DETAILED ACTION
This is a Non-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Claims 3, 5, 11, 14-18, 21-22, 24-25 and 29-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.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.
Applicant's election with traverse of the species associated with Fig. 4 in the reply filed on September 23, 2025 is acknowledged. The traversal is on the ground(s) that Applicant asserts that several figures that were separated by the examiner are the same species and that 15 distinct species is overly restrictive. This is not found persuasive because Applicant has not provided a specific argument as to which distinct species indicated by the examiner are actually the same species. Additionally, the number of species is not a consideration when making an election of species requirement but rather if each species has nonobvious mutually exclusive characteristics. While the species are identified by a representative figure, the species election includes the specification relating to each species, which is used to determine which claims are drawn to a given species.
Applicant further asserts that the species associated with Fig. 4 encompasses claims 1-30. This is not persuasive as the following claims recite features not found in the species associated with Fig. 4.
Claims 3 and 5 recite a functionally separate vertical beam element which is drawn to the embodiment of the species associated with Fig. 6.
Claim 11 recites a garment which is drawn to the embodiment of the species associated with Fig. 7.
Claims 14 and 15 recite a plurality of correction components which is drawn to the embodiment of the species associated with Fig. 10.
Claims 16 and 17 recite a wedge shaped panel which is drawn to the embodiment of the species associated with Fig. 14.
Claims 18, 21-22, 24-25, and 29-30 recite wherein by applying tension to the at least one flexible tension component, at least part of the first body plate element is forced away from the second body plate element which is drawn to the embodiment of the species associated with Fig. 12.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2, 4, 6-10, 12, 19-20, 23 and 26-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “the first functionally separate body panel element” and “the second functionally separate body panel element” in lines 4-5. Although the claim previously recites “two or more rigid, semi-rigid, or flexible functionally separate body panel elements”, there should still be proper antecedent basis for the claim terminology such that it is clear that the first and second elements are two of the two or more elements already recited. This rejection may be overcome with language such as “[[the]]a first functionally separate body panel element of the two or more rigid, semi-rigid, or flexible functionally separate body panel elements” and “[[the]]a second functionally separate body panel element of the two or more rigid, semi-rigid, or flexible functionally separate body panel elements”.
Claim 6 recites the limitation "the two or more functionally separate body plate elements" in line 3. There is insufficient antecedent basis for this limitation in the claim. This rejection may be overcome with language such as “the two or more functionally separate body panel elements”.
Claims 2, 4, 7-10, 12, 19-20, 23 and 26-28 are rejected for depending from and including the limitations of a rejected claim without curing the deficiencies thereof. These 112(b) rejections may be overcome by overcoming the 112(b) rejections of the claims from which they depend.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-2, 4, 6-10, 12-13, 19-20, 23 and 26-28 rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the limitation “two or more rigid, semi-rigid, or flexible functionally separate body panel elements contacting a body of a wearer” in lines 2-3 recites a body of a wearer as part of the invention. This rejection may be overcome with language such as “two or more rigid, semi-rigid, or flexible functionally separate body panel elements configured to contact
Regarding claim 4, the limitation “a main body which wraps around a waist of the wearer” in lines 1-2 recites a waist of the wearer as part of the invention. This rejection may be overcome with language such as “a main body which is configured to wrap
Regarding claim 6, the limitation “wherein the two or more functionally separate body wrapping elements secure the two or more functionally separate body plate elements to a torso of the wearer” in lines 2-3 recites a torso of the wearer as part of the invention. This rejection may be overcome with language such as “wherein the two or more functionally separate body wrapping elements are configured to secure the two or more functionally separate body plate elements to a torso of the wearer”.
Regarding claim 10, the limitation “wherein the one or more moveable anchor or anchor points direct a force or forces generated by the at least one flexible tensioning component across and/or around one or more axes of rotation of a wearer's back joint” in lines 3-5 recites a wearer’s back joint as part of the invention. This rejection may be overcome with language such as “wherein the one or more moveable anchor or anchor points are configured to direct a force or forces generated by the at least one flexible tensioning component across and/or around one or more axes of rotation of a wearer's back joint”.
Regarding claim 13, the limitation “wherein the first anchor point of the first functionally separate body plate element is laterally and vertically offset with respect to a wearer's spine” in lines 4-5 recites a wearer’s spine as part of the invention. This rejection may be overcome with language such as “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 wearer's spine”.
Claims 2, 7-9, 12, 19-20, 23 and 26-28 are rejected for depending from and not curing the deficiencies of a claim rejected under 35 U.S.C. 101. These rejection may be overcome by overcoming the 35 U.S.C. 101 rejections of the preceding claims.
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 1-2, 4, 6-7, 10, 12-13, 19-20, 23 and 27-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2023/090535 (Choi).
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 contacting 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 the first functionally separate body panel element, the second functionally separate body panel element, 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.);
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.).
Regarding claim 2, Choi 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 discloses the back orthosis of claim 1, further comprising a main body which wraps 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 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 secure the two or more functionally separate body plate 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 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 10, Choi discloses the back orthosis of claim 1, further comprising one or more moveable anchor or anchor points attached to 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 direct a force or forces generated by the at least one flexible tensioning component across and/or around one or more axes of rotation of a wearer's back joint (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 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 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 laterally and vertically offset with respect to a wearer's spine from 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.);
wherein an 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.);
wherein the adjustable tensioning mechanism comprises a flexible tension component and a tension adjustment component (The wire WI is interpreted as a flexible tension component and the wire adjustment unit 24 is interpreted as a tension adjustment component.);
wherein 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 a wearer's spine (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.).
Regarding claim 19, Choi 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 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 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 27, Choi 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 discloses the back orthosis of claim 1, further comprising one or more compliant materials, wherein the compliant materials form to the 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.).
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 8, 9 and 26 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 8, Choi 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 26, Choi 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.).
Conclusion
The following prior art made of record and not relied upon are considered pertinent to
applicant's disclosure.
US 2006/0173391 (Bodenschatz)
US 2019/0076287 (Wilson et al.)
US 2015/0297387 (Thompson et al.)
US 2023/0018799 (Choi)
US 2017/0196722 (Murdock)
CN 115317214 (Fan et al.)
KR 20200009470 (Hwang et al.)
CN 109498235 (Fan et al.)
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/SETH R. BROWN/Examiner, Art Unit 3786
/KERI J NELSON/Primary Examiner, Art Unit 3786