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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/29/2026 has been entered.
Response to Amendment
Applicant’s amendments of claims 33, 53, and 62 are acknowledged by the Examiner.
Applicant’s addition of new claims 72-77 are acknowledged by the Examiner.
Currently claims 33, 35-37, 42-53 and 55-77 are pending in the application.
Response to Arguments
Applicant's arguments filed 01/29/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments with respect to the cited references fail to disclose of suggest applying a tightening force by tightening at least one elongate member of the binding that extends superior to the malleoli bones between a lower portion of the calf member and a portion of the anterior member that is above the foot of the patient. Examiner respectfully disagrees. Chella teaches tensioning (tensioning force applied by 50) at least one elongate member (60) that extends superior to the malleoli bones (See figure 4) between a lower portion of the calf member (14) and a portion of the anterior member (16) that is above the foot of the patient (see figure 5). Thus, the combination of Keith-Lucas and Chella discloses this limitation as will be addressed below.
In response to Applicant’s arguments that a rotary lacing system does not include an elongate member that extends superior to the malleoli bones between a lower portion of the calf member and a portion of the anterior member that is above the foot of the patient. Examiner respectfully disagrees. Lace (60) of Chella is an elongate member, and extends as claimed (see figure 5). Thus, the combination of Keith-Lucas and Chella discloses this limitation as will be addressed below.
In response to Applicant’s arguments regarding “relative to a heel portion of the binding”. Examiner respectfully disagrees. Examiner first asserts that Applicant’s specification at (pg 22 ln 20-22), (pg 25 ln 25-pg 26 ln 6), and (pg 37 ln 3-5) each establish that the binding is specifically designed without a heel portion of the binding, and thus, the methods steps of drawing the collar/lower portion anteriorly with respect to a heel portion of the binding are considered new matter and will be addressed below as such. Nonetheless, Chella teaches that the tightening device draws the anterior portion towards the lower portion of the calf member (see [0041]. Based on Newton’s third law, which is known to one of ordinary skill in the art, every action there is an equal and opposite reaction. When two objects interact, they exert forces of equal magnitude in opposite directions. Therefore, when the tightening device exerts a drawing force to pull the anterior portion towards the lower portion of the calf member, the lower portion of the calf member exerts an equal and opposite drawing force toward the anterior portion. Thus, the combination of Keith-Lucas in view of Chella does in fact, disclose drawing the collar anteriorly. With respect to the limitation “relative to a heel portion”, Keith-Lucas discloses a heel portion of the binding (108), which is not directly connected to the lower portion of the calf member, and thus, when the lower portion of the calf member is drawn anteriorly as discussed above, it is with respect to the heel portion which engages a user’s heel as the heel is pulled into the opening under the collar as will be further discussed below.
Thus, Applicant’s arguments are non-persuasive and the rejections are maintained and updated below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the heel portion of the binding as recited in claims 33, 53, and 62 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the specification does not provide proper antecedent basis for the claimed subject matter of “a heel portion of the binding” as recited in claims 33, 53, and 62 and thus, does not provide antecedent basis for the specific step of “drawing a collar of the lower portion of the calf member anteriorly relative to a heel portion of the binding” recited in claim 33, “draws a collar of the lower portion of the calf member anteriorly relative to a heel portion of the binding” recited in claim 53, and “draws a collar of the lower portion of the calf member anteriorly relative to a heel portion of the binding” recited in claim 62.
Applicant should not amend the specification to provide antecedent support for these limitations, as the structure of “a heel portion of the binding” was not recited in the originally filed specification, or in the parent applications from which this application claims benefit. Thus, any amendment of the specification to provide support for the heel portion of the binding will be considered new matter.
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.
Claims 33, 35-37, 42-46, 53 and 55-77 are 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 33 recites the limitation “the tightening force drawing a collar of the lower portion of the calf member anteriorly relative to a heel portion of the binding”.
Claim 53 recites the limitation “wherein tightening the first portion of the binding draws a collar of the lower portion of the calf member anteriorly relative to a heel portion of the binding”.
Claim 62 recites the limitation “the lower portion of the calf member anteriorly relative to a heel portion of the binding”.
Each of the above limitations recites a drawing of the calf portion anteriorly with respect to a heel portion of the binding. Applicant’s originally filed disclosure does not provide support for the structure of “a heel portion of the binding”. Applicant’s originally filed specification contrarily states:
- “bottom portion 170 of calf shell 120 projects towards the Achilles tendon of the patient, but stops short of the heel of the patient” (pg 22 ln 20-22)
-“Plantar shell 115 and calf shell 120 are spaced apart from one another in the region of the heel of the patient. In addition, curved portion 145 of long, narrow spine 105 is spaced away from the heel of the Patient. Thus, binding 35 is open in the region of the heel of the patient, and does not cover the heel of the patient or otherwise engage the heel of the patient” (pg 25 ln 25-pg 26 ln 6).
-“no portion of binding 35 covers or engages the heel of the patient” (pg 37 ln 3-5)
Each of which establish that the binding is specifically designed without a heel portion of the binding, and thus, the methods steps of drawing the collar/lower portion anteriorly with respect to a heel portion of the binding are considered new matter.
Claims 35-37, 42-46, 55-61, and 63-77 are rejected under 35 U.S.C. 112(a) as being dependent on a rejected claim, and thus, contain the same offending limitaitons.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 33, 35-37, 42-46, 53 and 55-77 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.
Claims 33, 53, and 62 each recites the structure “a heel portion of the binding”. This limitation renders the claims indefinite because it is unclear in view of the specification (which as discussed above, teach away from any such heel portion of the binding), and in view of the figures what structure of the binding applicant considers to be “a heel portion of the binding”. For the purpose of examination, Examiner will interpret this limitation as best understood.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 33, 35-37, 42-46, and 53-77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keith-Lucas et al. (US 2012/0305006 A1) (hereinafter Keith) in view of Chella et al. (US 2011/0197362 A1) (hereinafter Chella).
In regards to claim 33, Keith discloses A method for distracting a hip joint (see [0028] and [0048]; see figure 9), the method comprising:
positioning a lower leg and foot of a patient in a binding (10; see [0028]; see figure 1) such that a calf member (12; see [0028]; see figure 2) of the binding (12) is positioned along a calf side of the lower leg of the patient (see figure 6) and an anterior member (96; see [0046]; see figure 5) of the binding (10) is positioned along an anterior side of the lower leg of the patient (see figure 5);
applying a tightening force (52T and similar forces applied by 72 and 92; see [0030]; see figure 6)) around the lower leg at a tightening location (location of 52T) such that movement of the binding (10) is restricted by inability of the malleoli bones to slip past the tightening location (location of 52t) due to a size of the malleoli bones (see [0030] and figure 6 that 52t secures a user’s foot within the binding and thus, due to the size of the user’s foot, and the securement of the straps which clamps 101 down onto the patient’s malleoli bones, prevents movement of the binding due to the securement to the size of the patient’s foot (and therefore the size of the malleoli bones)) and a heel portion (108; see [0034]; see figure 2) of the binding (10);
a lower portion (26; see [0029]; see figure 2) of the calf member (12) comprising a collar (as indicated in annotated figure 2 above) against an Achilles tendon of the patient (see [0034] that 108 is positioned on a user’s heel; see figure 2 that the indicated collar is located above 108 and therefore is positioned on a user’s Achilles tendon);
applying a distracting force (see [0028] in reference to a caregiver distracting a patient’s hip) to the binding (10).
Keith does not disclose the tightening force is applied around a portion of the lower leg that is above the foot of the patient, the tightening force being applied at a tightening location is directly superior and adjacent to malleoli bones of the patient, wherein the tightening force is applied by tensioning at least one elongate member of the binding that extends superior to the malleoli bones between the lower portion of the calf member to a portion of the anterior member that is above the foot of the patient, the tightening force drawing the collar of the lower portion of the calf member anteriorly relative to the heel portion of the binding, such that the collar is drawn against an Achilles tendon of the patient superior to the calcaneus bone of the patient, and forcing the portion of the anterior member against the anterior side of the lower leg above the foot of the patient.
However, Chella teaches an analogous method for distracting a hip joint (see [abstract]) comprising a binding (12; see [0029]; see figure 1) comprising a calf member (18; see [0030]; see figure 1) and an analogous anterior member (16; see [0030]; see figure 1) and tightener (50; see [0032]; see figure 1); wherein the tightening force (force applied by 50) is applied around a portion of the lower leg that is above the foot of the patient (see figure 1), the tightening force (force applied by 50) being applied at a tightening location is directly superior and adjacent to malleoli bones of the patient (see figure 5 that the tightening force is applied at a location which is directly superior and adjacent to malleoli bones of the patient), wherein the tightening force is applied by tensioning at least one elongate member (60; see [0033]; see figure 2) of the binding (12) that extends superior to the malleoli bones (see figure 2 that 60 extends above a user’s foot and thus, superior to the malleoli bones) between the lower portion of the calf member (18) to a portion of the anterior member (16) that is above the foot of the patient (see figure 5) forcing the lower portion of the calf member against the calf side of the lower leg of the patient superior to the calcaneus bone of the patient (see figure 5 that the upper line of 60 which enters into 50 is superior to the calcaneus bone, therefore the tightening force applied by 50 forces the lower portion of the calf member against the user as claimed), and forcing the portion of the anterior member (16) against the anterior side of the lower leg above the foot of the patient (see figure 5) for the purpose of rigidly hold the lower portion of the leg and the foot within the surgical boot (see [0031]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anterior member and the tightener as disclosed by Keith and to have formed the anterior member in the design and shape as taught by Chella’s anterior member, and to have substituted the tightener of Keith for the tightener of Chella which includes at least one elongate member and applies the tightening force as discussed above for the purpose of providing an improved method for distracting a hip joint which would add the benefit of rigidly hold the lower portion of the leg and the foot within the surgical boot (see [0031]). Furthermore a change in shape of the anterior member as disclosed by Keith to be the design and shape as taught by Chella would add the benefit of providing an increased surface area in which the anterior member engages the user’s lower leg thereby increasing the securement capability of the anterior member.
Thus, as now combined, the tightening mechanism of Chella included into the device of Keith-Lucas discloses “the tightening force (tightening force applied by 50 via 60 of Chella) drawing the collar (collar of Keith) of the lower portion of the calf member (26 of 12 of Keith) anteriorly relative to the heel portion of the binding (108 of 10 of Keith), such that the collar (collar of Keith) is drawn against an Achilles tendon of the patient” (the collar of Keith is positioned against an Achilles tendon of the patient (see Keith figure 6); the tightening mechanism of Chella exerts a posterior drawing force which draws the anterior member towards the lower portion of the calf member, and thus, based on Newton’s third law, the lower portion of the calf member exerts an equal and opposite anterior drawing force which draws the lower portion of the calf member anteriorly, towards the anterior member, and when utilized in the binding of Keith, draws the collar anteriorly into the engagement with the user’s Achilles tendon as seen in figure 6 of Keith; the heel portion 108 of Keith is intended to engage a posterior aspect of a user’s foot, and is not directly connected to the lower portion of the binding (see Keith-Lucas figure 6) thus, when the lower portion of the binding is drawn anteriorly, the user’s heel (and therefore the heel portion) moves posteriorly into the opening of the binding (see Keith-Lucas figure 2); thus, the combination of Keith as now modified by Chella draws the collar of the binding anteriorly with respect to the heel portion of the binding which is moving posteriorly).
In regards to claim 35, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the binding (10) further comprises a plantar member (25; see [0029]; see figure 1) configured to extend under the foot of the patient (see figure 5).
In regards to claim 36, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the plantar member (25) is connected to the calf member (12; see figure 2).
In regards to claim 37, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the lower portion (26) comprises a cantilever (see figure 2 and 9 that 10 is intended to be coupled to a coupler at 15 (see [0028]), this connection to 15 of and nowhere else, creates a cantilever formed by 12 (and therefore 26) wherein 12 is supported at its lowest portion, but is unsupported along 12).
In regards to claim 42, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein when the distracting force (force applied by caregiver; see [0028]) is applied to the binding (10), the lower portion (26) of the calf member (12) inhibits the relative motion between the calcaneus bone of the patient and the binding (10; see [0034]).
In regards to claim 43, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella further discloses wherein the tightening force (tightening force applied by 50 of Chella substituted into the device of Keith) is configured to apply a clamping force between the anterior member (16 of Chella) and the calf member (12 of Keith; see Chella figure 5 that the clamping force applied by 50 of Chella is between the claimed structures) whereby to grip the lower leg of the patient above the malleoli bones (see figure 5 of Chella that the tightening force is above the malleoli bones and thus would grip the lower leg of the patient above the malleoli bones as claimed).
In regards to claim 44, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses further comprising covering at least a portion of the lower leg with a soft wrap (48; see [0041]; see figure 5 that 48 is covering at least a portion of the user’s lower leg).
In regards to claim 45, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the soft wrap (48) covers the lower leg of the patient superior to the malleoli bones (see figure 5 that 48 engages the user’s calf and thereby covers the posterior portion of the user’s leg superior to the malleoli (ankle) bones).
In regards to claim 46, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella further discloses wherein the tightening force ((tightening force applied by 50 of Chella substituted into the device of Keith) is configured to apply a clamping force onto the soft wrap (48; 52t applies a clamping force on 48 by securing the user’s leg within the device (see [0053]); thus, the tightening force applied by 50 of Chella which has been included into the device of Keith would still apply the same clamping force onto 48).
In regards to claim 53, Keith discloses A method for distracting a hip joint (see [0028] and [0048]; see figure 9), the method comprising:
positioning a lower leg and foot of a patient in a binding (10; see [0028]; see figure 1) such that a calf member (12; see [0028]; see figure 2) of the binding (10) is positioned along a calf side of the lower leg of the patient, and an anterior member (96; see [0046]; see figure 5) of the binding (10) is positioned along an anterior side of the lower leg of the patient (see figure 5);
tightening a first portion (55/57; see [0031], see figure 5)) around a portion of the lower leg, above the foot of the patient (see figure 5 that 55/57 is around the lower leg, above the foot of the patient);
a lower portion (26; see [0029]; see figure 2) of the calf member (12) comprising a collar (as indicated in annotated figure 2 above) against an Achilles tendon of the patient (see [0034] that 108 is positioned on a user’s heel; see figure 2 that the indicated collar is located above 108 and therefore is positioned on a user’s Achilles tendon) and a heel portion (108; see [0034]; see figure 2) of the binding (10);
applying a distracting force (see [0028] in reference to a caregiver distracting a patient’s hip) to the binding (10).
Keith does not disclose tightening the first portion of the binding by tensioning at least one elongate member of the binding that extends from the lower portion of the calf member around the lower leg directly superior and adjacent to malleoli bones of the patient to a portion of the anterior member that is above the foot of the patient, such that movement of the binding is restricted by inability of the malleoli bones to slip past the first portion of the binding due to a size of the malleoli bones, wherein tightening of the first portion of the binding draws the collar of the lower portion of the calf member anteriorly relative to a heel portion of the binding, such that the collar is drawn against an Achilles tendon of the patient superior to the calcaneus bone of the patient, and forces the portion of the anterior member that is above the foot of the patient against the anterior side of the lower leg above the foot of the patient.
However, Chella teaches an analogous method for distracting a hip joint (see [abstract]) comprising a binding (12; see [0029]; see figure 1) comprising a calf member (18; see [0030]; see figure 1) and an analogous anterior member (16; see [0030]; see figure 1) and first portion (50; see [0032]; see figure 1); tightening the first portion (50) of the binding (12) by tensioning at least one elongate member (60; see [0033]; see figure 2) that extends from a lower portion of the calf member (18) around the lower leg directly superior and adjacent to malleoli bones of the patient (see figure 5 that 60 of 50 extends from the lower portion of 18 around the lower leg directly superior and adjacent to malleoli bones of the patient) to a portion of the anterior member (16) that is above the foot of the patient (see figure 1) such that movement of the binding (12) is restricted by inability of the malleoli bones to slip past the first portion (50) of the binding (12) due to a size of the malleoli bones (50 applies a tightening force which tightens 16 onto 18 and therefore prevents the movement of the binding due to a size of the user’s foot and lower leg including the malleoli bones), wherein tightening of the first portion (50) of the binding (12) forces the lower portion of the calf member (18) against the calf side of the lower leg of the patient superior to the calcaneus bone of the patient (see figure 5 that the upper line of 60 which enters into 50 is superior to the calcaneus bone, therefore the tightening force applied by 50 forces the lower portion of the calf member against the user as claimed), and forces the portion of the anterior member (16) against the anterior side of the lower leg above the foot of the patient (see figure 5) for the purpose of rigidly hold the lower portion of the leg and the foot within the surgical boot (see [0031]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anterior member and the tightener as disclosed by Keith and to have formed the anterior member in the design and shape as taught by Chella’s anterior member, and to have substituted the tightener of Keith for the tightener of Chella which includes at least one elongate member and applies the tightening force as discussed above for the purpose of providing an improved method for distracting a hip joint which would add the benefit of rigidly hold the lower portion of the leg and the foot within the surgical boot (see [0031]). Furthermore a change in shape of the anterior member as disclosed by Keith to be the design and shape as taught by Chella would add the benefit of providing an increased surface area in which the anterior member engages the user’s lower leg thereby increasing the securement capability of the anterior member.
Thus, as now combined, the tightening mechanism of Chella included into the device of Keith-Lucas discloses “the tightening force (tightening force applied by 50 via 60 of Chella) draws the collar (collar of Keith) of the lower portion of the calf member (26 of 12 of Keith) anteriorly relative to the heel portion of the binding (108 of 10 of Keith), such that the collar (collar of Keith) is drawn against an Achilles tendon of the patient” (the collar of Keith is positioned against an Achilles tendon of the patient (see Keith figure 6); the tightening mechanism of Chella exerts a posterior drawing force which draws the anterior member towards the lower portion of the calf member, and thus, based on Newton’s third law, the lower portion of the calf member exerts an equal and opposite anterior drawing force which draws the lower portion of the calf member anteriorly towards the anterior member, and when utilized in the binding of Keith, draws the collar anteriorly into the engagement with the user’s Achilles tendon as seen in figure 6 of Keith; the heel portion 108 of Keith is intended to engage a posterior aspect of a user’s foot, and is not directly connected to the lower portion of the binding (see Keith-Lucas figure 6) thus, when the lower portion of the binding is drawn anteriorly, the user’s heel (and therefore the heel portion) moves posteriorly into the opening of the binding (see Keith-Lucas figure 2); thus, the combination of Keith as now modified by Chella draws the collar of the binding anteriorly with respect to the heel portion of the binding which is moving posteriorly).
In regards to claim 55, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella further discloses wherein the tightening the first portion (50 of Chella) of the binding (10 of Keith) is configured to apply a clamping force between the anterior member (16 of Chella) and the calf member (12 of Keith; see Chella figure 5 that the clamping force applied by 50 of Chella is between the claimed structures) whereby to grip the lower leg of the patient above the malleoli bones (see figure 5 of Chella that the tightening force is above the malleoli bones and thus would grip the lower leg of the patient above the malleoli bones as claimed).
In regards to claim 56, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein when the distraction force (force applied by caregiver; see [0028]) is applied to the binding (10), the lower portion (26) of the calf member (12) inhibits the relative motion between the calcaneus bone of the patient and the binding (10; see [0034]).
In regards to claim 57, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses further comprising covering at least a portion of the lower leg with a soft wrap (48; see [0041]; see figure 5 that 48 is covering at least a portion of the user’s lower leg).
In regards to claim 58, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the soft wrap (48) covers the lower leg of the patient superior to the malleoli bones (see figure 5 that 48 engages the user’s calf and thereby covers the posterior portion of the user’s leg superior to the malleoli (ankle) bones).
In regards to claim 59, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella further discloses wherein tightening the first portion (50 of Chella) of the binding (10 of Keith) is configured to apply a clamping force onto the soft wrap (48; 52t applies a clamping force on 48 by securing the user’s leg within the device (see [0053]); thus, the tightening force applied by 50 of Chella which has been included into the device of Keith would still apply the same clamping force onto 48).
In regards to claim 60, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the calf member (12) comprises an upper portion (24; see [0028]; see figure 2) and the lower portion (26) that is movable relative to the upper portion (24; 12 (and therefore 24 and 26) are formed from a monolithic plastics material with a thickness of .2 inches, and thus 12 is considered to be flexible due to the material and thickness, thus 26 is considered movable by this flexibility with respect to 24).
In regards to claim 61, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the calf member (12) comprises an upper portion (24; see [0028]; see figure 2) and the lower portion (26) that is movable relative to the upper portion (24; 12 (and therefore 24 and 26) are formed from a monolithic plastics material with a thickness of .2 inches, and thus 12 is considered to be flexible due to the material and thickness, thus 26 is considered movable by this flexibility with respect to 24).
In regards to claim 62, Keith discloses A method for distracting a hip joint (see [0028] and [0048]; see figure 9), the method comprising:
positioning a lower leg and foot of a patient in a binding (10; see [0028]; see figure 1) such that a calf member (12; see [0028]; see figure 2) of the binding (10) is positioned along a calf side of the lower leg of the patient, and an anterior member (96; see [0046]; see figure 5) of the binding (10) is positioned along an anterior side of the lower leg of the patient (see figure 5);
applying a tightening force (52t; see [0030], see figure 6) around the lower leg, above the foot of the patient (see figure 5 that 55/57 is around the lower leg, above the foot of the patient);
a lower portion (26; see [0029]; see figure 2) of the calf member (12) comprising a collar (as indicated in annotated figure 2 above) against an Achilles tendon of the patient (see [0034] that 108 is positioned on a user’s heel; see figure 2 that the indicated collar is located above 108 and therefore is positioned on a user’s Achilles tendon) and a heel portion (108; see [0034]; see figure 2) of the binding (10);
applying a distracting force (see [0028] in reference to a caregiver distracting a patient’s hip) to the binding (10).
Keith does not disclose applying the tightening force around a portion of the lower leg that is above the foot of the patient, wherein the tightening force is applied by tensioning at least one elongate member of the binding that is directly superior and adjacent to malleoli bones of the patient and extends from a lower portion of the calf member diagonally around the lower leg to a portion of the anterior member that is above the foot of the patient proximal to the lower portion of the calf member, wherein applying the tightening force draws the collar of the lower portion of the calf member anteriorly relative to the heel portion of the binding, such that the collar is drawn against an Achilles tendon of the patient, superior to the calcaneus bone of the patient, and forces the portion of the anterior member against the anterior side of the lower leg above the foot of the patient.
However, Chella teaches an analogous method for distracting a hip joint (see [abstract]) comprising a binding (12; see [0029]; see figure 1) comprising a calf member (18; see [0030]; see figure 1) and an analogous anterior member (16; see [0030]; see figure 1) and first portion (50; see [0032]; see figure 1); applying the tightening force (force applied by 50) around a portion of the lower leg that is above the foot of the patient (see figure 5), wherein the tightening force (force applied by 50) is applied by tensioning at least one elongate member (60; see [0033]; see figure 2) of the binding (12) that is directly superior and adjacent to malleoli bones of the patient (see figure 2 that 60 is directly superior and adjacent to malleoli bones of the patient) and extends from a lower portion of the calf member (18) diagonally around the lower leg to a portion of the anterior member (16) that is above the foot of the patient proximal to the lower portion of the calf member (18; see figure 5 that the tightening force applied by 50 and 60 together is applied diagonally as claimed), wherein applying the tightening force (force applied by 50) forces the lower portion of the calf member (18) against the calf side of the lower leg of the patient, superior to the calcaneus bone of the patient (see figure 5 that the upper line of 60 which enters into 50 is superior to the calcaneus bone, therefore the tightening force applied by 50 forces the lower portion of the calf member against the user as claimed), and forces the portion of the anterior member (16) against the anterior side of the portion of the lower leg that is above the foot of the patient (see figure 5) for the purpose of rigidly hold the lower portion of the leg and the foot within the surgical boot (see [0031]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the anterior member and the tightener as disclosed by Keith and to have formed the anterior member in the design and shape as taught by Chella’s anterior member, and to have substituted the tightener of Keith for the tightener of Chella which includes at least one elongate member and applies the tightening force as discussed above for the purpose of providing an improved method for distracting a hip joint which would add the benefit of rigidly hold the lower portion of the leg and the foot within the surgical boot (see [0031]). Furthermore a change in shape of the anterior member as disclosed by Keith to be the design and shape as taught by Chella would add the benefit of providing an increased surface area in which the anterior member engages the user’s lower leg thereby increasing the securement capability of the anterior member.
Thus, as now combined, the tightening mechanism of Chella included into the device of Keith-Lucas discloses “the tightening force (tightening force applied by 50 via 60 of Chella) draws the collar (collar of Keith) of the lower portion of the calf member (26 of 12 of Keith) anteriorly relative to the heel portion of the binding (108 of 10 of Keith), such that the collar (collar of Keith) is drawn against an Achilles tendon of the patient” (the collar of Keith is positioned against an Achilles tendon of the patient (see Keith figure 6); the tightening mechanism of Chella exerts a posterior drawing force which draws the anterior member towards the lower portion of the calf member, and thus, based on Newton’s third law, the lower portion of the calf member exerts an equal and opposite anterior drawing force which draws the lower portion of the calf member anteriorly towards the anterior member, and when utilized in the binding of Keith, draws the collar anteriorly into the engagement with the user’s Achilles tendon as seen in figure 6 of Keith; the heel portion 108 of Keith is intended to engage a posterior aspect of a user’s foot, and is not directly connected to the lower portion of the binding (see Keith-Lucas figure 6) thus, when the lower portion of the binding is drawn anteriorly, the user’s heel (and therefore the heel portion) moves posteriorly into the opening of the binding (see Keith-Lucas figure 2); thus, the combination of Keith as now modified by Chella draws the collar of the binding anteriorly with respect to the heel portion of the binding which is moving posteriorly).
In regards to claim 63, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the binding (10) further comprises a plantar member (25; see [0029]; see figure 1) configured to extend under the foot of the patient (see figure 5).
In regards to claim 64, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the plantar member (25) is connected to the calf member (12; see figure 2).
In regards to claim 65, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the lower portion (26) comprises a cantilever (see figure 2 and 9 that 10 is intended to be coupled to a coupler at 15 (see [0028]), this connection to 15 of and nowhere else, creates a cantilever formed by 12 (and therefore 26) wherein 12 is supported at its lowest portion, but is unsupported along 12).
In regards to claim 66, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein when the distracting force (force applied by caregiver; see [0028]) is applied to the binding (10), the lower portion (26) of the calf member (12) inhibits the relative motion between the calcaneus bone of the patient and the binding (10; see [0034]).
In regards to claim 67, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella further discloses wherein the tightening force (tightening force applied by 50 of Chella substituted into the device of Keith) applies a clamping force between the anterior member (16 of Chella) and the calf member (12 of Keith; see Chella figure 5 that the clamping force applied by 50 of Chella is between the claimed structures) whereby to grip the lower leg of the patient above the malleoli bones (see figure 5 of Chella that the tightening force is above the malleoli bones and thus would grip the lower leg of the patient above the malleoli bones as claimed).
In regards to claim 68, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses further comprising covering at least a portion of the lower leg with a soft wrap (48; see [0041]; see figure 5 that 48 is covering at least a portion of the user’s lower leg).
In regards to claim 69, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the soft wrap (48) covers the lower leg of the patient superior to the malleoli bones (see figure 5 that 48 engages the user’s calf and thereby covers the posterior portion of the user’s leg superior to the malleoli (ankle) bones).
In regards to claim 70, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella further discloses wherein the tightening force (tightening force applied by 50 of Chella) applies a clamping force onto the soft wrap (48; 52t applies a clamping force on 48 by securing the user’s leg within the device (see [0053]); thus, the tightening force applied by 50 of Chella which has been included into the device of Keith would still apply the same clamping force onto 48).
In regards to claim 71, Keith as now modified by Chella discloses the invention as discussed above.
Keith further discloses wherein the calf member (12) comprises an upper portion (24; see [0028]; see figure 2) and the lower portion (26) that is movable relative to the upper portion (24; 12 (and therefore 24 and 26) are formed from a monolithic plastics material with a thickness of .2 inches, and thus 12 is considered to be flexible due to the material and thickness, thus 26 is considered movable by this flexibility with respect to 24).
In regards to claim 72, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella further discloses wherein each elongate member of the at least one elongate member (60 of Chella) extends superior to the malleoli bones (see figure 2 of Chella that 60 extends above a user’s foot, and thus extends superior to the malleoli bones).
In regards to claim 73, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella further discloses wherein the at least one elongate member (60 of Chella) comprises at least one cable (see Chella [0033]).
In regards to claim 74, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella does not disclose wherein the calf member comprises at least one mounting portion for connecting the at least one elongate member to the lower portion of the calf member, wherein the at least one mounting portion is located superior to the calcaneus bone.
However, Chella further teaches wherein the calf member (18) comprises at least one mounting portion (80; see [0035]; see figure 5) for connecting the at least one elongate member (60) to the lower portion of the calf member (see figure 5), wherein the at least one mounting portion is located superior to the calcaneus bone (see figure 5 that 80 is located superior to (higher than) the calcaneus bone) for the purpose of receiving and retaining the at least one elongate member and providing an easy mechanism to remove the at least one elongate member and open the binding for removal (see [0037-0038]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calf member as disclosed by Keith as now modified by Chella and to have included the mounting portion for connecting the at least one elongate member to the lower portion of the calf member as further taught by Chella in order to have provided an improved calf member that would add the benefit of providing a mechanism of receiving and retaining the at least one elongate member and providing an easy mechanism to remove the at least one elongate member and open the binding for removal (see [0037-0038]).
In regards to claim 75, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella does not disclose wherein the calf member comprises at least one mounting portion for connecting the at least one elongate member to the lower portion of the calf member, wherein the at least one mounting portion is located superior to the malleoli bones.
However, Chella further teaches wherein the calf member (18) comprises at least one mounting portion (80; see [0035]; see figure 5) for connecting the at least one elongate member (60) to the lower portion of the calf member (see figure 5), wherein the at least one mounting portion is located superior to the malleoli bones (see figure 5 that 80 is located superior to the calcaneus bone in a lateral direction) for the purpose of receiving and retaining the at least one elongate member and providing an easy mechanism to remove the at least one elongate member and open the binding for removal (see [0037-0038]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calf member as disclosed by Keith as now modified by Chella and to have included the mounting portion for connecting the at least one elongate member to the lower portion of the calf member as further taught by Chella in order to have provided an improved calf member that would add the benefit of providing a mechanism of receiving and retaining the at least one elongate member and providing an easy mechanism to remove the at least one elongate member and open the binding for removal (see [0037-0038]).
In regards to claim 76, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella further discloses wherein the at least one elongate member (60 of Chella) is connected to the anterior member (96 of Keith as now modified by Chella) at a connection location that is located superior to the malleoli bones (see figure 2 of Chella that 60 is connected to the anterior member above a user’s foot, and thus, is connected at a location superior to the malleoli bones)
In regards to claim 77, Keith as now modified by Chella discloses the invention as discussed above.
Keith as now modified by Chella further discloses wherein the at least one elongate member (60 of Chella) is connected to the anterior member (96 of Keith as now modified by Chella) at a connection location that is located on the lower leg of the patient, spaced apart from a dorsal surface of the foot of the patient (see figure 2 of Chella that 60 is connected to the anterior member at a location where the lower leg and foot meet, and thus, is connected at a location that is located at least partially on the lower leg of the patient which is spaced apart from a dorsal surface of the foot of the patient near the user’s toes)
Allowable Subject Matter
Claims 47-52 are allowed.
The following is an examiner’s statement of reasons for allowance: The subject matter not disclosed either singly or in combination is that of “wherein the upper portion is directly mounted to a rigid spine and the lower portion is not secured to the rigid spine”.
The closest art of record is that of Keith which discloses A method for distracting a hip joint (see [0028] and [0048]; see figure 9), the method comprising:
positioning a lower leg and foot of a patient in a binding (10; see [0028]; see figure 1) such that a calf member (12; see [0028]; see figure 2) of the binding (10) is positioned along a calf side of the lower leg of the patient, wherein the calf member (12) comprises an upper portion (24; see [0028]; see figure 2) and a lower portion (26; see [0034]; see figure 6) wherein the lower portion is flexibly connected to the upper portion (24) so that the lower portion (26) can flex relative to the upper portion (24; 12 (and therefore 24 and 26) are formed from a monolithic plastics material with a thickness of .2 inches, and thus 12 is considered to be flexible due to the material and thickness, thus 26 is considered movable by this flexibility with respect to 24);
tightening a tightener (90/92, 55/57, and 70/72; see [0031], [0045-0046]; see figure 5)) to apply a force to the lower portion (26) of the calf member (12; 90/92 applies a tightening force between 24 and 26 and therefore applies a force to 26) whereby to hold the lower portion (26) of the calf member (12) superior to the calcaneus bone of the patient (see figure 5 that when 90/92 apply their clamping force to hold the patient’s leg within the binding, 26 is held superior to the patient’s heel bone);
applying a distracting force (see [0028] in reference to a caregiver distracting a patient’s hip) to the binding (10).
Keith fails to disclose “wherein the upper portion is directly mounted to a rigid spine and the lower portion is not secured to the rigid spine”. As discussed in the allowance of parent application (15/889,998; now US Pat. No. 11,510,805), a direct mounting of a rigid spine to the calf member is not taught or made obvious by the art found in the examiner’s search. Therefore, the more specific recitation of “wherein the upper portion is directly mounted to a rigid spine and the lower portion is not secured to the rigid spine” is similarly not taught or made obvious by the art found in the examiner’s search. Therefore, it is for at least this reason claim 47 is considered allowable.
Claims 48-52 are considered allowable insofar as the claims depend from claim 47 and thus, contain the same allowable limitation.
Conclusion
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/DANIEL A MILLER/Primary Examiner, Art Unit 3786
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