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 claim(s) 1-5, 7-8 and 20-21 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.
Claim Objections
Claim 1 objected to because of the following informalities: "plurality of indexing recess" should read "plurality of indexing recesses". Appropriate correction is required.
Claim 26 objected to because of the following informalities: "an indexing recess" should read "one of the plurality of indexing recesses". Appropriate correction is required.
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 28-31 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.
Claim 28 recites “a distal interface part” in line 2 and “the distal interface part” in line 4. It is unclear if this is the same distal interface part in claim 24 line 2 or a separate and distinct distal interface part.
Claim 28 recites “a convex interface surface” in line 4. It is unclear if this is the same convex interface surface in claim 24 line 6 or a separate and distinct convex interface surface.
Claim 29 recites the limitation "the anchoring member" in line 2. There is insufficient antecedent basis for this limitation in the claim. An anchoring member is recited in claim 24 line 4 as a part of the functional language, it has not been positively recited. Dependent claims 30-31 are likewise rejected.
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.
Claim(s) 24-25 and 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dalla Pria (US 2007/0100458 A1).
Regarding claim 24, Dalla Pria teaches a joint member (110 and 125, attachment element and articular insert, fig. 3) for a joint replacement,
the joint member comprising a proximal end (see annotated fig. 3, below) and a distal interface part (see annotated fig. 3, below), the proximal end being formed as a joint surface (fig. 4) and the distal interface part being configured for mounting an anchoring member of claim 1 (The phrase “the distal interface part being configured for mounting an anchoring member of claim 1” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the distal interface part is considered to be capable of mounting an anchoring member of claim 1.),
wherein the joint surface is a ball joint surface (fig. 4), and
wherein the distal interface part comprises a convex interface surface (fig. 3).
PNG
media_image1.png
287
466
media_image1.png
Greyscale
Regarding claim 25, Dalla Pria further teaches wherein the joint member comprises an intermediate component (110, attachment element, fig. 3) and a joint component (125, articular insert, fig. 3),
wherein the intermediate component and the joint component are fixedly attached to each other by means of a friction fit or a form fit (¶ [0062]).
Regarding claim 27, Dalla Pria further teaches the joint member is configured as an anatomical or reverse joint member (¶ [0010]).
Regarding claim 28, Dalla Pria further teaches wherein the intermediate component comprises a proximal engagement portion (see annotated fig. 3, below) and a distal interface part (see annotated fig. 3, below),
wherein the proximal engagement portion is configured to engage the joint component (¶ [0062]), and
wherein the distal interface part comprises a convex interface surface (see annotated fig. 3, below), and
wherein the intermediate component comprises a plurality of holes arranged circumferentially and penetrating the distal interface part(127, holes, fig. 3).
PNG
media_image2.png
287
625
media_image2.png
Greyscale
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 and 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nerot (US 2009/0210065 A1) in view of Stone (US 6,783,549 B1), Murray (US 2003/0074080 A1) and Bonitati (US 2013/0304220 A1).
Regarding claim 1, Nerot teaches an anchoring member for a joint replacement (1, rod, fig. 1),
the anchoring member comprising a proximal interface part (7, surface, fig. 1) and a distal portion (4, stem, fig. 1), the distal portion being configured to be anchored within bone tissue (¶ [0022]) and the proximal interface part being configured for mounting a joint member of the joint replacement (fig. 3),
wherein the anchoring member comprises a proximal part (5, head, fig. 1) and a distal part (4, stem, fig. 1), wherein the distal part comprises a substantially even surface configured for bone ingrowth (fig. 1). The phrase “the distal part . . . configured for bone ingrowth” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the surface of the stem is considered to be capable of having bone ingrowth.
wherein the anchoring member comprises a mounting hole in the proximal interface part (8, hole, fig. 1),
Nerot fails to teach a concave interface surface. However, Stone teaches a modular humeral head implant that includes a concave interface surface (56, concave surface, fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Nerot to include a concave interface surface as taught by Stone since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Nerot and Stone fail to teach an indexing structure comprising a plurality of indexing recesses arranged circularly around the mounting hole. However, Murray teaches a modular neck for a hip replacement that includes wherein the concave interface surface comprises an indexing structure (36, peg holes, fig. 10), wherein the indexing structure is configured for adjustment of an orientation between the anchoring member and the joint member (¶ [0054]) and wherein the indexing structure comprises a plurality of indexing recess arranged circularly around the mounting hole (36, peg holes, fig. 10), each of the plurality of indexing recess being able to mate with a corresponding protrusion of the joint member (34, peg, fig. 8). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the anchoring member of Nerot and Stone to include an indexing structure comprising a plurality of indexing recesses arranged circularly around the mounting hole as taught by Murray in order to provide the desired degree of anteversion (¶ [0054], Murray).
Nerot, Stone and Murray fail to teach the proximal part comprises both a substantially even surface and a textured surface of protrusions. However, Bonitati teaches a bone prosthesis that includes the proximal part comprises both a substantially even surface (47, fin, fig. 5) and a textured surface of protrusions (46, side wing portion, fig. 5), wherein the protrusions are configured to contact soft tissue (46, side wing portion, fig. 5). The phrase “the protrusions are configured to contact soft tissue” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the side wing portion is considered to be capable of contacting soft tissue. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Nerot, Stone and Murray to include the proximal part comprises both a substantially even surface and a textured surface of protrusions as taught by Bonitati in order to provide additional support or fixation on either the medial or lateral side of a metaphysis of the bone (¶ [0063], Bonitati).
Regarding claim 2, Nerot fails to teach a recess. However, Stone further teaches the concave interface surface is formed as a recess (fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Nerot to include a recess as taught by Stone since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 3, Nerot fails to teach the recess has a curved profile. However, Stone further teaches the recess has a curved profile, the curved profile being spherical, ellipsoidal, or ovoid shaped (fig. 4). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Nerot to include the recess has a curved profile as taught by Stone since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 4, Nerot further teaches the anchoring member comprises a mounting hole in the proximal interface part (8, hole, fig. 1), the mounting hole being disposed in the concave interface surface for fixedly attaching the joint member (¶ [0025]), the mounting hole comprising a thread (10, screw-threaded portion, fig. 3) for engagement with a fixation member (3, screw, fig. 10).
Regarding claim 5, Nerot further teaches the anchoring member comprises a plurality of fins extending in radial directions in relation to a direction of insertion of the anchoring member into the bone tissue (6, ribs, fig. 1).
Regarding claim 7, Nerot and Stone fail to teach the plurality of indexing recesses are arranged equidistantly on a circle around the mounting hole. However, Murray further teaches the plurality of indexing recesses are arranged equidistantly on a circle around the mounting hole (fig. 10). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the anchoring member of Nerot and Stone to include the plurality of indexing recesses are arranged equidistantly on a circle around the mounting hole as taught by Murray in order to provide the desired degree of anteversion (¶ [0054], Murray).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nerot in view of Stone, Murray and Bonitati as applied to claim 1 above, and further in view of Rockwood (US 5,314,479 A).
Regarding claim 8, Nerot in view of Stone, Murray and Bonitati fails to teach a modular stem. However, Rockwood teaches a modular bone joint implant that includes the anchoring member further comprising a stem part (20a, 20b, stems, fig. 1) that is configured to be inserted into the bone tissue (col 2, lines 36-51), wherein the stem part is modular (fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Nerot, Stone, Murray and Bonitati to include a modular stem as taught by Rockwood in order to allow assembly of a humeral prosthesis have a desired size and shape without requiring a large inventory of differently sized and shaped unitary prostheses for replacement or portions of the humerus (col 3 lines 59-col 4 line 8, Rockwood).
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nerot in view of Stone, Murray and Bonitati as applied to claim 5 above, and further in view of Glien (US 2004/0225367 A1).
Regarding claim 20, Nerot in view of Stone, Murray and Bonitati fails to teach two pairs of symmetrical fins arranged opposite to each other. However, Glien teaches a bone joint implant that includes the plurality of fins comprises two pairs of symmetrical fins arranged opposite to each other with respect to an axis of insertion into a bone (12, ribs, fig. 7). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Nerot, Stone, Murray and Bonitati to include two pairs of symmetrical fins arranged opposite to each other as taught by Glien in order to produce a press fit of the prosthesis in the spongiosa (¶ [0039], Glien).
Regarding claim 21, Nerot in view of Stone and Bonitati fails to teach two pairs of same size fins. However, Glien teaches a bone joint implant that includes the plurality of fins comprises two pairs of fins (12, ribs, figs. 7 and 10), wherein the two pairs of fins are each the same size (figs. 7-10). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Nerot, Stone, Murray and Bonitati to include two pairs of same size fins as taught by Glien in order to produce a press fit of the prosthesis in the spongiosa (¶ [0039], Glien).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dalla Pria in view of Murray (US 2003/0074080 A1).
Regarding claim 26, Dall Pria fails to teach an indexing structured comprising a protrusion. However, Murray teaches a hip implant that includes an indexing structure comprises a protrusion (34, peg, fig. 8) configured to mate with an indexing recess of the anchoring member (¶ [0054]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the joint member of Dall Pria to include an indexing structure comprising a protrusion as taught by Murray in order to provide the desired degree of anteversion (¶ [0054], Murray).
Claim(s) 29-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glien (US 2004/0225367 A1).
Regarding claim 29, Dalla Pria fails to teach the anchoring member comprising a plurality of fins. However, Glien teaches a bone joint implant that includes the anchoring member comprises a plurality of fins extending in radial directions in relation to a direction of insertion of the anchoring member into the bone (12, ribs, figs. 7-10). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Dall Pria to include a plurality of fins as taught by Glien in order to produce a press fit of the prosthesis in the spongiosa (¶ [0039], Glien).
Regarding claim 30, Dalla Pria fails to teach two pairs of symmetrical fins arranged opposite to each other. However, Glien further teaches the plurality of fins comprises two pairs of symmetrical fins arranged opposite to each other with respect to an axis of insertion into a bone (12, ribs, fig. 7). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Dall Pria to include two pairs of symmetrical fins arranged opposite to each other as taught by Glien in order to produce a press fit of the prosthesis in the spongiosa (¶ [0039], Glien).
Regarding claim 31, Dalla Pria fails to teach two pairs of same size fins. However, Glien further teaches the plurality of fins comprises two pairs of fins (12, ribs, figs. 7 and 10), wherein the two pairs of fins are each the same size (figs. 7-10). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the implant of Dalla Pria to include two pairs of same size fins as taught by Glien in order to produce a press fit of the prosthesis in the spongiosa (¶ [0039], Glien).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dalla Pria in view of Iannotti (US 2011/0054624 A1).
Regarding claim 32, Dalla Pria fails to teach a fixation member that is offset from a cent of the distal interface part. However, Iannotti teaches a joint replacement component that includes a fixation member (126, taper feature, fig. 8) that is offset from a center of the distal interface part (fig. 8). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the intermediate component of Dalla Pria to include a fixation member that is offset from a cent of the distal interface part as taught by Iannotti in order to for the head to remain positioned in the desired anatomic orientation prescribed by the patient’s anatomy (¶ [0079], Iannotti).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, THOMAS BARRETT can be reached at (571) 272-4746. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799