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 Objections
Claim 8 is objected to because of the following informalities:
In regard to claim 8, “from a negative leg cord angle of -10°” should be “for a negative leg cord angle of -10 degrees”. It appears this is a typo of from rather than for based on the instant disclosure. Using the term “from” would require clarification of from -10 degrees to another point.
Appropriate correction is required.
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.
Claim(s) 6-9 is/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.
In regard to claim 6, the use of “in particular above 5 degrees” renders the scope of the claim unclear as it is not clear if the level must be above 5 degrees. It is recommended to remove the phrase “in particular”.
In regard to claim 7, the use of “in particular in the case of a positive leg cord angle greater than 30 degrees and a negative leg cord angle of less than -10 degrees” renders the scope of the claim unclear if the range is positively recited. It is recommended to remove the phrase “in particular”.
In regard to claim 9, the use of “in particular within a range between a positive inclination angle of less than 15 degrees and a negative inclination angle of greater than -5 degrees” renders the scope of the claim unclear as it is not clear if the range of below 15 degrees is being positively claimed. It is recommended to remove the phrase “in particular”.
Since claim 8 depends from claim 7, claim 8 is also rejected under 112b.
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 are rejected under 112b but would be objected to as dependent upon a rejected base claim if the 112b issues were corrected appropriately. Claim 10 is objected to as depending from a rejected base claim.
In regard to claim 6, the closest prior art Seifert (2018/0125681) in view of Kampas (WO2011/057795A1) meets all of the claim limitations except “in the case of a decrease of the axial force to a level above a limit value and a determined positive leg cord angle above a limit value, in particular above 5 degrees, no reduction of the flexion resistance takes place” in combination with the other claim limitations. The claim has been interpreted as best understood to require the limit to be 5 degrees. While Seifert does teach using the axial force compared to a limit to change the resistance [0052, 0021] and separately using the chord angle compared to a threshold [0022] to determine the phase of gait, Seifert does not teach the limit of the cord angle above 5 degrees in combination with the decrease of the axial force to above a limit value to determine not to reduce the flexion resistance.
In regard to claim 7, the closest prior art Seifert (2018/0125681) in view of Kampas (WO2011/057795A1) meets all of the claim limitations except “in the case of a decrease of the axial force to a level below a limit value and a determined leg cord angle outside a defined angle range about the vertical, in particular in the case of a positive leg cord angle greater than 30 degrees and a negative leg cord angle of less than -10°, no reduction of the flexion resistance takes place” in combination with the other claim limitations. The claim has been interpreted as best understood to require the range of 30 to -10 degrees.
While Seifert does teach determining walking backwards [0012], using an axial force compared to a limit to determine if the device is in swing phase and accordingly adjusting the resistance [0021] and separately using the leg chord compared to a threshold to adjust resistance [0022], Seifert does not teach the combination of axial force compared to a limit and a leg cord angle outside the range of 30 to -10 degrees to determine not to reduce flexion resistance.
In regard to claim 8, the closest prior art Seifert (2018/0125681) in view of Kampas (WO2011/057795A1) meets all of the claim limitations except “a complete reduction of the flexion resistance takes place in the case of a positive leg cord angle of up to 20 degrees and the flexion resistance is increased in the case of a larger leg cord angle, or in that a complete reduction of the flexion resistance takes place from a negative leg cord angle of -10° and the flexion resistance is increased in the case of a smaller leg cord angle” in combination with the other claim limitations. As best understood “from a negative leg cord angle of -10 degrees” is interpreted as “for a negative leg cord angle of -10 degrees”.
While Seifer does teach using the leg chord compared to a threshold to adjust resistance [0022], Seifert does not teach the specific claimed values for altering flexion resistance.
In regard to claim 9, the closest prior art Seifert (2018/0125681) in view of Kampas (WO2011/057795A1) meets all of the claim limitations except “in the case of a decrease of the axial force to a level below a limit value, in particular below 10% of the body weight of the patient, and a determined inclination angle of the lower part relative to the vertical within a defined angle range about the vertical, in particular within a range between a positive inclination angle of less than 15 degrees and a negative inclination angle of greater than - 5°, no reduction of the flexion resistance takes place” in combination with the other claim limitations. As best understood, the claimed ranges of below 10% and inclination of 15 degrees to -5 degrees are interpreted as being positively recited.
While Seifert teaches using an axial force compared to a limit to determine if the device is in swing phase and accordingly adjusting the resistance [0021] and separately using the leg chord compared to a threshold to adjust resistance [0022], Seifert does not teach the combination of axial force compared to a limit and a leg cord angle outside the range of 30 to -10 degrees to determine not to reduce flexion resistance.
Herr (2012/0283845A1) [0003] and Herr (2011/0295385A1) [0017] are also relevant and teach normalizing the torque to the user’s weight but does not teach that value is below 10%.
In regard to claim 10, Seifert meets the claim limitations as discussed in the rejection of claim 1, meets all of the claim limitations except “a complete reduction of the flexion resistance takes place in the case of a positive inclination angle of the lower part of 20 degrees or more and the flexion resistance is increased in the case of a smaller inclination angle, or in that a complete reduction of the flexion resistance takes place from a negative inclination of the lower part of -10° and the flexion resistance is increased in the case of a larger negative inclination angle” in combination with the other claim limitations.
While Seifert does teach using the leg cord angle to adjust resistance [0022], Seifart does not teach the threshold angles or specific flexion resistance or reduction as claimed.
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774