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 .
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) 19-21 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 19, the terms “means of at least one sensor” and “means of at least one inertial measurement” are unclear. If 112f is trying to be invoked the phrase needs to say “means for” and then a verb. As best understood by the examiner the terms are interpreted to mean at least one sensor and at least one inertial measurement unit. It is not clear what the “means of” term refers to, even in light of the instant disclosure which does not provide any further clarification. It is recommended to remove the “means of” terminology.
In regard to claim 20, “determined by means of a ground reaction force” and “means of at least one force sensor” are unclear. If 112f is trying to be invoked the phrase needs to say “means for” and then a verb. As best understood by the examiner the terms are interpreted to mean “determined using a ground reaction force” and “at least one force sensor”. It is not clear what the “means of” term refers to, even in light of the instant disclosure which does not provide any further clarification. It is recommended to remove the “means of” terminology.
In regard to claim 21, “means of at least one acceleration sensor” is unclear. If 112f is trying to be invoked the phrase needs to say “means for” and then a verb. As best understood by the examiner the terms are interpreted to mean “means of at least one acceleration sensor”. It is not clear what the “means of” term refers to, even in light of the instant disclosure which does not provide any further clarification. It is recommended to remove the “means of” terminology.
Since claim 1 is rejected under 112b, claims 22-36 that depend therefrom are also rejected under 112b.
Claim Objections
Claim(s) 19, 27-34 is/are objected to because of the following informalities:
In regard to claim 19, “by means of at least one sensor” should be “by means of the at least one sensor” for consistent antecedent basis throughout since at least one sensor is already recited in the preamble.
In regards to claims 27-34, “dorsal” flexion should be dorsiflexion.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19-27, 35-36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martin (2015/0257902A1.)
In regard to claim 19, Martin discloses a method for controlling a prosthetic foot that comprises an upper part 24 having a fastening element 58 for a proximal prosthesis component (male pyramid therefore capable of connecting to another endoskeletal component) and a foot part 12 mounted thereon so as to be pivotable about a pivot axis 64, having a resistance device 60 with which an adjustable resistance is presented against a pivoting movement of the foot part relative to the upper part, and having a control device [0189: microprocessor; 172; 0244: feedback control system will provide damping system 18 with information] which is coupled with the resistance device 60 and with at least one sensor 174 and by means of which the resistance against pivoting is set as a function of sensor data [0315],
the method comprising:
determining ground contact of the foot part with the ground by means of at least one sensor [0315: heel sensor system 174 detects contact],
determining the spatial attitude of the foot part and/or of the upper part by means of an inertial measurement unit, [0229: accelerometers in combination with gyroscopes; detect inertial elements of gait, notably foot position]
and modifying the resistance against pivoting as a function of at least one of the presence or absence of ground contact and the spatial attitude that has been determined or the profile that has been determined of the spatial attitude. [0315: as force of the heel portion increases or angular change or moment sensors detect contact, damper resistance will increase to limit the force of plantarflexion].
In regard to claim 20, Martin discloses the method of claim 19, and further discloses the presence or absence of ground contact is determined by means of a ground reaction force, the ground reaction force being determined by means of at least one force sensor on at least one of the foot part, the upper part, or the proximal prosthesis component. [0315: heel sensor system 174 detects contact; load sensor; see figure 12: heel load sensor, toe load sensor; on the foot part as shown in figure 3A: 174 includes 178, 180, 182, 184; 0228]
In regard to claim 21, Martin discloses the method of claim 19, and further discloses the presence or absence of ground contact is determined by means of at least one acceleration sensor [0234: accelerometer] on at least one of the foot part, the upper part, or on the proximal prosthesis component [0022: sensors may be located on the keel, brackets, damper, pylon or other parts of the device]. [0294: force data may be extrapolated from angular acceleration data; 0315: detecting angular change is functionally equivalent to detecting force]
In regard to claim 22, Martin discloses the method of claim 19, and further discloses determining at least one of a status of the foot part relative to the upper part (fig 12, angle)
or a pivoting movement of the foot part with respect to the upper part (angle sensor, fig 12),
and modifying the resistance against pivoting as a function of at least one of the status or pivoting movement that has been determined. (see arrows in figure 12; 0270: damping changes as pressure, angle change)
In regard to claim 23, Martin discloses the method of claim 19, and further discloses the ground reaction force is determined by one or more of at least one contact switch, a deformation of a resilient element, the recording of one or more of a rotational or translational relative position of two components connected flexibly to one another, a pressure measurement film or a strain gauge as the sensor. [0324: strain gauge]
In regard to claim 24, Martin discloses the method of claim 19, and further discloses the magnitude of the ground reaction force is measured,
and the pivoting resistance is reduced or increased, or pivoting is blocked, when a threshold value of the ground reaction force is reached or exceeded. [0330: after the load sensor equals zero, damper resistance goes to zero; zero is considered the threshold, and pivoting resistance is reduced as it goes to zero; 0315: damper resistance increased as force of heel contact increases, the threshold to increase would be above zero]
In regard to claim 25, Martin meets the claim limitations as discussed in the rejection of claim 24, but remains silent to the exact threshold.
It has been held that a mere optimization of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Since the threshold is result effective variable with a greater threshold resulting in less safety but also less accidental activation and a lower threshold resulting in greater safety but greater accidental activation, it would have been obvious to one of ordinary skill in the art at the time the invention was field to optimize the threshold to between 5% and 50% of the body weight of the patient for providing appropriate patient safety. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.05IIB
In regard to claim 26, Martin discloses the method of claim 19, and further discloses the angle (190 angle sensor; [0234]) between the foot part and the upper part or the proximal prosthesis component is measured [0234],
and the measured angle or angle profile and the spatial attitude that has been determined of the upper part or of the proximal prosthesis component are used in order to modify the resistance. [0235: change damper characteristics as speed increases or decreased or walking on non level terrain based on the feedback systems; 0294: angle data used to extrapolate force data]
In regard to claim 27, Martin meets the claim limitations as discussed in the rejection of claim 26, a dorsal movement is enabled or prevented as a function at least one of the measured angle between the upper part and the foot part or a spatial attitude angle. [0164: restricted from rotating up past 15 degrees by stop 88 and down past 45 degrees by stop 90; stop is active or not active based on the angle]
In regard to claim 35, Martin discloses the method of claim 19, and further discloses the foot part is moved back into an initial status (interpreted as dorsiflexion) in a swing phase. [0330: resistance goes to zero and allows for foot to dorsiflex in swing phase]
In regard to claim 36, Martin meets the claim limitations as discussed in the rejection of claim 19, and further teaches wherein the resistance of the resistance device is set to a minimum value (the claim does not specify what minimum is compared to and therefore the value could be any value) in the event of a vertical orientation of the upper part. [0330, 0332: set to min value in swing]. The zero crossing point (vertical orientation of the upper part) occurs at toe off. As shown in the graphs in figures 14 and 14A, the resistance decreases at the zero crossing point at toe off. The claim does not require the vertical orientation be measured or controlled by sensors, only that resistance is decreased at this point in gait.
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) 28-29, 33-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin (2015/0257902A1) in view of Moser (2008/0300692A1).
In regard to claim 28, Martin discloses the method of claim 27, but does not teach the maximum dorsiflexion angle is adjusted as a function of the ground inclination or heel height.
Moser teaches the maximum dorsal flexion angle between the upper part and the foot part is adjusted as a function of at least one of the ground surface inclination or heel height. [0098: adjusted based on terrain; 0081: required range of motion are maintained irrespective of heel height; 0099: variable end stop; depending on selected heel height]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the dorsiflexion stop adjustment of Mosler in the ankle joint of Martin because this allows the ankle joint to adjust to varying terrain [0098] and because an appropriate range of motion allows improved posture [0004].
In regard to claim 29, Martin meets the claim limitations as discussed in the rejection of claim 28, but does not teach the dorsiflexion stop is adjustable.
Moser further teaches the adjustment of a dorsal flexion stop is carried out through a plurality of substeps up to the maximum dorsal flexion angle. [0098: adjusted based on terrain; 0081: required range of motion are maintained irrespective of heel height; 0099: variable end stop; depending on selected heel height] Under the broadest reasonable interpretation, adjustment between angles would necessarily be carried out via a series of substeps (interpreted as the angles in between the initial and final angle).
In regard to claims 33-34, Martin meets the claim limitations as discussed in the rejection of claim 19, and further teaches a dorsiflexion stop, but does not teach the stop is adjustable.
Moser teaches wherein when walking on variable terrain a dorsal flexion stop is adjusted. [0098: the adjustable dorsiflexion end stop adjust the range downwardly when signals indicate stair descent or changing terrain]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the dorsiflexion stop adjustment of Mosler in the ankle joint of Martin because this allows the ankle joint to adjust to varying terrain [0098] and because an appropriate range of motion allows improved posture [0004].
While Mosler does not specifically sate that the adjustment is an increased doriflexion angle for a downward sloping surface, or the exact change to the dorsiflexion stop, it has been held that a mere optimization of the working parts of the invention, yielding a predictable result, requires no more than routine skill in the art. The dorsiflexion stop is a result effective variable with the stop at a greater angle allowing more dorsiflexion and adjustment to terrain and a lower angle allowing less dorsiflexion and adjustment to terrain. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the dorsiflexion stop of Martin in view of Moser increased by from 100% to 500% when walking on a downward sloping ground surface compared with walking on the flat. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.05IIB
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin (2015/0257902A1) in view of Bonnet (2015/0182354A1).
In regard to claim 31, Martin discloses the method of claim 19, and further teaches the ankle joint may lock against dorsiflexion [0325: dorsiflexion may lock out; 0392: may lock at a certain angle; 0487: electronic lock to adjust heel height, lock at a given angle to provide a user adjustable varied heel height; claim 25].
However, Martin does not teach the dorsiflexion is locked based on a defined threshold value of the spatial orientation of the upper part of proximal prosthesis component.
Bonnet teaches during standing, a dorsal flexion is locked when reaching a defined threshold value of the spatial orientation of the upper part or of the proximal prosthesis component. [0076: once the tibia returns to vertical position (vertical is an angular threshold) the ankle is locked in dorsiflexion]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the control of Bonnet to lock the ankle in dorsiflexion when the upper part reaches a vertical threshold because this allows the blade of the foot to deform to store energy [0076]
In regard to claim 32, Martin meets the claim limitations as discussed in the rejection of claim 31, but does not teach the criteria to lock the ankle as discussed in the rejection of claim 31.
Bonnet further teaches the locking of the dorsal flexion is released in the event of one or more of an increase in a ground reaction force to more than 50% of the patient's weight, a change in a rotation rate of the upper part or occurrence of an angular acceleration of the upper part. [0097: accelerometer to determine angle of the tibia; 0109: accelerometer is higher than a value, the prosthetic returns to stance; according below that value will be in swing] [0058: swing phase: dorsiflexion of the ankle] [0077: swing phase dorsiflexion of the ankle]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the control of Bonnet to unlock the ankle after the blade is done storing energy [0076] in order to allow the ankle to conform to the terrain for stability.
Allowable Subject Matter
Claim 30 would be objected to as being dependent upon a rejected base claim if the 112b rejection was overcome without changing the claim scope.
In regard to claim 30, the closest prior art Martin (2015/0257902A1) in view of Moser (20080300692A1) meets all of the claimed limitations except “wherein a further dorsal flexion is prevented when a limit value is reached for an inclination of the upper part or of the proximal prosthesis component, and a further dorsal flexion is prevented when a limit value is reached for the angle between the upper part and the foot part, the criterion occurring earlier being dominant.”
Conclusion
Relevant prior art includes:
Mosler (2009/0204229A1) and Bonnet (2015/0182354A1) teach that the dorsal stop is changed based on ramp inclination. Harris (2012/0130508A1) also teaches an adjustable dorsiflexion stop.
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