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 .
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 “first or second members modeled to conform with and contact over 20% of a surface area of a limb of the wearer of the orthosis, the prosthesis or both” and “the third member” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. It is suggested to use the term “approximately” since it is not clear from the figures the exact percentage of coverage and this range is not recited in the instant disclosure.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 4, 6-7, 12, 14, 22, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1).
In regard to claim 1, MCOP teaches a suspension system for removably (the brace of MCOP is cable of being removed from the prosthesis given the right tools) coupling an orthosis to a prosthesis comprising:
a first rigid or compliant member of an orthosis positioned on a first side of a prosthesis (see annotated figure, lateral side; the carbon fiber lamination is considered rigid but either rigid or compliant covers all options);
a second rigid or compliant member of an orthosis positioned on a second side of a prosthesis (see annotated figure, medial side; the carbon fiber lamination is considered rigid but either rigid or compliant covers all options);
and a tensioning system (straps, see annotated figure) directly or indirectly connecting the first member with the second member.
However, MCOP does not teach the tensioning system includes an adjustment mechanism or that the system is used to couple the orthosis to the prosthesis.
Capra teaches the tensioning system (22a, b) comprises at least one adjustment mechanism 25 and at least one flexible tensioning component 23;
wherein upon adjusting the at least one adjustment mechanism 25, a tensioning force is applied to the at least one flexible tensioning component [0023];
and wherein when a tensioning force is applied to the at least one flexible tensioning component 23, the first member and the second member are pulled, pushed, or drawn together, to secure or couple the orthosis to the prosthesis [0023: tightening; see fig 1]. (will be applied to the prosthesis when applied to the knee brace of MCOP which is over a prosthetic socket)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the brace of MCOP to use the tensioning system of Capra in order to improve fit and comfort [0002] and to allow adjustment [0005].
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Annotated figure 1
In regard to claim 2, MCOP teaches a system for coupling an orthosis to a prosthesis comprising:
a first member of an orthosis that partially conforms to a prosthesis; (see annotated figure, conforms to lateral side))
a second member of an orthosis that partially conforms to another part of the prosthesis (see annotated figure, conforms to medial side).
However, MCOP does not teach the tensioning system with an adjustment mechanism as claimed.
Capra teaches a tensioning system 22a,b directly or indirectly connecting the first member with the second member (connects to brace in fig 1);
wherein the tensioning system 22a,b comprises at least one adjustment mechanism 25 and at least one flexible tensioning component 23;
wherein adjusting the adjustment mechanism 25 causes a tensioning force to be applied to the at least one flexible tensioning component 23 [0023];
and wherein when the tensioning force is imparted from the orthosis members to the prosthesis, the orthosis is secured or coupled to the prosthesis. (will be applied to the prosthesis when applied to the knee brace of MCOP which is over a prosthetic socket)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the brace of MCOP to use the tensioning system of Capra in order to improve fit and comfort [0002] and to allow adjustment [0005].
In regard to claim 4, MCOP meets the claim limitations as discussed in the rejection of claim 1, but does not teach the tensioning system as claimed.
Capra further teaches the tensioning system 22a,b is configured to be adjusted incrementally [0046: reel is for micro adjustments] and wherein the at least one adjustment mechanism 25 is a rotary device [0023: reel].
In regard to claim 6, MCOP meets the claim limitations as discussed in the rejection of claim 1, wherein the first and/or second members (see annotated figure 1) are designed around a limb of a wearer of the orthosis or the prosthesis, based on a three-dimensional scan of the limb of the wearer of the orthosis or the prosthesis. This is a product-by-process limitation, patentable only based on the resulting structure. Since the end structure first around a limb of the wearer of the device, the limitations have been met.
In regard to claim 7, MCOP meets the claim limitations as discussed in the rejection of claim 1, and further teaches the first and/or second members (see annotated figure) are modeled to conform with and/or contact over 20% of a surface area of a limb of the wearer of the device, the prosthesis, or both. This will depend on the residual limb and the brace of MCOP is capable of contacting over 20% of a surface area of a limb of some wearer of the orthosis, the prosthesis, or both. The examiner suggests claiming the structural features of the device by itself rather than in reference to a limb which may be different sizes.
In regard to claim 12, MCOP meets the claim limitations as discussed in the rejection of claim 1, and further teaches the first member is a distal frame of an orthotic device (see annotated figure 1); wherein the first member (see annotated figure 1) is connected to a proximal frame of the orthotic device by a hinge (see annotated figure 1); and wherein the hinge articulates with movement of a wearer's joint or body part (capable of based on the location next to the knee joint, as seen in the annotated figure 1).
In regard to claim 14, MCOP meets the claim limitations as discussed in the rejection of claim 12, but does not teach a tensioning system with an adjustment mechanism.
Capra further teaches a tensioning system 22a,b, wherein the tensioning system 22a,b comprises an adjustment mechanism 25 coupled to a flexible tensioning element 23;
and wherein the tensioning system 22a,b is directly or indirectly connected to the proximal frame and the distal frame of the orthotic device (fig 1, coupled to both the proximal and distal half of the device).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the brace of MCOP to be fully adjustable by modifying the brace to apply the tensioning system of Capra to both the proximal and distal device in order to make the brace adjustable and removable. (This would involve also applying the split of the distal brace to the distal brace of MCOP)
In regard to claim 22, MCOP meets the claim limitations as discussed in the rejection of claim 1, wherein the suspension system is provided as a kit to be assembled with an orthosis, a prosthesis, or combinations thereof, by a clinical professional, a physician, or a wearer of the suspension system, the orthosis, the prosthesis, or combinations thereof. This is intended use. All of the structural limitations have been met and the system is capable of being assembled by a clinical professional or provided as a kit. The examiner suggests claiming any structural limitations or additional parts that are in a kit that would distinguish the kit from the device itself.
In regard to claim 25, MCOP meets the claim limitations as discussed in the rejection of claim 1, and further teaches the prosthesis is a post-operative prosthesis or an immediate post-operative prosthesis. The prosthesis is capable of being used as a post-operative prosthesis. The examiner suggests claiming any structural differences as this can currently be interpreted as intended use.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and further in view of Johnson (WO2022204445).
In regard to claim 5, MCOP meets the claim limitations as discussed in the rejection of claim 1, but does not teach the unloading hinge as claimed.
Johnson teaches wherein the first member and the second member are connected by an unloading hinge (abstract: unloading hinge assembly) configured to sustain forces of 10lbs or greater transmitted by the unloading hinge to the prosthesis [00111: medium: range of 3-15lbs].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the unloading hinge of Johnson in place of the hinge of MCOP because this allows deeper flexion of the knee joint for a user with osteoarthritis pain [00112].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and further in view of Chappell (4144881).
In regard to claim 11, MCOP meets the claim limitations as discussed in the rejection of claim 1, but does not teach the first and second member comprise multiple segments or elements.
Chappell teaches the first member, the second member or combinations thereof, comprise multiple panels, segments, or elements. (2) As shown in figure 1, a strut for a brace utilizes multiple segments instead of one single hinge.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the multiple segments of Chappell in place of the single hinge of MCOP because the hinge has adjustable stops to restrict motion when desired (abstract)
Claim(s) 3, 10, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and in view of Peckham (4428369A) and in view of Flanagan (1370299A).
In regard to claim 3, MCOP teaches an orthosis comprising:
a first member having at least one vertical support comprising a rigid or compliant cuff (see annotated figure 2; the carbon fiber lamination is considered rigid; however rigid or compliant covers all options),
a second member having at least one vertical support comprising a rigid or compliant cuff (see annotated figure 2; the carbon fiber lamination is considered rigid; however rigid or compliant covers all options),
wherein the first member is hingedly connected to the second member (see annotated figure 2) and wherein the second member (see annotated figure 2) is located relative to one side of a prosthesis (see annotated figure 2, lateral side),
wherein the first member (see annotated figure 2) is configured to be worn on the worn upon a first body part (thigh);
wherein the second member is modeled and fixed around the prosthesis (see annotated figure, fixed over the prosthetic socket);
wherein the hinge articulates with the articulation of the articulating body joint. (capable of due to the location about the knee joint),
the second member modeled (product by process) and fixed around the prosthesis (see annotated figure, fixed around the prosthesis with the same shape).
However, MCOP does not teach a third member as claimed or the tensioning system and it is unclear if the orthosis is attachable to and detachable from the prosthesis (interpreted as repeatedly).
Capra teaches a tightening of the tensioning system 22a,b draws, pulls, or pushes the second and third members together thereby creating a compressive force around the prosthesis (compresses medial and lateral sides together, see figure 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the brace of MCOP to use the tensioning system of Capra in order to improve fit and comfort [0002] and to allow adjustment [0005]. The modification will include the split between members to allow the tensioning system to operate as intended.
Peckham teaches a third member 88 comprising of a rigid or compliant plate (rigid or compliant covers all options, however the plate appears to be rigid to function as intended) located relative to a second side of the prosthesis (in the middle);
the third members are modeled and fixed around the prosthesis (attached to the lower brace and will therefore be fixed to the prosthesis when applied to the brace of MCOP).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the plate of Peckman on the brace of MCOP because the plate allows the sides to be adjusted when applied between the sides of the brace (Col 7, lines 20-31).
Flanagan teaches the orthosis is attachable to and detachable from the prosthesis (see figure 1; orthosis portion (C) is attached to the prosthetic socket 30-33 by screws).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the screw attachment of Flanagan to attach the brace to the prosthesis of MCOP because this allows the brace to be removable for repair or adjustments.
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Annotated Figure 2 (applied to the rejection of claims 3, 8-10, 23)
In regard to claim 10, MCOP meets the claim limitations as discussed in the rejection of claim 3, and further teaches the orthosis is for a knee (see annotated figure), an ankle, a hip, an elbow, or a wrist.
In regard to claim 23, MCOP meets the claim limitations as discussed in the rejection of claim 3, and further teaches at least one of the first member, the second member, or the third member, is fabricated continuously with the prosthesis. This is a product-by-process limitation, patentably only based on the resulting structure of a prosthesis and orthosis that fit together. The instant disclosure gives the example of 3D printing as fabricating continuously.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and in view of Peckham (4428369A) in view of Flanagan (1370299A) and further in view of Sieller (2003/0144620A1).
In regard to claim 8, MCOP meets the claim limitations as discussed in the rejection of claim 3, but does not teach elastic elements or the third element.
Sieller teaches the second and third members house or include one or more elastic elements 115 [0034: rubber cord; based on the location of the cord in figure 7, the cord will fasten on the second and third members of MCOP in view of Peckham]
that span the hinged connection (also spans hinge; see fig 7) between (a) the first member and (b) the second members (see fig 7, will span the proximal member, distal member and plate of Peckman in the distal member middle when applied to the device of MCOP in view of Peckman).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the cable of Sieller in the orthosis of MCOP because it allows the brace to apply adjustable flexion and tension moments to assist in gait [0034].
In regard to claim 9, MCOP meets the claim limitations as discussed in the rejection of claim 8, but does not teach the elastic element.
Shirley further teaches the one or more elastic elements 115 are attached to a rotary device 120 that is configured to increase or decrease tension across the hinged connection (increases or decreases tension relative to not being used [0039: create appropriate flexion and extension moments]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the cable of Sieller in the orthosis of MCOP because it allows the brace to apply adjustable flexion and tension moments to assist in gait [0034].
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and further in view of Nace (2015/0290010A1).
In regard to claim 13, MCOP meets the claim limitations as discussed in the rejection of claim 1, but does not teach an energy storage element.
Nace teaches an energy storage element 60 [0045: rubber band, resilient member, elastic band], wherein the energy storage element 60 is configured to generate a force within, across, or between a wearer's joint or body part (fig 1, across the knee joint; 0045; 0048: aid in leg extension].
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the energy storage element of Nace in the brace of MCOP because this assists patients in gait kinetics [0045].
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and further in view of Einarsson (2007/0083136A1).
In regard to claim 19, MCOP meets the claim limitations as discussed in the rejection of claim 1, and further teaches the first member, the second member, or combinations thereof, comprise a friction or adhesive material at an interface between the orthosis and the prosthesis (see annotated figure, laminated).
While it is well known in the art that a lamination uses an adhesive material such as resin, in the interest of compact prosecution, Einarsson teaches fabricating a brace using carbon fiber with a thermoplastic resin (adhesive, which will also be on the outer brace and therefore at the prosthesis orthosis interface).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the lamination materials of Einarsson in the brace and prosthesis of MCOP (which will include at the interfacing faces) through functional equivalents. MPEP 2144.06
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and further in view of Blecher (2016/0256310A1).
In regard to claim 20, MCOP meets the claim limitations as discussed in the rejection of claim 1, but does not teach the first or second member are made of a compliant material or the tensioning system.
Capra teaches the tensioning system 22a,b, as discussed in the rejection of claim 1.
Blecher teaches the first member, the second member, or combinations thereof, comprise a compliant material [0024: plastic material],
wherein the complaint material deforms to match a surface of the prosthesis when the tensioning system is tensioned.
When the brace of MCOP is combined with the tensioning system of MCOP and the material of Becher, the orthosis will be compliant and capable of conforming when tensioned.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the material of Blecher in the orthosis of MCOP in order to allow thermoforming for adjustments [0024].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and further in view of Flanagan (1370299A).
In regard to claim 21, MCOP meets the claim limitations as discussed in the rejection of claim 1, but does not teach slots which interlock with pegs, buttons or protrusions on the prosthesis.
Flanagan teaches the first member, the second member, or both, comprise one or more slots 39, which interlock with pegs, buttons, or protrusions (the screw head of 27 meets the definition of a protrusion) on the prosthesis.
It would have been obvious to one of ordinary skill in the art of connections, at the time the invention was filed to use the slot and protrusion of Flanagan to attach the first and second members of MCOP to the prosthetic socket of MCOP instead of laminating the brace into the socket, in order to allow adjustment and removal of the brace from the prosthesis for repairs.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and further in view of Ingimundarson (9375341B2).
In regard to claim 24, MCOP meets the claim limitations as discussed in the rejection of claim 1, but does not teach the connection mechanism as claimed.
Ingimundarson teaches one or more tabs and slots, lips and shelves, bead and cove, clips and posts, or combinations thereof. (slot 167, post 168)
It would have been obvious to one of ordinary skill in the art of connections at the time the invention was filed to connect the brace and prosthesis of MCOP as taught by Ingumundarson in order to make the brace and prosthesis separable for repairs and adjustments.
Response to Arguments
It is noted the applicant asserts there are no prior public disclosures.
In regard to the drawing objection for failing to include 64, the third member and the first and second members contacting over 60% of an area of a limb, the addition of element 64 to the specification overcomes that part of the drawings objection. The amendment of the claim to state over 20% of the surface area. If the applicant is relying on the figures for support it is suggested to use approximately language since the percentage has not been measured and is not disclosed in the instant disclosure. Further, the applicant has not labeled “the third member”.
In regard to the 101 rejection of claims 3, 8-10 and 23, the amendment overcomes the rejection.
In regard to the 112b rejection of claims 1-14 and 19-25, the amendments overcome the rejection.
In regard to the 103(a) rejection of claims 1-2, 4-7, 12, 14, 22, 25 as being unpatentable over MCOP in view of Capra (2015/0190262A1), the applicant’s arguments have been fully considered.
The applicant states that the frame elements of MCOP are permanently affixed to the prosthetic using rivets and not removably attachable. This is directed towards a newly added claim limitation. However, rivets and orthosis are removable given the right tool.
The applicant further argues the tensioning element is not adjustable. Capra was used to teach the tensioning mechanism and adjustability.
The applicant argues that Capra discloses adjusting the tightness of a strap that is already fastened and states this is not material to the current invention. The applicant has not pointed out how the adjusting mechanism of Capra does not mean the particular claim limitations. If the instant invention has a different structure that should be claimed. While the claims are read in light of the specification, the specification is not read into the claims.
The applicant argues Capra is nonanologous art because it is used in an orthotic or garment. The joint and corset portion of MCOP is an orthotic device (used to support an existing joint). Further both are straps in the art of rehabilitation devices. Accordingly the art is analogous.
The applicant argues that the tensioning system of the present invention is not to adjust tightness but to connect the orthotic to the prosthetic without a permanent connection. This is a statement of intended use, patentable only based on the resulting structure. Further, this is not claimed. Removable only means capable of being removed.
The applicant argues the strap of Capra is a brace and the strap overlaps itself which is not how the instant invention is configured. It is suggested to claim the structural differences between the two. The applicant has not argued what claim limitations are not met by the strap of Capra.
In regard to the 103(a) rejection of claim 11 as being unpatentable over MCOP in view of Capra (2015/0190262A1) and further in view of Chappell (4144881), no further arguments have been presented.
In regard to the 103(a) rejection of claims 3, 10 and 23 as being unpatentable over MCOP in view of Capra (2015/0190262A1) and in view of Peckham (4428369A), the applicant’s arguments have been fully considered. The applicant argues that the latch linkage and plate of Peckham function differently than the third element of the instant invention, but has not pointed out any specifics about how they function differently. It is suggested to ensure any differences are amended into the claims. While the claims are read in light of the specification, the specification is not imported into the claims.
In regard to the 103(a) rejection of claims 8-9 as being unpatentable over MCOP in view of Capra (2015/0190262A1) and in view of Peckham (4428369A) and further in view of Sieller (2003/0144620A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claim 13 as being unpatentable over MCOP in view of Capra (2015/0190262A1) and in view of Nace (2015/0290010A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 19 as being unpatentable over MCOP in view of Capra (2015/0190262A1) and in view of Einarsson (2007/0083136A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 20 as being unpatentable over MCOP in view of Capra (2015/0190262A1) and in view of Blecher (2016/0256310A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 21 as being unpatentable over MCOP in view of Capra (2015/0190262A1) and in view of Flanagan (1370299A) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 24 as being unpatentable over MCOP in view of Capra (2015/0190262A1) and in view of Ingimundarson (9375341B2), no further arguments have been submitted.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTIE BAHENA whose telephone number is (571)270-3206. The examiner can normally be reached M-F 9-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774