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 .
Election/Restrictions
Applicants’ election without traverse of claims 1-10, 12-20,23-36 and 38 in the reply filed on 06/22/2026 is acknowledged.
No claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, since filed an Applicant amendment with the election, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/22/2026.
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.
Claim(s) 1-2, 5-6, 10, 13, 24-25, 29 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lerner et al. U.S. Publication No. (2022/0133519 A1).
With respect to claim 1, Lerner et al. discloses an ankle-foot orthosis (Abstract; AFO 100, Fig.1) comprising a leg portion (member 105 and cuff 115, Fig. 1) and a foot portion (foot plate 130 is below pulley 125 [note element number 130 is obscured and appears as '1'] in Fig.1, however, fig.7A depicts the element number 130) biased toward an equilibrium angle with respect to the leg portion (equilibrium angle of footplate 130 is biased via springs 145 and 150, Paras. [0048]-[0050]), wherein the equilibrium angle is adjustable (bias and tension is adjusted/set by bias and tensioning mechanisms 140, Para [0047]; Fig.1).
With respect to claim 2, Lerner et al. discloses a spring that biases the foot portion toward the equilibrium angle (springs 145 and 150, Fig. 1), wherein the spring has a variable stiffness (variable stiffness delivered through passive mechanical adjustment, Para [0006]; bias and tension of springs 145 and 150 adjusted/set by bias and tensioning mechanisms 140, Para [0047]; Fig.1).
With respect to claim 5, Lerner et al. discloses a pivot joint coupling the leg portion to the foot portion (rotational bearing 120, Fig. 1), wherein the equilibrium angle is adjustable about the pivot joint in dorsiflexion and plantar flexion directions (equilibrium angle of footplate 130 is biased via springs 145 and 150, Paras. [0048]-[0050]; pivot joint 120 would allow for dorsiflexion and plantar flexion rotations of the footplate 130, Fig. 1).
With respect to claim 6, Lerner et al. discloses the leg portion comprises a frame (member 105, Fig. 1) and a leg stay (cuff 115, Fig. 1), the frame having a first end coupled with the foot portion at a pivot joint (end of member 105 attaches to footplate 130 via pivot joint 120, Fig. 1) and a second end coupled with the leg stay (second end of member 105 coupled to the cuff 115, Fig. 1), wherein a position of the second end of the frame relative to the leg stay is adjustable about the pivot joint (cuff 115 can be adjusted onto different distances along member 105 with respect to rotational bearing 120, Para. [0022]; Fig. 1).
With respect to claim 10, Lerner et al. discloses a biasing force or spring (150, fig.1) is applied to the foot portion anterior to the heel of a person wearing the orthosis when the foot portion is away from the equilibrium angle [0047].
With respect to claim 13, Lerner et al. discloses the leg portion further comprises a frame (member 105, Fig. 1) and a leg stay (cuff 115, Fig. 1), the frame having a first end coupled with the foot portion at a pivot joint (end of member 105 attaches to footplate 130 via pivot joint 120, Fig. 1) and a second end coupled with the leg stay second end of member 105 coupled to the cuff 115, Fig. 1), wherein the frame (member 105, Fig. 1) is lateral to the leg of the person wearing the orthosis [0044, the member 105 of the AFO is located on the lateral side of a user's leg] and (as shown in fig.1).
With respect to claim 24, Lerner et al. discloses a sensor configured to determine an angle of the foot portion with respect to the leg portion about the first axis [0065, angular sensor].
With respect to claim 25, Lerner et al. discloses a range of angular motion of the foot portion with respect to the leg portion is adjustable via pivot joint (rotational bearing 120, fig.1).
With respect to claim 29, regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed, it will inherently perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of anticipation has been established. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) and In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); (under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device) see MPEP 2112.01(1), as such, Lerner et al. discloses a method of fitting the orthosis of claim 1 to a person, the method comprising the step of adjusting the equilibrium angle of the orthosis to match a stance angle of the person [0041].
With respect to claim 32, Lerner et al. discloses the step of adjusting a reaction force applied to the leg of the person wearing the orthosis during dorsiflexion and plantarflexion [0051, by adjusting the spring weight, the user can vary the amount of resistance and assistance provided. By adjusting the spring positions, the user can change the equilibrium point, and therefore, can vary the points in the gait cycle where resistance and assistance are provided] and [0056].
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.
Claim(s) 3 is rejected under 35 U.S.C. 103 as being unpatentable over Lerner et al. as applied to claim 1 above, and further in view of Hirotaka et al. (JP5493724 B2, translation attached).
With respect to claim 3, Lerner et al. substantially discloses the invention as claimed except a cam and a cam follower, one of which is mounted for movement with the leg portion about a pivot joint coupling the leg portion to the foot portion and the other of which is mounted for movement with the foot portion about the pivot joint, wherein the cam and the cam follower are biased against each other when the foot portion is away from the equilibrium angle.
Hirotaka et al. in the field of ankle foot orthosis (Abstract; see machine translation) and teaches a cam (guide groove 22 is a linear cam, Fig.1 and [0038]) and a cam follower (cam follower 26, Fig.1), one of which is mounted for movement with the leg portion about a pivot joint coupling the leg portion to the foot portion (guide groove 22 mounted for movement while attached to the thigh member 12 about pivot at rotational axis C that couples thigh member 12 to foot member 14, Fig. ) and the other of which is mounted for movement with the foot portion about the pivot joint (cam follower 26 mounted for movement with rotation of the foot member 14 about rotational axis C, Fig.1), wherein the cam and the cam follower are biased against each other when the foot portion is away from the equilibrium angle (when spring unit 50 and one-way damper 40 are at a neutral position, an equilibrium angle of foot member 14 would be reached, and the guide groove 22 walls would be biased against the cam follower 26, Fig. 1).
In view of the teachings of Hirotaka et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the orthosis of Lerner et al. by incorporating a cam and a cam follower, one of which is mounted for movement with the leg portion about a pivot joint coupling the leg portion to the foot portion and the other of which is mounted for movement with the foot portion about the pivot joint, wherein the cam and the cam follower are biased against each other when the foot portion is away from the equilibrium angle in order to provide a means to limit rotation of the ankle such that the wearer only experiences natural/safe amounts of movement.
Claim(s) 4, 12 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Lerner et al. as applied to claim 1 above, and further in view of Agrawal et al. U.S. Patent No. (7,878,993).
With respect to claim 4, Lerner et al. substantially discloses a pivot joint coupling the leg portion to the foot portion (rotational bearing 120, Fig. 1). Lerner et al. fails to explicitly disclose wherein the pivot joint provides two rotational degrees of freedom.
Agrawal et al. is in the field of ankle-foot orthosis devices (Abstract) and teaches the pivot joint (frame 16 connecting foot member 14 to leg cradle 32, Fig. 1) provides two rotational degrees of freedom (two rotational degrees of freedom provided by frame 16 at revolute joints 18 and 22, Fig. 1) and ([Col.2], lines 53-60) and ([Col.3], lines 10-18 and 28-46).
In view of the teachings of Agrawal et al. it would have been obvious to one of ordinary skill in the art before the effective filing date of Lerner et al. to modify the orthosis such that the pivot joint provides two rotational degrees of freedom in order to support natural ankle movement, including flexion, extension, inversion and eversion.
With respect to claim 12, Lerner et al. substantially discloses a pivot joint coupling the leg portion to the foot portion (rotational bearing 120, Fig. 1). Lerner et al. fails to explicitly disclose the pivot joint provides two rotational degrees of freedom including a first degree of freedom about a first axis in dorsiflexion and plantarflexion directions, and a second degree of freedom about a second axis in inversion and eversion directions.
Agrawal et al. is in the field of ankle-foot orthosis devices (Abstract) and teaches the pivot joint (frame 16 connecting foot member 14 to leg cradle 32, Fig. 1) provides two rotational degrees of freedom (two rotational degrees of freedom provided by frame 16 at revolute joints 18 and 22, Fig. 1) and ([Col.2], lines 53-60) and ([Col.3], lines 10-18 and 28-46).
In view of the teachings of Agrawal et al. it would have been obvious to one of ordinary skill in the art before the effective filing date of Lerner et al. to modify the orthosis such that the pivot joint provides two rotational degrees of freedom including a first degree of freedom about a first axis in dorsiflexion and plantarflexion directions, and a second degree of freedom about a second axis in inversion and eversion directions in order to support natural ankle movement, including flexion, extension, inversion and eversion.
With respect to claim 23, Lerner et al. substantially discloses a pivot joint coupling the leg portion to the foot portion, wherein: the pivot joint comprises a joint body (rotational bearing 120, Fig. 1) except the joint body and the foot portion pivot together about a first axis in dorsiflexion and plantarflexion directions with respect to the leg portion, and the foot portion pivots about a second axis in inversion and eversion directions with respect to the joint body.
Agrawal et al. is in the field of ankle-foot orthosis devices (Abstract) and teaches the pivot joint (frame 16 connecting foot member 14 to leg cradle 32, Fig. 1) provides two rotational degrees of freedom (two rotational degrees of freedom provided by frame 16 at revolute joints 18 and 22, Fig. 1) and ([Col.2], lines 53-60) and ([Col.3], lines 10-18 and 28-46).
In view of the teachings of Agrawal et al. it would have been obvious to one of ordinary skill in the art before the effective filing date of Lerner et al. to modify the orthosis such that the joint body and the foot portion pivot together about a first axis in dorsiflexion and plantarflexion directions with respect to the leg portion, and the foot portion pivots about a second axis in inversion and eversion directions with respect to the joint body in order to support natural ankle movement, including flexion, extension, inversion and eversion.
Claim(s) 26 is rejected under 35 U.S.C. 103 as being unpatentable over Lerner et al. as applied to claim 1 above, and further in view of Radwan U.S. Publication No. (2022/0304840 A1).
With respect to claim 26, Lerner et al. substantially discloses the invention as claimed except the orthosis is configured for use on one of: a right leg or a left leg of a user, wherein the orthosis is convertible for use on the other leg of the user by replacing only a foot plate of the orthosis.
Radwan however, teaches an orthopedic device for treating musculoskeletal disorders of the lower limb (abstract) comprising a foot portion or foot plate (14, fig.1) and [0019]; wherein the device is used on either the user's left leg or right leg [0055].
In view of the teachings of Radwan, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the orthosis of Lerner et al. such that the orthosis is configured for use on one of: a right leg or a left leg of a user for or the treatment of disorders of the lower limb. While Radwan fail to disclose orthosis is convertible for use on the other leg of the user by replacing only a foot plate of the orthosis, it would have been obvious to one of ordinary skill in the art to provide a convertible for use on the other leg of the user by replacing only a foot plate of the orthosis as the right leg and the left leg are not exact matches in size or shape.
Allowable Subject Matter
Claims 7-9,14-20,27-28,30-31,33-36 and 38 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.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The closest prior art drawn to Lerner et al. fails to show or make obvious the claimed combinations of elements particularly the limitations as set forth in dependent claims 7-9, 14-20, 27-28, 30-31, 33-36 and 38 which recite features not taught or suggested by the prior art drawn to Lerner et al., in combination with the other elements (or steps) of the apparatus and method recited in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 5712703076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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