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 .
Claim Objections
Claims 1 and 14 are objected to because of the following informalities:
Claim 1, lines 10-11: “tab having a first protrusion extending from the first flexible tab, and the second flexible tab having a second protrusion extending from the second flexible tab, the first protrusion and the second”.
Claim 14, line 1: “is” (after “lever”) should be removed.
Claim 14, line 2: “about” (between “at” and “a”) should be removed.
Appropriate correction is required.
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) 1-4, 7-11 and 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Malandain, U.S. PG-Pub 2014/0277477.
Regarding claim 1, Malandain discloses an implant inserter adapted to secure and facilitate insertion of a surgical implant having an inserter attachment interface having a narrow external opening at a surface thereof and a broader internal opening disposed within a ventral half of the surgical implant, the implant inserting comprising: a handle (108); an inserter shaft (102) coupled to and extending from a distal end of the handle; a first flexible tab (112) and a second flexible tab (114) extending from a distal end of the inserter shaft, the first flexible tab and the second flexible tab being separated by an inter-tab space (space between tabs 112 and 114), the first flexible tab having a first protrusion (118) extending from the first flexible tab, and the second flexible tab having a second protrusion (120) extending from the second flexible tab, the first protrusion and the second protrusion each being adapted to extend into the broader internal opening of the surgical implant and selectively catch on an interface between the broader internal opening and the narrow external opening, thereby preventing the first flexible tab and the second flexible tab from being withdrawn back through the narrow external opening; and an expansion shaft (126) adapted to selectively extend into the inter-tab space whereby when the expansion shaft extends into the inter-tab space and when the first flexible tab and the second flexible tab catch on the interface, the expansion shaft prevents flexion of the first flexible tab toward the second flexible tab such that the first protrusion and the second protrusion are blocked from being pressed together to allow them to pass back through the narrow external opening of the surgical implant, and whereby when the expansion shaft does not extend into the inter-tab space and when the fist flexible tab and the second flexible tab are inserted into the surgical implant and passed the narrow external opening, the first flexible tab and the second flexible tab are configured to be flexed into the inter-tab space to cause the first flexible tab and the second flexible tab to together have a narrower profile that is able to be passed through the narrow external opening of the surgical implant (Figs. 3-7).
Regarding claims 2-4 and 7, Malandain discloses wherein a distal end of the expansion shaft (126) is configured to slidingly extend into and out of the inter-tab space (space between tabs 112 and 114); wherein a distal end of the expansion shaft is configured to extend into and out of the inter-tab space as a result of an at least partially rotational motion; wherein the inserter shaft (102) comprises a channel formed in the inserter shaft extending from the handle (108) to the distal end of the inserter shaft, the channel being configured to receive the expansion shaft; and wherein the surgical implant comprises a cervical interbody implant (Figs. 3-7 and paragraph [0020]).
Regarding claims 8 and 15, Malandain discloses a surgical system/an implant inserter adapted to secure and facilitate insertion of a spinal interbody surgical implant, the implant inserter comprising: an interbody implant (10) comprising an inserter implant interface comprising: a first opening (opening near 38) at a surface of the interbody implant; and a second opening (interior space/opening leading to 30) formed within a body of the interbody implant, wherein the second opening is broader than the first opening and is in communication with the first opening; and the implant inserter (100) comprising: a handle portion (108) having a proximal end of the handle portion and a distal end of the handle portion; an inserter shaft (102) having a proximal end of the inserter shaft extending from the distal end of the handle portion, and a distal end of the inserter shaft; a first flexible tab (112) and a second flexible tab (114) disposed at the distal end of the inserter shaft, the first flexible tab and the second flexible tab being configured to flex toward each other in order to enable coupling and uncoupling of the implant inserter with the spinal interbody surgical implant; and an expansion shaft (126) having a distal end of the expansion shaft adapted to be selectively disposed between the first flexible tab and the second flexible tab in a manner configured to prevent the first flexible tab and the second flexible tab from flexing toward each other, thereby locking the implant inserter such that it is prevented from at least one of (i) coupling with and (ii) uncoupling from the spinal interbody surgical implant, wherein an entirety of a length of the expansion shaft is disposed between the proximal end of the handle portion and the distal end of the inserter shaft (Figs. 3-7).
Regarding claims 9-11 and 16-18, Malandain discloses wherein the distal end of the expansion shaft (126) is configured to slidingly extend into and out of an inter-tab space (space between tabs 112 and 114) to prevent the first flexible tab and the second flexible tab from flexing toward each other; wherein the distal end of the expansion shaft comprises a broad profile in a first cross-sectional direction (length wise) and a narrow profile in a second cross-sectional direction (height wise) that is orthogonal to the first cross-sectional direction, whereby the expansion shaft is configured to be moved to a first orientation in which the expansion shaft prevents the first flexible tab (112) and the second flexible tab (114) from being flexed toward each other, and to a second orientation in which the first flexible tab and the second flexible tab are permitting to flex toward each other; and wherein the inserter shaft (102) comprises a channel formed in the inserter shaft extending from the handle portion (108) to the distal end of the inserter shaft, and wherein a length of the expansion shaft is entirely disposed within the channel (Figs. 3-7).
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 5, 6, 12, 13, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Malandain, U.S. PG-Pub 2014/0277477 in view of Kiester, U.S. Patent 6,893,464.
Regarding claims 5, 6, 12, 13, 19 and 20, Malandain discloses the invention essentially as claimed except for wherein the expansion shaft has an expansion handle disposed at a proximal end of the expansion shaft that facilitates manipulation of the expansion shaft within the channel of the inserter shaft and having a lever operatively attached between the proximal end of the handle/handle portion and the distal end of the handle portion, whereby manipulation of the lever causes a distal end of the expansion shaft to selectively extend into the inter-tab space between the first flexible tab and the second flexible tab.
Kiester discloses a device having an expansion shaft (44) with an expansion handle (50) at a proximal end thereof and a lever (52) operatively attached between the handle and the expansion shaft, whereby manipulation of the handle/lever causes a distal end of the expansion shaft to selectively extend into an inter-tab space (space between tabs 48a, 48b) (Figs. 5 and 10).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the inserter of Malandain to include an expansion shaft handle and lever in view of Kiester to permit easier handling and manipulation of the expansion shaft by a surgeon to securely hold the implant for implantation within a patient.
Allowable Subject Matter
Claim 14 is 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.
Response to Arguments
Applicant’s arguments, see Remarks, filed 14 February 2025, with respect to the objection of claims 6, 8, 13, 15 and 20 have been fully considered and are persuasive. The objection of claims 6, 8, 13, 15 and 20 has been withdrawn.
Applicant's arguments filed 14 February 2025, regarding claims 1, 8 and 15 have been fully considered but they are not persuasive. Applicant contends that the office has now shown that each and every claim element was known or would have been obvious in light of the cited references, either separately or in combination. However, applicant has not provided any argument specifically pointing out how the cited references to not show each and every claim element, thus being mere conclusory statements. Furthermore, the it is shown in the rejections above how Malandain discloses each claim element of claims 1, 8 and 15. Therefore, claims 1, 8 and 15 still stand rejected under 35 U.S.C. 102(a)(1) to Malandain.
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 Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775