DETAILED ACTION
This office action is responsive to the amendment filed December 22, 2025. By that amendment, claims 1, 16, and 17 were amended. Claims 1-20 are pending.
Claims 14 and 15 were previously indicated as containing allowable subject matter. However, claim 1 was amended such that scope of these claims was amended. Upon further search and consideration, new rejections are now required.
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 .
Response to Arguments
Applicant’s arguments with respect to the rejections of claim(s) 1-6, 8-10, and 16 under 35 USC 102(a)(1) in view of Reich et al. (US 2008/0306603 A1); claims 17-20 under 35 USC 102(a)(1) in view of Metzger et al. (US 2008/0167722 A1); claims 7, 12, 13, and 17-20 under 35 USC 103 in view of Reich and Metzger; and claim 11 under 35 USC 103 in view of Reich; have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The newly presented rejections were necessitated by the amendments to the claims of December 22, 2025.
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.
Claim(s) 1, 3-10, 16, 17 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu (US 8,721,729 B1).
Regarding claim 1, Lu teaches a joint replacement assembly as at figs. 1 and 2, comprising:
a baseplate 2 having an articulating side (up in fig. 1) and a bone facing side (down in fig. 1);
a proximal member 31 having a proximal end up in fig. 2 and a distal end down in fig. 2 spaced apart from the proximal end, the proximal end being connectable to the bone facing side of the baseplate 2 (by joining 31 and 21), the distal end having a plurality of grooves 313 arranged about a first axis extending through the proximal member in a lengthwise direction (an up/down axis in fig. 2); and
a distal member 32 having a proximal end up in fig. 2) and a distal end (down in fig. 2), the proximal end being connectable to the distal end of the proximal member 31 (by connecting 323 to 313) and having a plurality of protrusions 323 configured to engage with the plurality of grooves 313 and prevent rotation of the distal member about the first axis relative to the proximal member 31.
Regarding claim 3, the distal end of the distal member 32 includes a distal bore seen clearly in fig. 3 configured to engage an intramedullary stem 1.
Regarding claims 4 and 5, the distal bore is centered about an axis laterally offset (by a distance D) from the central axis of the proximal member 31 (as seen clearly in fig. 3), or is coaxial with the axis as seen at fig. 4 (depending on installation of 31).
Regarding claim 6, the fig. 6 embodiment will now be relied upon. The proximal member 31a includes a proximal bore 314a coaxial with the first axis.
Regarding claim 7, the baseplate 2, proximal member 31, and distal member 32 are each formed separately from each other as in fig. 2.
Regarding claim 8, a distal surface of the baseplate 2 includes a hole 21 extending through the baseplate 2.
Regarding claim 9, a proximal surface of the proximal member 31 includes a first protrusion 311 configured to engage with the hole 21 of the baseplate 2 to prevent rotation of the proximal member 31 relative to the baseplate 2 due to the tapered fit between 21 and 311.
Regarding claim 10, the fig. 8 embodiment will now be relied upon. The distal member 32 includes a proximally extending boss 4b and the baseplate includes a distally extending boss about 21, the proximally extending boss 4b being extendable through the proximal member 31 and receivable within the distally extending boss 21 of the baseplate 2. See fig. 8. There is no reason that the screw 4b protruding from 32 cannot be considered to read on the limitation “boss”.
Regarding claim 16, Lu teaches a joint replacement system as at figs. 1 and 2, including:
a baseplate 2 having an articular side (up in fig. 1) and a bone facing side (down in fig. 1);
a proximal member 31 having a first end 311 and a second end at 313 spaced apart from the first end, the first end 311 being engageable with the bone facing side of the baseplate 2, and the second end having a first indexing feature (the configuration of 313 permitting multiple different couplings in an indexed fashion); and
a distal member 32 having a first end at 322 and a second end (down in fig. 2), the first end having a second indexing feature 323 configured to engage and index with the first indexing feature 313 so as to prevent relative rotation between the proximal and distal members 31/32 when the distal member 32 is engaged with the proximal member 31.
Regarding claim 17, Lu teaches a joint replacement assembly as in figs. 6-8, including:
a baseplate 2 having an articular side (up in fig. 7) and a bone facing side (down in fig. 7) wherein a boss 21 extends from the bone facing side;
a proximal member 31a having a first end (up in fig. 6), a second end (down in fig. 6), and a first axis extending through the first and second ends, the first end removably engaged to the bone facing side of the baseplate 2 at 311a; and
a distal member 32a having a first end (up in fig. 6) and a second end (down in fig. 6), the first end removably engaged to the second end of the proximal member 31a (at joining 323/313) and the boss 21 (engaged by use of 4a), the second end having an opening defining a second axis (e.g. as in fig. 7 for receiving 1, therein), the second axis being offset from the first axis in a radial direction by a distance D in fig. 7.
Regarding claim 20, the distal member 32a has an axial opening extending therein and defining a second axis radially offset from the first axis (note two openings 321a on different axes).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of Metzger (US 2012/032333 A1).
Regarding claim 2, Lu teaches the limitations of claim 1, as above. However, the grooves are taught as dovetail grooves which are arranged at 180 degrees. It is noted that Lu uses an inserting member 4 across the joint for purposes of fixing the joint.
Metzger teaches a coupling mechanism in a baseplate device as at fig. 9. This coupling mechanism includes many grooves which are arranged such that at least some of these grooves are at 30 degree increments relative to one another about the first axis. This mechanism includes a set screw 220 for fixing the joint.
It would have been obvious to one with ordinary skill in the art at the time to have modified the dovetail and pin arrangement of Lu to a splined and set screw arrangement as taught by Metzger. Both arrangements are known to permit multiple connection directions, while permitting selective fixation of the joint. One would have made the modification in order to permit additional orientations to be permitted between the components, as suggested by Metzger.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu.
Regarding claim 11, Lu teaches the limitations of claim 10, as above. Further, the proximally extending boss 4b of the distal member 32 is threaded, but the claimed threaded relationship is reversed to that shown at Lu.
Lu teaches a threaded bore 321a for receiving a screw. The claim requires a threaded boss extending through the baseplate.
It would have been obvious to one with ordinary skill in the art to have reversed the arrangement between male/female threaded arrangements, such that a threaded boss (e.g. stud) extends out of the top of 32a to permit receipt of a threaded nut thereon to achieve the same coupling as shown accomplished by screw 4a and bore 321a. It has been held by the courts that a mere reversal of the essential working parts of a device involves only routine skill in the art.
Claim(s) 12-14, 18 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lu in view of Brown (US 7,998,217 B1).
Regarding claims 12, 13 and 18, the limitations of claims 1 and 17 are taught by Lu, as above. Further, there is no reason the proximal member 31 and distal member 32 cannot be capable of use as a proximal void filler.
However, Lu’s members 31/32 are not taught having a frustoconical body having an outer surface tapering inwardly from the proximal end to the distal end thereof.
Brown teaches a connection mechanism as at fig. 1. The device includes a base member 102, a proximal member 106a and a distal member 106b. The proximal member 106a and distal member 106b are tapered inwardly from the proximal end to the distal end thereof.
It would have been obvious to one with ordinary skill in the art at the time of the invention to add interacting tapered designs to the Lu design in order to ease insertion into a difficult to access surgical site.
In an alternate interpretation regarding claims 12 and 13: portion 106b will be considered the proximal member, and the protrusion including bore 120 will be considered the distal member.
Regarding claims 14, 15 and 19, the Brown distal member 106b further includes a lobe portion 120 integral with the frustoconical body, the lobe portion extending along at least a portion of a length of the frustoconical body 106b and having an axial bore 120 extending into the lobe, the axial bore defining a second axis offset from the first axis by an offset distance as seen clearly in fig. 1.
It would have been obvious to configure the Lu member 32 with such an arrangement in order to provide for additional adjustability in the modification of distance D in the Lu arrangement by providing for an additional offset coupling.
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.
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/DAVID W BATES/Primary Examiner, Art Unit 3799