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 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 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(s) 1-9, 11-13, and 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (Pub. No. AU 2018330957 A1) in view of Casey et al. (Pat. No. US 9517089).
Regarding claims 1-9, 11-13, and 18, Zhu et al. discloses a bone screw (figures 1-3 and 13-14) comprising: a bone screw shank 6 comprising a shank head 61; a dual-head receiver 1/2 comprising: a first receiver 1 comprising a first base having a cavity 11 therewithin, the cavity 11 configured to securely receive the shank head 61, a first pair of arms extending upwardly from the first base (figure 13), and a first rod channel 4 defined between the first pair of arms (figure 13); a second receiver 2 comprising a second base having a second rod channel 4 defined between a second pair of arms (figure 13); and a connection 3 (figures 2, 13, 14) between the first receiver 1 and the second receiver 2, wherein the connection 3 is integral to one arm of the first pair of arms and is movable relative to the second pair of arms (figures 1-3, 13, 14; page 6, third paragraph of the translation), wherein the second receiver is movable in multiple dimensions including roll and pitch (figures 1-3). The first rod channel 4 extends in a first direction, and the second rod channel 4 extends in a second direction substantially parallel to the first direction (figure 13). The first rod channel 4 extends in a first direction, and the second rod channel 4 extends in a second direction that is tilted by an angle relative to the first direction (figures 1 and 3). The first rod channel 4 and the second rod channel 4 are at an identical level along a proximal to distal direction (figure 13). The first rod channel 4 and the second rod channel 4 are at two different levels along a proximal to distal direction (in figure 1, when the channels are tilted, they are at different levels along a proximal to distal direction). The first receiver 1 comprises a longitudinal axis extending in a proximal to distal direction, and wherein the connection 3 between the first receiver 1 and the second receiver 2 extends substantially perpendicular to the longitudinal axis of the first receiver 1 (figure 13). The connection 3 between the first receiver 1 and the second receiver 2 extends in a direction that is perpendicular to a direction of extension of the first rod channel 4 or tilted by an angle from the direction of extension of the first rod channel 4 (figure 13). The connection 3 between the first receiver 1 and the second receiver 2 extends laterally from an outer surface of one arm of the first pair of arms (figure 13), wherein the second receiver 2 is movably coupled with the connection 3 (page 6, third paragraph of the translation; figure 1-3), wherein the second receiver 2 comprises a slot 21 in one arm of the second pair of arms (figure 2), wherein the connection 3 extends through the slot 21 and permits rotation (figure 1), and tilting (figure 3) of the second receiver 2 relative to the connection 3 (figure 7). The first receiver 1 comprises a first tool engagement groove (illustrated in figure 14) at an outer surface of the first pair of arms at or Serial No. 16/880,8184near a top surface thereof, and wherein a top edge of the connection 3 between the first receiver 1 and the second receiver 2 is distal to the first tool engagement groove (figures 13 and 14). The first receiver 1 comprises a proximal opening (illustrated in figure 13) that is configured to receive a first closure top that presses against a first rod within the first rod channel 4 thereby securing the first rod therewithin (figures 13, 16, and 17). The second receiver 2 is shorter than the first receiver 1 along a proximal to distal direction (figure 14). The second receiver 2 is rotatable relative to an axis of the connection to position the second receiver 2 at an acute angle relative to the axis of connection 3 (figure 3), and wherein the connection 3 is monolithic with the one arm of the first pair of arms (figure 13). A second arm of the second pair of arms is closed at an outer surface thereof such that the connection does not extend through the second arm (figures 1 and 5)
Zhu et al. discloses the claimed invention except wherein the second receiver is moveable in directions including translation, roll, pitch, and yaw. Zhu et al. teaches wherein the second receiver is moveable in directions including roll and pitch.
Casey et al. teaches a connection 70/46 between a first receiver 18 and a second receiver 16 wherein the connection is integral to the first receiver 18 and moveable relative to the second receiver 16 in all axes (figures 2-7; col. 5, lines 1-18), wherein relative to the connection between the first receiver and the second receiver, the second receiver 16 is movable in multiple dimensions including translation, roll, pitch, and yaw (col. 5, lines 1-18 discloses that the spherical connection 70 in combination with the passage 68 allows rotation of the receiver 16 in all directions, and sliding between arm 46 and collet 70). Casey et al. teaches that such a connection is advantageous because it allows the receivers to better accommodate the patient’s anatomy (col. 3, lines 34-43).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the bone screw /receiver disclosed by Zhu et al. to comprise a connection as taught by Casey et al., wherein the second receiver is moveable in directions including translation, roll, pitch, and yaw, in order to better accommodate the patient’s anatomy (col. 3, lines 34-43).
Regarding claims 15-17 and 19, as modified, a gap exists between the second receiver 1 and the first receiver 2 during movement of the second receiver 2 in each of the multiple dimensions (figure 2 of Casey et al.); wherein the gap is sufficient to prevent contact between the first receiver 1 and the second receiver 2 during movement of the second receiver in all of the multiple dimensions (when the receivers are fully translated apart from one another, such a gap exists); wherein the first and second rod channels are aligned substantially parallel with one another, and are offset in each of two dimensions (they are offset laterally, and when tilted away from each other); wherein a gap exists between the second receiver 1 and the first receiver 2 during movement of the second receiver 2 in each of the multiple dimensions (figure 2 of casey et al), wherein a primary axis of the gap is aligned with the axis of the connection between the first receiver and the second receiver (Casey, figure 2).
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Regarding claim 14, Zhu et al. as modified by Casey et al. discloses the claimed invention except wherein the bone screw further comprises a load ring configured to be bottom-loaded into the first receiver, wherein the shank head is configured to be bottom loaded with space for a clip ring or a lock ring to be assembled below the shank head.
Casey et al. teaches wherein a bone screw further comprises a load ring 42 configured to be bottom-loaded into the first receiver 34, wherein the shank head 26 is configured to be bottom loaded with space for a clip ring 42 or a lock ring to be assembled below the shank head (figure 2-4), for the purpose of allowing the screw shank to be anchored into the vertebrae before attaching it to the dual head receiver (col. 4, lines 32-42).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the bone screw disclosed by Zhu to further comprise a load ring configured to be bottom-loaded into the first receiver, wherein the shank head is configured to be bottom loaded with space for a clip ring or a lock ring to be assembled below the shank head, as taught by Casey et al., for the purpose of allowing the screw shank to be anchored into the vertebrae before attaching it to the dual head receiver (col. 4, lines 32-42).
Claim 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (Pub. No. AU2018330957 A1) in view of Casey et al. (Pat. No. US 9517089) and further in view of Yacoub et al. (Pub. No. US 2018/0325558 A1).
Regarding claim 10, Zhu et al. as modified by Casey et al. discloses the claimed invention, except wherein the second receiver 2 comprises a second tool engagement groove at an outer surface of the second pair of arms at or near a top surface thereof, and wherein a top edge of the connection between the first receiver and the second receiver is distal to the second tool engagement groove. Zhu et al. discloses that the first receiver comprises a tool engagement groove (figure 14), but does not show a tool engagement groove on the second receiver.
Yacoub et al. teaches wherein both receivers of a dual-headed receiver comprise tool engagement grooves 782 (figure 56), wherein the second receiver comprises a second tool engagement groove 782 at an outer surface of the second pair of arms at or near a top surface thereof, and wherein a top edge of the connection 750 between the first receiver and the second receiver is distal to the second tool engagement groove (figure 56).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the second receiver to comprise a tool engagement groove at an outer surface of the second pair of arms at or near a top surface thereof, and wherein a top edge of the connection between the first receiver and the second receiver is distal to the second tool engagement groove, as taught by Yacoub et al., in order to make it easier to grasp the dual-headed receiver during placement thereof.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11684395. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include more elements and are thus more specific. Thus the invention of the patent claims are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Response to Arguments
Applicant's arguments filed 11/13/2025 have been fully considered but they are not persuasive.
Applicant’s argument that Casey fails to disclose the feature of the second receiver is movable in multiple dimensions including roll, pitch, and yaw is not persuasive. Casey clearly discloses a spherical connection 70 with an arm 46 in figures 3-5. Col. 5, lines 9-18 discloses that the spherical connection 70/arm 46 allows for translation and rotation of the tulip in all directions. Applicant’s argument that the connection of Casey is flat is irrelevant, since the spherical collet 70 of Casey allows for rotation in all directions. The pending rejection modifies Zhu to comprise connection as taught by Casey in order to provide more axes of rotation and thereby better accommodate the patient’s anatomy. Such a modification does not destroy the function of Zhu, because Zhu can still operate as intended with the added advantage of additional dimension of angulation and movement to better accommodate the patient.
Conclusion
THIS ACTION IS MADE FINAL. 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 Lynnsy Summitt whose telephone number is (571)270-78567856. The examiner can normally be reached on Monday through Thursday from 8am until 5pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNNSY M SUMMITT/Primary Examiner, Art Unit 3773