DETAILED ACTION
This action is in response to Applicant’s amendment filed on September 11, 2025.
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 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 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vandewalle (U.S. Patent No. 7207995).
Vandewalle et al. discloses a device for implanting a screw into a bone of a patient (Figure 3) comprising: a carrier (14) comprising: a first portion (38); a threaded second portion (34) opposite the first portion (Figure 2); an opening (56) extending from the first portion to the second portion (Figure 2), wherein the opening is configured to receive a stylet (44); and a lock (46), wherein the lock is in communication with the opening and can be moved between a locked position and an unlocked position (Column 4, Lines 35-48), wherein the lock engages the stylet disposed within the opening to lock a position of the stylet relative to the carrier (Figure 3); a handle (12) having a threaded portion (22), wherein the second portion of the carrier threadably engages with the threaded portion of the handle (Figure 3); and, a screwdriver (16) coupled to the handle and configured to engage a threaded screw, wherein the screwdriver comprises a lumen configured to receive the stylet (Figure 3).
It is noted that the stylet and all its limitations are only functionally claimed, thus it is considered that the opening of the carrier is capable of receiving the claimed stylet. Furthermore, the lock also is only configured to engage the functionally claimed stylet. F
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) 1-3, 6-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vandewalle (U.S. Patent No. 7207995) in view of Gladieux et al. (U.S. Publication No. 2022/0280206).
The following rejection is written based on a positive recitation of the stylet.
Vandewalle et al. discloses a device for implanting a screw into a bone of a patient (Figure 3) comprising: a carrier (14) comprising: a first portion (38); a threaded second portion (34) opposite the first portion (Figure 2); an opening (56) extending from the first portion to the second portion (Figure 2), wherein the opening is configured to receive a stylet (44); and a lock (46), wherein the lock is in communication with the opening and can be moved between a locked position and an unlocked position (Column 4, Lines 35-48), wherein the lock engages the stylet disposed within the opening to lock a position of the stylet relative to the carrier (Figure 3); a handle (12) having a threaded portion (22), wherein the second portion of the carrier threadably engages with the threaded portion of the handle (Figure 3); and, a screwdriver (16) coupled to the handle and configured to engage a threaded screw, wherein the screwdriver comprises a lumen configured to receive the stylet (Figure 3).
Vandewalle fails to disclose that the stylet comprises an elongate needle and a needle head, wherein the needle head comprises a plurality of grooves and a plurality of measurement indicators such that the lock engages the grooves when locked and the measurement indicator indicates a length a distal tip protrudes beyond the screw. Gladieux teaches a device for implanting a screw comprising a carrier (75) having a opening for receiving a stylet (Figure 1G, 2B). The stylet has an elongate needle (20) with a needle head (5) having a plurality of grooves (paragraph 102, Figure 6d), and a plurality of measurement indicators (102). Such that a surgeon can have visual feed back of the extension of the stylet tip from the driver and thus the screw (Paragraph 76). It would have been obvious to one skilled in the art to construct the stylet of Vandewalle comprising needle head comprises a plurality of grooves and a plurality of measurement indicators such that the lock engages the grooves when locked and the measurement indicator indicates a length a distal tip protrudes beyond the screw in view of Gladieux et al. to provide a visual feedback of the extension of the stylet while the grooves provide a better engagement between the lock and stylet.
It is noted that the following claims are obvious under Vandewalle in view of Gladieux, however only individual texts are cited for brevity of the Office Action.
Regarding claim 2, Vandewalle discloses the claimed invention except for the first thread pitch of the threaded second portion of the carrier is greater than a second thread pitch of the threaded screw. Vandewalle however, does contemplate that the pitches can be different to affect a certain outcome of the carrier (Column 5, Lines 62-67 and Column 1, Lines 1-6). It would have been obvious to one skilled in the art to construct the device of Vandewalle the first thread pitch of the threaded second portion of the carrier is greater than a second thread pitch of the threaded screw since such would provide a desired outcome of extraction rate of the stylet.
Regarding claim 3, Vandewalle discloses a first thread pitch of the threaded second portion of the carrier is equal to a second threaded pitch of the threaded screw (Column 4, Lines 48-51).
Regarding claim 6, it can be seen in Figure 6D of Gladieux et al. that the plurality of grooves are arranged vertically along a length of the needle head.
Regarding claim 7, each groove of the plurality of grooves corresponds to the length that the distal tip of the needle extends past a distal end of the screw, and wherein each groove of the plurality of grooves corresponds to a respective measurement indicator of the plurality of measurement indicators (Paragraph 102, Figure 6d, Gladieux et al.).
Regarding claim 8, Vandewalle discloses a device for implanting a screw into bone (Figure 3) comprising: a carrier (14) comprising: a first portion (38); a threaded second portion (34); an opening (56) extending from the first portion to the second portion; and a lock (46) moveable between a locked position and an unlocked position; a stylet (44) having an elongate needle and a needle head (as seen in Figure 4, the stylet has a needle portion and a proximal end of the stylet can be considered a needle head), wherein at least a portion of the needle head is disposed within the carrier (Figure 6), wherein the lock (46) engages the needle head in the locked position (Figure 3); a handle (12) having a third portion (22) and a fourth portion (24), wherein the third portion of the handle is threadably engaged with the threaded second portion of the carrier (Figure 1, 2); a screwdriver (16) coupled to the fourth portion of the handle; and, a screw (26) coupled to the screwdriver.
Vandewalle fails to disclose that the stylet comprises an elongate needle and a needle head, wherein the needle head comprises a plurality of grooves and a plurality of measurement indicators. Gladieux teaches a device for implanting a screw comprising a carrier (75) having a opening for receiving a stylet (Figure 1G, 2B). The stylet has an elongate needle (20) with a needle head (5) having a plurality of grooves (paragraph 102, Figure 6d), and a plurality of measurement indicators (102). Such that a surgeon can have visual feed back of the extension of the stylet tip from the driver and thus the screw (Paragraph 76). It would have been obvious to one skilled in the art to construct the stylet of Vandewalle comprising needle head comprises a plurality of grooves and a plurality of measurement indicators such that the lock engages the grooves when locked and the measurement indicator indicates a length a distal tip protrudes beyond the screw in view of Gladieux et al. to provide a visual feedback of the extension of the stylet while the grooves provide a better engagement between the lock and stylet.
It is noted that the following claims are obvious under Vandewalle in view of Gladieux, however only individual texts are cited for brevity of the Office Action.
Regarding claim 9, Vandewalle discloses the claimed invention except for the first thread pitch of the threaded second portion of the carrier is greater than a second thread pitch of the threaded screw. Vandewalle however, does contemplate that the pitches can be different to affect a certain outcome of the carrier (Column 5, Lines 62-67 and Column 1, Lines 1-6). It would have been obvious to one skilled in the art to construct the device of Vandewalle the first thread pitch of the threaded second portion of the carrier is greater than a second thread pitch of the threaded screw since such would provide a desired outcome of extraction rate of the stylet.
Regarding claim 10, Vandewalle discloses a first thread pitch of the threaded second portion of the carrier is equal to a second threaded pitch of the threaded screw (Column 4, Lines 48-51).
Regarding claim 11, Vandewalle discloses the stylet is moveable within the carrier when the lock is in the unlocked position. (It can be construed from the figures that the stylet is movable within the carrier when the lock is not screwed into the carrier).
Regarding claim 12, Gladieux et al. teaches the lock engages at least of the plurality of grooves (Paragraph 102)
Regarding claim 13, Gladieux et al. teaches the plurality of grooves are arranged vertically along a length of the needle head (Figure 2b, 6d).
Regarding claim 15, Gladieux et al. teaches that each groove of the plurality of grooves corresponds to the length of the distal tip of the needle that extends past the distal end of the screw (paragraph 76)
Regarding claim 16, Vandewalle discloses a method of implanting a screw into a bone of a patient (Figure 3), comprising the steps of: providing an instrument comprising: a carrier (14) defining an opening (56) configured to receive a stylet, the carrier comprising a lock (46) moveable between a locked position and an unlocked position (Column 4, Lines 35-48); a handle (12) having a third portion (22) and a fourth portion (24), wherein the third portion of the handle is threadably engaged with the carrier (Figure 1, 2); a screwdriver (16) coupled to the fourth portion of the handle; inserting the stylet (44) into the instrument (Figure 4-6), the stylet having an elongated needle and a needle head (It can be considered that the proximal portion in the carrier portion 38 is a needle head and the rest of the stylet an elongated needle), wherein the elongate needle extends through the instrument and the screw (Figure 3), and wherein at least a portion of the needle head is disposed within the carrier and the lock engages the needle head such that a first length of a tip of the needle extends past a distal end of the screw (Figure 3); implanting the first length of the tip of the needle into the bone; and implanting the screw into bone (Figure 3).
Vandewalle fails to disclose that the stylet comprises an elongate needle and a needle head, wherein the needle head comprises a plurality of grooves and a plurality of measurement indicators such that the lock engages the grooves when locked and the measurement indicator indicates a length a distal tip protrudes beyond the screw. Gladieux teaches a device for implanting a screw comprising a carrier (75) having a opening for receiving a stylet (Figure 1G, 2B). The stylet has an elongate needle (20) with a needle head (5) having a plurality of grooves (paragraph 102, Figure 6d), and a plurality of measurement indicators (102). Such that a surgeon can have visual feed back of the extension of the stylet tip from the driver and thus the screw (Paragraph 76). It would have been obvious to one skilled in the art to construct the stylet of Vandewalle comprising needle head comprises a plurality of grooves and a plurality of measurement indicators such that the lock engages the grooves when locked and the measurement indicator indicates a length a distal tip protrudes beyond the screw in view of Gladieux et al. to provide a visual feedback of the extension of the stylet while the grooves provide a better engagement between the lock and stylet.
It is noted that the following claims are obvious under Vandewalle in view of Gladieux, however only individual texts are cited for brevity of the Office Action
Regarding claim 17, Vandewalle discloses the method further comprises the steps of: adjusting, after implanting the first length of the tip of the needle into the bone, the instrument so that the needle extends a second length past the distal end of the screw; and, implanting the second length of the tip of the needle into the bone (Column 6, Lines 1-6, the member 14 translating toward the driver member while the stylet 44 is locked therein, would indicate the length tip of the length of the needle would increase to a second distance past the screw tip).
Regarding claim 18, Vandewalle discloses adjusting the instrument comprises moving the lock of the carrier into an unlocked position. In order to remove the device after the screw has been implanted, the lock 46 must be unlocked. It is considered that the step of adjusting includes the whole process of inserting the screw and removal of the tool.
Regarding claim 19, Gladieux teaches that the needle head of the stylet comprises a plurality of grooves (paragraph 102).
Regarding claim 20, adjusting the instrument comprises: moving the lock into an unlocked position; moving the carrier relative to the stylet such that the lock aligns with a groove of the plurality of grooves; and, moving the lock into a locked position, wherein the lock engages the groove of the plurality of grooves. It can be construed from Vandewalle and Gladieux that when the lock is unclocked the stylet can move to a certain position and locking within the groove at a desired location. Furthermore, the step of adjusting as stated above, is considered the entire process of inserting the screw and removing the instrument.
Regarding claim 21, 22, Vandewalle discloses the threaded second portion is configures such that, when the handle is rotated, and the carrier held stationary, the screw is driven into the bone without increase a depth of the distal tip of the elongate needle (Column 5, Lines 45-62).
Regarding claim 23, Vandewalle discloses the carrier comprise a threaded portion configured to threadably engage the handle, wherein the threaded portion is configured such that, when the handles is rotated and the carrier held stationary, the screw is driven into the bone without increasing the depth of the tip of the elongate needle in the bone (Column 5, Lines 45-62).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 8, 16 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.
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 ANDREW YANG whose telephone number is (571)272-3472. The examiner can normally be reached 9:00 - 9:00 M-F.
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/ANDREW YANG/Primary Examiner, Art Unit 3775