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 .
DETAILED ACTION
Election/Restrictions
Applicant timely traversed the restriction requirement in the reply filed on 05/01/2026 with the election of Claims 1-7, newly added claims 21-32 and Figs. 1-6. Therefore, claims 3, 23-25 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species of Fig. 11 (claims 3, 24-25 and 30) and Fig. 9B (claim 23), there being no allowable generic or linking claim. Thus, claims 1-2, 4-7, 21-22, 26-29 and 30-32 are presently pending in this application.
Applicant's election with traverse is acknowledged. The traversal is on the grounds that all species share the same capture element/bushing/recess structural relationship and would be found in the same prior art categories with minimal search burden. This is not found persuasive because each of species are directed to mutually exclusive species with mutually exclusive characteristics that are not obvious variants of each other due to the different capture element structure. If the applicant believes that these are in fact similar and should not be considered mutually exclusive species, the applicant is required to state that these embodiments do not have mutually exclusive characteristics and a single prior art disclosing one would disclose the other since they are obvious variants of each other.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 31 is rejected under 35 U.S.C. 112(a) 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. The specification fails to provided support for the limitations “to engage a distal face of the capture element in a second rotational orientation angularly offset from the first rotational orientation, such that rotation of the hinge post from the first rotational orientation to the second rotational orientation retains the hinge post against proximal withdrawal through the capture element”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 21-22 and 28 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Boettiger (2018/0243100).
Regarding claim 1, Boettiger discloses a prosthesis assembly for a constrained knee (abstract and Fig. 1) comprising: a femoral component 18/20; a tibial bearing component 38 engaged by the femoral component (Fig. 1); a tibial baseplate 30 (Fig. 7 and par. 0094) having a distal surface 32, a proximal surface opposite the distal surface and facing the tibial bearing component 38, a periphery extending between the proximal surface and the distal surface (the periphery of plate 30; Fig. 7) and a keel 28 (Fig. 1; par. 0093) extending distally from the distal surface (as shown in Fig. 7); a bushing 176 received in a recess 170 in the tibial baseplate 30 (Fig. 6 and par. 0131); a hinge post 220 coupled to the femoral component (hinge post 220 couples to joint element 26 of the femoral component 18/20; par. 0148 and Figs. 1 and 8) and the bushing 176 (Fig. 8), wherein the hinge post 220 is at least partially received by the bushing 176 (Fig. 8 discloses the tapered end of hinge post 220 is placed inside bushing 176); and a capture element 186 coupled to the tibial baseplate 30 (Fig. 6), wherein the capture element 186 is engaged by at least one of the bushing 176 or the hinge post to limit distraction of the femoral component from the tibial bearing component and tibial baseplate (as shown in Fig. 6, the structure of the capture element 186 having the annular projection 188 and the bushing having the annular projection 178 is fully capable of performing this intended use; pars. 0136-0137).
Regarding claim 2, Boettiger discloses wherein the capture element 186 comprises one of a snap fit component or a threaded nut 184 configured to be at least partially received in the recess in the tibial baseplate (Fig. 6), wherein the capture element has a thru hole configured to allow at least a portion of the hinge post 220 to pass through the capture element (as shown in Fig. 8).
Regarding claim 4, Boettiger discloses wherein the capture element 186 is proximal to and abuts a proximal end of the bushing (the capture element 186 has a portion 184 which abuts a proximal or top part of the bushing 176 which is considered to be its proximal end) and thereby entirely limits distraction of the femoral component from the tibial bearing component and tibial baseplate (the structure of the annular end face 192 of capture element 186 and the stop 192 of the bushing 176 prevents distraction of the joint).
Regarding claim 21, Boettiger discloses wherein the capture element has a thru hole sized to allow at least a portion of the hinge post to pass distally therethrough into the recess while a radially outward portion of the capture element is retained against the tibial baseplate, such that proximal movement of the bushing along the hinge post brings the bushing into contact with the capture element to halt distraction of the femoral component (as shown in Fig. 6, the structure of the capture element 186 having the annular projection 188 and the bushing having the annular projection 178 is fully capable of performing this intended use; pars. 0136-0137).
Regarding claim 22, Boettiger discloses wherein the capture element comprises a threaded nut having external threads along an outer diameter thereof, the external threads being constructed and arranged to engage corresponding internal threads formed in the recess of the tibial baseplate to retain the capture element at a fixed axial position within the recess (threads 182 and 184; par. 0136 and Fig. 6).
Regarding claim 28, Boettiger discloses further comprising a shackle 24 (Fig. 7) having a proximal end rotatably coupled to the femoral component via a hinge axle 82 (Fig. 8) and a distal end coupled to a proximal end of the hinge post 220 by a threaded connection 236, wherein the threaded connection between the shackle and the hinge post is constructed and arranged to permit selective decoupling of the hinge post from the shackle to allow exchange of the hinge post without removal of the femoral component (as shown in Figs. 7-8).
Claims 1 and 31 are rejected under 35 U.S.C. 102(a)(1) and 102 (a)(2) as being anticipated by Hagen et al. (2017/0027706) “Hagen”.
Regarding claim 1, Hagen discloses a prosthesis assembly for a constrained knee (abstract and Fig. 1) comprising: a femoral component 12; a tibial bearing component 16 engaged by the femoral component (Fig. 1); a tibial baseplate 94 having a distal surface 98, a proximal surface opposite the distal surface and facing the tibial bearing component 16, a periphery extending between the proximal surface and the distal surface (the periphery of plate 94; Fig. 1) and a keel 102 (Fig. 3) extending distally from the distal surface (as shown in Fig. 3); a bushing 134 received in a recess 110 in the tibial baseplate 94 (Fig. 2); a hinge post 84 coupled to the femoral component (hinge post 84 couples to pivot pin 56 of the femoral component 12; Fig. 1) and the bushing 134 (Fig. 1), wherein the hinge post 84 is at least partially received by the bushing 134 (Fig. 2); and a capture element 118 coupled to the tibial baseplate 94 (Fig. 2), wherein the capture element 118 is engaged by at least one of the bushing 134 or the hinge post to limit distraction of the femoral component from the tibial bearing component and tibial baseplate (as shown in Fig. 2, the structure of the capture element 118 having the threads 116 is fully capable of performing this intended use; par. 0068).
Regarding claim 31, as best understood, wherein the hinge post 84 includes one or more engagement features 92 (Fig. 1) constructed and arranged to pass through a thru hole of the capture element 118 in a first rotational orientation and to engage a distal face of the capture element in a second rotational orientation angularly offset from the first rotational orientation, such that rotation of the hinge post from the first rotational orientation to the second rotational orientation retains the hinge post against proximal withdrawal through the capture element (par. 0089 discloses the stop 92 retains the joint movement)
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.
Claims 5-6 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Hagen et al. (2017/0027706) “Hagen” in view of May et al. (2009/0149964) “May”.
Regarding claims 5-6, Hagen discloses the claimed invention of claim 1; except for wherein hinge post is coupled to the bushing by first threads that couple with second threads of the bushing and wherein coupling of the first threads with the second threads positions the bushing a desired location with respect to the capture element. However, May teaches a similar prosthesis comprising a post 66 having threads coupled to an internally threaded aperture 72 of bushing 20 (Fig. 2 and par. 0083). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hinge post in Hagen to include first threads that couple with second threads of the bushing and wherein coupling of the first threads with the second threads positions the bushing a desired location with respect to the capture element, as taught and suggested by May, for allowing a secured threaded connection.
Regarding claim 32, Hagen discloses the claimed invention of claim 1; except for wherein the tibial baseplate has a receptacle formed in the periphery thereof, the receptacle being adjacent to and communicating with the recess, and wherein the capture element is constructed and arranged to be inserted laterally through the receptacle and translated medially or laterally into the recess to a seated position within the recess. However, May teaches a similar prosthesis comprising a tibial baseplate 22 having a receptacle 84 formed in the periphery thereof (opening 81 formed in the sidewall of the tibial component; Fig. 4), the receptacle being adjacent to and communicating with the recess 81, and wherein a capture element 90 is constructed and arranged to be inserted laterally through the receptacle 84 and translated medially or laterally into the recess 81 to a seated position within the recess (par. 0084). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tibial baseplate in Hagen to include f the tibial baseplate has a receptacle formed in the periphery thereof, the receptacle being adjacent to and communicating with the recess, and wherein the capture element is constructed and arranged to be inserted laterally through the receptacle and translated medially or laterally into the recess to a seated position within the recess, as taught and suggested by May, for facilitating the insertion of the capture element.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Hagen et al. (2017/0027706) “Hagen” in view of May et al. (2009/0149964) “May” further in view of May et al. (2010/0292695) “May ‘695”.
Hagen discloses the claimed invention of claim 1 including wherein the hinge post 84 has a proximal threaded portion 86 constructed and arranged to couple with a shackle 56 (par. 0064), an unthreaded intermediate portion 88; except for a distal threaded portion constructed and arranged to couple with internal threads of the bushing, wherein a pitch of the distal threaded portion differs from a pitch of the internal threads of the bushing such that threaded engagement between the distal threaded portion and the internal threads draws the bushing to a predetermined axial position within the recess relative to the capture element.
However, May teaches a similar prosthesis comprising a hinge post 66 having a distal threaded portion 70 (par. 0083 and Fig. 2). Furthermore, May ‘695 discloses a pitch of the distal threaded portion differs from a pitch of the internal threads (Fig. 5 and par. 0027 disclose the different pitches of internal threads 40 and external threads 14). The combination of Hagen, May and May ‘695 would result in the threaded engagement between the distal threaded portion and the internal threads draws the bushing to a predetermined axial position within the recess relative to the capture element.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hinge post in Hagen to include a distal threaded portion constructed and arranged to couple with internal threads of the bushing, wherein a pitch of the distal threaded portion differs from a pitch of the internal threads of the bushing such that threaded engagement between the distal threaded portion and the internal threads draws the bushing to a predetermined axial position within the recess relative to the capture element, as taught and suggested by May and May ‘695, for allowing a secured threaded connection that keeps the joined fixed in the desired position (par. 0028 of May ‘695).
Allowable Subject Matter
Claims 7 and 26-27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “the capture element is initially coupled to the bushing by a frangible connection, wherein the frangible connection is severed by threading of the hinge post with the bushing to separate the capture element from the bushing” as set forth in claim 7 and “wherein the capture element and the bushing are initially formed as a single unitary component having a proximal capture portion and a distal bushing portion joined by a frangible intermediate connection element, wherein the frangible intermediate connection element is constructed and arranged to sever upon threaded engagement of the hinge post with internal threads of the distal bushing portion, thereby separating the proximal capture portion from the distal bushing portion and positioning the distal bushing portion distally within the recess at a spacing from the proximal capture portion that defines a distraction gap” as set forth in claim 26, which has not been found anticipated by or obvious over prior art. The closest prior art of record fails to disclose these limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah Edwards, can be reached at 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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