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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (KR 101650101 B1).
Regarding claim 1, Kim teaches a mechanical foot, comprising a mechanical ankle joint (Fig. 2-4),
wherein the mechanical ankle joint comprises a leg portion configured to be fixed to a patient's leg (see Fig. 2 and Paragraph 0016, the device includes an upper leg portion which is fixed to the leg via fixing band 230 on the frames 210), a foot portion configured to be fixed to a patient's foot (Fig. 2-3 and Paragraph 0028, the device includes a lower first connecting part 100 about the foot and front frame 120 which the foot rests on), and a revolute, the leg portion is connected with the foot portion through the revolute in a manner of being rotatable relative to each other (see Fig. 2-4 and Paragraph 0028, 0034-0035; Elastic body 300 joins fixing part 132 and fixing part 220 on the upper and lower frames; The frames are rotatable about the hinge connecting the frames), and
wherein the revolute comprises a foot connecting portion and a leg connecting portion, the foot connecting portion is connected to the foot portion, the leg connecting portion is connected to the leg portion, and the foot connecting portion is connected with the leg connecting portion in a manner of being rotatable relative to each other (see Fig. 2-4, 7 and Paragraph 0028, 0034-0035, foot connecting portion is connected to a fixing part 220 and leg connecting part is connected to fixing part 132; The two are connected via rotation about hinge connecting the foot/leg frames, and via the spring 300), and the revolute further comprises a first elastic element, wherein one end of the first elastic element is connected to the foot connecting portion, and the other end of the first elastic element is connected to the leg connecting portion, so that a force for maintaining the patient's foot substantially horizontal is provided through the revolute at a position of the mechanical ankle joint (see Fig. 2-4, 7 and Paragraph 0037-0039, a spring is provided in the revolute which connects fixing parts 132 and 220 of the foot and leg frames, respectively; The spring provides a restorative force against flexion of the foot to maintain the foot substantially horizontal; Dorsiflexion or plantar flexion compresses/stretches the spring which provides a counteracting force that biases the ankle back into a horizontal position).
Regarding claim 3, Kim discloses the device of claim 1.
Kim further discloses wherein the leg connecting portion is provided with a first connection supporting point, the foot connecting portion is provided with a second connection supporting point, and the first connection supporting point is connected with the second connection supporting point through the first elastic element (see Fig. 3; The leg connection portion has a bracket 222 of two protruding frames that supports the connection to the upper leg frame; Similarly, the elastic fixing part 132 has protrusions that retain the spring thereon; The two elastic fixing parts of 132 and 220, and their connection supporting points, are all connected via the elastic element 300).
Regarding claim 5, Kim discloses the device of claim 3.
Kim further discloses wherein the leg connecting portion is provided thereon with a connecting rod, and the first connection supporting point is arranged at an end of the connecting rod away from the leg portion (see annotated Fig. 2 below; The leg connecting portion can be subdivided into a connection rod connected to the leg connecting portion, the first connection supporting point being at the end of the connection rod away from the leg portion).
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Regarding claim 6, Kim discloses the device of claim 3.
Kim further discloses wherein one end of the first elastic element connected to the first connection supporting point is configured to rotate freely around a central axis of the first connection supporting point, and the other end of the first elastic element connected to the second connection supporting point is configured to rotate freely around a central axis of the second connection supporting point (see Fig. 4a-c; The ends of the elastic elements connected to the supporting points rotate angularly about the hinge connecting the leg/foot frames; Thus, they also rotate freely about an axis funning through the connection supporting points, since the movement is not strictly linear between the two connection points). Furthermore, it is noted that the central axis is not defined with respect to any other dimension or axis, and thus may be broader than applicant may intend, since there are several axes through the connection points.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 101650101 B1).
Regarding claim 2, the device of Kim discloses the device of claim 1.
Kim is silent regarding specifically wherein the leg connecting portion is provided with a hole, the foot connecting portion is provided with a shaft, and the shaft is configured in such a way of being provided in the hole in a rotatable manner.
However, Kim teaches that the leg connecting portion and the foot connecting portions are joined by a hinge formed via cooperating holes and a shaft between the two frame portions, such that the shaft is configured in such a way of being provided in the hole in a rotatable manner (see Fig. 2-4, 7 and Paragraph 0034; Rotation in a-b direction). Additionally, providing either the upper or lower frames with the holes or with a shaft for cooperating with the holes of the other frame is merely a matter of rearrangement of parts to achieve the same functionality. The hinge would operate equally regardless of whether the upper or lower frame had the holes/shaft.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kim to have included the leg connecting portion with the hole and the foot connecting portion with the shaft to form the hinge which is rotatable to one another, since it has been held that merely changing the position of components is an obvious matter of design choice absent any new or unexpected results, and since the operation of the hinge would work equally well with either frame portion having the cooperating shaft/holes (MPEP 2144.04 (VI)(C)).
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 101650101 B1), as applied to claim 1 and 3, in view of Malewicz (U.S 5,571,078 A).
Regarding claim 4, Kim discloses the device of claim 3.
Kim is silent regarding wherein the foot connecting portion are provided with side walls, and the side walls are configured to limit, when the leg connecting portion and the foot connecting portion rotate relative to each other, a movement position of the first connection supporting point.
However, Malewicz teaches a foot brace wherein the foot connecting portion are provided with side walls, and the side walls are configured to limit, when the leg connecting portion and the foot connecting portion rotate relative to each other, a movement position of the first connection supporting point (see Fig. 1-6 and Col. 5 line 61 – Col. 6 line 10; The foot/ankle bracket includes ROM adjustment mechanism 140 on a sidewall of the foot connecting portion; The adjustment of the mechanism moves pins 144 into threaded holes to control the ROM between the ankle and foot brackets). Limiting of movement between the upper bracket and lower brackets would thus limit movement of the first connection supporting point in Kim since the two brackets are pivotally connected, and movement up the upper/leg bracket moves the first connection supporting point (see rejection of claim 3 above).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kim to have included the foot connecting portion with side walls configured to limit the rotation of the leg and foot portions relative to another and the movement of the first connection supporting point, such as that taught by Malewicz, in order to allow for physician adjustment of the ROM of the joint for enhanced/customized recovery (Col. 5 lines 61 – Col. 6 line 10).
Regarding claim 8, Kim discloses the device of claim 1.
Kim is silent regarding wherein the mechanical ankle joint further comprises a cover plate, and an edge of the cover plate is of a shape matched with shapes of the side walls of the foot connecting portion.
However, Malewicz teaches a cover plate with an edge matching the side walls of a joint rotation mechanism (Figs. 4-8 and Col. 3 lines 47-62; The spring mechanism for the joint is covered with a cover 58 to prevent exposure of the internal components).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kim to include a cover plate matching the shape of side walls of the foot connecting frame, such as that taught by Malewicz, in order to cover up the rotation mechanism and prevent exposure of the mechanism and potential jamming by foreign objects or the body into the mechanism (Col. 3 lines 47-62, the housing/cover protects the internal components from external influence).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 101650101 B1) in view of Malewicz (U.S 5,571,078 A), as applied to claim 1 and 3-4, in further view of Wang (CN 105616113 A).
Regarding claim 7, the modified device of Kim discloses the device of claim 4.
Kim is silent regarding wherein the second connection supporting point is provided at a bottom position of the foot connecting portion close to a side wall of the side walls.
However, Wang teaches an alternative configuration for the second connection supporting point of an ankle brace which is provided at a bottom position of the foot connecting portion (see Paragraph 0057 and Fig. 1-2 and 9; The spring 6 for providing resistive force to the ankle is disposed at a bottom position of the foot connecting portion, on a rotating shaft 603). Additionally, movement of the supporting point to a lower position on the foot bracket would keep it in close proximity to the walls as taught by Malewicz above.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kim to include the second connection supporting point of the spring at a lower/bottom position on the foot connecting portion, such as that taught by Wang, in order to provide a known alternative configuration for providing resistive force against the movement of the ankle while wearing the supportive brace (Fig. 1-2 and 9).
Claims 9-10 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 101650101 B1), as applied to claim 1, in view of Yan (CN 109276409 A).
Regarding claim 9, Kim discloses the device of claim 1.
Kim is silent regarding wherein the foot portion of the mechanical foot comprises a rear portion and a forefoot portion, the rear portion and the forefoot portion constitute a bottom portion configured to be attached to the patient's foot, the foot connecting portion is connected to the bottom portion, and the rear portion is movably connected to the forefoot portion.
However, Yan teaches a mechanical foot/ankle brace wherein the mechanical foot comprises a rear portion and a forefoot portion, the rear portion and the forefoot portion constitute a bottom portion configured to be attached to the patient's foot, the foot connecting portion is connected to the bottom portion, and the rear portion is movably connected to the forefoot portion (Fig. 1-7, Paragraph 0065-0069, 0073; The brace has a rearfoot portion 21 and forefoot/toe portion 23 to support the foot and provide support/corrective force to the foot when loaded).
Kim also discloses wherein the lower frame is connected to a sub-frame portion 120 on which the foot rests (see Fig. 1-7 and Paragraph 0013).
Furthermore, it is noted that mere separability of components is an obvious matter of design choice barring any new or unexpected results (MPEP 2144.04 (V)(C)). The forefoot and rearfoot portions are connected via a hinged arrangement and thus it is obvious to have them be separable for maintenance or substitution of components to better fit the user’s feet.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kim to have included a rear and forefoot portions, connectable and rotatable about one another, such as that taught by Yan, in order to provide support across the entirety of the foot and to provide corrective restorative forces to the toes (Paragraph 0065-0069).
Regarding claim 10, Kim discloses the device of claim 1.
Kim is silent regarding wherein the foot portion of the mechanical foot comprises a forefoot rear-side portion and a forefoot portion, the forefoot rear-side portion is movably connected with the forefoot portion, the forefoot rear-side portion and the forefoot portion constitute a bottom portion configured to be attached to the patient's foot, the foot connecting portion is connected to the bottom portion, and a damping structure is provided at a junction between the forefoot rear-side portion and the forefoot portion, so as to make the forefoot rear-side portion angularly changed relative to the forefoot portion.
However, Yan teaches a mechanical foot/ankle brace wherein the foot portion of the mechanical foot comprises a forefoot rear-side portion and a forefoot portion, the forefoot rear-side portion is movably connected with the forefoot portion, the forefoot rear-side portion and the forefoot portion constitute a bottom portion configured to be attached to the patient's foot, the foot connecting portion is connected to the bottom portion, and a damping structure is provided at a junction between the forefoot rear-side portion and the forefoot portion, so as to make the forefoot rear-side portion angularly changed relative to the forefoot portion (Fig. 1-7, Paragraph 0065-0069, 0073; The brace has a rearfoot portion 21 and forefoot/toe portion 23 to support the foot and provide support/corrective force to the foot when loaded; The two portions are moveable about one another via a torsion spring hinge at 11; Thus, the torsion spring biases the toe portion and adjusts the angle of the toe portion relative to the rear-side portion and dampens motion in the plantar direction). It is noted that applicant has not claimed both rear and forefoot rear-side portions and thus is broader than applicant intends.
Kim also discloses wherein the lower frame is connected to a sub-frame portion 120 on which the foot rests (see Fig. 1-7 and Paragraph 0013).
Furthermore, it is noted that mere separability of components is an obvious matter of design choice barring any new or unexpected results (MPEP 2144.04 (V)(C)). The forefoot and rearfoot portions are connected via a hinged arrangement and thus it is obvious to have them be separable for maintenance or substitution of components to better fit the user’s feet.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kim to have included a rear and forefoot portions, connectable and rotatable about one another, such as that taught by Yan, in order to provide support across the entirety of the foot and to provide corrective restorative forces to the toes (Paragraph 0065-0069).
Regarding claim 16, the modified device of Kim discloses the device of claim 9.
Kim is silent regarding specifically wherein the leg portion and the bottom portion have an angle of 92°-95°.
However, Kim teaches that the angle between the leg and bottom portions can be adjust by rotation through the hinge (see Fig. 2-4, 7 and Paragraph 0034; Rotation in a-b direction) such that the angle between the two will be in the range of 92°-95°. Additionally, it is noted that applicant has not defined any particular axes of the leg and bottom portions, nor that the angles must be formed during a neutral/standing posture while worn on the patient. As such, the limitations are broader than applicant intends. For example, in Fig. 4(b), the major axis of the leg portion 220 and the horizontal axis of the bottom portion of 120 forms substantially a 90 degree angle. Plantarflexion such as shown in Fig. 4a extends this angle beyond 90 degrees and thus the angles between the two will be at 92°-95° in use.
Claims 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 101650101 B1) in view of Yan (CN 109276409 A), as applied to claims 1 and 9-10, in further view of Parks (U.S 4,573,457 A).
Regarding claim 11, the modified device of Kim discloses the device of claim 10.
Kim is silent regarding wherein the damping structure comprises a damping rotating shaft, the forefoot rear-side portion is provided with at least one first mounting station, the forefoot portion is provided with at least one second mounting station, and the at least one first mounting station and the at least one second mounting station are each provided with at least one first connecting hole configured for allowing the damping rotating shaft to be mounted.
However, Parks teaches a toe-lifting support for the foot wherein the damping structure comprises a damping rotating shaft, the forefoot rear-side portion is provided with at least one first mounting station, the forefoot portion is provided with at least one second mounting station, and the at least one first mounting station and the at least one second mounting station are each provided with at least one first connecting hole configured for allowing the damping rotating shaft to be mounted (see Col. 2 line 53 – Col. 3 line 14, Col. 4 lines 1-15; There is a rotating hinge pin 28 which allows for connection and rotation between plates 22 and 24; The hinge pin is located within the cylindrical hinge formed by holes between the two plates and thus the plates include mounting stations form the cylinder in which the pin is located; Further, a torsion spring is wound around the pin to provide resistive force and lifting of the toe upward).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Parks to have included a rotating shaft/pin within the torsional spring which is connected to first and second mounting stations of the two foot portions, such as that taught by Parks, in order to provide a known structure for a torsional spring hinge which allows rotation and biasing upward of the toe portion (see Col. 2 line 53 – Col. 3 line 14, Col. 4 lines 1-15).
Regarding claim 15, the modified device of Kim discloses the device of claim 9.
Yan further teaches wherein the forefoot portion and the forefoot rear-side portion are connected with each other in a rotatable manner through an elastic rotating connection, a second elastic element is provided inside the elastic rotating connection (Fig. 1-7, Paragraph 0065-0069, 0073; A torsional spring hinge provides rotational connection between the forefoot and forefoot rear-side portion), and the second elastic element is configured in such a manner that when the mechanical foot is not worn or when a patient wears the mechanical foot and lifts the foot up, the forefoot portion forms an angle with the forefoot rear-side portion under an action of a biasing force of the second elastic element (Fig. 1-7, Paragraph 0065-0069, 0073; The torsional spring provides an upward biasing force that forms an angle of the toe portion relative to the rear-toe portion); and that when the patient wears the mechanical foot and steps on the ground with the foot, a force applied by the patient resists the biasing force applied by the second elastic element, so that the forefoot portion is flush with the forefoot rear-side portion (Fig. 1-7 and Paragraph 0069; The torsional spring provides force to ensure flatness of the toes and thus when the user applies their weight with flat feet, they resist the upward biasing force and the two foot portions will be flush and flat).
Kim is silent regarding wherein the rotation is provided via an elastic rotating shaft.
However, Parks teaches a toe-lifting support for the foot wherein the damping structure comprises a damping rotating shaft, the torsional spring about a rotating shaft within the hinge (see Col. 2 line 53 – Col. 3 line 14, Col. 4 lines 1-15; There is a rotating hinge pin 28 which allows for connection and rotation between plates 22 and 24; The torsion spring providing the upward biasing against the toes is wound around the pin).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Parks to have included a rotating shaft/pin within the torsional spring, such as that taught by Parks, in order to provide a known structure for a torsional spring hinge which allows rotation and biasing upward of the toe portion (see Col. 2 line 53 – Col. 3 line 14, Col. 4 lines 1-15).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 101650101 B1) in view of Yan (CN 109276409 A) and Parks (U.S 4,573,457 A), as applied to claims 1 and 10-11, in further view of Jones (U.S 4,962,760 A).
Regarding claim 12, the modified device of Kim discloses the device of claim 11.
Kim is silent regarding wherein a limiting structure is provided at a connecting position of the forefoot rear-side portion and the forefoot portion, so as to avoid excessive rotation of the damping rotating shaft.
However, Jones teaches a foot brace wherein a limiting structure is provided at a connecting position of the forefoot rear-side portion and the forefoot portion, so as to avoid excessive rotation of the two portions relative to one another (see Fig. 1-4 and Col. 3 lines 20-42; Hinge 22, where the toe portion and rear-foot portion are connected, include cooperating shoulders 110/112 and 114/116 which limit excessive rotation of the hinge joint in the upward(dorsal) and downward (plantar) directions when the toes are flexed; Additionally, external sidewalls 120/122 of the two foot portions limit rotation by collision).
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Kim to have included cooperating rotation limiting grooves/shoulders to avoid excess rotation of the toes relative to the rest of the foot, such as that taught by Jones, in order to keep the foot stable and prevent flexion which would inhibit healing or cause potential injury (Col. 3 lines 20-42). Such rotation limitation would also prevent the torsional spring from rotating beyond its limit and plastically deforming.
Allowable Subject Matter
Claims 13 and 14 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 closest prior art is Kim (KR 101650101 B1), Yan (CN 109276409 A), Parks (U.S 4,573,457 A), Jones (U.S 4,962,760 A), Malewicz (U.S 5,571,078 A), Hepburn (U.S 5,070,868 A), Phillips (U.S 2012/0209163 A1), Kazerooni (U.S 2017/0367852 A1), Patterson (U.S 3,064,644 A), Wang (CN 105616113 A).
Regarding claim 13, none of the prior art teaches wherein the forefoot portion is provided with a first groove configured to face the at least one first mounting station, and the at least one first mounting station is configured in such a manner that when the forefoot portion rotates to an extreme position, the at least one first mounting station partially extends into the first groove, so as to abut against the first groove. While the prior art generally teaches spring/tension resistance to movement of the forefoot relative to the rest of the brace, it does not specifically teach the cooperation of a first groove which faces the mounting station which cooperate with the damping rotation shaft. Jones, while having a rotatable male hinge portion 102 within a defined groove 104, it is not connected to any shaft which facilitates the rotation. Instead, the male hinge is snapped into the groove and held in place through interference fit. The claim requires a substantially different configuration than any taught by the prior art unless through impermissible hindsight or arbitrary reconstruction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS WILLIAM GREIG whose telephone number is (571)272-5378. The examiner can normally be reached Monday - Thursday: 7:30AM - 5:00PM.
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785