DETAILED ACTION
This is a Final Rejection for Application 19/074,263 filed March 7, 2025. The present application relies on the disclosures of and claims priority to and the benefit of the filing date of U.S. Patent Application No. 63/562,351, filed March 7, 2024. Claims 1-30 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 .
Election/Restrictions
Claims 3, 5, 11, 14-18, 21-22, 24-25 and 29-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on September 23, 2025. The requirement was made final in the Office action filed October 20, 2025 and is maintained.
Response to Amendment
The amendments to claims 1-2, 4, 6-10, 12-13, 19-20, 23 and 26-28 are acknowledged.
The 112(b) rejections indicated in the Office action filed October 20, 2025 have been overcome by amendment and are hereby withdrawn.
The 101 rejections indicated in the Office action filed October 20, 2025 have been overcome by amendment and are hereby withdrawn.
The amendments to claim 1 add the limitation of the tensioning mechanism anchored on an uppermost functionally separate body panel element which was not previously claimed and changes the scope of the claim. Therefore, new grounds of rejection are presented below to address the change in scope.
The amendment to claim 13 do not change the scope of the claim therefore, the 35 USC 102 rejection indicated in the Office action filed October 20, 2025 is maintained. Minor corrections to form have been made and are addressed in the 35 USC 102 rejection below.
Response to Arguments
Applicant's arguments filed March 19, 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that Choi cannot accomplish the intended use of the current invention, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Additionally, the intended uses of rapidly and conveniently adjusting the device during activity, while the device is being worn, and user manipulation of the brace are not claimed.
Applicant further argues that Choi does not teach the limitations of claim 13. This is unpersuasive as there are no limitations as to what can be interpreted as the first and second anchor, so a first wire hole 2204 of a first functionally separate body plate element is interpreted as a first anchor point and a second wire hole 2204 of a second functionally separate body plate element is interpreted as a second anchor point. These anchor points are laterally offset since they are on different body plate elements, and are laterally offset since the wire holes run parallel. The wire WI connects the two anchor points and, when tensioned, move the two anchor points towards one another as the body plate elements are hinged to one another and tensioning the wire WI closes the hinge.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references to teach the tension adjustment mechanism anchored to the upper portion of the device, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Hiemenz does teach anchoring their tension adjustment mechanism to the upper portion of the device. [0037] – “In yet another embodiment, mechanical control element 52 and controller 60 may be integrated into upper body adapter 14, and lower body adapter 12 functions solely to couple SVS 30 to the wearer's lower body and/or seat support 50 to enable SVS 30 to assist in actively positioning the wearer's body in response to a shock event or the like.” Therefore, the prior art does suggest modifying the tension adjustment mechanism to be anchored to the upper portion of the device.
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2023/090535 (Choi).
Regarding claim 13, Choi discloses a back orthosis (The invention of Choi describes a posture corrector for fixing Kyphosis comprising a band unit 10 and a correction unit 20. See the abstract and Fig. 2. The kyphosis corrector 1 is interpreted as a back orthosis.) comprising:
a first functionally separate body plate element with at least a first anchor point (The correction unit 20 comprises a body portion 22 with a plurality of unit body portions 220. See Fig. 3. The unit body portions 220 are attached to one another by hinge bodies 2201. Each of the unit body portions 220 comprises two parallel wire holes 2204. Se Figs. 6A and 6B. The wire holes 2204 are interpreted as anchor points since a wire WI is fixed to each unit body portion 220 by the wire holes 2204. The unit body portion 221 is the uppermost unit and is interpreted as a first functionally separate body plate element with a first anchor point in the form of a first wire hole 2204.); and
a second functionally separate body plate element with at least a second anchor point (The unit body portion 222 is the lowermost unit and is interpreted as a second functionally separate body plate element with a second anchor point in the form of a second wire hole 2204.),
wherein the first anchor point of the first functionally separate body plate element is configured to be laterally and vertically offset with respect to a spine of a wearer relative to the second anchor point of the second functionally separate body plate element (The first wire hole 2204 of the uppermost unit body portion 221 is laterally and vertically offset from the second wire hole 2204 of the lowermost unit body portion 222.); and
wherein an adjustable tensioning mechanism comprising a flexible tension component and a tension adjustment component, wherein the adjustable tensioning mechanism connects the first anchor point of the first functionally separate body plate element to the second anchor point of the second functionally separate body plate element (The correction unit 20 comprises a wire adjustment unit 24 that is connected directly to a wire WI that is directly connected to the unit body portions 220, 221, 222. The wire WI is interpreted as a flexible tension component and the wire adjustment unit 24 is interpreted as a tension adjustment component.);
wherein one or more tensile forces applied by the adjustable tensioning mechanism draw the first anchor point of the first functionally separate body plate element towards the second anchor point of the second functionally separate body plate element, thereby straightening the spine of the wearer (Choi discloses that “the wire adjustment unit 24 allows an expert to easily wind and unwind the wire WI by rotating the handle unit 240 in one direction, and can adjust the length of the body unit 22 step by step according to the number of rotations.” The winding of the wire WI with the wire adjustment unit 24 applies a tension force to the unit body portions 220 that causes the unit body portions 220 to rotate with respect to one another thereby bringing the drawing the first and second wire holes 2204 towards one another and providing a force to a spine of the wearer to straighten the wearer’s spine.).
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 1-2, 4, 6-10, 12, 19-20, 23 and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2023/090535 (Choi) in view of US 2014/0224849 (Hiemenz et al.).
Regarding claim 1, Choi discloses a back orthosis (The invention of Choi describes a posture corrector for fixing Kyphosis comprising a band unit 10 and a correction unit 20. See the abstract and Fig. 2. The kyphosis corrector 1 is interpreted as a back orthosis.) comprising:
two or more rigid, semi-rigid, or flexible functionally separate body panel elements configured to contact a body of a wearer (The correction unit 20 comprises a body portion 22 with a plurality of unit body portions 220. The body portion 22 is disclosed as “formed of a material that has elasticity, is lightweight, and is not deformed by external impact, and synthetic resin such as plastic may be used. However, it is not limited thereto, and all materials used in the technical field of the present invention can be used.” See Fig. 3. The unit body portions 220 are attached to one another by hinge bodies 2201. Therefore, the unit body portions 220 are interpreted a two or more semi-rigid functionally separate body panel elements contacting a body of a wearer. Each unit body portion 220 correlates to a unit body base plate 210 which is also interpreted as a part of each functionally separate body panel elements.);
at least one flexible tensioning component that is connected directly or indirectly to a first functionally separate body panel element of the two or more rigid, semi-rigid, or flexible functionally separate body panel elements, a second functionally separate body panel element of the two or more rigid, semi-rigid, or flexible functionally separate body panel elements, and a tensioning adjustment mechanism (The correction unit 20 comprises a wire adjustment unit 24 that is connected directly to a wire WI that is directly connected to the unit body portions 220. The wire WI is interpreted as a flexible tensioning component which in combination with the wire adjustment unit 24, is interpreted as a tensioning adjustment mechanism.); and
wherein when a tension force on the at least one flexible tensioning component is increased, a position or positions of the first functionally separate body panel element and the second functionally separate body panel element move rotationally, translationally, or both, with respect to each other to provide a force or forces to a spine of the wearer (Choi discloses that “the wire adjustment unit 24 allows an expert to easily wind and unwind the wire WI by rotating the handle unit 240 in one direction, and can adjust the length of the body unit 22 step by step according to the number of rotations.” The winding of the wire WI with the wire adjustment unit 24 applies a tension force to the unit body portions 220 that causes the unit body portions 220 to rotate with respect to one another thereby providing a force to a spine of the wearer.).
Choi does not disclose wherein the tensioning adjustment mechanism is anchored on an uppermost functionally separate body panel element of the two or more rigid, semi-rigid, or flexible functionally separate body panel elements.
However, Hiemenz discloses an active spinal support system comprising vertebral elements 32. Each vertebral element 32 has a hole 42 through which a tendon 46 passes and each tendon is affixed to a mechanical control element 52. The mechanical control element 52 is any electromechanical actuator (e.g., DC or stepper motors), or hydraulic actuators, pneumatic, electric or mechanical actuators. See [0030]-[0033] and Figs. 1-4. The vertebral element 32 is analogous to the unit body portions 220 of Choi, the tendon 46 is analogous to the wire WI of Choi, and the mechanical control element 52 is analogous to the wire adjustment unit 24 of Choi. Hiemenz teaches wherein the tensioning adjustment mechanism is anchored on an uppermost functionally separate body panel element of the two or more rigid, semi-rigid, or flexible functionally separate body panel elements ([0037] – “In yet another embodiment, mechanical control element 52 and controller 60 may be integrated into upper body adapter 14, and lower body adapter 12 functions solely to couple SVS 30 to the wearer's lower body and/or seat support 50 to enable SVS 30 to assist in actively positioning the wearer's body in response to a shock event or the like.”).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the position of the wire adjustment unit 24 of Choi to be on the uppermost unit base plate 211 as taught by Hiemenz. A skilled artisan would have been motivated to do so because Hiemenz teaches that integrating the mechanical control element 52 into the upper body adapter 14 allows for active control of the SVS 30 ([0036]-[0037]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to back orthoses with connecting plates that are moved by a tensioning mechanism.
Regarding claim 2, Choi in view of Hiemenz discloses the back orthosis of claim 1, wherein the first functionally separate body panel element and the second functionally separate body panel element are slidably attached along at least one edge of one or both of the first functionally separate body panel element and the second functionally separate body panel element (The unit body portions 220 rotate via hinge bodies 2201 that slide in a rotational manner and are attached along an edge of each unit body portion 220.).
Regarding claim 4, Choi in view of Hiemenz discloses the back orthosis of claim 1, further comprising a main body which is configured to wrap around a waist of the wearer (The band unit 10 is “a part worn on the upper body of a user, in particular, a patient with kyphosis (KP), and may include a waist band part 11, a thoracic spine band part 12, and a shoulder band part 13.” Band part 11 is interpreted as a main body.).
Regarding claim 6, Choi in view of Hiemenz discloses the back orthosis of claim 1, further comprising two or more functionally separate body wrapping elements, wherein the two or more functionally separate body wrapping elements are configured to secure the two or more functionally separate body panel elements to a torso of the wearer (The band unit 10 is “a part worn on the upper body of a user, in particular, a patient with kyphosis (KP), and may include a waist band part 11, a thoracic spine band part 12, and a shoulder band part 13.” Waist band part 11 and shoulder band part 13 are interpreted as two functionally separate body wrapping elements.).
Regarding claim 7, Choi in view of Hiemenz discloses the back orthosis of claim 1, wherein the tensioning adjustment mechanism is a dial, a pull tab, a lever, a ratchet and pawl system, a pulley, an electric motor, or combinations thereof (The wire adjustment unit 24 includes “a handle unit 240, a fixed gear 241, a winding unit 242, an adjustment body 243 and a fixing plate 244.” The handle unit 240 is interpreted as a dial since a dial is generally defined in the art as a plate on a piece of equipment that is tuned to select a setting, which applies to the handle unit 240. See Fig. 14.).
Regarding claim 8, Choi in view of Hiemenz discloses the back orthosis of claim 1.
Choi does not disclose an energy storage component, wherein the energy storage component is connected in line with the at least one flexible tensioning component.
However, Hiemenz discloses an active spinal support system comprising vertebral elements 32. Each vertebral element 32 has a hole 42 through which a tendon 46 passes and each tendon is affixed to a mechanical control element 52. The mechanical control element 52 is any electromechanical actuator (e.g., DC or stepper motors), or hydraulic actuators, pneumatic, electric or mechanical actuators. See [0030]-[0033] and Figs. 1-4. The vertebral element 32 is analogous to the unit body portions 220 of Choi, the tendon 46 is analogous to the wire WI of Choi, and the mechanical control element 52 is analogous to the wire adjustment unit 24 of Choi.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to modify the wire adjustment unit 24 of Choi to be a pneumatic artificial muscle as taught by Hiemenz. A skilled artisan would have been motivated to do so because Hiemenz teaches that the pneumatic artificial muscles offer high performance, light weight, and an inherent compliance ([0034]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to back orthoses with connecting plates that are moved by a tensioning mechanism.
As a result of the modification, Choi in view of Hiemenz discloses an energy storage component, wherein the energy storage component is connected in line with the at least one flexible tensioning component (In view of Hiemenz, the wire adjustment unit 24 is a pneumatic artificial muscle. The pneumatic artificial muscle is interpreted as an energy storage component and in connected by the wire WI with the unit body portions 220.).
Regarding claim 9, Choi in view of Hiemenz discloses the back orthosis of claim 8, wherein the energy storage component is a tensioning component comprising an elastomer, spring, or a hydraulic, magnetic, electromagnetic, or pneumatic mechanism (The wire adjustment unit 24 is a pneumatic artificial muscle. The pneumatic artificial muscle is interpreted as a tensioning component.).
Regarding claim 10, Choi in view of Hiemenz discloses the back orthosis of claim 1, further comprising one or more moveable anchor or anchor points attached to or integrated with at least one of the two or more functionally separate body panel elements (Each of the unit body portions 220 comprises two parallel wire holes 2204. Se Figs. 6A and 6B. The wire holes 2204 are interpreted as anchor points since the wire WI is fixed to each unit body portion 220 by the wire holes 2204.),
wherein the one or more moveable anchor or anchor points are configured to direct the force or forces, including the tension force on the at least one flexible tensioning component, across and/or around one or more axes of rotation of the spine of the wearer (The wire holes 2204 assist in directing the force generated by the winding of the wire WI about the transverse axis of the wearer to assist in the correction of Kyphosis.).
Regarding claim 12, Choi in view of Hiemenz discloses the back orthosis of claim 1, further comprising one or more hinge, bracket, or track system, wherein the first functionally separate body panel element and the second functionally separate body panel element are connected by the one or more hinge, bracket, or track system (The unit body portions 220 are attached to one another by hinge bodies 2201. See Figs. 5a-7c.).
Regarding claim 19, Choi in view of Hiemenz discloses the back orthosis of claim 1, wherein the two or more rigid, semi-rigid, or flexible functionally separate body panel elements are custom fabricated to match a morphology of the body of the wearer (Choi discloses that “the unit base plate 210 has a width and a side shape that are formed according to the shape of the user's waistline, so that the user does not feel uncomfortable when receiving spinal (SC) correction service.” Forming to the shape of the user’s waistline is interpreted as being fabricated to match a morphology of the body of the wearer which makes it custom to the wearer.).
Regarding claim 20, Choi in view of Hiemenz discloses the back orthosis of claim 1, wherein the two or more rigid, semi-rigid, or flexible functionally separate body panel elements are custom fabricated to correct a wearer's anatomy (Choi discloses that “the unit base plate 210 has a width and a side shape that are formed according to the shape of the user's waistline, so that the user does not feel uncomfortable when receiving spinal (SC) correction service.” Forming to the shape of the user’s waistline is interpreted as being fabricated to correct a wearer’s anatomy which makes it custom to the wearer.).
Regarding claim 23, Choi in view of Hiemenz discloses the back orthosis of claim 1, wherein the two or more rigid, semi-rigid, or flexible functionally separate body panel elements, the at least one flexible tensioning component, and the tensioning adjustment mechanism, are supplied as a kit for assembly by a certified professional or the wearer to meet one or more clinical needs of the wearer (A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114(II). In the instant case, Choi discloses all of the components of the claimed invention so the intended use of supplying them as a kit for assembly by a certified professional or the wearer to meet one or more clinical needs of the wearer does not result in a structural difference and the invention of Choi is capable of the performing the intended use.).
Regarding claim 26, Choi in view of Hiemenz discloses the back orthosis of claim 1.
Choi does not disclose one or more sensors, wherein the one or more sensors are capable of measuring a tensile force, a pressure, a compressive force, a position, an angle, or an acceleration corresponding to the two or more rigid, semi-rigid, or flexible functionally separate body panel elements, the at least one flexible tensioning component, the tensioning adjustment mechanism, or combinations thereof.
However, Hiemenz discloses an active spinal support system comprising one or more sensors 65 indicating tension in each tendon 46. See [0035]. The tendon 46 is analogous to the Wire WI of Choi.
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date to add the sensors 65 of Hiemenz to the wire adjustment unit 24 of Choi as taught by Hiemenz. A skilled artisan would have been motivated to do so because Hiemenz teaches that the sensor 65 provides feedback to accommodate forward and sideways bending of the wearer's back ([0035]). A skilled artisan would have a reasonable expectation of success given that all references are analogous and drawn to back orthoses with connecting plates that are moved by a tensioning mechanism.
As a result of the combination, Choi in view of Hiemenz discloses one or more sensors, wherein the one or more sensors are capable of measuring a tensile force, a pressure, a compressive force, a position, an angle, or an acceleration corresponding to the two or more rigid, semi-rigid, or flexible functionally separate body panel elements, the at least one flexible tensioning component, the tensioning adjustment mechanism, or combinations thereof (In view of Hiemenz, the wire adjustment unit comprises a sensor capable of measuring the tensile force of the wire WI.).
Regarding claim 27, Choi in view of Hiemenz discloses the back orthosis of claim 1, further comprising one or more modular components; wherein the modular components can be added, subtracted, or assembled in various orientations based on a clinical need of the wearer (Choi discloses a plurality of weights WE wherein “a weight WE having a weight suitable for correcting the user's spine may be selected and fastened to the correction unit 20”. The weights WE are interpreted as modular components and are added and subtracted in various orientations based on a clinical need of the wearer. See Fig. 3.).
Regarding claim 28, Choi in view of Hiemenz discloses the back orthosis of claim 1, further comprising one or more compliant materials, wherein the one or more compliant materials conform to a body of the wearer when compressed to improve a comfort, a fit, and/or a function, of the back orthosis (Choi discloses that “the unit base plate 210 has a width and a side shape that are formed according to the shape of the user's waistline, so that the user does not feel uncomfortable when receiving spinal (SC) correction service.” The unit base plate 210 is made of “a material that can support the rest of the components of the correction unit 20”. The base plate 210 is interpreted as being made of a compliant material and forms to the body of the wearer to improve comfort.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Seth Brown whose telephone number is (571)272-5642. The examiner can normally be reached 8:00 AM – 11:00 AM or 1:00 PM – 3:00 PM ET.
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/SETH R. BROWN/Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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