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 .
Status of Claims
Claims 1-14 are pending
Response to Arguments
The remarks of 01/23/2026 have been fully considered but they are not persuasive.
Applicant argues that the prior art combination doesn't explicitly teach or disclose all of the elements of claim 1, in particular the following claim language:
“a flexion resistance is changed on the basis of sensor data in an early and mid-stance phase after initial heel contact up to the mid stance phase”
“after the initial heel contact, the flexion resistance is increase to a value at which further flexion is blocked or at least slowed”
Regarding the first bullet point - Paragraph 0034 discloses that adjustment device 7 is activated or deactivated by sensors 9. Paragraph 0035 clarifies that sensors 9 are configured to monitor the entire gait cycle. This corresponds to changing a flexion resistance based on sensor data recorded in an early and mid-stance phase.
Regarding the second bullet point - Paragraph 0137 discloses ‘as illustrated in typical ambulation, the knee resistance increases 211 as post heel strike stance flexion occurs, to limit the amount of stance flexion speed and angle”. In this paragraph “post heel strike” corresponds to “after the initial heel contact”. Further, “limiting the amount of stance flexion speed and angle” corresponds to “at least slowed”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-14, claim 1 recites “a flexion resistance is changed on the basis of sensor data in an early and mid-stance phase after initial heel contact up to the midstance phase”. The scope of the claim 1 is made indefinite with the introduction of the phrase “in an early and mid-stance phase after initial heel contact up the the midstance phase”. Does this describe the time period over which the sensor data is recorded? Or does it describe the duration of time that flexion resistance is increased? Claims 2-14 are also rendered indefinite due to their dependency on claim 1. For examination purposes – the claim will be interpreted to require a change in flexion resistance that occurs after initial heel contact based on sensor data recorded from initial heel contact to midstance.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 8, 9 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0125681 (‘681) in view of US 2009/0192619 (Martin) in view of US 2022/0304831 (‘831)
Regarding claim 1, ‘681 discloses a method for controlling a prosthesis or orthosis of the lower extremity (¶0001), having an upper part (Fig. 1, 1) and having a lower part (Fig. 1, 2) which is connected to the upper part via a knee joint (Fig. 1, 4) and is mounted so as to be pivotable relative to the upper part about a joint axis (Fig. 1, wherein 2 can pivot relative to 1 via knee axis 4), wherein there is arranged between the upper part and the lower part an adjustable resistance device (Fig. 1, 6, ¶0033) by means of which, during walking, a flexion resistance (¶0033, “resistance R”) is changed on the basis of sensor data (¶0034, “activated or deactivated on the basis of sensor data” in an early and mid-stance phase after initial heel contact up to the mid stance phase (¶0035, wherein the entire gait cycle is monitored – corresponding to at least heel strike to mid stance)
‘681 doesn't explicitly teach or disclose after the initial heel contact, the flexion resistance (Rf) is increased to a value at which further flexion is blocked or at least slowed,
Martin discloses a method for controlling a prosthesis (Abstract) wherein after the initial heel contact (¶0133, “upon heel strike”), the flexion resistance is increased to a value at which further flexion is blocked or at least slowed (¶0137, wherein “knee resistance increases at post heel strike stance flexion occurs” corresponds to flexion resistance is increased to a value at which further flexion is slowed)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 to increase the knee flexion resistance at heel strike, as taught by Martin, in order to provide a smooth transition of the knee motion and maintain symmetry with the user’s sound side (¶0137).
‘681 doesn't explicitly teach or disclose wherein the temporal profile of the flexion resistance increase and/or the maximum achievable flexion angle is changed in dependence on the inclination of the surface or a height difference to be overcome. Martin doesn't explicitly teach or disclose wherein the temporal profile of the flexion resistance increase and/or the maximum achievable flexion angle is
changed in dependence on the inclination of the surface or a height difference (AH) to be overcome.
‘831 discloses wherein the temporal profile of the flexion resistance increase and/or the maximum achievable flexion angle is changed (¶0019, wherein knee flexion with low resistance in dependence on the inclination of the surface or a height difference (AH) to be overcome. (¶0045, wherein reduction of resistance to knee flexion corresponds to changing the temporal profile of the flexion resistance increase”
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 in view of Martin to change the temporal profile of the flexion resistance increase in dependence on the inclination of the surface, as taught by ‘831, in order to maintain the natural sequence of movement when walking up an incline
Regarding claim 2, ‘681 doesn't explicitly teach or disclose the maximum achievable flexion angle and/or the flexion angle at which the maximum flexion resistance is achieved is increased in the case of an increasingly steep surface. Martin doesn't explicitly teach or disclose the maximum achievable flexion angle and/or the flexion angle at which the maximum flexion resistance is achieved is increased in the case of an increasingly steep surface.
‘831 discloses a method for controlling a prothesis characterized in that the maximum achievable flexion angle (¶0045, “achievable knee angle”) and/or the flexion angle at which the maximum flexion resistance is achieved is increased in the case of an increasingly steep surface (¶0045, wherein the achievable knee angle is increased walking up an incline)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 in view of Martin to increase the maximum achievable flexion angle in the case of an increasingly steep surface, as taught by ‘831, in order to provide a safe mode of ambulation for the user
Regarding claim 3, ‘681 doesn't explicitly teach or disclose in the case of an increasingly steep surface, the maximum flexion resistance is reduced. Martin doesn't explicitly teach or disclose in the case of an increasingly steep surface, the maximum flexion resistance is reduced.
‘831 discloses in the case of an increasingly steep surface (¶0045, wherein walking up an incline corresponds to an increasingly steep surface) the maximum flexion resistance is reduced (¶0045, wherein knee flexion is permitted with low flexion resistance corresponds to reducing the maximum flexion resistance)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 in view of Martin to decrease the maximum flexion resistance in the case of an increasingly steep surface, as taught by ‘831, in order to allow the user to maintain a natural sequence of movement while walking up and incline.
Regarding claim 8, ’681 doesn't explicitly teach or disclose the inclination of the surface is calculated from at least one of a vertical and/or horizontal distance travelled in the preceding swing phase by the knee joint, as determined by a reference point in the vicinity of the sole of the foot or from the ratio of a vertical and horizontal distance travelled in the preceding swing phase by the knee joint, in particular by a reference point in the vicinity of the sole of the foot, as a displacement calculation criterion. Martin doesn't explicitly teach or disclose the inclination of the surface can be calculated from a vertical and/or horizontal distance travelled in the preceding swing phase by the knee joint, in particular by a reference point in the vicinity of the sole of the foot or from the ratio of a vertical and horizontal distance travelled in the preceding swing phase by the knee joint, in particular by a reference point in the vicinity of the sole of the foot, as a displacement calculation criterion.
‘831 discloses that the inclination of the surface (¶0017, walking up an incline”) is calculated from at least one a vertical or a horizontal distance travelled in the preceding swing phase by the knee joint (1), as determined by a reference point in the vicinity of the sole of the foot (¶0017, wherein the “height difference that the ipsilateral foot overcomes in swing phase” corresponds to a ratio of the vertical and horizontal distance traveled by a reference point in the vicinity of the sole of the foot”) or from the ratio of a vertical and horizontal distance travelled in the preceding swing phase by the knee joint, as determined by a reference point in the vicinity of the sole of the foot, as a displacement calculation criterion
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify ‘681 in view of Martin with to determine the incline of the surface by a ration of the vertical and horizontal distances traveled by a reference point in the vicinity of the sole of the foot, as taught by ‘831, in order to better inform the control system.
Regarding claim 9, ‘681 further discloses that the beginning of the stance phase to be controlled (¶0031, “stance phase”) is determined on the basis of an axial force impulse (¶0021, wherein stance phase is determined based on an axial force acting on the lower part – corresponding to an axial force impulse), a plantar flexion acceleration and/or an ankle moment.
Regarding claim 13, ‘681 doesn't explicitly teach or disclose wherein position and/or orientation of a ground reaction force vector in relation to the orthosis or prosthesis is used as a control parameter. Martin doesn't explicitly teach or disclose wherein position and/or orientation of a ground reaction force vector in relation to the orthosis or prosthesis is used as a control parameter.
‘831 discloses wherein position and/or orientation of a ground reaction force vector (¶0037, “location and extend of ground reaction force”) in relation to the orthosis or prosthesis is used as a control parameter (¶0037, wherein “extension movement is controlled” corresponds to a control parameter)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 in view of Martin to use the ground reaction force vector as a control parameter, as taught by ‘831, in order to controllably extend the knee during stance phase
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0125681 (‘681) in view of US 2009/0192619 (Martin) in view of US 2022/0304831 (‘831), as applied to claims above, and further in view of US 2014/0379096 (Zahedi)
Regarding claim 4, ‘681 doesn't explicitly teach or disclose that the flexion block or the flexion resistance increase is maintained for a defined period of time, and then the flexion resistance is reduced. Martin discloses that the flexion resistance is increased (see rejection of claim 1) but doesn't explicitly teach or disclose the flexion resistance is reduced after a defined period of time. ‘831 doesn't explicitly teach or disclose a flexion resistance decrease after a defined period of time.
Zahedi discloses disclose that the flexion block or the flexion resistance increase is maintained for a defined period of time (¶0028, wherein the “first level” corresponds to a flexion resistance increase), and then the flexion resistance is reduced (¶0028, wherein the “second level” corresponds to a flexion resistance decrease)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 in view of Martin in view of ‘831 to increase the flexion resistance after a defined period of time, as taught by Zahedi, in order to provide safe control of the prosthetic knee.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0125681 (‘681) in view of US 2009/0192619 (Martin) in view of US 2022/0304831 (‘831) in view of US 2014/0379096 (Zahedi), as applied to claims above, and further in view of US 2016/0206447 (Auberger)
Regarding claim 5, ‘681 doesn't explicitly teach or disclose reducing flexion resistance after a flexion block or after the flexion resistance increase if a measure of the transverse force in the lower part exceeds a limit value dependent on the inclination of the surface and/or a leg cord exceeds a forward inclination dependent on the inclination of the surface and/or a measure of the hip moment initially exceeds and then falls below a limit value. Martin doesn't explicitly teach or disclose reducing flexion resistance after a flexion block or after the flexion resistance increase if a measure of the transverse force in the lower part exceeds a limit value dependent on the inclination of the surface and/or a leg cord exceeds a forward inclination dependent on the inclination of the surface and/or a measure of the hip moment initially exceeds and then falls below a limit value. ‘831 doesn't explicitly teach or disclose reducing flexion resistance after a flexion block or after the flexion resistance increase if a measure of the transverse force in the lower part exceeds a limit value dependent on the inclination of the surface and/or a leg cord exceeds a forward inclination dependent on the inclination of the surface and/or a measure of the hip moment initially exceeds and then falls below a limit value. Zahedi doesn't explicitly teach or disclose reducing flexion resistance after a flexion block or after the flexion resistance increase if a measure of the transverse force in the lower part exceeds a limit value dependent on the inclination of the surface and/or a leg cord exceeds a forward inclination dependent on the inclination of the surface and/or a measure of the hip moment initially exceeds and then falls below a limit value.
Auberger discloses the flexion resistance is reduced (¶0048, “resistance R of the resistance device is reduced”) after the flexion block or after the flexion resistance increase if a measure of the transverse force in the lower part exceeds a limit value dependent on the inclination of the surface (¶0048, wherein static load corresponds to transverse force in the lower part) and/or a leg cord exceeds a forward inclination dependent on the inclination of the surface (¶0048, “forward inclination”) and/or a measure of the hip moment initially exceeds and then falls below a limit value.
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 in view of Martin in view of ‘831 in view of Zahedi to reduce flexion resistance after a measure of the transverse force in the lower part exceeds a limit value, as taught by Auberger, in order to provide safer control of the prosthetic knee joint.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0125681 (‘681) in view of US 2009/0192619 (Martin) in view of US 2022/0304831 (‘831) in view of US 2014/0379096 (Zahedi) in view of US 2016/0206447 (Auberger), as applied to claims above, and further in view of US 2012/0226364 (Kampas)
Regarding claim 6, ‘681 doesn't explicitly teach or disclose that the measure of the transverse force is determined by means of a transverse force sensor or from a difference in transverse force components of an ankle moment and knee moment. Martin doesn't explicitly teach or that the measure of the transverse force is determined by means of a transverse force sensor or from a difference in transverse force components of an ankle moment and knee moment.’831 doesn't explicitly teach or disclose the measure of the transverse force is determined by means of a transverse force sensor or from a difference in transverse force components of an ankle moment and knee moment. Zahedi doesn't explicitly teach or disclose the measure of the transverse force is determined by means of a transverse force sensor or from a difference in transverse force components of an ankle moment and knee moment. Auberger doesn't explicitly teach or disclose the measure of the transverse force is determined by means of a transverse force sensor or from a difference in transverse force components of an ankle moment and knee moment
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Kampas discloses method for controlling a prosthetic or orthotic joint characterized in that the measure of the transverse force (¶0068, wherein C in the equation corresponds to transverse force) is determined by means of a transverse force sensor or from a difference in transverse force components of an ankle moment and knee moment (¶0068, see equation provided below wherein M2 is the knee torque and M1 is the ankle torque)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 in view of Martin in view of ‘831 in view of Zahedi in view of Auberger with a calculation of transverse force using the traverse components of the ankle and knee moments, as taught by Kampas, in order to provide a useful auxiliary variable to inform the control system (¶0068)
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0125681 (‘681) in view of US 2009/0192619 (Martin) in view of US 2022/0304831 (‘831), as applied to claims above, and further in view of US 2016/0206447 (Auberger)
Regarding claim 7, ‘681 doesn't explicitly teach or disclose flexion resistance is reduced after an increase to below a blocking level if a predefined flexion angle is exceeded. Martin doesn't explicitly teach or disclose flexion resistance is reduced after an increase to below a blocking level if a predefined flexion angle is exceeded. ‘831 doesn't explicitly teach or disclose flexion resistance is reduced after an increase to below a blocking level if a predefined flexion angle is exceeded.
Auberger discloses that the flexion resistance (Rf) is reduced (¶0035, “reduce flexion resistance”) after an increase to below a blocking level if a predefined flexion angle is exceeded (¶0035, wherein knee angle is checked – corresponding to a predefined flexion angle is exceeded)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify ‘681 in view of Martin in view of ‘831 to reduce flexion resistance if a predetermined flexion angle is exceeded, as taught by Auberger, in order to initiate swing flexion.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0125681 (‘681) in view of US 2009/0192619 (Martin) in view of US 2022/0304831 (‘831), as applied to claims above, and further in view of US 2006/0224246 (Clausen)
Regarding claim 10, ‘681 doesn't explicitly teach or disclose inclination of the surface is calculated from an evaluation of a flexion angle and of an absolute angle of the upper part or of the lower part or from the evaluation of two absolute angles of the upper part and lower part, as a kinematic criterion. Martin doesn't explicitly teach or disclose inclination of the surface is calculated from an evaluation of a flexion angle and of an absolute angle of the upper part or of the lower part or from the evaluation of two absolute angles of the upper part and lower part, as a kinematic criterion. ‘831 doesn't explicitly teach or disclose inclination of the surface is calculated from an evaluation of a flexion angle and of an absolute angle of the upper part or of the lower part or from the evaluation of two absolute angles of the upper part and lower part, as a kinematic criterion.
Clausen discloses a prosthetic or orthotic system wherein inclination of the surface (¶0208, “relative incline and/or decline of the terrain”) is calculated from an evaluation of a flexion angle (¶0208, wherein angle between 102 and 104 corresponds to the flexion angle) and of an absolute angle of the upper part or of the lower part or from the evaluation of two absolute angles of the upper part and lower part, as a kinematic criterion (¶0208, wherein the absolute position of 102 corresponds to an absolute angle of the lower part)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 in view of Martin in view of ‘831 to calculate the inclination of the terrain based on an evaluation of the two absolute angles of the upper part, as taught by Clausen, in order to adapt the prosthesis to different surfaces
Regarding claim 11, ‘681 further discloses that the knee angular velocity and lower part angular velocity during walking are determined (¶0018, wherein change in the thig angle or lower leg angle corresponds to knee angular velocity and lower part angular velocity), and the quotient of the two angular velocities is calculated therefrom (¶0018, “quotient of change”), wherein the inclination of the surface is determined on the basis of the change of the quotient of the angular velocities (¶0018, wherein assessment of the walking situation corresponds to the inclination of the surface)
Regarding claim 12, ‘681 doesn't explicitly teach or disclose that the displacement calculation criterion is used for determining the surface inclination. Martin doesn't explicitly teach or disclose that the displacement calculation criterion is used for determining the surface inclination.
‘831 discloses that the displacement calculation criterion (¶0017, wherein the heigh difference the ipsilateral foot overcomes in swing phase corresponds to the displacement calculation criterion) is used for determining the surface inclination (¶0017, “walking up an incline”)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify ‘681 in view of Martin with to determine the surface inclination with the displacement calculation criterion, as taught by ‘831, in order to inform the control scheme.
‘681 doesn't explicitly teach or disclose that the kinematic criterion is used for determining the surface inclination. Martin doesn't explicitly teach or disclose that kinematic criterion is used for determining the surface inclination. ‘831 Martin doesn't explicitly teach or disclose that kinematic criterion is used for determining the surface inclination.
Clausen discloses a kinematic criterion is used for determining the surface inclination (see rejection of claim 8, see also ¶0208, wherein the angle between 102 and 104 as well as the absolute position of 102 is used to calculate surface inclination) wherein the kinematic criterion is determined as one of: an evaluation of a flexion angle and an absolute angle of the upper part or of the lower part; or an evaluation of two absolute angles of the upper part and the lower part (¶0109, wherein the absolute angles of the upper and lower part can be determined using triaxial accelerometers and gyroscopes)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 in view of Martin in view of ‘831 to also calculation the surface inclination with the kinematic criterion, as taught by Clausen, in order to provide a redundant measure to avoid control errors related to faulty sensors or sensor artifacts.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0125681 (‘681) in view of US 2009/0192619 (Martin) in view of US 2022/0304831 (‘831), as applied to claims above, and further in view of US 2015/0164660 (Will)
Regarding claim 14, ‘681 doesn't explicitly teach or disclose detection of a roll- over of a foot part over an edge prevents a flexion resistance increase or reduces the increased flexion resistance again. Martin doesn't explicitly teach or disclose detection of a roll- over of a foot part over an edge prevents a flexion resistance increase or reduces the increased flexion resistance again. ‘831 doesn't explicitly teach or disclose detection of a roll- over of a foot part over an edge prevents a flexion resistance increase or reduces the increased flexion resistance again.
Will discloses a prosthetic or orthotic joint device (see abstract) characterized in that the detection of a roll- over of a foot part (Fig. 1, 9) over an edge prevents a flexion resistance increase or reduces the increased flexion resistance again (¶0063, wherein flexion damping is reduced corresponds to reduces the increases flexion resistance)
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention to modify the method of ‘681 in view of Martin in view of ‘831 to reduce flexion resistance when a foot is detected to roll over an edge, as taught by Will, in order to help clear the foot when climbing stairs.
Conclusion
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 extension fee 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 date of this final action.
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/MAXIMILIAN TOBIAS SPENCER/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774