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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/21/2026 has been entered.
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 third member” 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.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
In regard to claim 1, the claim recites “the second and third members together partially or completely surround at least a portion the prosthesis” should be “a portion of the prosthesis” for proper grammar.
Appropriate correction is required.
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(s) 1 is/are 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 1 recites the limitation "the prosthesis" in line 10 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Since claims 4-6, 8-11, 13, 19-25 depend from claim 1, all claims are rejected under 112b.
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, 4, 6, 10, 22-23, 25 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and in view of Striede (AT177215B).
In regard to claim 1, MCOP teaches an orthosis comprising:
a first rigid or compliant member of the orthosis (see annotated figure; the carbon fiber lamination is considered rigid but either rigid or compliant covers all options);
a second rigid or compliant member of the orthosis (see annotated figure; the carbon fiber lamination is considered rigid but either rigid or compliant covers all options);
wherein the first member (see annotated figure) is hingedly connected (see hinge in annotated figure) to the second member (see annotated figure),
wherein the first member is positioned vertically above, beside, next to or adjacent to the second member when the orthosis is being worn by a wearer; (see annotated figure, the first member is positioned vertically above the second member)
a third rigid or compliant member (see annotated figure),
and a tensioning system (straps, see annotated figure)
wherein the second and third members together partially or completely surround at least a portion the prosthesis (see the figure, the second and third members are on opposite sides of a socket and therefore partially surround a portion of the prosthesis),
and wherein the first member (see annotated figure) is configured to be worn upon a first body part (thigh) connected to a second body part (lower limb) by an articulating body joint (knee joint).
However, MCOP does not teach the tensioning system includes an adjustment mechanism, or that the second and third members adjustably engage to attach and detach the prosthesis from 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];
wherein adjusting the at least one flexible tensioning component 23 using the at least one adjustment mechanism 25 draws, pulls, or pushes the second and third members (medial and lateral struts) together thereby creating a compressive force partially or completely around the at least a portion of the prosthesis to attach the prosthesis to the orthosis (see figure 1; cord 23 extends between a second and third member (medial and lateral struts shown in figure 1);
wherein the third member is completely or partially disengageable from the second member by decreasing or releasing a tensioning force applied to the at least one flexible tensioning element using the at least one adjustment mechanism 25 (by loosening 23, the second and third member will be partially disengaged from one another), which decreases or releases the compressive force partially or completely around the at least a portion of the prosthesis, such that the prosthesis is detachable from the orthosis; (by disengaging 23, when applied to the prosthetic socket of MCOP, the orthosis will be capable of being detached when the screws of Streide are also removed).
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].
Striede teaches the second and third members (7; a joint and corset is symmetric for operation and accordingly there will also be another strut on the opposite side) adjustably engage to attach and detach the orthosis from the prosthesis (see fig 1-3; detaches from socket 5).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make the orthosis of MCOP detachable from the prosthetic socket as taught by Striede in order to allow for easier adjustment or replacement of the orthosis.
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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 10, MCOP meets the claim limitations as discussed in the rejection of claim 1, 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 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 23, MCOP meets the claim limitations as discussed in the rejection of claim 1, 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.
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 in view of Striede (AT177215B) 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) 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 Striede (AT177215B) 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 1, 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] that span the hinged connection (also spans hinge; see fig 7) between (a) the first member and (b) the second members (see fig 8).
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.
Sieller 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 and rotary device of Sieller in the orthosis of MCOP because the cable and rotary device allow the brace to apply adjustable flexion and tension moments to assist in gait [0034].
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and in view of Striede (AT177215B) 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, the third 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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and in view of Striede (AT177215B) 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], connecting the first member to the second member (connects upper and lower struts, fig 1), wherein the energy storage element 60 is configured to generate a force within, across, or between the wearer's articulating body joint or the wearer’s first body part or second 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 in view of Striede (AT177215B) 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, the third 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 in view of Striede (AT177215B) 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, the third 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 Capra 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 in view of Striede (AT177215B) 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.
Striede teaches the second member, and the third member comprise one or more slots (holes within which screws 12 fit) which interlock with pegs, buttons or protrusions (screws 12 can be considered protrusions) on the prosthesis (screws fit into the holes).
However, the combination of MCOP in view of Striede teaches the use of holes instead of slots.
Flanagan teaches the use of slots 39 in place of holes to attach an orthotic brace to a prosthetic using a protrusion (screw, fig 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to replace the holes 12 in MCOP in view of Streide with the slots of Flanagan for increased adjustability.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable MCOP in view of Capra (2015/0190262A1) and in view of Striede (AT177215B) and further in view of Ingimundarson (9375341B2).
In regard to claim 24, MCOP in view of Striede 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 in view of Streide, in place of the screw and holes of Streide in order to make the brace and prosthesis quickly separable without tools for repairs and adjustments.
Response to Arguments
In regard to the drawing objections for failing to show a contact area over 20% of a surface of a limb and the third member, the applicant states claim 7 is cancelled. While this overcomes a portion of the drawing objection, the third member is not labeled in the figures. It does appear the third member may be in the figures based on the description but the examiner is unable to determine which element in the figures the third member refers to. Accordingly, a portion of the drawing objections are maintained.
In regard to the 103(a) rejection of claims 1-2, 4, 6-7, 12, 14, 22 and 25 as unpatentable over MCOP in view of Capra (2015/0190262A1), the applicant’s arguments have been fully considered.
The applicant argues the combination of references do not teach an orthotic capable of donning and doffing without sliding over the limb of the wearer. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
The applicant argues that MCOP functions differently than the claimed invention by requiring the right tools to deconstruct the orthotic. The claim does not require the orthotic to be able to be removed without the use of tools. However, this is moot in view of new grounds of rejection necessitated by the amendments as discussed above.
The applicant argues that Capra does not disclose the third member but discloses straps. The applicant argues that the instant tensioning system connects an orthotic to a prosthetic without a permanent connection. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Capra was not used to teach a third member.
The remainder of the arguments are directed toward newly amended claim limitations which have been addressed above.
In regard to the 103(a) rejection of claim 5 as unpatentable over MCOP in view of Capra (2015/0190262A1) and further in view of Johnson (WO202204445), no further arguments have been submitted.
In regard to the 103(a) rejection of claim 11 as unpatentable over MCOP in view of Capra (2015/0190262A1) and further in view of Chappell (4144881) no further arguments have been submitted.
In regard to the 103(a) rejection of claims 3, 10, 23 as unpatentable over MCOP in view of Capra (2015/0190262A1) and in view of Peckham (4428369A) and in view of Flanagan (1370299A), the applicant’s arguments have been fully considered but are directed toward amended claim limitations which have been addressed above.
In regard to the 103(a) rejection of claims 8-9 as unpatentable over MCOP in view of Capra (2015/0190262A1) and in view of Peckham in view of Flanagan 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 unpatentable over MCOP in view of Capra (2015/0190262A1) and further in view of Nace (2015/0290010A1), no further arguments have been submitted.
In regard to the 103(a) rejection of claim 19 as unpatentable over MCOP in view of Capra (2015/0190262A1) and further in view of Einarsson (2007/0083136A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 20 as unpatentable over MCOP in view of Capra (2015/0190262A1) and further in view of Blecher (2016/0256310A1) no further arguments have been submitted.
In regard to the 103(a) rejection of claim 21 as unpatentable over MCOP in view of Capra (2015/0190262A1) and further in view of Flanagan the applicant’s arguments have been fully considered. The applicant argues the orthosis portion the office refers to is merely the thigh portion of the limb and states Flanagan does not teach an orthosis. An orthosis is defined as an external medical device for supporting muscles or joints. Since Flanagan’s joint and corset portion of the limb C in figure 1 supports an anatomical knee joint, the definition of orthosis has been met.
In regard to the 103(a) rejection of claim 24 as unpatentable over MCOP in view of Capra (2015/0190262A1) and further in view of Ingimundarson (9375341B2), no further arguments have been submitted.
Conclusion
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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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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