DETAILED ACTION
This office action is responsive to the amendment and RCE filed June 2, 2026. By that response, claims 1, 16, and 17 were amended. Claims 1-20 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 June 2, 2026, has been entered.
Response to Arguments
Applicant’s arguments with respect to the rejection of claim(s) 1, 3-1, 16, 17, and 20 under 35 USC 102(a)(1) of in view of Lu (US 8,721,729); and under 35 USC 103 of claim 2 in view Lu and Metzger (US 2012/032333); and of claim 11 in view of Lu; and of claims 12-14, 18 and 19 in view of Lu and Brown (US 7,998,217); 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 are necessitated by the amendments to the claims of June 2, 2026.
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.
Claims 8, 9, 13-15, and 17-20 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.
At claim 8, examiner believes an ‘already-named’ structure is being given a new name. Particularly, examiner believes the “distal surface” of the base plate of claim 8 to be the same structure as the bone-facing surface of the base plate of claim 1. Clarification is requested.
Further, claims 3 and 14 appear to refer to the same structure by different names – the ‘axial bore’ and the ‘distal bore’. Clarification is requested.
Further, claims 17 and 20 appear to refer to the same structure by different names – the ‘opening’ and the ‘axial opening. Clarification is requested.
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) 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rochetin (US 2007/0179628 A1).
Regarding claim 16, Rochetin teaches a joint replacement system 1, including:
a baseplate 20 having an articular side 21A and a bone facing side 21B;
a proximal member 10 having a first end 12A and a second end 12B spaced apart from the first end, the first end being engageable with the bone facing side 21B of the baseplate 20, and the second end having a first indexing feature 15 [0055]; and
a distal member 40 having a first end 43 and a second end 45, the first end 43 having a second indexing feature 47 configured to engage and index with the first indexing feature 15 so as to prevent relative rotation in a first plane perpendicular to a first axis 11 extending through between the proximal and distal members 10/40 when the distal member 40 is engaged with the proximal member 10.
Regarding claim 17, Rochetin teaches a joint replacement assembly 1, including:
a baseplate 20/50 having an articular side 21A and a bone facing side 21B wherein a boss within 50 extends from the bone facing side 21B (note that 20 can be fixed or removeable from various components [0042]);
a proximal member 10 having a first end 12A, a second end 12B, and a first axis 11 extending through the first and second ends 12A/B, the first end 12A removably engaged to the bone facing side 21B of the baseplate 20; and
a distal member 40 having a first end 43 and a second end 45, the first end 43 removably engaged to the second end 12B of the proximal member 10 and at least partially received within the boss of 50 (especially when threaded together by use of threads 34 [0063], the second end 45 having an opening 44 defining a second axis 31, the second axis being offset from the first axis 11 in a radial direction.
Regarding claim 18, the distal member 40 is capable of use as a distal void filler having a frustoconical body 45 and a lobe portion connected to the frustoconical body 54, the opening 44 extending into the lobe portion.
Regarding claim 19, the lobe portion about 44 extends along at least a portion of a length of the frustoconical body 45.
Regarding claim 20, as best understood, the distal member 40 has an axial opening 44 extending therein and defining a second axis 31 radially offset from the first axis 11.
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) 1-10 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rochetin (US 2007/0179628 A1).
Regarding claim 1, Rochetin teaches a joint replacement assembly 1, comprising:
a baseplate 20 having an articulating side 21A and a bone facing side 21B;
a proximal member 10 having a proximal end 12A and a distal end 12B spaced apart from the proximal end, the proximal end being connectable to the bone facing side 21B of the baseplate 20, the distal end 12B having a plurality of protrusions 15 arranged circumferentially about a first axis 11 extending through the proximal member 10 in a lengthwise direction; and
a distal member 40 having a proximal end 43 and a distal end 45, the proximal end 43 being connectable to the distal end 12B of the proximal member 10 and having a plurality of grooves 47 configured to engage with the plurality of protrusions 15 and prevent rotation of the distal member 40 about the first axis 11 relative to the proximal member 10 [0055].
Rochetin’s grooves and protrusions arrangement is reversed to what is claimed, in that in the claim, the grooves are on the proximal member, and the distal member includes the protrusions. Rochetin does, however, teach that alternate arrangements of the protrusions and grooves are contemplated [0056].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Rochetin’s device to include grooves on a portion of proximal member 10 and protrusions on the distal member 40 to serve the same indexing function described at [0055], since 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.
Regarding claim 2, the plurality of grooves are arranged in 30 degree increments about the first axis: It is noted that the grooves are specifically shown at 15 degree increments, which means that every other groove is in the claimed 30 degree increment. Additionally, various teachings provide for any number of grooves having angular pitch between 15 and 180 degrees. E.g. [0018], [0024], [0055], etc.
Regarding claim 3, the distal end 45 of the distal member 40 includes a distal bore 44 configured to engage an intramedullary stem 30.
Regarding claim 4, as discussed at [0053], the distal bore 44 can become coaxial with the first axis 11 of the proximal member 10 (merged, colinear).
Regarding claim 5, the distal bore 44 is centered about an axis 31 laterally offset from the central axis 11 of the proximal member 10.
Regarding claim 6, the proximal member 10 includes a proximal bore 16 coaxial with the first axis 11.
Regarding claim 7, the baseplate 20, proximal member 10, and distal member 40 are each formed separately from each other.
Regarding claim 8, a distal surface (e.g. bone facing surface) 21B of the baseplate includes a hole 22 extending through a volume of the baseplate.
Regarding claim 9, a proximal surface 12A of the proximal member 10 includes a first protrusion 13 configured to engage with the hole 22 of the baseplate 20 to prevent rotation of the proximal member 10 relative to the baseplate 20 [0042].
Regarding claim 10, the distal member 40 includes a proximally extending boss 42 and the baseplate 10 includes a distally extending boss 17. The distally extending boss 17 is extendable through the distal member and receivable within the proximally extending boss 42 of the distal member 40. This relationship is exactly reversed to that claimed.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Rochetin’s device to cause 40 to include an extension that fit within portion 17, since 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.
Regarding claim 12, the proximal member 10 is capable of use as a proximal void filler having a frustoconical body having an outer surface tapering inwardly from the proximal end to the distal end thereof – configuration of elements 15B is particularly noted, and are considered to be at least a portion of a frusto-conical shape.
Regarding claim 13, the distal member 40 is capable of use as a distal void filler having a frustoconical body having an outer surface 45 tapering inwardly from the proximal end to the distal end thereof.
Regarding claim 14, the distal member 40 further includes a lobe portion integral with the frustoconical body of 45, the lobe portion extending along at least a portion of a length of the frustoconical body and having an axial bore 44 extending into the lobe, the axial bore defining a second axis offset from the first axis by an offset distance. (the configuration of portion 45 is considered to form a lobe at the offset bore 44)
Regarding claim 15, the lobe portion of 45 and second axis 31 are positionable at a plurality of rotational positions about the first axis [0055].
Allowable Subject Matter
Claim 11 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BATES/Primary Examiner, Art Unit 3799
