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 with respect to claim(s) 1, 2, 4, 8, 11, 12, 14, 20-26 have been considered but are moot because the new ground of rejection over Ralph et al. US 5607426, as further discussed below. New claims 42 and 43 have been added.
Election/Restrictions
Newly submitted claims 44-50 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Applicant points to claims 44-50 as being based upon claims 1 and 8, but additionally added language such as “wherein the bone plate with the at least one bone plate hole cap secured in the one of the plurality of through-openings, said convex surface of the button is disposed above the first surface of the bone plate” as directed to figures 20-27. Examiner notes figures 20-27 are directed to non-elected species, as indicated in the restriction requirement on 12/6/24.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 44-50 have been withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 1 is objected to because of the following informalities:
Line 10 discloses “plate)” and should be changed to “plate” to correct the typo.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4, 8, 11, 12, 14, 20, 24-26 and 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ralph et al. US 5607426.
Regarding claim 1, Ralph et al. discloses a bone plate system comprising: a bone plate 100 comprising a body having a first surface (108, figure 3a, 3b), a bone-engaging surface (bottom surface 103, figure 3b), and a plurality of through-openings extending from said first surface to said bone-engaging surface (110, 112, figure 3a), said plurality of through-openings defining an inner surface extending between said first surface to said bone-engaging surface of said bone plate (along surfaces 111 and 113, figure 3b); at least one bone plate hole cap 132 comprising a body having a first surface (see annotated figure 5 below), a second surface (see annotated figure 5 below), and a peripheral surface disposed between said first surface and said second surface of said at least one bone plate hole cap (see annotated figure 5 below), said at least one bone plate hole cap securable in at least one of said plurality of through-openings in said bone plate (figure 7); said first surface and/or said second surface of said bone plate hole cap is configured for receiving a drive tool operable for inserting and/or removing the bone plate hole cap into and/or from the bone plate (column 9, lines 29-47; screw is inserted within the coupling element including cap 132, which is then moved and positioned into the through openings 110 or 112, the tapered surface 135 of the cap 132 is positioned against the head of the screw 120, figure 7); at least one cover 142 attachable to said at least one bone plate hole cap (figure 6), said at least one cover having a top portion and a lower portion (see annotated figure 5 below); wherein when said bone plate hole cap is secured in said at least one of said plurality of through-openings, said second surface of said bone plate hole cap is disposed adjacent to said bone-engaging surface of said bone plate (figure 7); and wherein the bone plate with the at least one bone plate hole cap secured in the one of the plurality of through-openings increases the bending strength of a portion of said bone plate across said bone plate hole cap compared to said portion of said bone plate without the bone plate hole cap (Examiner notes that any structural piece inserted into the one the through openings would “increase bending strength” compared to a portion of the plate without the cap, as it would provide additional resistance to fracturing or breaking within that opening, reducing stress concentrations around the openings and discontinuities that may cause fatigue, and thereby result in increased stiffness and bending strength).
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Regarding claims 2, 11 and 12, Ralph et al. discloses wherein the first surface and/or the second surface of the bone hole cap is configured for receiving a male drive tool operable for inserting or removing the bone plate hole cap into and/or from the bone plate (column 8, lines 18-27; any suitable screwdriving tool may be used such as a flat-headed, or allen wrench or hex driver inserted as the screw 120 is driven down and the cap is secured within the bone plate; column 9, lines 29-47; the at least first surface receives the drive tool within the opening recess 136).
Regarding claim 4, Ralph et al. discloses wherein said cover comprises a passageway for receiving a suture (passageway 146 extends through the cap and shaped and configured to receive a suture).
Regarding claim 8, Ralph et al. discloses wherein said top portion of said at least one cover comprises a convex surface (see annotated figure 5 below).
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Regarding claim 14, Ralph et al. discloses wherein said at least one bone plate hole cap comprises a through-opening extending from said first surface of said bone plate hole cap to said second surface of said bone plate hole cap (interior volume 134 is open at the top 136 of the cap 132 and at the bottom thereof 138, figure 5).
Regarding claim 20, Ralph et al. discloses wherein said bone plate comprises metal (column 7, lines 24-35).
Regarding claim 24, Ralph et al. discloses wherein said at least one bone plate hole cap comprises a plurality of bone plate hole caps (a plurality of bone plate hole cap configured for insertion into one of the plurality of openings 110 or 112, figure 3a).
Regarding claim 25, Ralph et al. further comprising a plurality of bone fixation elements 120 (figure 4), said plurality of bone fixation elements 120 extendable through at least some of said plurality of through-openings in said bone plate for securing said bone plate to a bone of a patient (receivable within the plurality of through-openings 110, 112 within bone plate hole cap, figure 3a, 6; column 8, lines 16-17; inserting the screw into the bone for securing the bone plate to a bone of a patient).
Regarding claim 26, Ralph et al. further comprising a plurality of bone screws 120, said plurality of bone screws extendable through at least some of said plurality of through-openings in said bone plate for securing said bone plate to bones of a patient (column 8, lines 16-17; inserting the screw into the bone for securing the bone plate to a bone of a patient, a plurality of screws receivable within each of the plurality of through-openings 110, 112).
Regarding claim 43, Ralph et al. discloses wherein said cover 142 is press fit to said at least one bone plate hole cap 132 (column 8, line 66- column 9, line 12; cover 142 has opening 143 to be inserted or press fit over the cap 132 portion, opening 143 provides an inward directed force to cause the upper section 139 to contract inward and the cover then engages with lip 140).
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.
Claim(s) 21, 22 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ralph et al. US 5607426 in view of Biedermann US 2012/0059425.
Regarding claims 21 and 22, Ralph et al. discloses a bone plate hole cap 142, but fails to disclose the bone plate hole cap being made of a material, the material being a metal or polymer material.
Biedermann teaches a bone plate system, wherein said elements such as the bone plate hole cap 8 comprises metal or a polymer material (paragraph 0055) the material may be of any body compatible material (paragraph 0055). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a bone plate hole cap being a metal or polymer material as desired and taught by Biedermann, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 23, Ralph et al. discloses a bone plate system, but fails to explicitly disclose wherein at least one of the plurality of through-openings in said bone plate comprises a compression opening.
Biedermann discloses wherein at least one of the plurality of through-openings in said bone plate comprises a compression opening (through opening 3, figure 12, paragraph 0057, 0060, provided for a self-compression effect to pull fragments together and provide stability and healing of the bone).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Ralph et al. with a compression opening, as taught by Biedermann, to provide a plate with a self-compression effect to pull fragments together and provide stability and healing of the bone.
Allowable Subject Matter
Claims 3, 5, 16-19 and 42 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 3, the prior art of record and at large fails to disclose wherein said lower portion of at least one cover is configured to correspond to the drive tool. Examiner notes the closest prior art, Ralph et al., discloses the lower portion of the cover is placed over an exterior of the bone plate hole cap, while the upper portion receives a drive tool. It would not be obvious for the lower portion to be configured to correspond to the drive tool, as it is not driven in by the drive tool and is on an exterior of the bone plate hole cap.
Regarding claim 5, the prior art of record and at large fails to disclose wherein said cover comprises a passageway comprising a hole having a first opening disposed adjacent a first peripheral portion of said cover and a second opening disposed adjacent a second peripheral portion of said cover, said hole extends completely within said cover from said first opening to said second opening. Examiner notes the closest prior art, Ralph et al., discloses an hole 148 through the cover, but does not include a first and second opening adjacent a peripheral portion.
Regarding claim 16, the prior art of record fails to disclose wherein some of the plurality of through-openings in the bone plate comprises tapered internal threads, and said peripheral surface of said at least one bone plate hole cap comprises corresponding tapered external threads. Examiner notes the closest prior art, Ralph et al., discloses bone plate comprises internal threads (111, figure 3b) with a tapered portion 113, however, the bone plate hole cap does not disclose threads, only the cover comprises threads. It would not be obvious to modify the surface 135 of the bone plate hole cap, as it is compressed within the through-opening 110 or 112 as the cover is threaded therein.
Regarding claim 19, the prior art of record fails to disclose wherein said at least one bone plate hole cap comprises a first thickness between said first surface and said second surface of said bone plate hole cap, said bone plate around said at least one of said plurality of through-openings comprises a second thickness between said first surface and said bone-engaging surface of said bone plate, and wherein said first thickness is the same as said second thickness. Examiner notes the closest prior art, Ralph et al., discloses a bone hole plate cap being a thickness less than the distance between the first surface and said-bone engaging surface of said bone plate, to allow for room for the cover 142 within the through opening . It would not be obvious to modify to have the bone plate hope cap extending to the first surface, as it would destroy the ability of the cover 148 to compress the socket 132 within the through-opening as the screw is driven into the bone while allowing for the entire coupling (132 and 142) to be sized to fit within the through-opening.
Regarding claim 42, the prior art of record or at large fails to disclose in combination, wherein said at least one cover extends completely across said at least one of said plurality of through-openings in said bone plate. Examiner notes the closest prior art, Ralph et al., discloses a cover having an opening 148 along the center of the cover, which is required for insertion and driving of screw 120. Therefore, it would not be obvious to modify the cover to extend over the entire through-opening in said bone plate, as it would not allow for the insertion tool.
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 CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/C.C.L/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/ Primary Examiner, Art Unit 3771