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 9 February 2026 have been entered. Claims 1-9 are pending.
Drawings
The drawings were received on 9 February 2026. These drawings are acceptable.
Response to Arguments
Applicant’s arguments regarding the objection to the drawings relating to the features of the “insert”, “plug”, and “insert element” are persuasive. The objection to the drawings is withdrawn.
Applicant’s arguments with respect to claims 1-9 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 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 1-9 are 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 1 recites the limitation "the body region of the ilium" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim. Claims 2-9 are rejected by dependency.
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.
Claim 1-4, 6-7, and 9 is rejected under 35 U.S.C. 103 as being unpatentable over RU 195377 U1, herein referred to as “RU 377” in view of Pappas et al. (US Pat. No. 4955919), “Pappas”.
Regarding claim 1, RU 377 teaches an acetabular implant comprising a spherical cup (Fig. 1, cup 1) provided with through openings for screws (Fig. 2, holes 3), wherein a hemisphere apex region (Fig. 2, region of cup 1 above (i.e., more central) boundary 7) of the spherical cup (Fig. 1, cup 1) is provided with a through opening for osteoplasty (Fig. 2, threaded hole 6 within boundary 7) of an acetabular floor, and wherein a third spherical surface segment (Modified Fig. 1 below, region on surface of cup 1 between flange 4 and hole 3b) between an edge of a rim (Fig. 1, flange 4) of said spherical cup (Fig. 1, cup 1) and the third through opening (Modified Fig. 1 below, hole 3b) is larger than a second spherical surface segment between the edge and the second through opening (Modified Fig. 1 below, region on surface of cup 1 between flange 4 and hole 3a is smaller than the region on surface of cup 1 between flange 4 and hole 3b), and a first spherical surface segment between the edge and the first through opening (Modified Fig. 1 below, region on surface of cup 1 between flange 4 and hole 3a is smaller than the region on surface of cup 1 between flange 4 and hole 3b), to form a supporting ledge in the body region of the ilium (Fig. 2, region of cup 1 below boundary 8), but fails to teach a first through hole for fixation in the ischium, a second through opening for fixation in the pubis, and a third through opening for fixation in the ilium.
Pappas teaches a multi-component joint prosthesis comprising a first through hole for fixation in the ischium (Fig. 1, metal screw 52 (not shown) fixed to the ischium 12 (col. 5, lines 4-10)), a second through opening for fixation in the pubis (Fig. 1, metal screw 53 fixed to the pubis 13 (col. 5, lines 4-10)), and a third through opening for fixation in the ilium (Fig. 1, metal screw 51 fixed to the ilium 11 (col. 5, lines 4-10)). Pappas discloses that to engage the best available bone accessible through the aperture, the spherical seats for the screws may be made oblong (col. 6, lines 22-27). 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 acetabular cup taught by RU 377 with the through holes taught by Pappas in order to best secure the cup to the bone.
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Modified Figure 1
Regarding claim 2, RU 377 teaches wherein said supporting ledge is extended into an outer surface of the spherical cup (Fig. 2, region below boundary 8 is comprised within cup 1),
which is formed by angle α between diametral planes in the range of 1° to 30° (Fig. 1, holes 3 formed along boundary 8 are angled at 26° (i.e., region below boundary 8 is angled at 26° or less)), said outer surface being adjacent to an equatorial plane of said hemisphere apex region (Fig. 1, horizontal axis of cup 1 relative to angles formed by holes 3 (i.e., 26° and 58°)).
Regarding claim 3, RU 377 teaches wherein, in the spherical cup (Fig. 1, cup 1), an additional undercut (Modified Fig. 1 below, empty angled region of flange 4) is cropped in the first and second spherical segments (Modified Fig. 1 below, flange 4 is formed from shaping (i.e., cropping) surface of cup 1), to prevent a conflict between soft tissues and the implant components (Fig. 1, flange 4 minimizes the risk of impingement).
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Modified Figure 1
Regarding claim 4, RU 377 teaches wherein said additional undercut (Fig. 1, flange 4 minimizes the risk of impingement) is cropped in a region of the outer surface (Modified Fig. 1 above, flange 4 is formed from shaping (i.e., cropping) surface of cup 1), which is formed by an angle β between the diametral planes in the range of 1°-20° and which is adjacent to the equatorial plane of said hemisphere apex region (Fig. 1, holes 3 formed along boundary 8 are angled at 26° (i.e., region below boundary 8 is angled at 26° or less)).
Regarding claim 6, RU 377 teaches wherein the spherical cup (Fig. 1, cup 1) is configured to have an insert mounted to create a sliding pair of a joint (cup 1 is cemented with an additional polyethylene cup or double mobility system on its inner surface [0050]).
Regarding claim 7, RU 377 teaches wherein the spherical cup (Fig. 1, cup 1) is configured to have a plug or an insert element fitted in the through opening for osteoplasty of the acetabular floor (Fig. 3, holes 3 comprise threaded hole 10 for plugs to be installed).
Regarding claim 9, RU 377 teaches wherein the outer surface of the spherical cup (Fig. 1, cup 1) has a porous coat (Fig. 2, cup 1 comprises porous outer coating 2) for achieving biological bone fixation to an acetabulum.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over RU 195377 U1, herein referred to as “RU 377” in view of Pappas et al. (US Pat. No. 4955919), “Pappas” and further in view of Smith et al. (US 2016/0015520 A1), “Smith”.
Regarding claim 5, RU 377 teaches the spherical cup (Fig. 1, cup 1), but fails to teach a thickness decreasing gradually in a direction from the hemisphere apex region towards said edge.
Smith teaches an acetabular prosthesis liner comprising a thickness decreasing gradually in the direction from the hemisphere apex towards said edge (Figs. 3-3A, thickness 25b near open portion 18b is thinner than thickness 25 near apical portion 18a [0020]). Smith discloses that the liner thickness is varied to best fit with the femoral head in order to reduce the risk of dislocation and minimize point loading on the head [0022]. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to modify the thickness of the cup taught by RU 377 to reflect the varying thickness of the liner taught by Smith in order to minimize point loading and possible dislocation of the device.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over RU 195377 U1, herein referred to as “RU 377” in view of Pappas et al. (US Pat. No. 4955919), “Pappas” and further in view of Nevins et al. (US 2012/0179270 A1), “Nevins”.
Regarding claim 8, RU 377 teaches the through hole opening for osteoplasty (Fig. 2, threaded hole 6 within boundary 7) of the acetabular floor and the openings for the attachment screws (Fig. 2, holes 3) and the diameter of the hemisphere forming the region of the outer spherical surface of the spherical cup (Fig. 1, cup 1 has a maximum diameter (including the rim) of 76 mm), but fails to teach wherein the diameter of the through opening for osteoplasty of the acetabular floor is no less than double respective diameters of the first, second, and third through openings for screws and no more than 0.75 of a diameter of the hemisphere apex region of the spherical cup.
Nevins teaches an acetabular component wherein the diameter of the through opening for osteoplasty of the acetabular floor is no less than double respective diameters of the first, second, and third through openings for screws (Fig. 4A, diameter D of openings 110 correspond to diameters of fasteners 120 which may be 6.5 millimeters in width (i.e., osteoplasty opening) and 2.7 millimeters in width (i.e., attachment screw openings) [0068]) and no more than 0.75 of a diameter of the hemisphere apex region of the spherical cup (Fig. 4A, diameter D of openings 110 is smaller than width of the base opening of shell 100). Nevins discloses that the use of multiple small diameter fasteners operates to spread the load over a larger area from the implant to the bone [0071]. 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 acetabular shell taught by RU 377 with the size of the through holes as taught by Nevins in order to reduce the stress concentration in any one area.
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 GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 EST.
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/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
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