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 .
Claim Objections
Claim 11 is objected to because of the following informalities: “the neck”. Even though claim 11 depends on claim 10, that positively claims the trial prosthesis. The Examiner suggests to add the following: ---of the trial prosthesis--- after the word “neck” to avoid any ambiguity, since, the neck is modular and claim 10 depends on claim 9. Finally, claim 9 discloses that the trial and the joint prosthesis both positively claim the word “neck”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 7 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kenyon et al US Patent 5,342,362.
Kenyon et al discloses a prosthesis alignment guide (50), comprising: a guide body (52) having an opening (58) extending at least partially therein and a first alignment hole (64) extending entirely therethrough. The opening (58) being configured to receive a trunnion of joint prosthesis for mounting the guide body to the joint prosthesis (see Fig. 6). An alignment member (68) disposed within the first alignment hole (64) and being axially moveable therein. A locking member (70) engaged to the guide body (52) and moveable from a first position in which the locking member is disengaged from the alignment member and a second position in which the locking member engages the alignment member and secures it from axial movement within the first alignment hole (see Figs. 4-6).
Regarding claim 7, the locking member (70) includes a head (See Fig. 6) and a threaded shaft (see Fig. 6) engaged to the guide body (52).
Regarding claim 8, see Fig. 4 showing the alignment member (68) with a headless pin.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kenyon et al US Patent 5,342,362 in view of Burrows et al US Patent 6,117,138.
Kenyon et al discloses the invention substantially as claimed. However, Kenyon et al does not disclose a trial prosthesis.
Regarding claims 9 and 10, Burrows et al discloses a variety of surgical instruments to facilitate the implantation of a femoral stem. As disclosed by the Burrows et al reference the implant is inserted within a bone cavity by using a broach mounted on a reamer, a variety of adapters selectively used with a head trial to check the exact location of the head trial and then properly implant the prosthesis. See col. 3, lines 47-63 disclosing that prior to implanting the femoral stem, a broach is used and later remove the broach to insert a trial femoral stem and perform a trial reduction to assure the proper size of the femoral stem. Additionally, col. 5, lines 38-52 disclose a trial prosthesis (112, see Fig. 3), having a neck (38) and a stem (124), wherein the stem comprises a plurality of teeth.
It would have been obvious to one ordinary skill in the art to add a trial prosthesis (a trial broach prosthesis) as disclosed by the Burrows et al reference to the Kenyon et al reference for the purpose of reducing a trial reduction of bone material to assure the proper size of the femoral stem.
Regarding claim 11, see Fig. 4 showing a modular neck (134) capable of being connected on top of the broach (22) body (24) in Figs. 1 and 2. For example, as disclosed in col. 5, lines 16-37, the broach (22) seats over element (19) of the reamer (10) and as disclosed in col. 5, lines 53-60, the modular neck (134) seats over element (35) of the reamer (10), therefore, the modular neck (134) is connectable to the stem (24), since, the modular neck (134) is on top of the broach (22).
Regarding claim 12, the guide body (52), includes a threaded opening (see Fig. 6) and intersect the alignment hole (see Fig. 6).
Regarding claim 13, the locking member (70, ‘362 reference) includes a head (See Fig. 6) and a threaded shaft (See Fig. 6), wherein the threaded shaft is configured to threadedly engage the threaded opening.
Regarding claim 14, the alignment member (68) is a headless pin (see Fig. 4).
Regarding claim 15, Kenyon et al and Burrows et al disclose the claimed invention except for a tapered opening configured to receive the trunnions of the trial prosthesis and joint prosthesis. It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the locking mechanism of the Kenyon et al reference with a tapered opening, since it has been held to be within the general skill of a worker in the art to select an equivalent known locking element on the basis of its suitability for the intended use as a matter of obvious design choice.
Allowable Subject Matter
Claims 19 and 20 are allowed.
Claims 2-6 and 16-18 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 1/15/26