0016/0029-0033, Piercy et al.).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kogler et al. (WO 2018175859 A1) in view of Piercy et al. (US 20160278948 A1) and in further view of Kazerooni et al. (US 20170367852 A1)
Regarding claim 4, Kogler et al. in view of Piercy et al. discloses the invention as discussed in claim 1. Kogler et al. further discloses wherein a joint (B - see annotated figure 3 above, a joint that connects the foot part [C] and leg rail [A]) is arranged between the leg rail (A) and the foot part (C), and a spring (interpreting as the motion resisting mechanism [108]).
However, Kogler et al. in view of Piercy et al. fails to disclose wherein the joint is assigned a brake and a damper device [the motion resisting mechanism] which is coupled to the control device and which is activated or deactivated in a manner dependent on the detected orthosis parameters.
Kazerooni et al. teaches wherein an analogous joint is assigned a brake (112 - figure 3, a locking mechanism that can include caliper brakes, disk brakes, band brake, ratchet and pawl assembly, linkage assemblies including bi-stable linkage assemblies: paragraph 0049) and a damper device (108 - figure 3, a torque generator that resists external flexion torques [torque imposed by user]; the torque generator can be pneumatic or hydraulic cylinder or a cylinder with hydraulic and pneumatic components, gas springs, hydraulic dampers, lockable gas springs, and lockable dampers: paragraph 0041) which is coupled to the control device (120 - figure 15, a controller: paragraph 0053) (the damper device and brake are coupled to the control device: paragraph 0053) and which is activated or deactivated in a manner dependent on the detected orthosis parameters (the sensors [123 - figure 15, can be rotary potentiometers , accelerometers, gyroscopes, and more: paragraph 0053] send signals [121 - figure 15] to the control device [120] to control the locking and unlocking states of the brake [112], which consequently results in the damper device [108] to provide [or not provide] resistance to flexion motion: paragraph 0038/0053).
The device of Kogler et al. and Kazerooni et al. are in the same general field of endeavor and are therefore, considered analogous art; both would be considered motion resisting mechanisms that prevent motion in at least one direction.
Therefore, at the time the invention was made, it would have been well within the skill of an ordinary artisan to substitute one known element for another to obtain predictable results. Substituting the springs (108) of Kogler et al. with a brake (112) and damper device (108) of Kazerooni et al. would have achieved the predictable result of restricting movement of the joint in at least one direction that the joint of the user moves in via the damper (paragraph 0041, Kazerooni et al.) and the brake is for locking and unlocking the damper device to function (paragraph 0038, Kazerooni et al.).
Examiner further notes: Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the claim is unpatentable under 35 U.S.C.