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 .
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 2 and 15 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.
Claim 15, “passive swing-flexion assistance” lacks antecedent basis. Claim 1 uses the language, “passive swing-flexion state”, "powered swing-assistance state” and “powered stance-assistance state”. It is unclear as to applicant’s intentions; the claim is indefinite.
Claim 2, “knee joint” lacks antecedent basis.
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 10, 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balboni et al (20110098828).
Balboni et al teaches a knee prosthesis system comprising:
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a knee prosthesis P including a thigh segment 1 and a shank segment 3;
at least one actuator (damper 5, gear motor 4) rotatably connecting the shank segment and the thigh segment, the at least one actuator being configured to controllably assume a powered knee behavior to generate knee motion or a passive knee behavior to resist knee motion (see at least par. 0175-0176; “In particular, gear motor 4 provides a torque, in some phases of the gait cycle, adapted to adjust the operation of the prosthesis with the needs of the user. For example, the gear motor 4, is operated when, during a slow gait, the inertia of the femur is not enough to align the tibial segment with the femoral segment.”); and
a controlling unit including a finite-state control structure (see at least par. 0173 microcomputer), the controlling unit electrically communicating with the at least one actuator (see claim 1), the control structure comprising at least three passive states and at least one powered state, the at least three passive states including a passive stance-resistance state, a passive swing-flexion state, and a passive swing-extension state. All three are included in a normal gait cycle (see claim 1 teaching “a phase of so-called swing” and a “phase of so-call stance”) shown below.
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The controlling unit including at least one of a powered swing-assistance state, a powered stance-assistance state, and a powered-swing state. Again see at least par. 0175-0176; “In particular, gear motor 4 provides a torque, in some phases of the gait cycle, adapted to adjust the operation of the prosthesis with the needs of the user. For example, the gear motor 4, is operated when, during a slow gait, the inertia of the femur is not enough to align the tibial segment with the femoral segment.”). This is interpreted as fulfilling at least one of a powered swing-assistance state, a powered stance-assistance state, and a powered-swing state.
Also see Par. [0268] In particular, the motor 96 intervenes assuring the correct realignment of tibia 3 if the patient, in particular a new amputee or an elder person, has hesitations during the gait.
Claim 16, see rotary actuator 96.
Claim 17, regarding the foot prosthesis, see at least par. 0027.
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 3 are rejected under 35 U.S.C. 103 as being unpatentable over Balboni et al (20110098828) in view of Goldfarb et al (2021/00598841).
Balboni et al teaches a knee prosthesis system as described above and, as interpreted in claim 1, teaches said at least a powered swing-assistance state is applied to the passive swing-flexion based on detection of an inherent entry condition, the controlling unit exiting the powered and an inherent exit condition based on the taught sensors, however, fails to teach existing the powered swing-assistance state within the passive swing-extension state.
Goldfarb et al (applicant’s PG Pub) teaches a very similar knee prosthesis system comprising a knee joint, at least one actuator configured to controllable assume a powered knee behavior or a passive knee behavior, and, a controlling unit configured to add a powered exclusively to the swing-assistance state to a passive swing-flexion state. See at least the abstract. Therefore both the detection of an entry condition and an exit condition are within the swing state; see at least claim 3 of Goldfarb et al.
It would have been obvious to one having ordinary skill in the art to have used the control of exiting the powered swing-assistance state as taught by Goldfarb et al with the system of Balboni et al to provide appropriate movement of the knee during swing (see par. 0007).
Claims 6, 10 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Balboni et al (20110098828).
Claim 6: Balboni et al teaches a knee prosthesis system as described above including:
Par. 0175-0176; “In particular, gear motor 4 provides a torque, in some phases of the gait cycle, adapted to adjust the operation of the prosthesis with the needs of the user. For example, the gear motor 4, is operated when, during a slow gait, the inertia of the femur is not enough to align the tibial segment with the femoral segment.”
It would have been obvious to one having ordinary skill in the art to have configured the controlling unit to have added powered stance-assistance state to the passive stance-resistance state based on detection of an inherent entry condition exiting the powered stance-assistance state into the passive stance-resistance state upon detection of an inherent exit condition (such as unweighted) because the stance phase is highly weight loaded and needs increase torque to prevent knee buckling adapted to adjust the operation of the knee system with the needs of the user.
Claim 10, giving reasonable interpretation, the gear motor 4, is operated when, during a slow gait, the inertia of the femur is not enough to align the tibial segment with the femoral segment is interpreted as both a powered swing-assist state or a powered-swing state which based on detection of an entry condition and controller detection of an exit condition. It would have been obvious to one having ordinary skill in the art that the computer would detect an entry condition and exit condition within the swing phase as is necessary for proper gait.
Claims 13-14, see explanation of claim 6 (powered stance-assistance state), claim 10 (powered swing-assist state), and claim 10 (powered-swing state).
Allowable Subject Matter
Claims 4-5, 7-9 and 11-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance: Goldfarb et al and Balboni et al are considered to be the closes prior art of record, however, fail to teach the combination of:
Claims 1, 3, and 4, wherein the entry condition selecting the powered swing-assistance state from the passive swing-flexion state includes at least a detection of estimated walking speed less than a predetermined speed, the exit condition exiting the powered swing-assistance state into the passive swing-extension state includes at least a detection of a knee extension.
Claims 1, 3, and 5, wherein the resistance in the passive swing-flexion state and assistance in the powered swing-assistance state provides a net energy dissipation at a knee that increases continuously and monotonically as a function of estimated walking speed.
Claims 1, 6 and 7, wherein the entry condition selecting the powered stance-assistance state from the passive stance-resistance state includes at least detection of a knee joint extension, the exit condition exiting the powered stance-assistance state into the passive stance-resistance state includes at least detection of knee joint flexion.
Claims 1, 6 and 8, wherein the powered stance-assistance state provides an assistive knee extension torque that is a function of at least a measured force in the knee prosthesis and a measured angular velocity of the thigh segment.
Claims 1, 6 and 9, wherein an assistive extension knee torque provided is proportional to the estimated hip torque exerted by a user and estimated thigh angular velocity.
Claims 1, 10 and 11, wherein the entry condition selecting the powered-swing state from the passive swing-flexion state includes at least detection of a full knee joint extension when the knee prosthesis is unloaded, or axial acceleration of the shank segment above a threshold value when the knee prosthesis is unloaded, and wherein the exit condition includes at least detection of prosthesis loading.
Claims 1, 10 and 12, wherein flexion knee assistance is a function of thigh angular velocity such that a knee will not initiate flexion until a thigh begins to flex.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCE EDWARD SNOW whose telephone number is (571)272-4759. The examiner can normally be reached 7:30 am - 5:00 pm Monday through Thursday.
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/BRUCE E SNOW/Primary Examiner, Art Unit 3774