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) 1-2, 5-10 and 13-15 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.
Applicant argues Alain is not analogous art as it is not a reverse-type shoulder implant. MPEP 2141.01(a)(I) states “a reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem). . .” Alain is a shoulder implant and from the same field of endeavor as the claimed invention.
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.
Claim(s) 1-2, 5-10 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oni (GB 2166654 A) in view of Alain (FR 2825263 A1), Lawrence (US 2019/0021867 A1) and Huebner (US 2016/0022425 A1).
Regarding claim 1, Oni discloses an apparatus (fig. 1) comprising:
a humeral tray (runner, fig. 1) configured to be mounted to a proximal end of a humeral stem (fig. 1, lines 88-96); and
an insert (meniscus, fig. 1) positioned on an outer surface of the humeral tray (fig. 1) configured to articulate with a glenosphere (nipple, fig. 1, lines 88-96);
wherein the insert is not attached to the humeral tray such that the insert can articulate and move relative to the humeral tray (lines 88-96).
Oni fails to teach the humeral tray includes a constraint ridge. However, Alain discloses a shoulder joint prosthesis comprising a tray (20, base, fig 4B), an insert (24, movable plate, fig. 4B) and a glenosphere (12, head of the humerus, fig. 4B) that includes the humeral tray includes a constraint ridge (36, rim, fig. 3A) located around a periphery of the humeral tray (20, base, fig. 3A), wherein a height of the constraint ridge and a height of the insert are such that the insert is constrained from moving past the constraint ridge (fig. 3A and 3B, lines 79-110). 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 apparatus of Oni to include the humeral tray includes a constraint ridges and the insert is circular as taught by Alain in order to control the degree of freedom of the relative movement (lines 81-83, Alain). For clarity, Alain is a teaching reference for the constraint rides it does not modify the shape of Oni.
Oni in view of Alain fail to teach the humeral tray and the insert is circular. However, Lawrence discloses a shoulder joint prosthesis that includes the insert includes a circular shape (4, plate, figs, 4a-4b) and the outer surface of the humeral tray within the constraint ridge defines a circular shape (3, second cup, figs. 3a-3b), wherein the circular shape of the insert is of a smaller diameter than a diameter of the outer surface of the humeral tray within the constraint ridge such that the insert articulates and moves in any direction relative to the humeral tray (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 shape of humeral tray and the insert of Oni to be circular as taught by Lawrence 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 2144.04) and since it would be obvious to try using a circular insert because the insert has to match the shape of the joint and the joint in this case is circular. Since matching the insert shape to joint shape merely involves choosing from a finite number of identified, predictable solutions which are known to be successful, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the invention to use a circular insert (see MPEP 2143 (I)(E))).
Oni, Alain and Lawrence fail to teach the constraint ridge defines a continuous upstanding straight wall without an inward-facing lip or snap-fit retention feature. However, Huebner teaches a bone prothesis with a floating articular member that includes wherein the constraint ridge defines a continuous upstanding straight wall extending around the periphery of the humeral tray without an inward-facing lip or snap-fit retention feature (fig. 21), such that the constraint ridge presents a straight inner surface against which the insert is constrained by contact (fig. 21).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 constraint ridge of Oni, Alain and Lawrence to include defining a continuous upstanding straight wall without an inward-facing lip or snap-fit retention feature as taught by Huebner since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized support a conclusion of obviousness (see MPEP 2144.04). It would have been an obvious matter of design choice to make the constraint ridge of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claim 2, Oni further discloses the humeral tray includes a concave articulation surface (fig. 1).
Regarding claims 5 and 13, Oni fails to teach the insert includes a circumferential groove. However, Alain further discloses the insert includes a circumferential groove (groove, 42, fig. 3A) around an outer periphery of the insert (24, movable plate, fig. 3A). 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 insert of Oni to include a circumferential groove as taught by Alain in order to house lugs (lines 190-200, Alain) and align with the constraint ridge.
Regarding claims 6 and 14, Oni fails to teach the insert has a height higher than a height of the constraint ridge. However, Alain further discloses the insert has a height higher than a height of the constraint ridge (fig. 3A). 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 apparatus of Oni to include the insert has a height higher that a height of the constraint ridge as taught by Alain in order to control the degree of freedom of the relative movement (lines 81-83, Alain).
Regarding claims 7 and 15, Oni in view of Alain fails to teach the humeral tray includes a cut-out and the insert includes a post. However, Lawrence further discloses wherein the humeral tray includes a cut-out in a central surface of the humeral tray (12, aperture, fig. 3a) and wherein the insert includes a post extending from a bottom surface of the insert (16, trunion, fig. 4a), wherein the post is configured to ride in the cut-out so as to prevent excessive motion of the insert relative to the humeral tray (functional language). The phrase “the post is configured to ride in the cut-out so as to prevent excessive motion of the insert relative to the humeral tray” 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 trunion is considered to be capable of preventing excessive motion of the insert relative to the humeral tray. 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 apparatus and system of Oni and Alain to include the humeral tray includes a cut-out and the insert includes a post as taught by Lawrence since it is a combining prior art elements according to known methods to yield predicable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 8, Oni further discloses the insert includes a convex articulation surface for articulating with the humeral tray (fig. 1, lines 99-104) and a concave articulation surface for articulating with the glenosphere (fig. 1, lines 99-104), wherein the convex articulation surface has a greater radius than the concave articulation surface (fig. 1).
Regarding claim 9, Oni discloses a system comprising (fig. 1):
a humeral stem configured to be implanted within a humerus (see annotated fig. 1, below);
a glenosphere (nipple, fig. 1) configured to be mounted on a scapula (see annotated fig. 1, below);
a humeral tray (runner, fig. 1) mounted to a proximal end of the humeral stem (fig. 1, lines 88-96);
an insert (meniscus, fig. 1) positioned on an outer surface of the humeral tray (fig. 1) configured to articulate with the glenosphere (lines 88-96);
wherein the insert is not attached to the humeral tray such that the insert can articulate and move relative to the humeral tray (lines 88-96).
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Oni fails to teach the humeral tray includes a constraint ridge. However, Alain discloses a shoulder joint prosthesis comprising a tray (20, base, fig 4B), an insert (24, movable plate, fig. 4B) and a glenosphere (12, head of the humerus, fig. 4B) that includes the humeral tray includes a constraint ridge (36, rim, fig. 3A) located around a periphery of the humeral tray (20, base, fig. 3A), wherein a height of the constraint ridge and a height of the insert are such that the insert is constrained from moving past the constraint ridge (fig. 3A and 3B, lines 79-110). 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 apparatus of Oni to include the humeral tray includes a constraint ridges and the insert is circular as taught by Alain in order to control the degree of freedom of the relative movement (lines 81-83, Alain). For clarity, Alain is a teaching reference for the constraint rides it does not modify the shape of Oni.
Oni in view of Alain fail to teach the humeral tray and the insert is circular. However, Lawrence discloses a shoulder joint prosthesis that includes the insert includes a circular shape (4, plate, figs, 4a-4b) and the outer surface of the humeral tray within the constraint ridge defines a circular shape (3, second cup, figs. 3a-3b), wherein the circular shape of the insert is of a smaller diameter than a diameter of the outer surface of the humeral tray within the constraint ridge such that the insert articulates and moves in any direction relative to the humeral tray (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 shape of humeral tray and the insert of Oni and Alain to be circular as taught by Lawrence 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 2144.04) and since it would be obvious to try using a circular insert because the insert has to match the shape of the joint and the joint in this case is circular. Since matching the insert shape to joint shape merely involves choosing from a finite number of identified, predictable solutions which are known to be successful, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the invention to use a circular insert (see MPEP 2143 (I)(E))).
Oni, Alain and Lawrence fail to teach the constraint ridge defines a continuous upstanding straight wall without an inward-facing lip or snap-fit retention feature. However, Huebner teaches a bone prothesis with a floating articular member that includes wherein the constraint ridge defines a continuous upstanding straight wall extending around the periphery of the humeral tray without an inward-facing lip or snap-fit retention feature (fig. 21), such that the constraint ridge presents a straight inner surface against which the insert is constrained by contact (fig. 21).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 constraint ridge of Oni, Alain and Lawrence to include defining a continuous upstanding straight wall without an inward-facing lip or snap-fit retention feature as taught by Huebner since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized support a conclusion of obviousness (see MPEP 2144.04). It would have been an obvious matter of design choice to make the constraint ridge of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results (see MPEP 2144.04).
Regarding claim 10, Oni further discloses the humeral tray includes a concave articulation surface (see annotated fig. 1, below).
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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.
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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.
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/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
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