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 1-2, 7-15, and 17-19 are rejected under 35 U.S.C. 102(a)(1) or (a)(2) as being anticipated by Petursson et al (US 2024/0189131 A1).
Regarding Claim 1, Petursson discloses an orthosis (an orthopedic device 100, Fig. 1; Para. [0088]) comprising: a plurality of cuffs (shells 102, 104, Fig. 1; Para. [0090]) including a first cuff (a first shell 102, Fig. 1; Para. [0090]) and a second cuff (a second shell 104, Fig. 1; Para. [0090]), wherein the first cuff comprises at least a first cuff plate (a first shell body 128, Fig. 1; Para. [0094]) and a first strap tensioning mechanism (a first tensioning mechanism 120, Fig. 1; Para. [0092]) coupled to the first cuff plate (The first tensioning mechanism 120 is mounted directly onto the first shell 102..., Para. [0093]; as shown in Fig. 1, the first tensioning mechanism 120 is coupled to the first shell body 128); one or more straps (dynamic force straps 112, 114, Fig. 1; Para. [0091]) including at least a first strap (a first strap or dynamic force strap 112, Fig. 1; Para. [0091]) that comprises a first end adjustably coupled to the first strap tensioning mechanism and a second end fixedly coupled to the second cuff (A first strap or dynamic force strap 112 has a first end slidably connecting to the first shell 102 and a second end removably anchoring to the second shell 104., Para. [0091]; The first tensioning mechanism 120 is mounted directly onto the first shell 102 and is movable relative to the first shell 102, e.g. via a rotation, to incrementally adjust a length of the first dynamic force strap 112 between the first and second shells 102, 104., Para. [0093]; A second connector 126, analogous to the structure of the first connector 124, releasably connects a second end of second circumferential strap 118 and the first dynamic force strap to the second shell 104., Para. [0096]); and a sleeve (an overlay 130, Fig. 1; Para. [0091]; [0029]) including one or more tunnel segments (pockets 170, 171, Fig. 5; Para. [0135]) formed within the sleeve (The overlays 130, 131 can also form pockets 170, 171 for receiving the straps 112, 114., Para. [0135]), wherein each of the one or more tunnel segments is configured to encapsulate a portion of a strap of the one or more straps (The overlays 130, 131 can also form pockets 170, 171 for receiving the straps 112, 114., Para. [0135]; alternatively sleeve 254 [0166], Fig. 10A).
Regarding Claim 2, Petursson discloses the orthosis of claim 1, wherein the sleeve further comprises a plurality of pockets (In areas of the first shell 102 not requiring overlay, islands 165, 166 may be formed where the overlay 130 does not extend over the shell body 128., Para. [0142]) formed within, a part of, or on the sleeve, the plurality of pockets include (i) a first pocket to house the first cuff excluding a control knob that controls a degree of tension applied by the first strap tensioning mechanism to the first strap (The islands 165, 166 may be in areas where it is undesirable for the tensioning mechanism 120, 122 to rub against the overlay, particularly since it is preferable that the shell bodies 128, 129 have a hardness greater than the hardness of the overlay 130, 131., Para. [0142]) and (ii) a second pocket to house the second cuff (The islands 165, 166 may be in areas where it is undesirable for the tensioning mechanism 120, 122 to rub against the overlay, particularly since it is preferable that the shell bodies 128, 129 have a hardness greater than the hardness of the overlay 130, 131., Para. [0142]).
Regarding Claim 7, Petursson discloses the orthosis of claim 1, wherein the one or more straps further comprises at least a second strap (a second dynamic force strap 114, Fig. 1; Para. [0091]) that comprises a first end adjustably coupled to the first strap tensioning mechanism and a second end fixedly coupled to the second cuff (The second dynamic strap 114 likewise has a first end slidably connecting to the first shell 102, and a second end removably anchors to the second shell 104 ... The second tensioning mechanism 122 is mounted directly onto the second shell 104 and is movable relative to the second shell 104, e.g. via a rotation, to incrementally adjust a length of the second dynamic force strap 114 between the first and second shells 102, 104., Para. [0093]).
Regarding Claim 8, Petursson discloses the orthosis of claim 1, wherein the second cuff comprises at least a second cuff plate (as shown in Fig. 1, opposite the liner 136, there is a second shell body on the second shell 104 that is similar to the first shell body 128) and a second strap tensioning mechanism (a second tensioning mechanism 122, Fig. 1; Para. [0093]) coupled to the second cuff plate (...by mounting tensioning mechanisms 120, 122 directly to the shells 102, 104..., Para. [0092]; as shown in Fig. 1, the second tensioning mechanism 122 is coupled to the second shell body of the second shell 104).
Regarding Claim 9, Petursson discloses the orthosis of claim 8, wherein the one or more straps further comprises at least a second strap (a second dynamic force strap 114, Fig. 1; Para. [0091]) that comprises a first end adjustably coupled to the second strap tensioning mechanism and a second end fixedly coupled to the first cuff (The second dynamic strap 114 likewise has a first end slidably connecting to the first shell 102, and a second end removably anchors to the second shell 104 ... The second tensioning mechanism 122 is mounted directly onto the second shell 104 and is movable relative to the second shell 104, e.g. via a rotation, to incrementally adjust a length of the second dynamic force strap 114 between the first and second shells 102, 104., Para. [0093]).
Regarding Claim 10, Petursson discloses the orthosis of claim 9, wherein the first end of the first strap is coupled to a first attachment member (a strap receiving area 161, Fig. 5; Para. [0134]) that is coupled to a first interconnect (a cable, not shown; Para. [0092]) adjustably coupled to the first strap tensioning mechanism so that tension applied to the first interconnect by the first strap tensioning mechanism applies tension to the first strap to apply an unloading effect to a knee of a patient (To reduce bulkiness of the orthopedic device 100, and to further provide a more stable platform for tensioning the dynamic force straps 112, 114, a cable connecting the dynamic force straps 112, 114 to a tensioning mechanism 120, 122, can be reduced in length by mounting tensioning mechanisms 120, 122 directly to the shells 102, 104 and confining the cable and the travel thereof within the shells 102, 104 ... The overlay 130 shields a portion of the dynamic force straps 112, 114, with the cable preferably concealed therein., Para. [0092]; The first tensioning mechanism 120 is mounted directly onto the first shell 102 and is movable relative to the first shell 102, e.g. via a rotation, to incrementally adjust a length of the first dynamic force strap 112 between the first and second shells 102, 104., Para. [0093]).
Regarding Claim 11, Petursson discloses the orthosis of claim 10, wherein the first strap tensioning mechanism is adapted to adjust tension of the first strap being an anteriorly positioned strap independent of an amount of tensioning applied to the second strap by the second strap tensioning mechanism (The first tensioning mechanism 120 is mounted directly onto the first shell 102 and is movable relative to the first shell 102, e.g. via a rotation, to incrementally adjust a length of the first dynamic force strap 112 between the first and second shells 102, 104., Para. [0093]; The second dynamic strap 114 likewise has a first end slidably connecting to the first shell 102, and a second end removably anchors to the second shell 104 ... The second tensioning mechanism 122 is mounted directly onto the second shell 104 and is movable relative to the second shell 104, e.g. via a rotation, to incrementally adjust a length of the second dynamic force strap 114 between the first and second shells 102, 104., Para. [0093]).
Regarding Claim 12, Petursson discloses the orthosis of claim 10, wherein the first cuff includes a plurality of guide members (channels 308, Fig. 2N; Para. [0122]) to direct the first interconnect to a posterior region of the first cuff (The shell 104 may likewise have channels 308 for accommodating the cable extending from the tensioning mechanism 122., Para. [0122]) in which the first strap tensioning mechanism is adapted to adjust tension of the first strap being a posteriority positioned strap (To reduce bulkiness of the orthopedic device 100, and to further provide a more stable platform for tensioning the dynamic force straps 112, 114, a cable connecting the dynamic force straps 112, 114 to a tensioning mechanism 120, 122, can be reduced in length by mounting tensioning mechanisms 120, 122 directly to the shells 102, 104 and confining the cable and the travel thereof within the shells 102, 104 ... The overlay 130 shields a portion of the dynamic force straps 112, 114, with the cable preferably concealed therein., Para. [0092]; The first tensioning mechanism 120 is mounted directly onto the first shell 102 and is movable relative to the first shell 102, e.g. via a rotation, to incrementally adjust a length of the first dynamic force strap 112 between the first and second shells 102, 104., Para. [0093]) independent of an amount of tensioning applied by the second strap tensioning mechanism to the second strap being an anteriorly positioned strap (The second dynamic strap 114 likewise has a first end slidably connecting to the first shell 102, and a second end removably anchors to the second shell 104 ... The second tensioning mechanism 122 is mounted directly onto the second shell 104 and is movable relative to the second shell 104, e.g. via a rotation, to incrementally adjust a length of the second dynamic force strap 114 between the first and second shells 102, 104., Para. [0093]).
Regarding Claim 13, Petursson discloses an orthosis (an orthopedic device 100, Fig. 1; Para. [0088]) comprising: a plurality of cuffs (shells 102, 104, Fig. 1; Para. [0090]) including a first cuff (a first shell 102, Fig. 1; Para. [0090]) and a second cuff (a second shell 104, Fig. 1; Para. [0090]), wherein the first cuff comprises at least a first cuff plate (a first shell body 128, Fig. 1; Para. [0094]) and a first strap tensioning mechanism (a first tensioning mechanism 120, Fig. 1; Para. [0092]) coupled to the first cuff plate (The first tensioning mechanism 120 is mounted directly onto the first shell 102..., Para. [0093]; as shown in Fig. 1, the first tensioning mechanism 120 is coupled to the first shell body 128) and a second cuff plate (as shown in Fig. 1, opposite the liner 136, there is a second shell body on the second shell 104 that is similar to the first shell body 128) and a second strap tensioning mechanism (a second tensioning mechanism 122, Fig. 1; Para. [0093]) coupled to the second cuff plate (...by mounting tensioning mechanisms 120, 122 directly to the shells 102, 104..., Para. [0092]; as shown in Fig. 1, the second tensioning mechanism 122 is coupled to the second shell body of the second shell 104); one or more straps (dynamic force straps 112, 114, Fig. 1; Para. [0091]) including at least a first strap (a first strap or dynamic force strap 112, Fig. 1; Para. [0091]) having a first end adjustably coupled to the first strap tensioning mechanism and a second end fixedly coupled to the second cuff (A first strap or dynamic force strap 112 has a first end slidably connecting to the first shell 102 and a second end removably anchoring to the second shell 104., Para. [0091]; The first tensioning mechanism 120 is mounted directly onto the first shell 102 and is movable relative to the first shell 102, e.g. via a rotation, to incrementally adjust a length of the first dynamic force strap 112 between the first and second shells 102, 104., Para. [0093]; A second connector 126, analogous to the structure of the first connector 124, releasably connects a second end of second circumferential strap 118 and the first dynamic force strap to the second shell 104., Para. [0096]) and a second strap (a second dynamic force strap 114, Fig. 1; Para. [0091]) having a first end adjustably coupled to the second strap tensioning mechanism and a second end fixedly coupled to the first cuff (The second dynamic strap 114 likewise has a first end slidably connecting to the first shell 102, and a second end removably anchors to the second shell 104 ... The second tensioning mechanism 122 is mounted directly onto the second shell 104 and is movable relative to the second shell 104, e.g. via a rotation, to incrementally adjust a length of the second dynamic force strap 114 between the first and second shells 102, 104., Para. [0093]); and a sleeve (an overlay 130, Fig. 1; Para. [0091]) including a plurality of tunnel segments (pockets 170, 171, Fig. 5; Para. [0135]) formed within the sleeve (The overlays 130, 131 can also form pockets 170, 171 for receiving the straps 112, 114., Para. [0135]), wherein at least a first tunnel segment (a pocket 170, Fig. 5; Para. [0135]) of the plurality of tunnel segments is adapted to encapsulate a portion of the first strap (The overlays 130, 131 can also form pockets 170, 171 for receiving the straps 112, 114., Para. [0135]) and a second tunnel segment (a pocket 171, Fig. 5; Para. [0135]) of the plurality of tunnel segments is adapted to encapsulate a portion of the second strap (The overlays 130, 131 can also form pockets 170, 171 for receiving the straps 112, 114., Para. [0135]).
Regarding Claim 14, Petursson discloses the orthosis of claim 13, wherein the sleeve further comprises a plurality of pockets (In areas of the first shell 102 not requiring overlay, islands 165, 166 may be formed where the overlay 130 does not extend over the shell body 128., Para. [0142]) formed on the sleeve, the plurality of pockets include (i) a first pocket to house the first cuff excluding a first control knob that controls a degree of tension applied by the first strap tensioning mechanism to the first strap (The islands 165, 166 may be in areas where it is undesirable for the tensioning mechanism 120, 122 to rub against the overlay, particularly since it is preferable that the shell bodies 128, 129 have a hardness greater than the hardness of the overlay 130, 131., Para. [0142]) and (ii) a second pocket to house the second cuff excluding a second control knob that controls a degree of tension applied by the second strap tensioning mechanism to the second strap (The islands 165, 166 may be in areas where it is undesirable for the tensioning mechanism 120, 122 to rub against the overlay, particularly since it is preferable that the shell bodies 128, 129 have a hardness greater than the hardness of the overlay 130, 131., Para. [0142]).
Regarding Claim 15, Petursson discloses the orthosis of claim 13 further comprising: a hinge component including a hinge (a hinge 110, Fig. 1; Para. [0090]) located on a side of the orthosis (According to the depicted embodiment, the orthopedic device 100 includes a first shell 102, such as a thigh shell, a second shell 104, such as a calf shell, and a hinge 110 connecting to the first and second shells 102, 104 by first and second struts 106, 108., Para. [0090]; see also Fig. 1), a first strut member (a first strut 106, Fig. 1; Para. [0090]) pivotally coupled to the hinge and fixedly coupled to the first cuff plate of the first cuff (According to the depicted embodiment, the orthopedic device 100 includes a first shell 102, such as a thigh shell, a second shell 104, such as a calf shell, and a hinge 110 connecting to the first and second shells 102, 104 by first and second struts 106, 108 ... Either or both struts 106, 108 may be slightly twisted from at least more than 0 degrees to 15 degrees of normal ... i.e., parallel to a sagittal or frontal plane ... and preferably around 5 degrees ... The twist T allows for a more anatomical fit and reduces rotation of the struts 106, 108 and hence the orthopedic device 100 on the leg of the user., Para. [0090]), and a second strut member (a second strut 108, Fig. 1; Para. [0090]) pivotally coupled to the hinge and fixedly coupled to the second cuff plate of the second cuff (According to the depicted embodiment, the orthopedic device 100 includes a first shell 102, such as a thigh shell, a second shell 104, such as a calf shell, and a hinge 110 connecting to the first and second shells 102, 104 by first and second struts 106, 108 ... Either or both struts 106, 108 may be slightly twisted from at least more than 0 degrees to 15 degrees of normal ... i.e., parallel to a sagittal or frontal plane ... and preferably around 5 degrees ... The twist T allows for a more anatomical fit and reduces rotation of the struts 106, 108 and hence the orthopedic device 100 on the leg of the user., Para. [0090]).
Regarding Claim 17, Petursson discloses the orthosis of claim 13, wherein the first end of the first strap is coupled to a first attachment member (a strap receiving area 161, Fig. 5; Para. [0134]) that is coupled to a first interconnect (a cable, not shown; Para. [0092]) adjustably coupled to the first strap tensioning mechanism so that tension applied to the first interconnect by the first strap tensioning mechanism applies tension to the first strap to apply an unloading effect to a knee of a patient (To reduce bulkiness of the orthopedic device 100, and to further provide a more stable platform for tensioning the dynamic force straps 112, 114, a cable connecting the dynamic force straps 112, 114 to a tensioning mechanism 120, 122, can be reduced in length by mounting tensioning mechanisms 120, 122 directly to the shells 102, 104 and confining the cable and the travel thereof within the shells 102, 104 ... The overlay 130 shields a portion of the dynamic force straps 112, 114, with the cable preferably concealed therein., Para. [0092]; The first tensioning mechanism 120 is mounted directly onto the first shell 102 and is movable relative to the first shell 102, e.g. via a rotation, to incrementally adjust a length of the first dynamic force strap 112 between the first and second shells 102, 104., Para. [0093]).
Regarding Claim 18, Petursson discloses the orthosis of claim 17, wherein the first strap tensioning mechanism is adapted to adjust an amount of tensioning to the first strap being an anteriorly positioned strap independent of an amount of tensioning applied to the second strap by the second strap tensioning mechanism being a posteriorly position strap of the orthosis (The first tensioning mechanism 120 is mounted directly onto the first shell 102 and is movable relative to the first shell 102, e.g. via a rotation, to incrementally adjust a length of the first dynamic force strap 112 between the first and second shells 102, 104., Para. [0093]; The second dynamic strap 114 likewise has a first end slidably connecting to the first shell 102, and a second end removably anchors to the second shell 104 ... The second tensioning mechanism 122 is mounted directly onto the second shell 104 and is movable relative to the second shell 104, e.g. via a rotation, to incrementally adjust a length of the second dynamic force strap 114 between the first and second shells 102, 104., Para. [0093]).
Regarding Claim 19, Petursson discloses the orthosis of claim 17, wherein the first cuff includes a plurality of guide members (channels 308, Fig. 2N; Para. [0122]) to direct the first interconnect to a posterior region of the first cuff plate (The shell 104 may likewise have channels 308 for accommodating the cable extending from the tensioning mechanism 122., Para. [0122]) in which the first strap tensioning mechanism is adapted to adjust tension of the first interconnect to adjust tension of the first strap being a posteriority positioned strap (To reduce bulkiness of the orthopedic device 100, and to further provide a more stable platform for tensioning the dynamic force straps 112, 114, a cable connecting the dynamic force straps 112, 114 to a tensioning mechanism 120, 122, can be reduced in length by mounting tensioning mechanisms 120, 122 directly to the shells 102, 104 and confining the cable and the travel thereof within the shells 102, 104 ... The overlay 130 shields a portion of the dynamic force straps 112, 114, with the cable preferably concealed therein., Para. [0092]; The first tensioning mechanism 120 is mounted directly onto the first shell 102 and is movable relative to the first shell 102, e.g. via a rotation, to incrementally adjust a length of the first dynamic force strap 112 between the first and second shells 102, 104., Para. [0093]) independently from an amount of tensioning applied by the second strap tensioning mechanism to the second strap being an anteriorly positioned strap (The second dynamic strap 114 likewise has a first end slidably connecting to the first shell 102, and a second end removably anchors to the second shell 104 ... The second tensioning mechanism 122 is mounted directly onto the second shell 104 and is movable relative to the second shell 104, e.g. via a rotation, to incrementally adjust a length of the second dynamic force strap 114 between the first and second shells 102, 104., Para. [0093]).
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 3-6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Petursson et al (US 2024/0189131 A1) in view of Sterling (US 7,662,122 B2).
Regarding claim 3, Petursson discloses that as applied above and discloses a sleeve (260) having a first tunnel segment (258) extending downwardly in a first direction (Figure 10A), a second tunnel segment extending downwardly in a second direction (see other upper portion 258), a third tunnel segment extending upwardly to become aligned with the second tunnel segment (see lower end panel 258), and a fourth tunnel segment extending upwardly to become aligned with the first tunnel segment (see other lower end portion 258; Figure 10A). Petursson does not disclose the sleeve has the first tunnel extending downwardly from the first pocket and that the sleeve houses both the cuffs and the straps. Sterling teaches a similar orthotic comprising a sleeve (70) having pockets (72; Figure 10) to house first and second cuffs (32, 34) and four tunnel portions (channels formed by padding 52/sleeve 70 and fabric cover 78; Col. 10 line 64 to Col. 11 line 17) for straps (50), wherein the first tunnel extends downwardly from the first pocket (Figures 1A-C and 10). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Petursson wherein the tunnel extending downwardly from the first pocket as taught by Sterling so that the sleeve houses both the cuffs and the straps for providing greater protection and comfort to the user.
Regarding claim 4, the first tunnel segment is adapted to encapsulate a first portion of the first strap, the second tunnel segment is adapted to encapsulate a first portion of a second strap, the third tunnel segment is adapted to encapsulate a second portion of the second strap, and the fourth tunnel segment is adapted to encapsulate a second portion of the first strap (see Figures 1A-B and 10A of Petursson; Figures 1A-C and 10 of Sterling).
Regarding claim 5, Petursson discloses a hinge component including a hinge (110), a first strut member (106) pivotally coupled to the hinge and fixedly coupled to the first cuff (Figures 1A-B), and a second strut member (108) pivotally coupled to the hinge and fixedly coupled to the second cuff (Figures 1A-B).
Regarding claim 6, Petursson discloses wherein the first strap and the second strap intersect at a medial side or a lateral side of the orthosis on an opposite side of the orthosis than the hinge component (Figures 1A-B).
Regarding claim 16, Petursson discloses a sleeve (260) having a first tunnel segment (258) extending downwardly in a first direction (Figure 10A), a second tunnel segment extending downwardly in a second direction (see other upper portion 258), a third tunnel segment extending upwardly to become aligned with the second tunnel segment to encapsulate a second portion of the second strap (see lower end panel 258), and a fourth tunnel segment extending upwardly to become aligned with the first tunnel segment to encapsulate a second portion of the first strap (see other lower end portion 258; Figure 10A). Petursson does not disclose the sleeve has the first tunnel extending downwardly from the first pocket and that the sleeve houses both the cuffs and the straps. Sterling teaches a similar orthotic comprising a sleeve (70) having pockets (72; Figure 10) to house first and second cuffs (32, 34) and four tunnel portions (channels formed by padding 52/sleeve 70 and fabric cover 78; Col. 10 line 64 to Col. 11 line 17) for straps (50), wherein the first tunnel extends downwardly from the first pocket (Figures 1A-C and 10). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Petursson wherein the tunnel extending downwardly from the first pocket as taught by Sterling so that the sleeve houses both the cuffs and the straps for providing greater protection and comfort to the user.
Conclusion
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
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