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 Status
Applicant’s Remarks and Amendments filed 26 May 2026 have been entered. Claim 16 is canceled. Claims 1-14 and 17-20 are pending.
Response to Arguments
Applicant’s arguments, see pgs. 9-10 of remarks, filed 26 May 2026, with respect to the 112(b) rejection has been fully considered and are persuasive. The rejection of claims 1-14 and 16 has been withdrawn.
Applicant's arguments filed 26 May 2026 have been fully considered but they are not persuasive. Regarding the amendments made to claims 1 and 17, Applicant’s argument that “there is no disclosure in Croxton indication that the shaded portion of modified Fig. 17 is, in fact, cylindrical”, and that “Croxton at paragraph [0007] discloses ‘an axis through a center of the concave surface’ of the liner, and that the axis of the liner ‘may or may not be aligned with the central axis of the shell’” (pg. 14 of remarks), Examiner respectfully disagrees. The shaded region of Modified Fig. 17, similar to Applicant’s cylindrical inner surface, follows the chamfer of component 76 which tilts at an angle similar to the insert central axis of Modified Fig. 19. Whereas, the semi-spherical surface of the insert, which stops approximately at the first rim of Modified Fig. 19, aligns with the central axis of Modified Fig. 19. These two axes coincide with each other as shown in Modified Fig. 19. Examiner is interpreting Applicant’s use of the term “coincident” to mean the axes coincide at some point, however Merriam-Webster defines “coincident” as “of similar nature” or “occupying the same space or time”. Examiner cautions that “coincident” may not explicitly define the meaning of Applicant’s claims, and further, may be too broad a term under the current broadest reasonable interpretation of the claim.
Regarding Applicant’s argument that the shaded portion of Modified Fig. 17 is cylindrical, Examiner respectfully disagrees. Croxton teaches that “the rim may be in the form of an edge, a chamfer, a radius, or a surface” or “a constant geometry relieved rim surface around the circumference of the internal diameter of the liner” [0015]. This surface, shaded in Modified Fig. 17, follows the curvature of the component and would therefore form a cylindrical shape if extended.
Further, Applicant’s arguments on pages 11-13 of the remarks are moot as Examiner is not relying upon the Perez and Termanini references to teach the amended portion of the claim.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Croxton et al. (US 2007/0106389 A1), “Croxton” in view of Perez (US 2018/0214274 A1), “Perez”, and further in view of Termanini et al (US 2018/0333265 A1), “Termanini”.
Regarding claim 1, Croxton teaches a method [0027-0045] comprising: aligning an insert component (Fig. 19, component 76) with a distal cavity of an acetabular shell component (Fig. 19, acetabular shell 80), wherein a distal rim of the acetabular shell component defines a first imaginary plane (Modified Fig. 19, first rim axis) and wherein the insert component (Fig. 19, component 76) includes an inner wall extending inwardly from an outer rim of the insert component (Modified Fig. 17, shaded region of component 76), the inner wall including a cylindrical inner surface extending inwardly from the outer rim to a first inner end (Modified Fig. 17, shaded region of component 76 extends inward from upper rim of component 76 and creates cylindrical shape around the circumference of component 76) and a semi-spherical inner surface is connected to the first inner end of the cylindrical inner surface (Modified Fig. 17, semi-spherical inner surface of component 76 connects to shaded region of component 76); rotating the insert component (Fig. 19, component 76), wherein the semi-spherical inner surface defines a first central axis (Modified Fig. 19, central axis defined by semi-spherical inner surface of component 76), and wherein the cylindrical inner surface defines a second central axis that is coincident with the first central axis (Modified Figs. 17 and 19, shaded region of component 76 ); rotating the insert component to position a first rim section of the outer rim (Fig. 18, hood member 40 of component 76) of the insert component (Fig. 19, component 76) superior of a second rim section of the outer rim (Fig. 18, lower edge of component 76 opposite hood member 40) of the insert component (Fig. 19, component 76), wherein the second rim section extends from a first side of the first rim section to a second side of the first rim section (Fig. 18, edges of component 76 extend from hood member 40 to opposite side of component 76 (i.e., rim surrounds component 76)) and wherein the cylindrical inner surface extends a first distance from the semi-spherical inner surface at the first rim section (Modified Fig. 17, shaded region extends into component 76 on side near hood member 40) and a second distance from the semi-spherical inner surface at the second rim section (Modified Fig. 17, shaded region extends into component 76 on side opposite hood member 40), and securing the insert component to the acetabular shell component (Fig. 19, component 76 fits into acetabular shell 80 [0086]), and the insert component (Fig. 19, component 76) is secured to the acetabular shell component (Fig. 19, component 76 fits into acetabular shell 80 [0086]), but fails to teach the second distance is greater than the first distance, and (i) a second imaginary plane defined by the second rim section is parallel to the first imaginary plane defined by the distal rim of the acetabular shell component and (ii) the first rim section of the insert component extends through the first imaginary plane defined by the distal rim of the acetabular shell component.
Perez teaches a dual mobility system comprising a semi-spherical inner surface (Fig. 2C, partially spherical first portion 12 [0004]) and a cylindrical inner surface (Fig. 2C, partially cylindrical second portion 14 [0004]) wherein the second distance (Fig. 2C, second portions 14 extending from first portion 12 comprising step 15 (i.e., left side of Fig. 2C)) is greater than the first distance (Fig. 2C, second portions 14 extending from first portion 12 (i.e., right side of Fig. 2C)). Perez discloses that the geometry of the interior surface of the device allows an insert to be advanced in a single orientation over certain portion of the cavity [0004]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the insert component taught by Croxton with the inner surfaces and distances taught by Perez in order to simplify assembly of the device during insertion. However Croxton in view of Perez fails to teach a second imaginary plane defined by the second rim section is parallel to the first imaginary plane defined by the distal rim of the acetabular shell component and (ii) the first rim section of the insert component extends through the first imaginary plane defined by the distal rim of the acetabular shell component.
Termanini teaches a reconfigurable hip prosthesis wherein a distal rim of the acetabular shell component (Fig. D15, acetabular cup liner 72) defines a first imaginary plane (Fig. D15, flat face 72’ forms an imaginary plane), wherein the second rim section extends from a first side of the first rim section to a second side of the first rim section (Fig. 16B, faces 73’, 73’’ extend across both sides of flat face 72’), (i) a second imaginary plane defined by the second rim section is parallel to the first imaginary plane defined by the distal rim of the acetabular shell component (Fig. 16B, imaginary plane formed by second arcuate flat face 73’’ is parallel to imaginary plane formed by flat face 72’ [0089]) and (ii) the first rim section of the insert component extends through the first imaginary plane defined by the distal rim of the acetabular shell component (Fig. 16B, imaginary plane formed by flat face 72’ intersects with imaginary plane formed by arcuate flat raised face 73’ [0089]). Termanini discloses that this acetabular cup liner is made to be used with one or more acetabular cups [0086]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the implantable components taught by Croxton in view of Perez with the imaginary planes and rims taught by Termanini in order to create a more adaptable implant.
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Modified Figure 17
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Modified Figure 19
Regarding claim 2, Croxton teaches further comprising advancing a femoral head component (Fig. 19, head 22) into engagement with the semi-spherical inner surface of the insert component to seat the femoral head component in the insert component (Fig. 19, head 22 is inserted into component 76).
Regarding claim 3, Croxton teaches wherein a geometric center of the femoral head (Fig. 19, head 22) component is positioned lateral of the first imaginary plane of the acetabular shell component when the femoral head component is seated in the insert component (Fig. 19, head 22 is lateral to rim of acetabular shell 80 when secured within acetabular shell 80).
Regarding claim 4, Croxton teaches wherein securing the insert component (Fig. 19, component 76) to the acetabular shell component (Fig. acetabular shell 80) comprises advancing a rib formed on one of the insert component and the acetabular shell component (Fig. 10, anti-rotation tabs 36) into a groove of the other of the insert component and the acetabular shell component (Fig. 10, anti-rotation tabs 36 fit within complimentary grooves of acetabular shell 80).
Regarding claim 5, Croxton teaches further comprising: inserting the acetabular shell component (Fig. 19, acetabular shell 80) into a patient's surgically prepared acetabulum (acetabular shell is surgically implanted into acetabulum of patient [0041]); and securing the acetabular shell component to the patient's bone (acetabular component is configured to be fixed within the acetabulum of a pelvis [0005]); wherein aligning the insert component (Fig. 19, component 76) with the distal cavity of the acetabular shell component (Fig. 19, acetabular shell 80) comprises aligning the insert component with the distal cavity of the acetabular shell component when the acetabular shell component is secured to the patient's bone (liner is secured in the internal concave surface of the shell [0042]).
Regarding claim 6, Croxton teaches further comprising: orienting the acetabular shell component (Fig. 19, acetabular shell 80) at a desired anteversion and inclination (use of the liner requires optimal positioning of the acetabular component [0011]); wherein securing the acetabular shell component comprises securing the acetabular shell component to the patient's bone (acetabular component is configured to be fixed within the acetabulum of a pelvis [0005]) when the acetabular shell component is oriented at the desired anteversion and inclination (acetabular shell is adapted to be received in an acetabulum and surgically implanted and secured into the acetabulum of the patient (i.e., shell is positioned by surgeon at desired orientation) [0040-0041]).
Regarding claim 7, Croxton teaches wherein rotating the insert component (Fig. 19, component 76) further comprises rotating the insert component to align a plurality of keys (Fig. 10, anti-rotation tabs 36 comprise serrated edges which allow liner 20 to interface with acetabular shell 80 and lock it in place [0084]) extending outwardly from an outer surface of the insert component (Fig. 10, anti-rotation tabs are on outer surface of first portion 70) with a plurality of slots defined in an inner wall of the acetabular shell component (Fig. 10, matching grooves of acetabular shell 80 are on inner wall of acetabular shell 80), wherein the inner wall defines the distal cavity of the acetabular shell component (Fig. 10, inner wall acetabular shell 80 forms cavity of acetabular shell 80).
Regarding claim 8, Croxton teaches wherein securing the insert component (Fig. 19, component 76) to the acetabular shell component (Fig. 19, acetabular shell 80) comprises advancing the plurality of keys into the plurality of slots (Fig. 10, anti-rotation tabs lock liner in place with complimentary grooves of acetabular shell 80 [0084]).
Regarding claim 9, Croxton teaches wherein the first rim section (Fig. 18, hood member 40 of component 76) extends at a non-orthogonal angle (Fig. 18, hood member 40 extends at a diagonal angle relative to the lower edge angle of component 76) relative to the second rim section (Fig. 18, lower edge of component 76 opposite hood member 40).
Regarding claim 10, Croxton teaches wherein the non-orthogonal angle is equal to about 15 degrees (Fig. 4, liner is angled from 10-30 degrees away from center axis 58 of the shell [0079]).
Regarding claim 11, Croxton teaches wherein the insert component (Fig. 19, component 76) includes an outer wall including a lateral edge that is positioned lateral of the first imaginary plane when the insert component is secured to the acetabular shell component (Fig. 19, component 76 comprises a rim that is lateral to the rim of the acetabular shell 80).
Regarding claim 12, Croxton teaches wherein the insert component (Fig. 19, component 76) defines a component axis that extends orthogonal to the second rim section (Modified Fig. 19 below, insert central axis is orthogonal to second rim axis), and the first central axis extends at a non-orthogonal angle relative to the component axis (Modified Fig. 19 below, insert central axis is non-orthogonal to central axis).
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Modified Figure 19
Regarding claim 13, Croxton teaches wherein the acetabular shell component (Fig. 19, acetabular shell 80) defines a third central axis (Modified Fig. 19, central axis) that is coincident with the component axis of the insert component (Modified Fig. 19, insert central axis) when the insert component is secured to the acetabular shell component (Modified Fig. 19, component 76 and acetabular shell 80 are engaged).
Regarding claim 14, Croxton teaches wherein the non-orthogonal angle is equal to about 15 degrees (Fig. 4, liner is angled from 10-30 degrees away from center axis 58 of the shell [0079]).
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Modified Figure 17
Regarding claim 17, Croxton teaches aligning an insert component (Fig. 19, component 76) with a distal cavity of an acetabular shell component (Fig. 19, acetabular shell 80), the insert component including an inner wall extending inwardly from an outer rim of the insert component (Modified Fig. 17, shaded region of component 76), the inner wall including a cylindrical inner surface extending from the outer rim to a first inner end (Modified Fig. 17, shaded region of component 76 extends inward from upper rim of component 76 and creates cylindrical shape around the circumference of component 76) and a semi-spherical inner surface is connected to the first inner end of the cylindrical inner surface (Modified Fig. 17, semi-spherical inner surface of component 76 connects to shaded region of component 76), wherein the semi-spherical inner surface defines a first central axis (Modified Fig. 19, central axis defined by semi-spherical inner surface of component 76), and wherein the cylindrical inner surface defines a second central axis that is coincident with the first central axis (Modified Figs. 17 and 19, shaded region of component 76 ); rotating the insert component (Fig. 19, component 76) to position a first side of the insert component superior (Fig. 18, hood member 40 of component 76) of a second side the insert component (Fig. 18, lower edge of component 76 opposite hood member 40), wherein the cylindrical inner surface extends a first distance from the semi-spherical inner surface at the first side of the insert component (Modified Fig. 17, shaded region extends into component 76 on side near hood member 40) and a second distance from the semi-spherical inner surface at the second side of the insert component (Modified Fig. 17, shaded region extends into component 76 on side opposite hood member 40); and securing the insert component to the acetabular shell component (Fig. 19, component 76 fits into acetabular shell 80 [0086]) such that a portion of the semi-spherical inner surface on the first side (Fig. 18, hood member 40 of component 76) extends through a first imaginary plane defined by a distal rim of the acetabular shell (Modified Fig. 19, first rim axis) component when the insert component is secured to the acetabular shell component (Fig. 19, hood member 40 extends past the first rim axis of Modified Fig. 19 when component 76 is engaged with acetabular shell 80), but fails to teach the second distance is greater than the first distance, the first imaginary plane defined by a distal rim of the acetabular shell component and through a second imaginary plane defined by the second side of the inset component, and wherein the second imaginary plane is parallel with the first imaginary plane.
Perez teaches a dual mobility system comprising a semi-spherical inner surface (Fig. 2C, partially spherical first portion 12 [0004]) and a cylindrical inner surface (Fig. 2C, partially cylindrical second portion 14 [0004]) wherein the second distance (Fig. 2C, second portions 14 extending from first portion 12 comprising step 15 (i.e., left side of Fig. 2C)) is greater than the first distance (Fig. 2C, second portions 14 extending from first portion 12 (i.e., right side of Fig. 2C)). Perez discloses that the geometry of the interior surface of the device allows an insert to be advanced in a single orientation over certain portion of the cavity [0004]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the insert component taught by Croxton with the inner surfaces and distances taught by Perez in order to simplify assembly of the device during insertion. However Croxton in view of Perez fails to teach the first imaginary plane defined by a distal rim of the acetabular shell component and through a second imaginary plane defined by the second side of the inset component, and wherein the second imaginary plane is parallel with the first imaginary plane.
Termanini teaches a reconfigurable hip prosthesis comprising a first imaginary plane defined by a distal rim of the acetabular shell (Fig. D15, flat face 72’ forms an imaginary plane) component and through a second imaginary plane defined by the second side of the inset component (Fig. 16B, imaginary plane formed by flat face 72’ intersects with imaginary plane formed by arcuate flat raised face 73’ [0089]), and wherein the second imaginary plane is parallel with the first imaginary plane (Fig. 16B, imaginary plane formed by flat face 72’ intersects with imaginary plane formed by arcuate flat raised face 73’ [0089]). Termanini discloses that this acetabular cup liner is made to be used with one or more acetabular cups [0086]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the implantable components taught by Croxton with the imaginary planes and rims taught by Termanini in order to create a more adaptable implant.
Regarding claim 18, Croxton teaches further comprising advancing a femoral head component (Fig. 19, head 22) into engagement with the semi-spherical inner surface of the insert component to seat the femoral head component in the insert component (Fig. 19, head 22 is inserted into component 76).
Regarding claim 19, Croxton teaches wherein a geometric center of the femoral head component (Fig. 19, head 22) is positioned lateral of the first imaginary plane of the acetabular shell component when the femoral head component is seated in the insert component (Fig. 19, head 22 is lateral to rim of acetabular shell 80 when secured within acetabular shell 80).
Regarding claim 20, Croxton teaches wherein securing the insert component (Fig. 19, component 76) to the acetabular shell component (Fig. 19, acetabular shell 80) comprises advancing a rib (Fig. 10, anti-rotation tabs 36) formed on one of the insert component and the acetabular shell component into a groove of the other of the insert component and the acetabular shell component (Fig. 10, anti-rotation tabs 36 fit within complimentary grooves of acetabular shell 80).
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.
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/G.G.R./ Examiner, Art Unit 3774
/JERRAH EDWARDS/ Supervisory Patent Examiner, Art Unit 3774
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