DETAILED ACTION
This action is in response to the Response to Election/Restriction filed 3/11/2026. Currently, claims 1-23 are pending in the application.
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
Applicant's election with traverse of Species 10, Figures 55 and 59-61(corresponding to claims 1-3, 6-12, 15-19 and 21-23) in the reply filed on 3/11/2026 is acknowledged. The traversal is on the ground(s) that at least Figures 55 and 57-61 all illustrate different views of portions of the same embodiment. This is found persuasive and Figures 57 and 58 are agreed to also correspond to the elected species.
Claims 4, 5, 13, 14 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.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 3/11/2026.
Claim Objections
Claims 1-3, 6-12, 15-19, 22 and 23 are objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), all recitations of “the orthosis” should be amended to recite ---the ankle orthosis---. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the closable flaps” in line 4 of the claim should be amended to recite ---the closure flaps---. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the upright assembly” in line 11 of the claim should be amended to recite ---the rigid upright assembly---. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), all recitations of “the user” (recited twice) should be amended to recite ---the wearer---. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the first, second and third cuff portions” in line 10 of the claim should be amended to recite ---the first, second and third anterior cuff portions---. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “extension of posterior cuff” in line 2 of the claim should be amended to recite ---extension of the posterior cuff---. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the first anterior cuff” in line 2 of the claim should be amended to recite ---the first anterior cuff portion---. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: in order to correct a typographical error, “a second end configured t could to the first fastener” in line 8 of the claim should be amended to recite ---a second end configured t could to the second fastener---. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the first end” in line 2 of the claim should be amended to recite ---the first end of the second midfoot strap---. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: in order to improve the clarity of the claim(s), “the strap extends toward the second end” in line 4 of the claim should be amended to recite ---the at least one of the first and second midfoot straps extends toward the respective second end---. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: in order to maintain consistency and clarity throughout the claim(s), “the closable flaps” in line 4 of the claim should be amended to recite ---the closure flaps---. Appropriate correction is required.
Claim 23 is objected to because of the following informalities: in order to correct a typographical error, “the same position on the medial side of the orthosis as the second fastener” should be amended to recite ---the same position on the lateral side of the orthosis as the second fastener---. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “locking feature” in claim 10.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
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 2 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 2 recites the limitation "the distal end of the fabric portion" in lines 5-6 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 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 2 recites the limitation "the proximal end of the fabric portion" in line 6 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 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 2 recites “a desired amount.” This claim limitation is unclear, because what is considered “desirable” varies among individual people or situations.
Claim 8 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 8 recites the limitation "the slot" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 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 9 recites the limitation "the slot" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 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 19 recites the limitation "the portion of the strap configured to be disposed against an underside of the arch of the foot of the wearer" in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 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 23 recites “a lateral side of the orthosis.” It is unclear if this recited “lateral side of the orthosis” is the same as, or distinct from, the “lateral side of the orthosis” that is previously recited in claim 22 (upon which claim 23 depends).
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.
Claims 1-3, 6-12 and 15-19 are rejected under 35 U.S.C. 101 because 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 1-3, 6-12 and 15-19 are 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). Claim 1 recites “a first fastener coupled to a lateral side of the orthosis at a position inferior of the ankle joint of the wearer,” which is a claim limitation indicating that Applicant is attempting to claims the ankle joint of the wearer (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claims 2-3, 6-12 and 15-19 depend on claim 1 and therefore, include the same error.
Claim 8 is rejected under 35 U.S.C. 101 because 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.
Claim 8 is 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). Claim 8 recites “the slot extends substantially parallel to a length of circumferential extension of posterior cuff portion about the lower leg of the wearer,” which is a claim limitation indicating that Applicant is attempting to claims the lower leg of the wearer (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error.
Claims 17-19 are rejected under 35 U.S.C. 101 because 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 17-19 are 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). Claim 17 recites “a second fastener coupled to a medial side of the orthosis at a position inferior of the ankle joint of the wearer,” which is a claim limitation indicating that Applicant is attempting to claims the ankle joint of the wearer (which is non-statutory subject matter). Applicant should utilize “adapted to” or “capable of” language to avoid this error. Claims 18 and 19 depend on claim 17 and therefore, include the same error.
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.
Claim(s) 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kallassy (US 4,729,370 A).
Regarding claim 21, Kallassy teaches in Figures 1-5 receiving at least a portion of a lower leg anteriorly into (column 3, lines 29-31 teaches “ankle support 10 is somewhat unique in that it receives the wearer's foot from the front and is a front closing brace;” claim 3 teaches “said underliner is open at the front thereof and further includes upper and lower closure means, each constructed to permit adjustable securement of said underliner, whereby the fit and compression thereof may be selectively adjusted”) a fabric portion (underliner 20; column 3, lines 17-18 teaches “the main body of ankle support 10 is an underliner 20, which is made of neoprene”) of the ankle orthosis (ankle support 10); tightening at least one strap (medial strap 70) around (as shown in Figures 1-5) the fabric portion (underliner 20) with the lower leg of the wearer secured therein (the abstract teaches “the medial strap extends underneath the foot and up the opposite side thereof, and it is inelastically secured to the leg near the top of the underliner, with provision being made for adjustment of its tension;” column 5, lines 8-20 teaches “Strap 70 balances out the force that straps 50 and 60 have on the heel and on the subtalar joint, as well as on the positioning of the calcaneus of the heel bone. Adjusting the pulling relationship of the straps 50 and 70 with respect to each other provides what is commonly called a "heel lock" in which the foot is cradled, and lateral movement of the ankle joint is limited, balanced and aligned. Strap 70 extends under the foot, upwardly along the inside surface of the foot and across the front of the ankle. As strap 70 is pulled upward, it provides an antipronational force, which prevents rolling-in of the foot, and it provides support to the arch which is very important in taping, strapping or supporting the ankle.”); and tightening (column 4, lines 15-18 teaches “to apply anchor strap 40, its end is inserted through a buckle 36 and the strap is pulled tight and folded back on itself”) at least one adjustable (column 4, lines 25-30 teaches “by using the hook and pile closure system for the anchor strap 40, it becomes an adjustable means of pressure or an adjustable means of tightness for the brace, so that it can also accommodate a wide range of lower leg sizes, yet it will encircle the leg and attach to itself”) cuff assembly (anchor strap 40) around (as shown in Figures 1-5) the fabric portion (underliner 20) with the lower leg of the wearer secured therein (column 4, lines 11-13 teaches “anchor strap 40 forms a loop going all the way around the brace and all the way around the leg above the ankle”), thereby preventing a tibia and fibula of the wearer from separating (via pressure/tightness applied by anchor strap 40, as shown in Figure 1; column 4, lines 25-30 teaches that the anchor strap 40 is “an adjustable means of pressure or an adjustable means of tightness for the brace”).
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) 1-3, 6, 8, 9, 15-16 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 5,226,875 A) in view of Krahenbuhl (US 5,016,623 A).
Regarding claims 1, 15 and 16, Johnson teaches in Figure 5
a fabric portion (shoe lining 24 and collar 28; column 5, lines 4-9 teaches “cuff or collar support 28 which contains a separate cushioning material,” “various resilient materials, such as foams or neoprene, or layered assemblies containing thinner, slippery, high durability materials are typically contained within the collar 28” and “similar materials may be used beneath the shoe lining 24”) comprising closure flaps (as defined in the annotated copy of Figure 5 provided below; shown in Figure 5 to be drawn closed by shoelaces), the fabric portion (shoe lining 24 and collar 28) configured to receive a lower leg of the wearer through (as shown in Figure 5) the closable flaps (as defined in the annotated copy of Figure 5 provided below);
a rigid upright assembly (pair of braces 18, 20; taught in column 5, line 19 to be “relatively stiff brace members 18, 20”), wherein at least a portion of the rigid upright assembly (pair of braces 18, 20) is disposed within (columns 4-5, lines 67-2 teaches “the braces 18, 20 project from the shoe 22 at a stitched or hemmed opening 26 to a channelway formed in a cushioned, inner lining 24;” column 5, lines 42-47 teaches “A pair of slots 42, which are also present in the collars 29 and 31, are formed adjacent the bottom peripheral edges of the collar 28 to receive the upper ends of the braces 18,20. The slots 42 align with the respective apertures 74 in the shoe 22 to receive the braces, either in a temporary or semi-permanent mounting.”) the fabric portion (shoe lining 24 and collar 28);
at least one adjustable cuff assembly (relatively wide strap 37) configured to encircle the lower leg of the wearer above the ankle (as shown in Figure 5) over (as shown in Figure 5; column 5, lines 33-34 teaches “secured to the outer cover of the collar 28 is a relatively wide strap 37 which contains end fasteners 38, 40”) the fabric portion (shoe lining 24 and collar 28) and apply medial-lateral force to the lower leg of the wearer (tightening of the relatively wide strap 37 about the lower leg of the wearer generates a medial-lateral force applied thereto; column 5, lines 33-41 teaches that the relatively wide strap 37 establishes “mounting tension with normal use”), thereby, preventing a tibia and fibula of the wearer from separating (by providing a tightening force therearound; column 5, lines 33-41 teaches that the relatively wide strap 37 establishes “mounting tension with normal use”).
PNG
media_image1.png
853
551
media_image1.png
Greyscale
Johnson does not teach a first fastener coupled to a lateral side of the orthosis at a position inferior of the ankle joint of the wearer; and a first midfoot strap configured to wrap at least partly around the midfoot of the wearer over the fabric portion, the first midfoot strap comprising: a first end coupled to the same position on the lateral side of the orthosis as the first fastener, and a second end configured to couple to the first fastener; wherein, when properly secured around the lower leg of the wearer, the first midfoot strap extends from the first end: under the foot of the wearer, up a medial side of the midfoot of the wearer, over a top of the foot of the wearer distal of the ankle, through a slot or around a bar of the first fastener, and doubling back and securing to itself inferior of the ankle, thereby, providing adjustable support at the midfoot of the wearer; and wherein the second end of the first midfoot strap comprises at least one of hook and look fasteners and complementary snap fasteners.
However, Krahenbuhl teaches in Figures 1 and 2 a first fastener (ring 30, flap 31 and rivet 32) coupled to a lateral side of (as shown in Figures 1 and 2; column 3, lines 33-35 teaches “ring 30 may be but need not be pivotally fixed to the foot support outer surface, or lateral heel area”) the orthosis (ankle support 10) at a position inferior of the ankle joint of the wearer (as shown in Figures 1 and 2); and a first midfoot strap (strap 25; column 3, lines 18-21 teaches “the strap 25 is passed through a sleeve 26 that is secured to the outside of foot support 11 and is positioned to direct the strap 25 across the fifth metatarsal;” the fifth metatarsal is positioned in the middle portion of the foot) configured to wrap at least partly around the midfoot of the wearer over (as shown in Figures 1 and 2; column 3, lines 18-21 teaches “the strap 25 is passed through a sleeve 26 that is secured to the outside of foot support 11 and is positioned to direct the strap 25 across the fifth metatarsal;” the fifth metatarsal is positioned in the middle portion of the foot) the fabric portion (fabric shell foot support 11), the first midfoot strap (strap 25) comprising: a first end (as defined in the annotated copy of Figure 2 provided below) coupled to the same position (inasmuch as it is shown in Figure 2 to be positioned on the same lateral side of the ankle support 10) on the lateral side of the orthosis (ankle support 10) as the first fastener (ring 30, flap 31 and rivet 32), and a second end (free end 34) configured to couple to (as shown in Figure 2; column 3, lines 40-44 teaches “the flap 31 and ring 30 may be arranged to pivot about the rivet 32 to accommodate reception of the strap 25 end through ring 30;” column 3, lines 46-48 teaches “strap 25 is removably attached to the ring 30 by passing a free end 34 of that strap through the ring and turning or bending the strap end back upon itself”) the first fastener (as defined in the annotated copy of Figure 2 provided below); wherein, when properly secured around the lower leg of the wearer, the first midfoot strap (strap 25) extends from the first end (as defined in the annotated copy of Figure 2 provided below): under the foot of the wearer, up a medial side of the midfoot of the wearer, over a top of the foot of the wearer distal of the ankle (straps 25 is capable of being routed from the first end, under the foot of the wearer, up a medial side of the midfoot of the wearer and over a top of the foot of the wearer distal of the ankle), through (column 3, lines 40-44 teaches “the flap 31 and ring 30 may be arranged to pivot about the rivet 32 to accommodate reception of the strap 25 end through ring 30”) a slot (ring 30) or around a bar (ring 30; ring 30 is shown in Figure 2 to be formed from elongated bars) of the first fastener (ring 30, flap 31 and rivet 32), and doubling back and securing to itself (column 3, lines 46-48 teaches “strap 25 is removably attached to the ring 30 by passing a free end 34 of that strap through the ring and turning or bending the strap end back upon itself”) inferior of the ankle (as shown in Figures 1 and 2), thereby, providing adjustable support at the midfoot of the wearer (adjusting the tension applied by strap 25 to the user’s anatomy functions to adjust the support provided thereby); and wherein the second end (free end 34) of the first midfoot strap (strap 25) comprises at least one of hook and look fasteners (hook and loop fastener 35; as shown in Figures 1 and 2; column 3, lines 46-52 teaches “Strap 25 is removably attached to the ring 30 by passing a free end 34 of that strap through the ring and turning or bending the strap end back upon itself. A hook and loop fastener 35, such as that marketed under the trademark "VELCRO", is preferably used to secure the end of the strap to the strap surface, after that strap has been pulled tight.”) and complementary snap fasteners.
PNG
media_image2.png
408
425
media_image2.png
Greyscale
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the orthosis of Johnson to include a first fastener coupled to a lateral side of the orthosis at a position inferior of the ankle joint of the wearer; and a first midfoot strap configured to wrap at least partly around the midfoot of the wearer over the fabric portion, the first midfoot strap comprising: a first end coupled to the same position on the lateral side of the orthosis as the first fastener, and a second end configured to couple to the first fastener; wherein, when properly secured around the lower leg of the wearer, the first midfoot strap extends from the first end: under the foot of the wearer, up a medial side of the midfoot of the wearer, over a top of the foot of the wearer distal of the ankle, through a slot or around a bar of the first fastener, and doubling back and securing to itself inferior of the ankle, thereby, providing adjustable support at the midfoot of the wearer; and wherein the second end of the first midfoot strap comprises at least one of hook and look fasteners and complementary snap fasteners as taught by Krahenbuhl because this element is known to prevent ankle sprains by counteracting “rolling of the foot and subsequent downward pulling and stretching of the lateral ankle ligaments” by providing a “strap 25 that holds the ankle to the foot from the area of the fifth metatarsal bone and from the heel,” as Krahenbuhl teaches in columns 3-4, lines 56-6.
Regarding claim 2, Johnson and Krahenbuhl teach the apparatus of claim 1. Johnson teaches in Figure 5 that the fabric portion (shoe lining 24 and collar 28) comprises at least one of: a first portion having a desired amount of stretchability (the amount of desired stretch depends on the preference of each individual) and comprising the closure flaps (as defined in the annotated copy of Figure 5 provided above), which are disposed at an anterior of (as shown in Figure 5) the fabric portion (shoe lining 24 and collar 28), wherein securing the closure flaps (as defined in the annotated copy of Figure 5 provided above) around the lower leg of the wearer (as shown in Figure 5) forms a foot hole at the distal end of (hollow interior of the shoe lining 24 in which the user’s foot is shown in Figure 5 to be positioned) the fabric portion (shoe lining 24 and collar 28) and a lower leg hole (formed by the top end of shoe lining 24) at (as shown in Figure 4) the proximal end (top end) of the fabric portion shoe lining 24 and collar 28); a heel hole disposed in a posterior portion of the fabric portion, between the foot hole and the lower leg hole; a second portion, having a lower degree of stretchability than the first portion, disposed on medial and lateral sides of the fabric portion and configured to encase at least a portion of the upright assembly; and a posterior spine configured to be disposed along an Achilles tendon of the wearer and comprising a polypropylene webbing or seam tape.
Regarding claim 3, Johnson and Krahenbuhl teach the apparatus of claim 1. The originally relied upon embodiment of Johnson and Krahenbuhl do not teach that the rigid upright assembly comprises: an underfoot portion that bends to form lateral and medial lower uprights extending substantially perpendicular to the underfoot portion; a lateral upper upright having a proximal end pivotally coupled to a distal end of the lateral lower upright by a lateral joint; and a medial upper upright having a proximal end pivotally coupled to a distal end of the medial lower upright by a medial joint, the medal and lateral upper uprights each extending proximally to approximately half way between the ankle and the calf of the wearer when the orthosis is donned by the wearer.
However, Johnson teaches in Figure 9 an alternate embodiment wherein the rigid upright assembly (pair of two-piece, hinged braces 92, upper portions 94, lower portions 96 and sole 46; column 7, lines 39-41 teaches “the brace 92 is constructed of a polymer material, such as previously described, and provides upper and lower portions 94 and 96;” column 4, lines 43-44 teaches the polymer material exhibiting “shape retention and flexion resistant properties”) comprises: an underfoot portion (sole 46 and bent minor end 98; column 7, lines 43-44 teaches “a bent minor end 98 which is secured to the shoe”) that bends to form (column 7, lines 43-44 teaches “the lower portion 96 includes a bent minor end 98 which is secured to the shoe”) lateral and medial lower uprights (medial and lateral lower portions 96) extending substantially perpendicular to (as shown in Figure 9) the underfoot portion (sole 46 and bent minor end 98); a lateral upper upright (lateral upper portion 94) having a proximal end (bottom end) pivotally coupled to a distal end (top end) of the lateral lower upright (lateral lower portion 96) by (as shown in Figure 9; column 7, lines 45-47 teaches “a pivot fastener 100, otherwise, retains the portions 94 and 96 to one another”) a lateral joint (lateral pivot fastener 100); and a medial upper upright (medial upper portion 94) having a proximal end (bottom end) pivotally coupled to a distal end (top end) of the medial lower upright (medial lower portion 96) by (as shown in Figure 9; column 7, lines 45-47 teaches “a pivot fastener 100, otherwise, retains the portions 94 and 96 to one another”) a medial joint (medial pivot fastener 100), the medal and lateral upper uprights (medial and lateral upper portions 94) each extending proximally to approximately half way between the ankle and the calf of the wearer when the orthosis is donned by the wearer (the medial and lateral upper portions 94 are each capable of extending proximally to approximately half way between the ankle and the calf of the wearer when the orthosis is donned by the wearer, depending on the size of the wearer).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the originally relied upon embodiment of Johnson as modified by Krahenbuhl such that the rigid upright assembly comprises: an underfoot portion that bends to form lateral and medial lower uprights extending substantially perpendicular to the underfoot portion; a lateral upper upright having a proximal end pivotally coupled to a distal end of the lateral lower upright by a lateral joint; and a medial upper upright having a proximal end pivotally coupled to a distal end of the medial lower upright by a medial joint, the medal and lateral upper uprights each extending proximally to approximately half way between the ankle and the calf of the wearer when the orthosis is donned by the wearer as taught by the alternate embodiment of Johnson because this element is known to be a suitable alternate construction of the rigid upright assembly comprises, as Johnson teaches in the abstract.
Regarding claim 6, Johnson and Krahenbuhl teach the apparatus of claim 1. Johnson teaches in Figure 5 that each of the at least one adjustable cuff assembly (relatively wide strap 37) comprises: a posterior cuff portion (rearward portion of relatively wide strap 37) configured to be disposed against posterior portions of the lower leg of the user above the ankle (as shown in Figure 5); a first anterior cuff portion (medial end fastener 38) pivotally coupled to (inasmuch as the relatively wide strap 37 is understood to be flexible and therefore, all portions thereof are capable of pivoting relative to one another) a first end (medial end of rearward portion of relatively wide strap 37) of the posterior cuff portion (rearward portion of relatively wide strap 37); a second anterior cuff portion (portion of relatively wide strap 37 extending between the rearward portion of relatively wide strap 37 and lateral end fastener 40) slidingly (inasmuch as the relatively wide strap 37 is understood to be flexible and therefore, adjacent portions of the relatively wide strap 37 are capable of being slide of the surface of each other) coupled to (as shown in Figure 5) a second end (lateral end of rearward portion of relatively wide strap 37) of the posterior cuff portion (rearward portion of relatively wide strap 37); and a third anterior cuff portion (lateral end fastener 40) pivotally coupled to (inasmuch as the relatively wide strap 37 is understood to be flexible and therefore, all portions thereof are capable of pivoting relative to one another) the second anterior cuff portion (portion of relatively wide strap 37 extending between the rearward portion of relatively wide strap 37 and lateral end fastener 40), wherein the first (medial end fastener 38), second (portion of relatively wide strap 37 extending between the rearward portion of relatively wide strap 37 and lateral end fastener 40) and third (lateral end fastener 40) cuff portions are configured to be disposed against respective portions of a side or anterior of the lower leg of the user above the ankle (as shown in Figure 5).
Regarding claim 8, Johnson and Krahenbuhl teach the apparatus of claims 1 and 6. Johnson teaches in Figure 5 that the slot (slot 42) extends substantially parallel to a length of circumferential extension of posterior cuff portion (rearward portion of relatively wide strap 37) about the lower leg of the wearer (as shown in Figure 5).
Regarding claim 9, Johnson and Krahenbuhl teach the apparatus of claims 1 and 6. Johnson teaches in Figure 5 the slot (lateral slot 42) is disposed toward (Figure 5 teaches the lateral slot 42 being positioned in a direction that extends toward the proximal end of the second anterior cuff portion) an opposite end (proximal end of the second anterior cuff portion) of the second anterior cuff portion (portion of relatively wide strap 37 extending between the rearward portion of relatively wide strap 37 and lateral end fastener 40) from an end (distal end of the second anterior cuff portion) that is pivotally attached to (inasmuch as the relatively wide strap 37 is understood to be flexible and therefore, all portions thereof are capable of pivoting relative to one another) the third anterior cuff portion (lateral end fastener 40).
Regarding claim 22, Johnson teaches in Figure 5
providing (as shown in Figure 5; column 4, lines 22-26 teaches the device being “used with” collar 28) a fabric portion (shoe lining 24 and collar 28; column 5, lines 4-9 teaches “cuff or collar support 28 which contains a separate cushioning material,” “various resilient materials, such as foams or neoprene, or layered assemblies containing thinner, slippery, high durability materials are typically contained within the collar 28” and “similar materials may be used beneath the shoe lining 24”) comprising closure flaps (as defined in the annotated copy of Figure 5 provided above; shown in Figure 5 to be drawn closed by shoelaces), the fabric portion (shoe lining 24 and collar 28) configured to receive a lower leg of the wearer through (as shown in Figure 5) the closable flaps (as defined in the annotated copy of Figure 5 provided above);
sewing or otherwise encapsulating at least a portion of a rigid upright assembly (pair of braces 18, 20; taught in column 5, line 19 to be “relatively stiff brace members 18, 20”) into (columns 4-5, lines 67-2 teaches “the braces 18, 20 project from the shoe 22 at a stitched or hemmed opening 26 to a channelway formed in a cushioned, inner lining 24;” column 5, lines 42-47 teaches “A pair of slots 42, which are also present in the collars 29 and 31, are formed adjacent the bottom peripheral edges of the collar 28 to receive the upper ends of the braces 18,20. The slots 42 align with the respective apertures 74 in the shoe 22 to receive the braces, either in a temporary or semi-permanent mounting.”) the fabric portion (shoe lining 24 and collar 28);
providing and/or assembling (column 5, lines 33-34 teaches “secured to the outer cover of the collar 28 is a relatively wide strap 37”) at least a first adjustable cuff assembly (relatively wide strap 37) configured to encircle the lower leg of the wearer above the ankle (as shown in Figure 5) over (as shown in Figure 5; column 5, lines 33-34 teaches “secured to the outer cover of the collar 28 is a relatively wide strap 37 which contains end fasteners 38, 40”) the fabric portion (shoe lining 24 and collar 28) and apply medial-lateral force to the lower leg of the wearer (tightening of the relatively wide strap 37 about the lower leg of the wearer generates a medial-lateral force applied thereto; column 5, lines 33-41 teaches that the relatively wide strap 37 establishes “mounting tension with normal use”) to, thereby, prevent a tibia and fibula of the wearer from separating (by providing a tightening force therearound; column 5, lines 33-41 teaches that the relatively wide strap 37 establishes “mounting tension with normal use”).
Johnson does not teach coupling a first fastener to a lateral side of the orthosis at a position inferior of the ankle joint of the wearer; and coupling a first end of a first midfoot strap to the same position on the lateral side of the orthosis as the first fastener.
However, Krahenbuhl teaches in Figures 1 and 2 an analogous method that includes coupling (column 3, lines 33-35 teaches “ring 30 may be but need not be pivotally fixed to the foot support outer surface, or lateral heel area;” column 3, lines 36-38 teaches “a flap 31 that is passed through the ring and has its ends anchored at the heel area of the foot support 11;” column 3, lines 38-39 teaches “the ring is anchored by a rivet 32”) a first fastener (ring 30, flap 31 and rivet 32) to a lateral side of (as shown in Figures 1 and 2; column 3, lines 33-35 teaches “ring 30 may be but need not be pivotally fixed to the foot support outer surface, or lateral heel area”) the orthosis (ankle support 10) at a position inferior of the ankle joint of the wearer (as shown in Figures 1 and 2; column 3, lines 33-35 teaches “ring 30 may be but need not be pivotally fixed to the foot support outer surface, or lateral heel area;” column 3, lines 36-38 teaches “a flap 31 that is passed through the ring and has its ends anchored at the heel area of the foot support 11”); and coupling (column 3, lines 18-21 teaches “a non-stretchable strap 25 is included that has one end attached to the outside surface of the foot support 11 in the area that fits over the fifth metatarsal bone of the user”) a first end (as defined in the annotated copy of Figure 2 provided above) of a first midfoot strap (strap 25; column 3, lines 18-21 teaches “the strap 25 is passed through a sleeve 26 that is secured to the outside of foot support 11 and is positioned to direct the strap 25 across the fifth metatarsal;” the fifth metatarsal is positioned in the middle portion of the foot) to the same position on the lateral side of (inasmuch as it is shown in Figure 2 to be positioned on the same lateral side of the ankle support 10) the orthosis (ankle support 10) as the first fastener (ring 30, flap 31 and rivet 32).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the method of Johnson to include coupling a first fastener to a lateral side of the orthosis at a position inferior of the ankle joint of the wearer; and coupling a first end of a first midfoot strap to the same position on the lateral side of the orthosis as the first fastener as taught by Krahenbuhl because this element is known to prevent ankle sprains by counteracting “rolling of the foot and subsequent downward pulling and stretching of the lateral ankle ligaments” by providing a “strap 25 that holds the ankle to the foot from the area of the fifth metatarsal bone and from the heel,” as Krahenbuhl teaches in columns 3-4, lines 56-6.
Claim(s) 10 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 5,226,875 A), in view of Krahenbuhl (US 5,016,623 A) and further in view of Verkade (US 2006/0084899 A1).
Regarding claim 10, Johnson and Krahenbuhl teach the apparatus of claims 1 and 6. Johnson and Krahenbuhl do not teach that at least one surface of the first anterior cuff portion comprises a plurality of ratcheting teeth configured to be received by a complementary locking feature.
However, Verkade teaches in Figures 1 and 2, [0035] and [0039] an analogous device wherein at least one surface of the first anterior cuff portion (lateral strap 141) comprises a plurality of ratcheting teeth (ridges 712) configured to be received by ([0039] teaches “ratcheted adjustment of the medial strap 140 with respect to the lateral strap 141 is provided by the engagement between a slot 710 disposed on the medial strap 140 and a plurality of ridges 712 disposed on the lateral strap 141”) a complementary locking feature (window 710; [0035] teaches “the interlocking nature of the strap” with the window 710).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the first anterior cuff portion of Johnson as modified by Krahenbuhl to provide that at least one surface of the first anterior cuff portion comprises a plurality of ratcheting teeth configured to be received by a complementary locking feature as taught by Verkade because this element is known in the art to be an alternative cuff adjustment mechanism for adjustably “maintaining the position of the two straps relative to each other” that “advantageously” “allows a wearer to repeatedly and reliably adjust the straps to a desired size of the ankle brace,” as Verkade teaches in [0035] and [0039].
Regarding claim 11, Johnson and Krahenbuhl teach the apparatus of claims 1 and 6. Johnson and Krahenbuhl do not teach that the third anterior cuff portion comprises an aperture configured to receive at least a terminal end of the first anterior cuff therethrough.
However, Verkade teaches in Figures 1 and 2 an analogous device wherein the third anterior cuff portion (medial strap 140) comprises ([0035] teaches “a window 710 in the medial strap 140”) an aperture (window 710) configured to receive at least a terminal end of the first anterior cuff (lateral strap 141) therethrough (as shown in Figure 1; [0035] teaches “the lateral strap 141 preferably extends through a window 710 in the medial strap 140”).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the third anterior cuff portion of Johnson as modified by Krahenbuhl to comprise an aperture configured to receive at least a terminal end of the first anterior cuff therethrough as taught by Verkade because this element is known in the art to be an alternative cuff adjustment mechanism for adjustably “maintaining the position of the two straps relative to each other” that “advantageously” “allows a wearer to repeatedly and reliably adjust the straps to a desired size of the ankle brace,” as Verkade teaches in [0035] and [0039].
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 5,226,875 A), in view of Krahenbuhl (US 5,016,623 A) and further in view of Johnson (US 5,865,778 A).
Regarding claim 12, Johnson (US 5,226,875 A) and Krahenbuhl teach the apparatus of claims 1 and 6. Johnson (US 5,226,875 A) and Krahenbuhl do not teach that the at least one adjustable cuff assembly comprises: a first adjustable cuff assembly configured to be disposed adjacent a proximal edge of the fabric portion and proximal of the ankle of the wearer; and a second adjustable cuff assembly configured to be disposed proximal of the ankle of the wearer and distal of the first adjustable cuff assembly.
However, Johnson (US 5,865,778 A) teaches in Figures 1 and 2 an analogous device wherein the at least one adjustable cuff assembly (straps 44, 46, buckles 52 and cushions 55) comprises: a first adjustable cuff assembly (strap 44, associated buckle 52 and associated cushion 55; column 5, lines 56-59 teaches “the straps 44, 46 presently include lengths of hook and loop fastener material 56 and 58 (i.e. VELCRO) which are mounted to overlap one another to secure the brace 2 to the leg;” Velcro® provides for adjustment of the length of the strap 44) configured to be disposed adjacent (as shown in Figures 1 and 2) a proximal edge (top edge) of the fabric portion (polyethylene cuff 40, calf cushion 42) and proximal (near; inasmuch as all parts of the device are positioned on the lower leg in use and therefore, can be considered to be positioned near the ankle) of the ankle of the wearer (as shown in Figures 1 and 2); and a second adjustable cuff assembly (strap 46, associated buckle 52 and associated cushion 55; column 5, lines 56-59 teaches “the straps 44, 46 presently include lengths of hook and loop fastener material 56 and 58 (i.e. VELCRO) which are mounted to overlap one another to secure the brace 2 to the leg;” Velcro® provides for adjustment of the length of the strap 46) configured to be disposed proximal (near; inasmuch as all parts of the device are positioned on the lower leg in use and therefore, can be considered to be positioned near the ankle) of the ankle of the wearer (as shown in Figures 1 and 2) and distal of (lower than, as show in Figure 1) the first adjustable cuff assembly (strap 44, associated buckle 52 and associated cushion 55).
It would have been obvious to one having ordinary skill in the art before the effective filing of the present application to modify the at least one adjustable cuff assembly of Johnson (US 5,226,875 A) as modified by Krahenbuhl to comprise: a first adjustable cuff assembly configured to be disposed adjacent a proximal edge of the fabric portion and proximal of the ankle of the wearer; and a second adjustable cuff assembly configured to be disposed proximal of the ankle of the wearer and distal of the first adjustable cuff assembly as taught by Johnson (US 5,865,778 A) because this element is known to provide an additional assembly to more securely “retain the brace 80 to the leg,” as Johnson (US 5,865,778 A) teaches in column 6, lines 54-55.
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten to overcome the claim objection(s), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Regarding claim 7, the prior art does not teach an orthosis wherein the posterior cuff portion comprises a post and the second anterior cuff portion comprises a slot configured to slidingly receive the post, in combination with other element(s) of the claim(s).
Claim 17 would be allowable if rewritten to overcome the claim objection(s) and the rejection(s) under 5 U.S.C. 101 and section 33(a) of the America Invents Act, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. Regarding claim 17, the prior art does not teach a second fastener coupled to a medial side of the orthosis at a position inferior of the ankle joint of the wearer; and a second midfoot strap configured to wrap at least partly around the midfoot of the wearer over the fabric portion, the second midfoot strap comprising: a first end coupled to the same position on the medial side of the orthosis as the second fastener, and a second end configured to couple to the second fastener, in combination with the other element(s) of the claim(s).
Claim 18 depends on claim 17 and therefore, would also be allowable if rewritten to overcome the claim objection(s) set forth in this Office action.
Claim 19 depends on claim 17 and therefore, would also be allowable if rewritten to overcome the claim objection(s) and the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph set forth in this Office action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Montag et al. (US 5,472,411 A)
INGIMUNDARSON et al. (US 2013/0184628 A1)
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VICTORIA HICKS FISHER/Primary Examiner, Art Unit 3786 9/29/2026
