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, 20-21 and 24-32 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 Status
The claim objections and 35 USC 112(b) rejections have been overcome.
Claims 1-5, 7-8, 20-21 and 24-33 are examined below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the two pairs of symmetrical fins wherein one pair of the two pairs of symmetrical fins is smaller than the other pair must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, how adjusting the orientation of the joint member relative to the anchoring member using the indexing structure for selectively configur must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 20-21 and 29-31 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 5, the specification and the drawings do not disclose wherein the anchoring member comprises a proximal part and a distal part joint at a defined boundary, wherein the distal part comprises a substantially even surface configured for bone ingrowth and the proximal part comprises both a substantially even surface and a textured surface of protrusion on a lateral exterior of the proximal part, wherein the protrusion are configured to contact soft tissue and wherein the anchoring member comprises a plurality of fins disposed on the distal portion and extending in radial direction in relation to a direction of insertion of the anchoring member in the bone tissue, wherein the fins extend to a peripheral edge of the distal portion. The specification and drawings disclose the anchoring member comprises a proximal part and a distal part joint at a defined boundary, wherein the distal part comprises a substantially even surface configured for bone ingrowth and the proximal part comprises both a substantially even surface and a textured surface of protrusion on a lateral exterior of the proximal part in page 22 line 9 – page 23 line 2 and figures 5A-5B. The specification and drawings disclose the anchoring member comprises a plurality of fins disposed on the distal portion and extending in radial direction in relation to a direction of insertion of the anchoring member in the bone tissue, wherein the fins extend to a peripheral edge of the distal portion in page 18 line 14 – page 19 line 4 and figures 2A-2C. The specification and the drawings do not describe or show the combination of limitations as claimed, but rather two separate embodiments. Dependent claims 20-21 are likewise rejected.
Regarding claim 27, the specification and the drawings do not clearly explain how the joint member is configurable as either an anatomical joint member or a reverse joint member by adjusting an orientation of the joint member relative to the anchoring member using the indexing structure. The specification discloses the joint member can be anatomical or reverse due to the joint component comprising an intermediate component and a joint component and explains rotating the intermediate member to accommodate the preferred joint member configuration. Without the inclusion of an intermediate component there is a lack of support for the claim limitation.
Regarding claim 29, the specification and the drawings do not disclose wherein the anchoring member comprises a proximal part and a distal part joint at a defined boundary, wherein the distal part comprises a substantially even surface configured for bone ingrowth and the proximal part comprises both a substantially even surface and a textured surface of protrusion on a lateral exterior of the proximal part, wherein the protrusion are configured to contact soft tissue and wherein the anchoring member comprises a plurality of fins extending in radial directions in relation to a direction of insertion of the anchoring member in the bone. The specification and drawings disclose the anchoring member comprises a proximal part and a distal part joint at a defined boundary, wherein the distal part comprises a substantially even surface configured for bone ingrowth and the proximal part comprises both a substantially even surface and a textured surface of protrusion on a lateral exterior of the proximal part in page 22 line 9 – page 23 line 2 and figures 5A-5B. The specification and drawings disclose the anchoring member comprises a plurality of fins extending in radial directions in relation to a direction of insertion of the anchoring member in the bone in page 18 line 14 – page 19 line 4 and figures 2A-2C. The specification and the drawings do not describe or show the combination of limitations as claimed, but rather two separate embodiments. Dependent claims 30-31 are likewise rejected.
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 24-32 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 24 recites the limitation "an anchoring member of claim 1" in line 2. There is insufficient antecedent basis for this limitation in the claim. By reciting “an anchoring member of claim 1”, claim 24 is dependent on claim 1 and requires proper antecedent basis. Dependent claims 25-32 are likewise rejected.
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) 1-4, 7-8, 24-27 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodorek (US 2014/0236304 A1) in view of Murray (US 2003/0074080 A1) and Meridew (US 2014/0058526 A1).
Regarding claim 1, Hodorek teaches an anchoring member for a joint replacement (1, 2, prosthesis, figs. 1-2),
the anchoring member comprising a proximal interface part (141, proximal end, fig. 6) and a distal portion (11, distal end, fig. 6), the distal portion being configured to be anchored within bone tissue (fig. 44) and the proximal interface part being configured for mounting a joint member of the joint replacement (fig. 44),
wherein the proximal interface part comprises a concave interface surface (13, concave portion, fig. 5),
the distal part (11, distal end, fig. 6) comprises a substantially even surface configured for bone ingrowth (fig. 3), and
wherein the anchoring member comprises a mounting hole in the proximal interface part (142, hole, fig. 5).
Hodorek fails to teach an indexing structure. However, Murray teaches a modular neck for a joint replacement that includes 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]), wherein the indexing structure comprises a plurality of indexing recesses arranged circularly around the mounting hole (36, peg holes, fig. 10), each of the plurality of indexing recesses being formed as a blind recess opening into the concave interface surface (the recesses would be in the concave surface and would thus be formed as blind recesses and ¶ [0054] discloses the holes 36 are only formed in an upper portion of the stem) and 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 Hodorek to include an indexing structure as taught by Murray in order to provide the desired degree of anteversion (¶ [0054], Murray).
Hodorek and Murray fail to teach a proximal part and a distal part joined at a defined boundary wherein the proximal part comprises both a substantially even surface and a texture surface. However, Meridew teaches a modular joint replacement that includes a proximal part (154, body portion) and a distal part (152, stem portion) joined at a defined boundary (where the two portions connect), wherein the proximal part comprises both a substantially even surface (202, solid region) and a textured surface (206, lattice region, fig. 5) of protrusions on a lateral exterior of the proximal part (210, macrobarbs, fig. 5), wherein the protrusions are configured to contact soft tissue (¶ [0049]). 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 Hodorek and Murray to include a proximal part and a distal part joined at a defined boundary wherein the proximal part comprises both a substantially even surface and a texture surface as taught by Meridew in order to offer a substantially permanent long term fixation of the soft tissue (¶ [0049], Meridew).
Regarding claim 2, Hodorek further teaches the concave interface surface is formed as a three-dimensionally curved recess having a depth sufficient to at least partially accommodate the joint member therein (fig. 1).
Regarding claim 3, Hodorek further teaches the recess has a curved profile (fig. 3), the curved profile being spherical, ellipsoidal, or ovoid shaped (fig. 5), and wherein a radius of curvature of the curved profile corresponds to a radius of curvature of a convex interface surface of the joint member such that the joint member is at least partially accommodated within the recess in an assembled state (fig. 1).
Regarding claim 4, Hodorek further teaches the mounting hole being centrally disposed in the concave interface surface for fixedly attaching the joint member (fig. 5), the mounting hole comprising a thread for engagement with a fixation member or a tapered portion (¶ [0116]), wherein the thread is configured to draw a convex interface surface of the joint member into seating contact with the concave interface surface upon tightening (¶ [0115-0116]).
Regarding claim 7, Hodorek as modified by Murray and Meridew discloses the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the plurality of indexing recesses are arranged equidistantly on a circle around the mounting hole (fig. 10, Murray).
Regarding claim 8, Hodorek as modified by Murray and Meridew the invention substantially as claimed and as discussed above with respect to claim 1, and additionally teaches the anchoring member further comprising a stem part (10, stem, fig. 3, Hodorek) that is configured to be inserted into the bone tissue (fig. 44, Hodorek), wherein the stem part is modular (fig. 5, Meridew).
Regarding claim 24, Hodorek further teaches a joint member for a joint replacement (20 and 30, metaphysis and inert, figs. 3-4),
an anchoring member of claim 1 (10, stem, fig. 3),
the joint member comprising a proximal end (30, insert, fig. 3) and a distal interface part (20, metaphysis, fig. 3), the proximal end being formed as a joint surface (fig. 45) and the distal interface part being configured for the anchoring member of claim 1 (fig. 45),
wherein the joint surface is a ball joint surface (figs. 1-2), and
wherein the distal interface part comprises a convex interface surface (27, curved surface, fig. 13).
Regarding claim 25, Hodorek further teaches the joint member comprises an intermediate component (20, metaphysis, fig. 3) and a joint component (30, 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 at an engagement portion having a non- circular cross-section configured to prevent relative rotation between the intermediate component and the joint component (36, octagonal locking protrusion, fig. 22).
Regarding claim 26, Hodorek as modified by Murray and Meridew discloses the invention substantially as claimed and as discussed above with respect to claim 25, and additionally teaches the indexing structure comprises a protrusion configured to mate with one of the plurality of indexing recesses of the anchoring member (34, peg, fig. 8, Murray).
Regarding claim 27, Hodorek further teaches the joint member is selectively configurable as either an anatomical joint member (fig. 2) or a reverse joint member (fig. 1) by adjusting an orientation of the joint member relative to the anchoring member using the indexing structure (figs. 32-37 shows how rotating the metaphysis changes the angle the joint member sits to accommodate the preferred joint member surface alignment for the anatomy of the patient), without requiring exchange of the anchoring member (figs. 3-4 use the same anchoring member).
Regarding claim 32, Hodorek further teaches the intermediate component comprises a fixation member that is offset from a center of the distal interface part (23, opening, figs. 13 and 16, ¶ [0117]).
Claim(s) 5, 21, 29 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodorek in view of Murray and Meridew as applied to claims 1 and 25 above, and further in view of Glien (US 2004/0225367 A1).
Regarding claims 5 and 29, Hodorek in view of Murray and Meridew fails to teach a plurality of fins. However, Glien teaches a bone joint with and anchor portion that includes 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 anchoring member of Hodorek in view of Murray and Meridew to include a plurality of fins as taught by Glien in order to produce a press fit of the prothesis in the spongiosa (¶ [0039, Glien).
Regarding claims 21 and 31, Hodorek as modified by Murray, Meridew and Glien discloses the invention substantially as claimed and as discussed above with respect to claims 5 and 29, and additionally teaches the plurality of fins comprises two pairs of fins (figs. 7-10), wherein the two pairs of fins are each the same size (figs. 7-10).
Claim(s) 20 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodorek in view of Murray, Meridew and Glien as applied to claims 5 and 29 above, and further in view of Nicol (US 7,097,633 B1).
Regarding claims 20 and 30, Hodorek as modified by Murray, Meridew and Glien discloses the invention substantially as claimed and as discussed above with respect to claims 5 and 29, and additionally 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 (figs. 7-10, Glien)
Hodorek in view of Murray, Meridew and Glien fails to teach one pair of the fins is smaller than the other pair of the fins. However, Sperling teaches a humeral anchor that includes fins of different sizes in the radial direction (¶ [0008 and 0081], figs. 4A-4J). 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 fins of Hodorek in view of Murray, Meridew and Glien to include differing sizes in the radial direction as taught by Sperling in order to dimension the implant for implantation into a humerus of a subject (¶ [0082], Sperling).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodorek in view of Murray and Meridew as applied to claim 25 above, and further in view of Chavarria (US 2017/0189196 A1).
Regarding claim 28, Hodorek further teaches the intermediate component comprises a proximal engagement portion (22, proximal end, fig. 16) and the distal interface part,
wherein the proximal engagement portion is configured to engage the joint component (figs. 1-2),
wherein the distal interface part comprises the convex interface surface (fig. 13).
Hodorek in view of Murray and Meridew fails to teach a plurality of holes arranged circumferentially and penetrating the distal interface part. However, Chavarria teaches a shoulder orthopedic implant that includes a plurality of holes arranged circumferentially and penetrating the distal interface part (76, holes, 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 intermediate component of Hodorek in view of Murray and Meridew to include a plurality of holes as taught by Chavarria in order to in order to secure various features of the patient’s humerus and surrounding soft tissue to the implant (¶ [0039], Chavarria).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hodorek in view of Murray and Meridew as applied to claim 1 above, and further in view of Splieth (US 2009/0099662 A1).
Regarding claim 33, Hodorek further teaches the concave interface surface and a convex interface surface of the joint member (27, curved surface, fig. 13) are at a distance from each other in an assembled state (gap, fig. 44, ¶ [0148]).
Hodorek in view of Murray and Meridew fails to teach the interfaces surfaces do not contact each other. However, Splieth teaches an orthopedic shoulder prothesis that includes the interface surfaces do not contact each other (fig. 11C, interface surface between 10’ and 80). 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 interfaces of Hodorek, Murray and Meridew to include the interface surfaces do not contact each other as taught by Splieth 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).
Conclusion
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 - Tuesday and Thursday - Friday 7:30 am - 6:00 pm EST.
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/T.M.D./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
