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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-8 in the reply filed on 6/17/2026 is acknowledged.
Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/17/2026.
Specification
The disclosure is objected to because of the following informalities: In par.117 of the specification as originally filed, 1109P is referred to as “posterior threads” (two instances). It is unclear if this was intended to be --proximal threads-- since threads 1109D are “distal” threads and the threads 1109P are not limited to the posterior and are proximal to the distal threads. Similarly, par.127 of the specification as originally filed refers to “posterior threads 1709P” (two instances). It is unclear if this was intended to be --proximal threads 1709P-- since the threads are proximal to distal threads 1709D.
Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Par. 128 refers to “intermediate connection element 1825” but the reference number “1825” is not in the drawings. 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. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figs. 21A and 21B include the reference number “1824” but this is not in the specification. It is possible 1824 is meant to be the intermediate connection element 1825 discussed above. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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 § 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.
Claims 1-4 and 6-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reich et al. DE 102009007724A1 (hereafter referred to as Reich; cited in IDS; refer to attached translation for passages referenced herein).
Regarding claim 1, Reich discloses a prosthesis system for a constrained knee (fig.1) comprising: a femoral component 12; a tibial bearing component 16 configured to articulate with the femoral component; a baseplate 14 having a distal surface 28, a proximal surface 22 opposite the distal surface and facing the tibial bearing component (figs. 1-2), a periphery (considered the side wall of the baseplate) extending between the proximal surface and the distal surface and a keel 30 extending distally from the distal surface (fig.1), a plurality of bushings 98, 126 each having a different configuration from one another (figs. 1-3 show the different size and shape of 98 and 126; further, pg.12, second to last paragraph discloses a plurality of lengths for 98 and 126 to allow the surgeon to elect the most suitable parts for each patient), wherein each of the plurality of bushings is configured to insert into a recess 80 in the baseplate (figs. 2-3 show 98 and 126 in recess 80 in the baseplate), one or more hinge posts 60 configured to couple with the femoral component and configured to be received by one or more of the plurality of bushings (fig.2), and a capture element 134 configured to couple with the baseplate and having a thru hole configured to allow at least a portion of the one or more hinge posts to pass therethrough (fig.3), wherein, when coupled to the baseplate, the capture element is configured to be engaged by at least one of the plurality of bushings or one of the one or more hinge posts to limit distraction of the femoral component from the tibial bearing component and baseplate (the ring 134 prevents unintentional release of 126 which means distraction is limited at least because 134 prevents the release of 126 which limits distraction of 98 and 60).
Regarding claim 2, hinge post 60 is a single hinge post that can couple to the two bushings 98 and 126 (figs. 2-3). Note post 60 directly couples to bushing 98 and at least indirectly couples to bushing 126.
Regarding claim 3, see pg.9, par. 3 and pg.12, second to last paragraph for a plurality of posts 60 of different lengths.
Regarding claim 4, the prosthesis system of Reich is capable of being used as claimed. For instance, the capture element 134 and element 126 could be excluded while bushing 98 and hinge post 60 are used and the femoral component, tibial bearing component and baseplate are capable of full distraction.
Regarding claim 6, hinge post 60 is selectively attachable to and removable from the femoral component (fig.1 shows separate components while fig.2 shows attached components).
Regarding claim 7, the bushings 98 and 126 are separate from the hinge post 60 and are capable of being attached and removed from the hinge post (fig.1 shows separate components while fig.2 shows attached components).
Regarding claim 8, fig.3 shows capture element 134 attached to the bushing 126. Page 11, par.4 discloses the capture element 134 is made of plastic, for example polyethylene. As such, at least the capture element can be cut/severed from the bushing and the bushing is severable from the capture element. It is also possible to sever the bushing by some means, therefore the bushing is severable from the capture element.
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Reich as applied to claim 1 above, and further in view of Slone et al. US 2013/0310945 (hereafter referred to as Slone). Reich discloses the prosthesis system of claim 1 as discussed above. Reich discloses “security tire 134” in the groove 132 prevents unintentional release of the bushing 126 (translation page 11, par.4). The ring 134 of Reich is configured to be at least partially received in the recess in the baseplate and selectively attachable to and removable from the baseplate (Reich fig.3 shows the ring 134 in the recess of the baseplate and the ring is attachable/removable from the baseplate since it is separate from the baseplate. Reich discloses the invention substantially as claimed, but Reich does not disclose that the ring 134 is a snap fit component.
Slone teaches a modular prosthesis system, in the same field of endeavor, wherein a snap fit locking ring 102 is used to lock two components together (par.53; figs. 8A-8C).
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 security tire/ring of Reich, if necessary, to be a snap-fit ring as taught by Slone in order to easily lock the bushing to the baseplate. Snap-fit rings are a well-known mechanism for securing modular components, therefore it would have been obvious to substitute the snap ring of Slone for the ring of Reich to obtain predictable results (see MPEP 2143B).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Wyss US 2008/0004708 discloses a hinged knee prosthesis with a moveable hinge post and a bushing (fig.3). Hershberger et al. US 2008/0234830 discloses a locking snap ring for securing modular components together (fig.8).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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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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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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