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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “53” has been used to designate both “the inertial angle sensor” and “an acceleration or transverse force sensor”. (see pg 11 of instant disclosure)
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 3-5, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seifert (2018/0125681) in view of Kampas (WO2011/057795A1).
In regard to claim 1, Seifert teaches a method for controlling a prosthesis (fig 1, prosthetic leg) or orthosis of the lower extremity,
having an upper part (10) and having a lower part (2) which is connected to the upper part (10) via a knee joint (1) and is mounted so as to be pivotable relative to the upper part (10) about a joint axis (4), wherein there is arranged between the upper part (10) and the lower part (2) an adjustable resistance device (6)
by means of which a flexion resistance is changed on the basis of sensor data, (abstract: sensor of a control unit activates the adjusting mechanism; resistance is changed as a function of the position or length)
wherein an axial force acting on the lower part is detected by at least one sensor 9 and used as the basis for a change of the flexion resistance [0021: force sensor to detect stance phase; swing phase requires a different setting of resistances than walking],
characterized in that a in the case of a decreasing axial force and/or an approximately vertical position of a leg cord (special definition in instant disclosure: pg 4 of disclosure: leg cord is defined as a connecting line between two defined points on the upper and lower part) and/or an extended knee joint, swing phase is detected [0021: force sensor detects an axial force; if unloaded it can be assumed the lower extremity is in swing phase which requires a different setting of resistance],
b. wherein the flexion resistance is raised again if,
within a fixed period of time, no knee flexion is detected and/or the knee joint
and/or the leg cord and/or the axial force exceed or fall below specific limit values. [0012: resistance is changed in a manner depending on the leg cord position and/or length; the change can be considered exceeding or falling below a limit value, compared to a limit of no change]
However, Seifert does not teach that flexion resistance is reduced in swing phase or raised again.
Kampas teaches in the case of swing phase, flexion resistance is reduced (see figure 14, To refers to toe off which is the start of swing phase and at this point resistance is reduced; pg 7, p7: decrease resistance to facilitate flexing).
Kampas further teaches wherein the flexion resistance is raised again if,
within a fixed period of time, no knee flexion is detected and/or the knee joint (claim 35 of translation: the resistance after a reduction is increased again to a value in stance phase, if within a specified time after the reduction of resistance a threshold value of an inertial angle of a joint component is not achieved for a joint angle; pg 5, p 9 of translation).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the swing phase resistance and time control of resistance of Kampas in the control method of Seifert during swing phase because this facilitates flexing when the forefoot leaves the floor (flexing properly during swing phase prevents tripping or stumbling) (pg 7, p7 of translation) and provides safety from the knee buckling if swing is discontinued to prevent buckling (pg 5, p 9).
In regard to claim 3, Siefert meets the claim limitations as discussed in the rejection of claim 1, and further teaches a decrease in the axial force indicates swing phase [0021].
However, Siefert does not teach that flexion resistance is reduced in swing phase.
Kampas further teaches in the case of swing phase, flexion resistance is reduced (see figure 14, To refers to toe off which is the start of swing phase and at this point resistance is reduced). Since the axial force indicates swing phase, when combined with the invention of Siefert, reduced axial force will result in reduced flexion resistance.
In regard to claim 4, Siefert meets the claim limitations as discussed in the rejection of claim 1, but does not teach that the flexion resistance is reduced to a level below a stance phase resistance.
Kampas further teaches in the case of swing phase, flexion resistance is reduced (see figure 14, To refers to toe off which is the start of swing phase and at this point resistance is reduced) to a level below a stance phase resistance. (figure 9; stance phase is from heel strike to knee break, after knee break resistance decreased)
In regard to claim 5, Seifert meets the claim limitations as discussed in the rejection of claim 1, and further teaches that the flexion resistance is reduced in dependence on the axial force, the leg cord angle and/or a spatial angle of the lower part. [0012: resistance is changed in a manner dependent on the position of the leg cord; flexion resistance is suitable increased or decreased]
In regard to claim 11, Seifert meets the claim limitations as discussed in the rejection of claim 1, and further teaches an increase of the axial force detected [0021: a force sensor detects an axial force to determine if in swing phase; different resistances for stance or swing].
However, Seifert does not teach an increase of axial force occurs if stance is occurring.
Kampas teaches that the flexion resistance is increased in stance phase (figure 14: resistance increases at heel strike which is the stance phase). When combined with Seifert, the axial force is used to indicate the start of stance and therefore the increased flexion resistance of Kampas will occur with an increase in axial force.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the increased flexion resistance of Kampas in the stance phase of Seifert because this prevents the knee buckling (pg 5, p 8 of translation: leg is loaded in the bending direction without buckling)
In regard to claim 12, Seifert meets the claim limitations as discussed in the rejection of claim 1, and further teaches a backward inclination of the lower leg part is detected and indicates heel strike [0018].
However, Seifert does not teach the resistance level that corresponds to heel strike (the start of stance phase).
Kampas further teaches the flexion resistance is not reduced if heel strike of the lower part is detected (when combined with Seifert, the backward inclination is used to indicate heel strike). (figure 4: resistance is increased at an indication of heel strike; pg 7, last paragraph of the translation: after heel strike there is a relatively high flexion resistance; pg 8, first paragraph of translation: in order to obtain sufficient security against uncontrolled buckling when placing the foot (this refers to heel strike), flexion resistance is at a high level) Further, the claim does not specify what the reduction in resistance level is in comparison to.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the resistance of Kampas after heel strike in the invention of Seifert because this prevents the knee buckling during stance (pg 8, first paragraph of translation: in order to obtain sufficient security against uncontrolled buckling when placing the foot (this refers to heel strike), flexion resistance is at a high level)
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seifert (2018/0125681) in view of Kampas (WO2011/057795A1) and further in view of Zahedi (WO2013/088142A1).
In regard to claim 2, Siefert meets the claim limitations as discussed in the rejection of claim 1, and further teaches distinguishing heel strike [0018] but remains silent to the flexion resistance when setting off (interpreted as best understood to refer to initiating walking).
Zahedi teaches that that the flexion resistance is reduced when setting off (interpreted as best understood to refer to initiating walking) from a standing position. (4A: the knee resistance is very high in standing and the swing resistance becomes low during level velocity walking. Swing phase is the first phase of gait when walking after standing during normal gait.) Further, the claim does not specify reduced compared to any reference point.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the flexion resistance of Zahedi when setting off in the control strategy of Seifert because this mimics normal human gait and the prosthesis is replacing a natural limb.
Allowable Subject Matter
Claims 6-9, 13-15 are objected to as being dependent upon a rejected base claim.
In regard to claims 6 and 13, the closest prior art Seifert (2018/0125681) in view of Kampas (WO2011/057795A1) meets all of the claimed limitations except “in the case of a decrease of the axial force (FA) to a level above a limit value and a determined positive leg cord angle (aLC) above a limit value
In regard to claims 7-8, the closest prior art Seifert (2018/0125681) in view of Kampas (WO2011/057795A1) meets all of the claimed limitations except “in the case of a decrease of the axial force (FA) to a level below a limit value and a determined leg cord angle (aLC) outside a defined angle range about the vertical no reduction of the flexion resistance (RD takes place” in combination with the other claimed limitations.
In regard to claim 9, the closest prior art Seifert (2018/0125681) in view of Kampas (WO2011/057795A1) meets all of the claimed limitations except “in the case of a decrease of the axial force (FA) to a level below a limit value and a determined inclination angle (as) of the lower part relative to the vertical (G) within a defined angle range about the vertical (G), no reduction of the flexion resistance takes place” in combination with the other claimed limitations.
Response to Arguments
In regard to the drawing objections, the applicant states the specification has been amended. However, no specification amendment is present. Accordingly, the objection has been maintained. Please check the referenced amendment was submitted to the file.
In regard to the objection of claim 8, the amendment overcomes the objection.
In regard to the 112b rejection of claims 6-9, the amendments overcome the rejections.
In regard to the 103(a) rejection of claims 1, 3-5, 11-12 as unpatentable over Seifert (2018/0125681) in view of Kampas (WO2011/057795A1), the applicant’s arguments have been fully considered. The applicant argues that claim 1 requires the flexion resistance is actively reduced in response to a triggering condition and is dynamic. The applicant acknowledges secondary reference Kampas was used to teach this but argues that Kampas teaches reducing flexion resistance during stance phase not the start of swing phase. The applicant argues that the reduction in resistance occurs only after toe off but the process of reducing resistance occurs during terminal stance phase but before toe off. Seifert teaches swing phase is identified by reducing flexion resistance as noted above [0021]. However, Seifert remains silent to the resistance controls in swing phase. Kampas was used to teach the flexion resistance reduction in response to swing phase (pg 7, p7: decrease resistance to facilitate flexing). Further, in figure 14 as discussed above, resistance decreases in response to swing phase or toe off. Toe off is not a single instant in time, as weight over the toe is decreased prior to toe off. As shown in figure 14, when force on the toe is reduce (ie starting swing phase), the resistance also drops.
The applicant further argues that the office action has misinterpreted “is reduced”. The applicant argues that is reduced means is actively being reduced rather than has already been reduced. It appears that the applicant and examiner have different interpretations for the start of swing phase. The start is not a single instant in time as when a user is walking they don’t immediately lift their leg at once to start swing. They roll over the toe and gradually remove weight from the toe. Toe off is labeled as when the full weight is removed, but this process starts prior as weight is gradually removed from the toe.
The applicant argues that Kampa’s mechanism of resistance reduction is different than the claimed method. The applicant argues that claim 1 requires the flexion resistance is reduced in case of a decreasing axial force or vertical leg cord or an extended knee joint. As shown in figure 14, the resistance is reduced as force on the leg is reduced. The applicant argues that the condition is conditioned on a detected decrease in axial loading. See figure 14. The applicant argues that Kampas reduces flexion resistance during terminal stance which is a different triggering mechanism. The triggering mechanism of Kampas was not used in the rejection. Kampas was used to teach a reduction during swing phase and Seifert was used to teach how swing phase is identified.
In regard to the 103(a) rejection of claim 2 as unpatentable over Seifert (2018/0125681) in view of Kampas (WO2011/057795A1) and further in view of Zahedi (WO2013/088142A1), no further arguments have been submitted.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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 nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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