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 .
Response to Arguments
Applicant's arguments filed August 31st, 2026 have been fully considered but they are not persuasive.
Applicant argues that currently amended claim 1 is not rendered obvious in view of Matityahu and Sanders. Specifically, Applicant argues that the proposed modification would change the principle of operation of the prior art invention (Matityahu) being modified and the Examiner is using impressible hindsight. The Examiner respectfully disagrees with these assertions. Both prior art references teach the use of projecting tabs to provide articulation of the bushing within the bone plate opening to raise/lower the bushing within the groove(s) of the plate hole. Sanders projections (62’s) are seated within grooves (42) of the plate. Further, the Examiner notes that the rejection is not to replace the entire system of Matityahu with that of Sanders, merely to modify the bushing to have to have a closed perimeter with a plurality of partial slots defining a plurality of deformable portions as Sanders establishes that these two bushing structures (bushing with a slit and absent any partial slots figure 5A and a bushing with a closed perimeter and a plurality of partial slots figures 4C/4D) are known equivalents which perform equally well to radially expanded to lock with an outer surface of a base element using a bone screw.
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.
Claim 16 is 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 16 recites the limitation "said base element" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of examination, the limitation has been interpreted to read “a base element” as this provides proper antecedence.
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.
Claims 1-5, 7-8, 10-14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Matityahu et al. (US 2007/0162016) in view of Sanders et al. (US 2009/0192549). Regarding claim 1, Matityahu discloses a polyaxial screw assembly comprising a base element (32) having a hole (102), said hole defining at least one recess (111/112) on a perimeter of said hole (figure 8); a substantially annular-shaped bushing (33), inserted in said hole (figure 9) and tiltable with respect to an axis of said hole (¶59), said bushing comprising at least one outer protrusion (81/82) fitted inside said at least one recess (figures 10-16); a screw (34) inserted in said bushing and passing in said hole, wherein said screw comprises a head (204) and a stem (186), said head being configured to cooperate with said bushing for an angular locking in a spatial direction of said stem with respect to said hole (¶60); wherein said at least one recess has a respective groove (113/114) that is open toward a top side of said base element (figure 8), and wherein said groove has an extent configured for a raising or lowering of said at least one outer protrusion (figures 10-16), allowing a first partial rotation of said bushing prior to said angular locking (figures 10-16). Matityahu disclose the claimed invention except for the bushing having a solid body and an open shape (figure 5) instead of a closed perimeter and further comprises a plurality of partial slots extending along an insertion direction of said screw, said plurality of partial slots defining a plurality of radially deformable portions of said bushing, said radially deformable portions of said bushing opening outward with insertion of said screw and providing a friction interaction with said base element. Sanders et al. show that a bushing (14) with a closed perimeter (figures 4C/4D) and further comprises a plurality of partial slots (63’s and/or 65’s) extending along an insertion direction of said screw, said plurality of partial slots defining a plurality of radially deformable portions of said bushing (figures 3A, 7B, ¶48-50, said radially deformable portions of said bushing opening outward with insertion of said screw and providing a friction interaction with said base element for said angular locking (figures 3A, 4C-4D, 7B, ¶48-50) is an equivalent structure known in the art. Therefore, because these two bushing configurations were art-recognized equivalents at the time the invention was made, one of ordinary skill in the art would have found it obvious to modify the open/split bushing perimeter of Matityahu to have the closed perimeter bushing of figures 4C-4D of Sanders et al. as it is a known, art-recognized equivalent for providing a bushing that can be radially expanded to lock with an outer surface of a base element using a bone screw (¶48-50 of Sanders et al. and ¶60 of Matityahu).
Regarding claim 2, Matityahu discloses the groove of the at least one recess has a depth extent inside said base element being deeper than a neutral position of said at least one outer protrusion (figures 13-15), said bushing being not tilted with respect to said axis of said hole in said neutral position (figures 10-16).
Regarding claim 3, Matityahu discloses the at least one outer protrusion is partially jutting above said respective groove of said at least one recess in a maximally tilted position of said bushing with respect to said axis of said hole (figures 12).
Regarding claim 4, Matityahu discloses the groove of said at least one recess has a substantially rectilinear development (figure 8, in a top down view), being free from localized enlargements and/or constrictions (figure 8). Regarding claim 5, Matityahu discloses the at least one recess comprises a pair of diametrically opposite recesses (111, 112) in said hole (figure 8) and wherein said at least one outer protrusion comprises a pair of diametrically opposite outer protrusions (81, 82) in said bushing, said pair of outer protrusions being fitted inside said pair of recesses (figure 13).
Regarding claim 7, Matityahu discloses the groove of said at least one recess is further configured for the passage of said at least one outer protrusion and for insertion of said bushing into said hole, said bushing being insertable un-angled and coaxial with respect to said axis of said hole (figure 13).
Regarding claim 8, Matityahu discloses the bushing is at least partially elastically deformable, for insertion into said hole so as to prevent said bushing from getting out of said hole prior to an insertion of said screw (¶44).
Regarding claim 10, Matityahu discloses the groove of said at least one recess is further configured for a second partial rotation of said bushing prior to said angular locking, allowing said bushing to pivot about said at least one outer protrusion (¶47).
Regarding claim 11, Matityahu discloses the at least one outer protrusion and said at least one recess are further configured to prevent a third partial rotation of said bushing about an axis of said hole during a screwing of said screw (¶59). Regarding claim 12, Matityahu discloses the top side, where said groove of said at least one recess is open, is a side of said base element (48, ¶37) being opposite to a final mounting position of said stem of said screw (figure 8).
Regarding claim 13, Matityahu discloses the hole defines an at least partially spherical side wall (106, figure 16) thereof, and wherein said bushing comprises a partially spherical outer contour (76, figure 5)configured for a shape coupling with said side wall to allow said angular locking by friction (¶60). Regarding claim 14, Matityahu discloses the head of said screw comprises a threading (figure 25, ¶54), and wherein said bushing further comprises an inner contour, said inner contour being threaded (74) correspondingly to said head, said head cooperating with said bushing in an at least partially conical coupling to allow said angular locking (¶60).
Regarding claim 16, Matityahu disclose an orthopedic component, such as a prosthesis element or a bone plate (32, figures 1-3), said orthopedic component having at least one hole (102), said at least one hole (102) defining at least one recess (111/112) on a perimeter of said at least one hole, wherein said at least one recess has a respective groove (113/114) being open toward a top side of said base element (48), characterized in that said at least one hole (102) is configured to receive a respective bushing (33) and a respective screw (34) of a polyaxially screw assembly according to claim 1.
Regarding claim 17, Matityahu discloses the head (204, figure 25) of said screw comprises a threading (¶54), and wherein said bushing further comprises an inner contour, said inner contour being threaded (74, figures 17, 20) correspondingly to said head, said head cooperating with said bushing in an at least partially conical coupling to allow said angular locking (¶54, ¶60).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Matityahu (US 2007/0162016) in view of Sanders (US 2009/0192549) in further view of Perrow et al. (US 2009/0062862). Regarding claim 9, Matityahu disclose the claimed invention including the at least one outer protrusion (81/82) comprises a button-like protrusion (figure 5).
However, Matityahu fails to teach the button-like protrusion has a substantially cylindrical body radially protruding from an annular body of said bushing.
Perrow et al. disclose the use of a bushing (150, figure 16) having at least one outer protrusion (160) which comprises a button-like protrusion (figures 16-18D), having a substantially cylindrical body (figures 16-18D) radially protruding from an annular body of the bushing (150) as it is a known alternative shape for allowing controlled pivoting of the bushing relative to the base element.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the button-like protrusions of Matityahu to be substantially cylindrical as taught by Perrow et al. as it is a known alternative shape for allowing controlled pivoting of the bushing relative to the base element.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Matityahu (US 2007/0162016) in view of Sanders (US 2009/0192549) in further view of Wiederkehr (US 2017/0265914).
Regarding claim 5, Matityahu discloses the claimed invention except for the at least one recess comprises a pair of diametrically opposite recesses in said hole and wherein said at least one outer protrusion comprises a pair of diametrically opposite outer protrusions in said bushing, said pair of outer protrusions being fitted inside said pair of recesses.
Regarding claim 5, Wiederkehr discloses the at least one recess comprises a pair of diametrically opposite recesses (113A, 113B, figure 2) in said hole (102), and wherein said at least one outer protrusion comprises a pair of diametrically opposite outer protrusions (358, 359) in said bushing, said pair of outer protrusions being fitted inside said pair of recesses (figures 2, 6) as it is a known alternative configuration/shape for creating an outer protrusion for movable engagement with a plate opening.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time of filing to have constructed the at least one recess to have a pair of diametrically opposite recesses in said hole, and wherein said at least one outer protrusion comprises a pair of diametrically opposite outer protrusions in said bushing as taught by Wiederkehr as it is a known alternative configuration/shape for creating an outer protrusion for movable engagement with a plate opening.
Regarding claim 6, Wiederkehr discloses a first protrusion (358) of said pair of outer protrusions is raised and a second protrusion (359) of said pair of outer protrusions is lowered in said first partial rotation of said bushing (201), said pair of outer protrusions being configured to slide inside two grooves of said pair of recesses, respectively (¶52, ¶55).
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 MATTHEW JAMES LAWSON whose telephone number is (571)270-7375. The examiner can normally be reached Mon - Fri 6:30-3:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anita Coupe can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW J LAWSON/Primary Examiner, Art Unit 3619
