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 .
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.
Response to Amendment
This action is in response to Applicant’s amendment received 6/29/2026. The amendments made to the claims do not place the application in condition for allowance for the reasons set forth below. Claims 1-20 remain pending.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 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
Claims 1 and 15 are objected to because of the following informalities: typographical errors.
Claim 1 recites “including fixation feature” in lines 7-8 and should be amended as follows: “the outer shell including a fixation feature configured to secure…”
Claim 15 recites “the fixation feature of the outer shell include” in lines 1-2 and should be amended as follows: “the fixation feature of the outer shell includes”
Appropriate corrections are required.
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.
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 1-11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Hanes (US 2004/0193282) in view of Melozzi (US 2016/0242914).
Regarding claim 1, Hanes discloses a joint replacement implant (Figs. 1-4) comprising a ball (120) including a monoblock neck (Fig. 3) and a shell mobility structure (140) protruding from a central proximal surface (138) opposite the monoblock neck (Figs. 3-4), an intermediate shell (14) adapted to receive the ball (Figs. 1-4), the intermediate shell (14) including a mobility ridge (edges of 36) configured to engage with the shell mobility structure at various angular positions of the ball within the intermediate shell (see [0046]), and an outer shell (12) adapted to receive the intermediate shell (Figs. 1-4). Hanes fails to disclose the outer shell including a fixation feature configured to secure the implant within a portion of a joint of a patient. Melozzi also discloses a joint replacement implant comprising an outer shell (4). Melozzi teaches the outer shell (4) comprises a fixation feature (circumferential ribs 47) configured to secure the implant within a portion of a joint of a patient (within the acetabular seat 8; see Fig. 4). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included a fixation features on Hanes’ outer shell as taught by Melozzi in order to facilitate press-fit coupling between the outer shell and acetabular seat, thereby preventing the outer shell from being pulled out, detached, or dislocated from the acetabular seat (see [0103]).
Regarding claim 2, Hanes as modified discloses the intermediate shell (14) is a partial sphere (see Figs. 1-2).
Regarding claim 3, Hanes as modified discloses the mobility ridge extends distally from an inner surface of the intermediate shell (distally from the top inner surface, for example; see Fig. 2).
Regarding claim 4, Hanes as modified discloses the mobility ridge forms an oval pattern across a segment of the inner surface of the intermediate shell (due to the intermediate shell being a ring type structure which is disclosed by applicant to yield an oval shape when projected on a 2D plane in [0062]).
Regarding claim 5, Hanes as modified discloses the mobility ridge forms the oval pattern when projected on a two-dimensional surface (due to the intermediate shell being a ring type structure which is disclosed by applicant to yield an oval shape when projected on a 2D plane in [0062]).
Regarding claim 6, Hanes as modified discloses the mobility ridge is formed by edges of a void (36) in the partial sphere (see Fig. 2).
Regarding claim 7, Hanes as modified discloses the void is an oval shape when projected into a two-dimensional plane (due to the intermediate shell being a ring type structure which is disclosed by applicant to yield an oval shape when projected on a 2D plane in [0062]).
Regarding claim 8, Hanes as modified discloses the intermediate shell (14) and the outer shell (12) interoperate (12 receives 14) to enable rotational ranges of the monoblock neck while preventing dislocation of the ball (see [0046] and Figs. 1-4). While Hanes as modified is silent as to the maximum degrees of rotation, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have enabled specifically abduction rotation up to 100 degrees, adduction rotation up to 45 degrees, internal rotation up to 50 degrees, external rotation up to 80 degrees, extension up to 25 degrees, and flexion up to 150 degrees, since such values are the maximum normal hip joint movements for the native joint (see instant specification [0046]) and one of ordinary skill in the art would have recognized that staying within the maximum normal native hip joint movements would increase the chances of a successful native joint replacement).
Regarding claim 9, Hanes as modified discloses interaction between the shell mobility structure and the mobility ridge on the intermediate shell operate to move the intermediate shell to cover the ball to prevent dislocation of the ball (see Figs.1-4).
Regarding claim 10, Hanes as modified discloses an inner surface of the outer shell (12) forms a partial sphere (see Figs. 1-2).
Regarding claim 11, Hanes as modified discloses a cross-section of the outer shell (12) forms a semi-circle extending approximately 190 degrees to 220 degrees (see Figs. 1-2).
Regarding claim 15, Hanes as modified discloses the fixation feature of the outer shell includes a conical portion at a proximal apex (see Fig. 6A illustrating 47s including conical portions).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Hanes and Melozzi as applied to claim 1 above, and further in view of Brandewie et al. (US 2021/0169654).
Hanes as modified fails to disclose a liner disposed between the intermediate shell and the outer shell, wherein the liner is a spherical frustum with an inner diameter corresponding to an outer diameter of the intermediate shell and an outer diameter corresponding to an inner diameter of the outer shell, and the liner comprises a plurality of liner sections that are configured to connect to the intermediate shell, the outer shell, or another of the plurality of liner sections. Brandewie also discloses a joint replacement implant comprising an intermediate shell (30) and outer shell (70). Brandewie teaches a liner (50) disposed between the intermediate shell (30) and the outer shell (70), wherein the liner (50) is a spherical frustum with an inner diameter corresponding to an outer diameter of the intermediate shell (30) and an outer diameter corresponding to an inner diameter of the outer shell (70; see Fig. 1), and the liner (50) comprises a plurality of liner sections (i.e., right side, left side, top, middle outer, inner, etc.) that are configured to connect to the intermediate shell (30), the outer shell (70), or another of the plurality of liner sections (Fig. 1). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the joint replacement system of Hanes in view of Melozzi to include a liner disposed between the intermediate shell and the outer shell, wherein the liner is a spherical frustum with an inner diameter corresponding to an outer diameter of the intermediate shell and an outer diameter corresponding to an inner diameter of the outer shell, and the liner comprises a plurality of liner sections that are configured to connect to the intermediate shell, the outer shell, or another of the plurality of liner sections as taught by Brandewie in order to add structural reinforcement to the system (see [0024]).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hanes and Melozzi as applied to claim 1 above, and further in view of McTighe et al. (US 2008/0200990).
Hanes as modified fails to disclose a modular neck couplable to the monoblock neck, wherein the modular neck includes an adjustable stem interface to enable femoral anteversion adjustment between the ball and a femoral stem. McTighe also discloses a joint replacement implant comprising a ball (90) including a monoblock neck (100; see [0075], [0077], and Fig. 34). McTighe teaches a modular neck (104) couplable to the monoblock neck (100; see [0085]), wherein the modular neck (104) includes an adjustable stem interface (106) to enable femoral anteversion adjustment between the ball and a femoral stem (Fig. 35, [0080], [0081], and [0083]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Hanes in view of Melozzi to include a modular neck couplable to the monoblock neck, wherein the modular neck includes an adjustable stem interface to enable femoral anteversion adjustment between the ball and a femoral stem as taught by McTighe in order to selectively attach and secure the neck to a stem (see [0088]).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hanes and Melozzi as applied to claim 1 above, and further in view of Hunter (US 2016/0029952).
Hanes as modified fails to disclose a sensor in the ball, wherein the sensor is an accelerometer or gyroscope configured to transmit data corresponding to a range of motion. Hunter also discloses a joint replacement implant comprising a ball (16; Fig. 7A). Hunter teaches a sensor (42) in the ball (16), wherein the sensor (42) is an accelerometer or gyroscope configured to transmit data corresponding to a range of motion (see [0061]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the ball of Hanes in view of Melozzi to include a sensor, wherein the sensor is an accelerometer or gyroscope configured to transmit data corresponding to a range of motion as taught by Hunter in order to permit the ability to measure performance of the joint replacement implant under various conditions and over long periods of time (see [0061]).
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 MELANIE TYSON whose telephone number is (571)272-9062. The examiner can normally be reached M-F 8:00 AM - 4:00 PM (ET).
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/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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