DETAILED ACTION
This action is in response to the amendment filed 3/31/2026. Currently, claims 1, 2 and 4-21 are pending in the application. Claim 3 is cancelled by Applicant. New claim 21 is added by Applicant.
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 .
Response to Arguments
Applicant’s amendment to the abstract is sufficient to overcome the previous objection to the specification.
Applicant’s amendment to claim 11 is sufficient to overcome the previous objection to claim 11. Applicant’s amendments to claims 11-13 and 16 are sufficient to overcome the previous objection to claims 11-13 and 16. Applicant’s amendment to claim 18 is sufficient to overcome the previous objection to claim 18.
Applicant’s amendment to claim 2 is sufficient to overcome the previous rejection of claim 2 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Applicant’s amendment to claim 8 is sufficient to overcome the previous rejection of claims 8 and 9 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Applicant failed to amend claim 4 to overcome the previous rejection of claim 4 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. Further, Applicant did not provide any arguments to this rejection. The rejection of claim 4 is therefore, maintained as detailed below.
Applicant's arguments filed 3/31/2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually (that Broussard does not teach each strut comprising two or more sheets of a material conformable to contours of a leg and insertable into a sleeve or pocket on the fabric or fabric wrap), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the substrate layers are impregnated with a moisture-curable resin) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to Applicant’s argument that Cassford does not teach two separate pieces of foam on an inner surface of the fabric or fabric wrap, so that when the fracture stabilization orthosis is wrapped around a lower leg, each foam piece rests along an opposing side of the tibia crest and is configured not to put direct pressure on the tibia or fibula bones, the examiner respectfully disagrees. As detailed below, Cassford teaches in Figures 1 and 2 and column 4, lines 1-3 and 8-9 an analogous device with two separate (inasmuch as they are spaced from each other by the central, longitudinal extent of flexible compressible pad 16) pieces (left and right projections of flexible compressible pad 16) of foam (column 4, lines 8-9 teaches “pad 16 is preferably formed from a sheet of an inexpensive lightweight synthetic foam”) on (as shown in Figures 1 and 2; column 4, lines 1-3 teaches “a flexible compressible pad 16 is positioned between the leg 12 and the support member 14 on the inner side 18 of the support member”) an inner surface (inner side 18) of the fabric or fabric wrap (support member 14), so that when the fracture stabilization orthosis (splint 10) is wrapped around a lower leg, each foam piece rests along an opposing side of the tibia crest (as shown in Figure 1; column 4, lines 16-18 teaches “the pad 16 is also sufficiently large to wrap around and enclose the topside contour of the leg 12”) and is configured not to put direct pressure on the tibia or fibula bones (the left and right projections of flexible compressible pad 16 are capable of avoiding direct pressure on the tibia or fibula bones, depending on the size of the limb of the user).
In response to Applicant’s argument that Gaylord does not teach a footplate connected to a bottom of the fabric or fabric wrap; wherein the footplate comprises plastic and has a rectangular-shaped piece that is foldable to have a curvature that substantially cover a top surface of a foot, the examiner again respectfully disagrees. As detailed below, Gaylord teaches a footplate (lower section 13, flexible panels 24, base pad 32, and pair of front or foot tensioning arms 30, 31) connected to a bottom of (as shown in Figure 9; [0007] teaches “the pair of foot tensioning arms 30, 31 is positioned at opposite sides of a lower portion of the flexible sheet member 15;” [0009] teaches “a base pad 32 fixed to a lower portion of the flexible sheet member 15”) the fabric or fabric wrap (flexible sheet member 15); wherein the footplate (lower section 13, flexible panels 24, base pad 32, and pair of front or foot tensioning arms 30, 31) comprises plastic ([0005] teaches “the body member 11 can be formed from plastic;” [0006] teaches “body member 11 having an upper section 12 for engaging an anterior portion of the lower leg and a lower section 13 for engaging a dorsal portion of a foot”) and has a rectangular-shaped piece (pair of front or foot tensioning arms 30, 31; Figure 9 teaches the pair of front or foot tensioning arms 30, 31 having a rectangular shape) that is foldable to have a curvature that substantially cover a top surface of a foot ([0039] teaches “during adjustment, the user draws the foot tensioning arms 30, 31 upward and against the external surface 20 of the lower section 13 of the body member 11, and releasably secures the foot tensioning arms 30, 31 to the body member 11 at a desired amount of support;” this results in the pair of front or foot tensioning arms 30, 31 being curved around the user’s foot).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 12 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 12 recites “two separate pieces of foam on an inner surface of the fabric or fabric wrap.” No support is provided for this claim limitation in Applicant’s specification as originally filed. Applicant’s original disclosure provides no description of the two stabilizing pads or pieces of foam 40 being separate from one another. Further, it is clear from at least Applicant’s Figure 5 that the two stabilizing pads or pieces of foam 40 are directly attached to one another, and not separate, as claimed.
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.
Claim 4 is 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 4 recites “four to eight sheets of material” in line 2 of the claim. It is unclear if these recited “sheets” are the same as, or distinct from, the “two or more sheets of a material” that is previously recited in claim 1 (upon which claim 4 depends).
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.
Claim(s) 1, 2, 4-11, 13-15 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Broussard (US 2021/0128336 A1), in view of WEIDEMANN, JR. (US 2,753,864 A) and further in view of Doubleday (US 5,470,306 A).
In regards to claims 1, 4, 6 and 8, Broussard teaches in Figures 1, 10A and 10B and [0029-0030] a fabric or fabric wrap (body 30; [0029] teaches “the body 30 may include a material selected from KEVLAR materials, GOR-TEX materials, nylon fabrics, ballistic nylon fabrics, polyester and cotton blended fabrics, and polyester fabrics, for example;” Figures 10A and 10B teach the body 30 wrapping around the user’s limb in use); and a plurality of struts (rigid slats 16, which are individually designated 16a, 16b, 16c, 16d, 16e, 16f), each strut (rigid slats 16, which are individually designated 16a, 16b, 16c, 16d, 16e, 16f) insertable into ([0030] teaches “each of the sleeves 46, 48, 50, 52, 54, 56 is configured to accept one of the rigid slats 16”) a sleeve or pocket (sleeves 46, 48, 50, 52, 54, 56) on ([0030] teaches “sleeves 46, 48, 50, 52, 54, 56 extend longitudinally through the body 30”) the fabric or fabric wrap (body 30), wherein the fabric or fabric wrap (body 30) to be wrapped around a limb (as shown in Figures 10A and 10B). Broussard teaches in Figure 1 and [0028] that the plurality of struts (rigid slats 16, which are individually designated 16a, 16b, 16c, 16d, 16e, 16f) comprises about six struts (rigid slats 16, which are individually designated 16a, 16b, 16c, 16d, 16e, 16f; six rigid slats 16a, 16b, 16c, 16d, 16e, 16f are taught in Figure 1 and [0028]).
Broussard does not teach each strut comprising two or more sheets of a material conformable to contours of a leg; and wherein the fabric or fabric wrap is shaped so that when it is wrapped around a limb it forms a frustum; wherein each strut comprises a plurality of layered sheets; and wherein each strut comprises four to eight sheets of material; and each strut comprising about three to about four sheets; and wherein each strut comprises two or more sheets, each sheet comprising aluminum, titanium, steel, nylon, carbon fiber laminate, fiberglass laminate, KEVLAR® laminate, ultra-high-molecular-weight polyethylene, or a laminated composite of any combination thereof.
However, WEIDEMANN, JR. teaches in Figures 1-5, column 2, lines 34-39 and 45-47 an analogous device wherein the fabric or fabric wrap (flexible limb portion 22) is shaped so that when it is wrapped around a limb it forms a frustum (as shown in Figures 3 and 5; column 2, lines 34-39 “the flexible limb portion 22 is preferably downwardly tapered or of "keystone" outline so that when the device is applied to the limb of the person (as for example, to a person's leg, Fig. 5 or to the back and head, Fig. 8), the said connector portion will conform to the contour of said body portions;” column 2, lines 45-47 teaches “these pockets and slats converge downwardly so as to fit the general tapering contour of the leg of a person”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the fabric or fabric wrap of Broussard such that the fabric or fabric wrap is shaped so that when it is wrapped around a limb it forms a frustum as taught by WEIDEMANN, JR. because this element is known to enable the fabric or fabric wrap “to fit the general tapering contour of the leg of a person,” as WEIDEMANN, JR. teaches in column 2, lines 45-47.
Broussard and WEIDEMANN, JR. do not teach each strut comprising two or more sheets of a material conformable to contours of a leg; wherein each strut comprises a plurality of layered sheets; and wherein each strut comprises four to eight sheets of material; and each strut comprising about three to about four sheets; and wherein each strut comprises two or more sheets, each sheet comprising aluminum, titanium, steel, nylon, carbon fiber laminate, fiberglass laminate, KEVLAR® laminate, ultra-high-molecular-weight polyethylene, or a laminated composite of any combination thereof.
However, Doubleday teaches in Figure 1, claim 1 and columns 3-4, lines 65-2 an analogous device with each strut (substrate 17) comprising (columns 3-4, lines 65-2 teaches “As shown in FIG. 1, the preferred embodiment of the present invention comprises between six and eight substrate layers 16 in vertical alignment such that they overlay one another. The substrate layers collectively may be referred to as a substrate 17 for convenience.”) two or more sheets of a material (between six and eight substrate layers 16) conformable to contours of a leg (claim 1 teaches the substrate being “flexible,” and therefore, the substrate 17 and the substrate layers 16 are capable of flexing to conform to contours of a leg); wherein each strut (substrate 17) comprises (columns 3-4, lines 65-2 teaches “As shown in FIG. 1, the preferred embodiment of the present invention comprises between six and eight substrate layers 16 in vertical alignment such that they overlay one another. The substrate layers collectively may be referred to as a substrate 17 for convenience.”) a plurality of layered sheets (between six and eight substrate layers 16); and wherein each strut (substrate 17) comprises (columns 3-4, lines 65-2 teaches “as shown in FIG. 1, the preferred embodiment of the present invention comprises between six and eight substrate layers 16 in vertical alignment such that they overlay one another.”) four to eight sheets of material (between six and eight substrate layers 16); and each strut (substrate 17) comprising about three to about four sheets (columns 3-4, lines 65-2 teaches “as shown in FIG. 1, the preferred embodiment of the present invention comprises between six and eight substrate layers 16 in vertical alignment such that they overlay one another;” since the substrate 17 includes between six and eight substrate layers 16, it necessarily includes three substrate layers 16 and four substrate layers 16; three substrate layers 16 and four substrate layers 16 are shown in Figure 1); and wherein each strut (substrate 17) comprises two or more sheets (columns 3-4, lines 65-2 teaches “As shown in FIG. 1, the preferred embodiment of the present invention comprises between six and eight substrate layers 16 in vertical alignment such that they overlay one another. The substrate layers collectively may be referred to as a substrate 17 for convenience.”), each sheet (between six and eight substrate layers 16) comprising aluminum, titanium, steel, nylon, carbon fiber laminate, fiberglass laminate (column 4, lines 2-3 teaches “each substrate layer is preferably knit of fiberglass fibers;” Figure 1 teaches the substrate layers 16 being layered and therefore, each substrate layer 16 can be considered a laminate), KEVLAR® laminate, ultra-high-molecular-weight polyethylene, or a laminated composite of any combination thereof.
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify each strut of Broussard as modified by WEIDEMANN, JR. to comprise two or more sheets of a material conformable to contours of a leg; wherein each strut comprises a plurality of layered sheets; and wherein each strut comprises four to eight sheets of material; and each strut comprising about three to about four sheets; and wherein each strut comprises two or more sheets, each sheet comprising aluminum, titanium, steel, nylon, carbon fiber laminate, fiberglass laminate, KEVLAR® laminate, ultra-high-molecular-weight polyethylene, or a laminated composite of any combination thereof. as taught by Doubleday because this element is known to form each strut as “a lightweight and rigid structure,” as Doubleday teaches in column 2, lines 28-31.
In regards to claim 2, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard teaches in Figure 1 and [0028] that the plurality of struts (rigid slats 16, which are individually designated 16a, 16b, 16c, 16d, 16e, 16f) comprises about 4 to about 12 vertical struts (rigid slats 16, which are individually designated 16a, 16b, 16c, 16d, 16e, 16f; six rigid slats 16a, 16b, 16c, 16d, 16e, 16f are taught in Figure 1 and [0028]) substantially extending a length of (as shown in Figure 1) the fabric or fabric wrap (body 30).
In regards to claim 5, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard reaches in [0029] that the fabric or fabric wrap (body 30) comprises an elastic material ([0029] teaches “the body 30 may include a material selected from KEVLAR materials, GOR-TEX materials, nylon fabrics, ballistic nylon fabrics, polyester and cotton blended fabrics, and polyester fabrics, for example;” at least nylon is an elastic material).
In regards to claim 7, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard, WEIDEMANN, JR. and Doubleday do not teach that a thickness of each sheet may be about 0.25 mm to about 2 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that a thickness of each sheet may be about 0.25 mm to about 2 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the thickness of each sheet could be modified as needed to provide the necessary rigidity and/or protection for each individual, and could be modified to accommodate the comfort preference or therapeutic needs of each individual.
In regards to claim 9, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claims 1 and 8. Broussard, WEIDEMANN, JR. and Doubleday do not teach that each strut comprises at least one sheet of ultra-high-molecular-weight polyethylene, at least one sheet of carbon fiber, at least one sheet of aluminum, or any combination thereof.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that each strut comprises at least one sheet of ultra-high-molecular-weight polyethylene, at least one sheet of carbon fiber, at least one sheet of aluminum, or any combination thereof, since it has been held to be within the general skill of a worker in the art so select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
In regards to claim 10, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard, WEIDEMANN, JR. and Doubleday do not teach that each strut has a length of about 30 cm to about 50 cm and a width of about 0.5 cm to about 2.0 cm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that each strut has a length of about 30 cm to about 50 cm and a width of about 0.5 cm to about 2.0 cm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the length and width of each strut could be modified to best accommodate the size and comfort of an individual user.
In regards to claim 11, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard teaches in Figure 1 and [0028] at least one fastener (straps 14) for affixing the fracture stabilization orthosis (splint system 10) to the limb ([0028] teaches “in isolated settings, for example, various combinations of orthopedic field splints 12, the straps 14, the rigid slats 16, the sling 18, the traction assembly 20, and attachment cords 22 for positioning, may be utilized to splint fractures, including fractures of the radius, ulna, humerus, tibia, fibula, femur, and pelvis, for example”), wherein the at least one fastener (straps 14) is one or more of a belt, strap (straps 14), buckle, zipper, snap, or a hook-and-loop fastener.
In regards to claim 13, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard teaches in Figure 10B that the fracture stabilization orthosis (splint system 10) is configured to completely enclose a calf of a wearer (as shown in Figure 10B).
In regards to claim 14, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard, WEIDEMANN, JR. and Doubleday do not teach that the frustum has a pitch of about 0.6 to about 0.7.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the frustum has a pitch of about 0.6 to about 0.7, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the pitch of the frustum could be modified in order to most closely fit the contour of an individual user’s limb.
In regards to claim 15, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard, WEIDEMANN, JR. and Doubleday do not teach that the frustum has a pitch of 0.66.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that the frustum has a pitch of 0.66, since it had been held that discovering the optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F. 2d 272, 205 USPQ 215 (CCPA 1980). One having ordinary skill in the art before the effective filing of the present invention would find it obvious that the pitch of the frustum could be modified in order to most closely fit the contour of an individual user’s limb.
In regards to claim 19, Broussard, WEIDEMANN, JR. and Doubleday teach providing the fracture stabilization orthosis of Claim 1 (see the rejection of claim 1 above). Broussard teaches in Figures 10A and 10B, [0038-0039] and [0043] wrapping (as shown in Figures 10A and 10B) the fracture stabilization orthosis (splint system 10) around a limb of a person having a bone fracture ([0038] teaches “in isolated settings, for example, various combinations of the orthopedic field splints 12, the straps 14, the rigid slats 16, the sling 18, and the traction assembly 20 may be utilized to splint fractures, including fractures of the radius (FIGS. 8A, 8B), ulna (FIGS. 8A, 8B), humerus (FIGS. 9A, 9B), tibia (FIGS. 10A, 10B), fibula (FIGS. 10A, 10B), femur (FIGS. 11A, 11B), and pelvis (FIGS. 12A, 12B), for example;” [0039] teaches “the splint system 10 may be expediently configured and provide a single-use platform for multiple fractures, including fractures of the radius (FIGS. 8A, 8B), ulna (FIGS. 8A, 8B), humerus (FIGS. 9A, 9B), tibia (FIGS. 10A, 10B), fibula (FIGS. 10A, 10B), femur (FIGS. 11A, 11B), and pelvis (FIGS. 12A, 12B), for example;” [0043] teaches “using the connection 300 and the connection 310, as appropriate, fractures of the radius (FIGS. 8A, 8B), ulna (FIGS. 8A, 8B), humerus (FIGS. 9A, 9B), tibia (FIGS. 10A, 10B), fibula (FIGS. 10A, 10B), femur (FIGS. 11A, 11B), and pelvis (FIGS. 12A, 12B), for example, may be medically addressed” and “in FIG. 10A and FIG. 10B, the splint system 10 utilizes the orthopedic field splint 12a, the orthopedic field splint 12b, the orthopedic field splint 12c, and the orthopedic field splint 12d with end-to-end connections 300a, 300b and side-to-side connections 310a, 310b to splint a fibula F or tibia T”).
In regards to claim 20, Broussard, WEIDEMANN, JR. and Doubleday teach the method of claim 19. Broussard teaches in [0038-0039] and [0043] that the bone fracture is a tibia or fibula bone fracture ([0038] teaches “in isolated settings, for example, various combinations of the orthopedic field splints 12, the straps 14, the rigid slats 16, the sling 18, and the traction assembly 20 may be utilized to splint fractures, including fractures of the radius (FIGS. 8A, 8B), ulna (FIGS. 8A, 8B), humerus (FIGS. 9A, 9B), tibia (FIGS. 10A, 10B), fibula (FIGS. 10A, 10B), femur (FIGS. 11A, 11B), and pelvis (FIGS. 12A, 12B), for example;” [0039] teaches “the splint system 10 may be expediently configured and provide a single-use platform for multiple fractures, including fractures of the radius (FIGS. 8A, 8B), ulna (FIGS. 8A, 8B), humerus (FIGS. 9A, 9B), tibia (FIGS. 10A, 10B), fibula (FIGS. 10A, 10B), femur (FIGS. 11A, 11B), and pelvis (FIGS. 12A, 12B), for example;” [0043] teaches “using the connection 300 and the connection 310, as appropriate, fractures of the radius (FIGS. 8A, 8B), ulna (FIGS. 8A, 8B), humerus (FIGS. 9A, 9B), tibia (FIGS. 10A, 10B), fibula (FIGS. 10A, 10B), femur (FIGS. 11A, 11B), and pelvis (FIGS. 12A, 12B), for example, may be medically addressed” and “in FIG. 10A and FIG. 10B, the splint system 10 utilizes the orthopedic field splint 12a, the orthopedic field splint 12b, the orthopedic field splint 12c, and the orthopedic field splint 12d with end-to-end connections 300a, 300b and side-to-side connections 310a, 310b to splint a fibula F or tibia T”).
In regards to claim 21, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard, WEIDEMANN, JR. and Doubleday do not teach that each strut comprises two or more sheets, each sheet comprising aluminum, titanium, steel, nylon, carbon fiber laminate, KEVLAR® laminate, ultra-high-molecular-weight polyethylene, or a laminated composite of any combination thereof.
However, it would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to provide that each strut comprises two or more sheets, each sheet comprising aluminum, titanium, steel, nylon, carbon fiber laminate, KEVLAR® laminate, ultra-high-molecular-weight polyethylene, or a laminated composite of any combination thereof, since it has been held to be within the skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Broussard (US 2021/0128336 A1), in view of WEIDEMANN, JR. (US 2,753,864 A), in view of Doubleday (US 5,470,306 A) and further in view of Cassford (US 5,385,534 A).
In regards to claim 12, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard, WEIDEMANN, JR. and Doubleday do not teach two separate pieces of foam on an inner surface of the fabric or fabric wrap, so that when the fracture stabilization orthosis is wrapped around a lower leg, each foam piece rests along an opposing side of the tibia crest and is configured not to put direct pressure on the tibia or fibula bones.
However, Cassford teaches in Figures 1 and 2 and column 4, lines 1-3 and 8-9 an analogous device with two separate (inasmuch as they are spaced from each other by the central, longitudinal extent of flexible compressible pad 16) pieces (left and right projections of flexible compressible pad 16) of foam (column 4, lines 8-9 teaches “pad 16 is preferably formed from a sheet of an inexpensive lightweight synthetic foam”) on (as shown in Figures 1 and 2; column 4, lines 1-3 teaches “a flexible compressible pad 16 is positioned between the leg 12 and the support member 14 on the inner side 18 of the support member”) an inner surface (inner side 18) of the fabric or fabric wrap (support member 14), so that when the fracture stabilization orthosis (splint 10) is wrapped around a lower leg, each foam piece rests along an opposing side of the tibia crest (as shown in Figure 1; column 4, lines 16-18 teaches “the pad 16 is also sufficiently large to wrap around and enclose the topside contour of the leg 12”) and is configured not to put direct pressure on the tibia or fibula bones (the left and right projections of flexible compressible pad 16 are capable of avoiding direct pressure on the tibia or fibula bones, depending on the size of the limb of the user).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the fabric or fabric wrap of Broussard as modified by WEIDEMANN, JR. and Doubleday to include two separate pieces of foam on an inner surface of the fabric or fabric wrap, so that when the fracture stabilization orthosis is wrapped around a lower leg, each foam piece rests along an opposing side of the tibia crest and is configured not to put direct pressure on the tibia or fibula bones as taught by Cassford because this element is known to “to provide cushioning of the leg 12 against” the fabric or fabric wrap, as Cassford teaches in column 4, lines 1-6.
Claim(s) 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Broussard (US 2021/0128336 A1), in view of WEIDEMANN, JR. (US 2,753,864 A), in view of Doubleday (US 5,470,306 A) and further in view of Gaylord (US 2008/0208094 A1).
In regards to claims 16-18, Broussard, WEIDEMANN, JR. and Doubleday teach the apparatus of claim 1. Broussard, WEIDEMANN, JR. and Doubleday do not teach that the fracture stabilization orthosis further comprises a footplate connected to a bottom of the fabric or fabric wrap; wherein the footplate comprises plastic and has a rectangular-shaped piece that is foldable to have a curvature that substantially cover a top surface of a foot; and wherein the footplate further comprises one or more sections that provide padding and are wrappable around at least part of a foot.
However, Gaylord teaches in Figure 9, [0005-0007], [0009] and [0039] an analogous device wherein the fracture stabilization orthosis (orthotic device 10) further comprises a footplate (lower section 13, flexible panels 24, base pad 32, and pair of front or foot tensioning arms 30, 31) connected to a bottom of (as shown in Figure 9; [0007] teaches “the pair of foot tensioning arms 30, 31 is positioned at opposite sides of a lower portion of the flexible sheet member 15;” [0009] teaches “a base pad 32 fixed to a lower portion of the flexible sheet member 15”) the fabric or fabric wrap (flexible sheet member 15); wherein the footplate (lower section 13, flexible panels 24, base pad 32, and pair of front or foot tensioning arms 30, 31) comprises plastic ([0005] teaches “the body member 11 can be formed from plastic;” [0006] teaches “body member 11 having an upper section 12 for engaging an anterior portion of the lower leg and a lower section 13 for engaging a dorsal portion of a foot”) and has a rectangular-shaped piece (pair of front or foot tensioning arms 30, 31; Figure 9 teaches the pair of front or foot tensioning arms 30, 31 having a rectangular shape) that is foldable to have a curvature that substantially cover a top surface of a foot ([0039] teaches “during adjustment, the user draws the foot tensioning arms 30, 31 upward and against the external surface 20 of the lower section 13 of the body member 11, and releasably secures the foot tensioning arms 30, 31 to the body member 11 at a desired amount of support;” this results in the pair of front or foot tensioning arms 30, 31 being curved around the user’s foot); and wherein the footplate (lower section 13, flexible panels 24, base pad 32, and pair of front or foot tensioning arms 30, 31) further comprises one or more sections (formed by flexible panels 24, base pad 32, and pair of front or foot tensioning arms 30, 31) that provide padding ([0009] teaches “the base pad 32 provides cushioning for the lower foot during limited activity”) and are wrappable around at least part of a foot ([0039] teaches “during adjustment, the user draws the foot tensioning arms 30, 31 upward and against the external surface 20 of the lower section 13 of the body member 11, and releasably secures the foot tensioning arms 30, 31 to the body member 11 at a desired amount of support;” Figure 9 teaches the flexible panels 24 being positioned to wrap around lateral sides of the user’s foot in use).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the fracture stabilization orthosis of Broussard as modified by WEIDEMANN, JR. and Doubleday to further comprise a footplate connected to a bottom of the fabric or fabric wrap; wherein the footplate comprises plastic and has a rectangular-shaped piece that is foldable to have a curvature that substantially cover a top surface of a foot; and wherein the footplate further comprises one or more sections that provide padding and are wrappable around at least part of a foot as taught by Gaylord because this element is known to “a user to adjustably secure the device 10 to the lower leg and foot,” “position lower portions of the sheet member 15 against a lower portion of the foot” and provide “cushioning for the lower foot during limited activity,” as Gaylord teaches in [0007-0009].
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 VICTORIA H FISHER whose telephone number is (571)270-7033. The examiner can normally be reached M-TH 6:00AM-4:00PM EST.
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/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 5/7/2026
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