DETAILED ACTION
This is a Non-Final Rejection for Application 18/643,367 filed April 23, 2024. This application claims priority to U.S. Patent Application No. 63/498,035 filed on April 25, 2023. Claims 1-20 are currently pending.
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
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 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2018/0193180 (Bejarano).
Regarding claim 18, Bejarano discloses a hinge assembly configured to adjustably fix an angle between a first arm and a second arm of an orthotic device (Bejarano discloses a locking abduction hinge 37 that is configured to adjustably fix an angle between a first arm and a second arm of an orthotic device. See Fig. 1.), the hinge assembly including:
a first hinge component configured for attachment to the first arm (The locking abduction hinge 37 comprises axial edge opening 43, which is interpreted as a first hinge component, and is configured for attachment to a first arm. See Fig. 1.);
a second hinge component configured for attachment to the second arm (The locking abduction hinge 37 comprises a torso hinge 38, which is interpreted as a second hinge component, and is configured for attachment to a second arm. See Fig. 1.); and
an actuator extending from a proximal end toward a distal end (The locking abduction hinge 37 further comprises a lock shaft 39, which is interpreted as an actuator, and extends from a proximal end toward a distal end. See Fig. 1.),
the distal end of the actuator being biased by a force from a biasing member into a locked position preventing the first and second hinge components from rotating relative to one another, and the proximal end of the actuator when actuated, displaces the actuator from the locked position into an unlocked position allowing the second hinge component to rotate relative to the first hinge component to adjust the angle between the first and second arms (The distal end of the lock shaft 39 is biased by a force from the spring 41 into a locked position preventing the axial edge opening 43 and the torso hinge 38 from rotating relative to one another, and the proximal end of the lock shaft 39 when actuated, displaces the lock shaft 39 from the locked position into an unlocked position allowing the torso hinge 38 to rotate relative to the axial edge opening 43.).
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Annotated Fig. 1 of Bejarano
Regarding claim 19, Bejarano discloses the hinge assembly of claim 18, further comprising: a gear engaging the distal end of the actuator, the gear having a first set of teeth (The lock shaft 39 comprises a gear engaging its distal end, the gear having shaft teeth 44, which are interpreted as a first set of teeth. See Fig. 1 of Bejarano.);
a second set of teeth on an interior surface of the first hinge component (The axial edge opening 43 comprises opposing edge teeth 45 on an interior surface, which are interpreted as a second set of teeth. See Fig. 1 of Bejarano.); and
a third set of teeth on an interior surface of the second hinge component (The torso hinge 38 comprises hinge opposing teeth 47 on an interior surface, which are interpreted as a third set of teeth. See Fig. 1 of Bejarano.),
wherein when in the locked position, the first set of teeth engages both the second and third sets of teeth preventing the first and second hinge components to rotate relative to one another (When in the locked position, the shaft teeth 44 engage both the opposing edge teeth 45 and the hinge opposing teeth 47 preventing the axial edge opening 43 and torso hinge 38 from rotating relative to one another. See [0068]-[0069] of Bejarano.).
Regarding claim 20, Bejarano discloses the hinge assembly of claim 19, wherein displacing the actuator from the locked position into the unlocked position causes the first set of teeth on the gear to disengage the third set of teeth allowing the first and second hinge components to rotate relative to one another (Displacing the lock shaft 39 from the locked position into the unlocked position causes the shaft teeth 44 on the gear to disengage the hinge opposing teeth 47 allowing the axial edge opening 43 and torso hinge 38 to rotate relative to one another. See [0068]-[0069] of Bejarano.).
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.
Claims 1-6, 9-10 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0067042 (Kang et al.) in view of US 2018/0193180 (Bejarano).
Regarding claim 1, Kang discloses an orthotic device for a medical boot (Kang discloses a medical leg placing device 1 which is interpreted as an orthotic device for a medical boot. See Figs. 1-3.), the orthotic device comprising:
a first arm for attachment to a first portion of the medical boot (The medical leg placing device 1 comprises a first placer 11 which is capable of attachment to a first portion of a medical boot. The first placer 11 is interpreted as a first arm. See Fig. 3 and [0034]-[0038].);
a second arm for attachment to a second portion of the medical boot (The medical leg placing device 1 comprises a second placer 12 which is capable of attachment to a second portion of a medical boot. The second placer 12 is interpreted as a second arm. See Fig. 3 and [0034]-[0038].); and
a hinge assembly configured to adjustably fix an angle between the first and second arms (The second placer 12 is hinged to the first placer 11 by a device, which is interpreted as a hinge assembly, and the device is configured to adjustably fix an angle between the first placer 11 and the second placer 12. See [0038].).
Kang does not disclose the hinge assembly including: a first hinge component attached to the first arm; a second hinge component attached to the second arm; and an actuator extending from a proximal end toward a distal end, the distal end of the actuator being biased by a force from a biasing member into a locked position preventing the first and second hinge components from rotating relative to one another, and the proximal end of the actuator when actuated, displaces the actuator from the locked position into an unlocked position allowing the second hinge component to rotate relative to the first hinge component to adjust the angle between the first and second arms.
However, Bejarano discloses a locking abduction hinge 37 that is capable of locking into predetermined angles. The locking abduction hinge 37 comprises axial edge opening 43, which is interpreted as a first hinge component, and a torso hinge 38, which is interpreted as a second hinge component. The locking abduction hinge 37 further comprises a lock shaft 39, which is interpreted as an actuator, and a spring 41, which is interpreted as a biasing member. See Fig. 1 and [0067]-[0068]. The distal end of the lock shaft 39 is biased by a force from the spring 41 into a locked position preventing the axial edge opening 43 and the torso hinge 38 from rotating relative to one another, and the proximal end of the lock shaft 39 when actuated, displaces the lock shaft 39 from the locked position into an unlocked position allowing the torso hinge 38 to rotate relative to the axial edge opening 43.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to use the locking abduction hinge 37 of Bejarano as the hinging device of Kang. A skilled artisan would have been motivated to do so because Kang is silent with regards to the specific structure of the hinging device and Bejarano teaches locking abduction hinge allows for the user to lock the hinge at a desired angle and unlock the hinge as needed to position the orthosis ([0069]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to hinging device for orthotics.
As a result of the combination, Kang in view of Bejarano discloses the hinge assembly including: a first hinge component attached to the first arm (The axial edge opening 43 is attached to the first placer 11.);
a second hinge component attached to the second arm (The torso hinge 38 is attached to the second placer 12.); and
an actuator extending from a proximal end toward a distal end (The lock shaft 39 extends from a proximal end toward a distal end.),
the distal end of the actuator being biased by a force from a biasing member into a locked position preventing the first and second hinge components from rotating relative to one another, and the proximal end of the actuator when actuated, displaces the actuator from the locked position into an unlocked position allowing the second hinge component to rotate relative to the first hinge component to adjust the angle between the first and second arms (The distal end of the lock shaft 39 is biased by a force from the spring 41 into a locked position preventing the axial edge opening 43 and the torso hinge 38 from rotating relative to one another, and the proximal end of the lock shaft 39 when actuated, displaces the lock shaft 39 from the locked position into an unlocked position allowing the torso hinge 38 to rotate relative to the axial edge opening 43 to adjust the angle between the first placer 11 and the second placer 12. See the annotated figure below.).
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Annotated Fig. 1 of Bejarano
Regarding claim 2, Kang in view of Bejarano discloses the orthotic device of claim 1, further comprising: a gear engaging the distal end of the actuator, the gear having a first set of teeth (The lock shaft 39 comprises a gear engaging its distal end, the gear having shaft teeth 44, which are interpreted as a first set of teeth. See Fig. 1 of Bejarano.);
a second set of teeth on an interior surface of the first hinge component (The axial edge opening 43 comprises opposing edge teeth 45 on an interior surface, which are interpreted as a second set of teeth. See Fig. 1 of Bejarano.); and
a third set of teeth on an interior surface of the second hinge component (The torso hinge 38 comprises hinge opposing teeth 47 on an interior surface, which are interpreted as a third set of teeth. See Fig. 1 of Bejarano.),
wherein when in the locked position, the first set of teeth engages both the second and third sets of teeth preventing the first and second hinge components to rotate relative to one another (When in the locked position, the shaft teeth 44 engage both the opposing edge teeth 45 and the hinge opposing teeth 47 preventing the axial edge opening 43 and torso hinge 38 from rotating relative to one another. See [0068]-[0069] of Bejarano.).
Regarding claim 3, Kang in view of Bejarano discloses the orthotic device of claim 2, wherein displacing the actuator from the locked position into the unlocked position causes the first set of teeth on the gear to disengage the third set of teeth allowing the first and second hinge components to rotate relative to one another (Displacing the lock shaft 39 from the locked position into the unlocked position causes the shaft teeth 44 on the gear to disengage the hinge opposing teeth 47 allowing the axial edge opening 43 and torso hinge 38 to rotate relative to one another. See [0068]-[0069] of Bejarano.).
Regarding claim 4, Kang in view of Bejarano discloses the orthotic device of claim 3, wherein the biasing member causes displacement of the actuator from the unlocked position into the locked position when the proximal end of the actuator is released (The spring 41 causes displacement of the lock shaft 39 from the unlocked position into the locked position when the proximal end of the lock shaft 39 is released. See [0067]-[0069] of Bejarano).
Regarding claim 5, Kang in view of Bejarano discloses the orthotic device of claim 2, wherein the biasing member is disposed inside an internal cavity of the first hinge component (The spring 41 is disposed inside an internal cavity of the axial edge opening 43. See Fig. 9 of Bejarano.).
Regarding claim 6, Kang in view of Bejarano discloses the orthotic device of claim 5, wherein the biasing member is compressed between the gear and a distal end of the internal cavity of the first hinge component (The spring 41 is compressed between the gear and a distal end of the internal cavity of the axial edge opening 43. See Figs. 1 and 9 of Bejarano and [0067]-[0069] of Bejarano.).
Regarding claim 9, Kang in view of Bejarano discloses the orthotic device of claim 1, wherein the hinge assembly adjustably fixes the angle between the first and second arms in a range between 0 degrees and 180 degrees (The locking abduction hinge 37 adjustably fixes the angle between the first placer 11 and the second placer 12 in a range between 0 degrees and 180 degrees. See [0054] of Bejarano.).
Regarding claim 10, Kang discloses a kit for mitigating health problems of a bedridden patient (Kang discloses a medical leg placing device 1 which is interpreted as an orthotic device for a medical boot. See Figs. 1-3. The medical leg placing device 1 and medical boot 30 together are interpreted as a kit.), the kit comprising:
a medical boot (Medical boot 30) including:
a posterior support portion configured to wrap around a lower leg of the bedridden patient (The medical boot 30 comprises a posterior support portion configured to wrap around a lower leg of the bedridden patient. See Fig. 3.); and
a planar support portion configured to wrap around a foot of the bedridden patient (The medical boot 30 comprises a planar support portion configured to wrap around a foot of the bedridden patient. See Fig. 3.); and
an orthotic device for supporting the planar support portion of the medical boot relative to the posterior support portion of the medical boot (Medical leg placing device 1), the orthotic device including:
a first arm configured for attachment to the posterior support portion of the medical boot (The medical leg placing device 1 comprises a first placer 11 which is configured for attachment to the posterior support portion of the medical boot 30. The first placer 11 is interpreted as a first arm. See Fig. 3 and [0034]-[0038].);
a second arm configured for attachment to the planar support portion of the medical boot (The medical leg placing device 1 comprises a second placer 12 which is configured for attachment to the planar support portion of the medical boot 30. The second placer 12 is interpreted as a second arm. See Fig. 3 and [0034]-[0038].); and
a hinge assembly configured to adjustably fix an angle between the first and second arms (The second placer 12 is hinged to the first placer 11 by a device, which is interpreted as a hinge assembly, and the device is configured to adjustably fix an angle between the first placer 11 and the second placer 12. See [0038].).
Kang does not disclose the hinge assembly including: a first hinge component attached to the first arm; a second hinge component attached to the second arm; and an actuator extending from a proximal end toward a distal end, the distal end of the actuator being biased by a force from a biasing member into a locked position preventing the first and second hinge components from rotating relative to one another, and the proximal end of the actuator when actuated, displaces the actuator from the locked position into an unlocked position allowing the second hinge component to rotate relative to the first hinge component to adjust the angle between the first and second arms.
However, Bejarano discloses a locking abduction hinge 37 that is capable of locking into predetermined angles. The locking abduction hinge 37 comprises axial edge opening 43, which is interpreted as a first hinge component, and a torso hinge 38, which is interpreted as a second hinge component. The locking abduction hinge 37 further comprises a lock shaft 39, which is interpreted as an actuator, and a spring 41, which is interpreted as a biasing member. See Fig. 1 and [0067]-[0068]. The distal end of the lock shaft 39 is biased by a force from the spring 41 into a locked position preventing the axial edge opening 43 and the torso hinge 38 from rotating relative to one another, and the proximal end of the lock shaft 39 when actuated, displaces the lock shaft 39 from the locked position into an unlocked position allowing the torso hinge 38 to rotate relative to the axial edge opening 43.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to use the locking abduction hinge 37 of Bejarano as the hinging device of Kang. A skilled artisan would have been motivated to do so because Kang is silent with regards to the specific structure of the hinging device and Bejarano teaches locking abduction hinge allows for the user to lock the hinge at a desired angle and unlock the hinge as needed to position the orthosis ([0069]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to hinging device for orthotics.
As a result of the combination, Kang in view of Bejarano discloses the hinge assembly including: a first hinge component attached to the first arm (The axial edge opening 43 is attached to the first placer 11.);
a second hinge component attached to the second arm (The torso hinge 38 is attached to the second placer 12.); and
an actuator extending from a proximal end toward a distal end (The lock shaft 39 extends from a proximal end toward a distal end.),
the distal end of the actuator being biased by a force from a biasing member into a locked position preventing the first and second hinge components from rotating relative to one another, and the proximal end of the actuator when actuated, displaces the actuator from the locked position into an unlocked position allowing the second hinge component to rotate relative to the first hinge component to adjust the angle between the first and second arms (The distal end of the lock shaft 39 is biased by a force from the spring 41 into a locked position preventing the axial edge opening 43 and the torso hinge 38 from rotating relative to one another, and the proximal end of the lock shaft 39 when actuated, displaces the lock shaft 39 from the locked position into an unlocked position allowing the torso hinge 38 to rotate relative to the axial edge opening 43 to adjust the angle between the first placer 11 and the second placer 12. See the annotated figure below.).
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Annotated Fig. 1 of Bejarano
Regarding claim 13, Kang in view of Bejarano discloses the kit of claim 10, wherein the hinge assembly further includes: a gear engaging the distal end of the actuator, the gear having a first set of teeth (The lock shaft 39 comprises a gear engaging its distal end, the gear having shaft teeth 44, which are interpreted as a first set of teeth. See Fig. 1 of Bejarano.);
a second set of teeth on an interior surface of the first hinge component (The axial edge opening 43 comprises opposing edge teeth 45 on an interior surface, which are interpreted as a second set of teeth. See Fig. 1 of Bejarano.); and
a third set of teeth on an interior surface of the second hinge component (The torso hinge 38 comprises hinge opposing teeth 47 on an interior surface, which are interpreted as a third set of teeth. See Fig. 1 of Bejarano.),
wherein when in the locked position, the first set of teeth engages both the second and third sets of teeth preventing the first and second hinge components to rotate relative to one another (When in the locked position, the shaft teeth 44 engage both the opposing edge teeth 45 and the hinge opposing teeth 47 preventing the axial edge opening 43 and torso hinge 38 from rotating relative to one another. See [0068]-[0069] of Bejarano.).
Regarding claim 14, Kang in view of Bejarano discloses the kit of claim 13, wherein displacing the actuator from the locked position into the unlocked position causes the first set of teeth on the gear to disengage the third set of teeth allowing the first and second hinge components to rotate relative to one another (Displacing the lock shaft 39 from the locked position into the unlocked position causes the shaft teeth 44 on the gear to disengage the hinge opposing teeth 47 allowing the axial edge opening 43 and torso hinge 38 to rotate relative to one another. See [0068]-[0069] of Bejarano.).
Regarding claim 15, Kang in view of Bejarano discloses the kit of claim 13, wherein the biasing member is compressed between the gear and a distal end of an internal cavity of the first hinge component (The spring 41 is compressed between the gear and a distal end of an internal cavity of the axial edge opening 43. See Figs. 1 and 9 of Bejarano and [0067]-[0069] of Bejarano.).
Regarding claim 16, Kang in view of Bejarano discloses the kit of claim 10, wherein the biasing member causes displacement of the actuator from the unlocked position into the locked position when the proximal end of the actuator is released (The spring 41 causes displacement of the lock shaft 39 from the unlocked position into the locked position when the proximal end of the lock shaft 39 is released. See [0067]-[0069] of Bejarano).
Regarding claim 17, Kang in view of Bejarano discloses the kit of claim 10, wherein the hinge assembly adjustably fixes the angle between the first and second arms in a range between 0 degrees and 180 degrees (The locking abduction hinge 37 adjustably fixes the angle between the first placer 11 and the second placer 12 in a range between 0 degrees and 180 degrees. See [0054] of Bejarano.).
Claims 7-8 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2023/0067042 (Kang et al.) in view of US 2018/0193180 (Bejarano), and further in view of US 5,367,789 (Lamont).
Regarding claim 7, Kang in view of Bejarano discloses the orthotic device of claim 1.
Kang in view of Bejarano does not disclose wherein the first arm includes a first fastener to removably attach the first arm to the first portion of the medical boot, and the second arm includes a second fastener to removably attach the second arm to the second portion of the medical boot.
However, Lamont discloses an orthotic splint and a protective medical boot, wherein the medical boot 10 comprises a continuous layer of small loops 20 on its entire inner and outer surfaces which makes the material compatible with fabric hook fastener means such as Velcro fasteners. See Col. 5, Lns. 35-52. Lamont further discloses that hook fastener fabric patches, such as patches 104 and 106, are attached to any suitable location of the boot cover. See Fig. 13. Patches 90 and 92 are shown to be on the sole portion in Fig. 8.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the medical boot 30 of Kang to have a boot cover made of a continuous layer of small loops and for the first placer 11 and the second placer 12 to have patches of hook material as taught by Lamont. A skilled artisan would have been motivated to do so because Lamont teaches that the loops of the boot cover are compatible with the hook of the patches to secure the orthotic splint to the medical boot (Col. 5, Lns. 35-52). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to medical boot orthotics.
As a result of the combination, Kang in view of Bejarano and Lamont discloses wherein the first arm includes a first fastener to removably attach the first arm to the first portion of the medical boot, and the second arm includes a second fastener to removably attach the second arm to the second portion of the medical boot (The first placer 11 and the second placer 12 both comprise patches of hook material that are removably attachable to the first portion and second portion of the medical boot 30, respectively.).
Regarding claim 8, Kang in view of Bejarano and Lamont discloses the orthotic device of claim 7, wherein the first and second fasteners include strips of hook material that removably attach to loop material on the medical boot (The first and second fasteners include strips of hook material that removably attach to loop material on the medical boot 30.).
Regarding claim 11, Kang in view of Bejarano discloses the kit of claim 10.
Kang in view of Bejarano does not disclose wherein the first arm includes a first fastener for securing the first arm to the posterior support portion of the medical boot, and the second arm includes a second fastener for securing the second arm to the planar support portion of the medical boot.
However, Lamont discloses an orthotic splint and a protective medical boot, wherein the medical boot 10 comprises a continuous layer of small loops 20 on its entire inner and outer surfaces which makes the material compatible with fabric hook fastener means such as Velcro fasteners. See Col. 5, Lns. 35-52. Lamont further discloses that hook fastener fabric patches, such as patches 104 and 106, are attached to any suitable location of the boot cover. See Fig. 13. Patches 90 and 92 are shown to be on the sole portion in Fig. 8.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date for the medical boot 30 of Kang to have a boot cover made of a continuous layer of small loops and for the first placer 11 and the second placer 12 to have patches of hook material as taught by Lamont. A skilled artisan would have been motivated to do so because Lamont teaches that the loops of the boot cover are compatible with the hook of the patches to secure the orthotic splint to the medical boot (Col. 5, Lns. 35-52). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to medical boot orthotics.
As a result of the combination, Kang in view of Bejarano and Lamont discloses wherein the first arm includes a first fastener for securing the first arm to the posterior support portion of the medical boot, and the second arm includes a second fastener for securing the second arm to the planar support portion of the medical boot (The first placer 11 and the second placer 12 both comprise patches of hook material that are removably attachable to the posterior support portion and planar support portion of the medical boot 30, respectively.).
Regarding claim 12, Kang in view of Bejarano and Lamont discloses the kit of claim 11, wherein the first and second fasteners include strips of hook material that removably attach to loop material on the medical boot (The first and second fasteners include strips of hook material that removably attach to loop material on the medical boot 30.).
Conclusion
The following prior art made of record and not relied upon are considered pertinent to
applicant's disclosure.
US 5,486,157 (DiBenedetto)
US 5,860,943 (Bloedau et al.)
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/SETH R. BROWN/ Examiner, Art Unit 3786
/KERI J NELSON/ Primary Examiner, Art Unit 3786