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 .
Election/Restrictions
Applicant’s election without traverse of Species 1 in the reply filed on 11/20/2025 is acknowledged. Claims 1-20 are pending.
Claim Objections
Claims 6 and 17 are objected to because of the following informalities:
In claim 6, change “grove” to --groove--.
In claim 17, line 1, insert –a—before “locking.” Appropriate correction is required.
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.
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Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4 and 5 of U.S. Patent No. 11,771,473 in view of Jackson (U.S. 2024/0252213 A1).
Claims 1, 4 and 5 of the patent disclose the invention of claims 1-7 of the application except for explicitly disclosing that the locking member is disposed in the tulip member and is configured to enable polyaxial movement between the tulip member and the locking member.
Jackson discloses a pedicle screw device comprising a locking member (see Fig. 5, element 22) that is disposed in a tulip member (20) and is configured to enable polyaxial movement between the tulip member and the locking member in the same field of endeavor for the purpose of surgical flexibility and ease of rod placement. The ability of the screw head to pivot within the tulip allows surgeons to adjust the angle after the screw is inserted into the pedicle. This makes it much easier to connect multiple screws with a rod, especially when dealing with anatomical variations or when screws aren’t perfectly aligned.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to dispose the locking member in the tulip member in a manner that enables polyaxial movement between the tulip member and the locking member, as disclosed by Jackson, in order to accommodate the natural curves and contours of the spine and thereby distribute forces evenly across the construct.
Claims 8-15 and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7-13, 15 and 18 of U.S. Patent No. 11,771,473. Although the claims at issue are not identical, they are not patentably distinct from each other because the differences between the application claims and the patent claims lies in the fact that the patent claims include the recitation of more elements and are thus more specific. Accordingly, the invention of claims 7-13, 15 and 18 of the patent is in effect a “species” of the “generic” invention of claims 8-15 and 17-20 of the application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 8-15 and 17-20 of the application are anticipated by claims 7-13, 15 and 18 of the patent, they are not patentably distinct from claims 7-13, 15 and 18 of the patent.
Regarding claim 8, see patent claim 7.
Regarding claim 9, see patent claim 9.
Regarding claim 10, see patent claim 10.
Regarding claim 11, see patent claim 11.
Regarding claim 12, see patent claim 12.
Regarding claim 13, see patent claim 7.
Regarding claim 14, see patent claim 8.
Regarding claim 15, see patent claim 13
Regarding claim 17, see patent claim 13.
Regarding claim 18, see patent claim 18.
Regarding claims 19 and 20, see patent claim 15.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 13 of U.S. Patent No. 11,771,473 in view of Campbell et al. (U.S. 2017/00494482 A1).
Claim 13 of the patent disclose the invention of claim 16 of the application except for explicitly disclosing one or more pins each configured to mate into one of one or more pin slots formed in the collet member through one of one or more pin holes formed in the tulip member, wherein the pins are configured to limit rotation of the collect member within the tulip member.
Campbell et al. disclose a pedicle screw device (see Fig. 1) comprising one or more pins (141) each configured to mate into one of one or more pin slots (148) formed in a collet member (140) through one of one or more pin holes (125) formed in a tulip member (120), wherein the pins are configured to limit rotation of the collect member within the tulip member in the same field of endeavor.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include one or more pins configured to mate into one of one or more pin slots formed in the collet member through one of one or more pin holes formed in the tulip member, wherein the pins are configured to limit rotation of the collect member within the tulip member, as taught by Campbell et al., in order to prevent loss of correction and construct failure.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson (U.S. 2007/0055244 A1).
Concerning claim 1, Jackson discloses a pedicle screw device, comprising: a bone screw member (see Fig. 22, element 414) having a head portion (418); and a head assembly comprising: a tulip member (see Fig. 22, element 420), and a locking member (422) having a bottom portion configured to engage with the head portion of the bone screw, wherein the locking member is disposed in the tulip member and is configured to enable polyaxial movement (see par. 0116) between the tulip member and the locking member.
Concerning claim 2, further comprising a collet member (522) that is received within the tulip member, wherein the collet member sits atop the locking member.
Concerning claim 3, wherein the locking member is configured with internal threading (see Fig. 14, element 198 and par. 0081) that engages with a threaded portion (see Fig. 14, element 136) of the head portion of the bone screw.
Claim(s) 1, 4-6, 15 and 17-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baynham (U.S. 2018/0221162).
Concerning claim 1, Baynham discloses a pedicle screw device, comprising: a bone screw member (see Fig. 4, element 12) having a head portion (18); and a head assembly comprising: a tulip member (84), and a locking member (40) having a bottom portion configured to engage with the head portion of the bone screw, wherein the locking member is disposed in the tulip member and is configured to enable polyaxial movement (see par. 0029) between the tulip member and the locking member.
Concerning claim 4, wherein the locking member (40) further comprises a top portion formed with a drive feature (see par. 0028, i.e., threaded aperture 47; and see Fig. 4 below).
[AltContent: arrow][AltContent: textbox (Groove)][AltContent: textbox (Locking Tabs)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Drive Feature)][AltContent: arrow]
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Concerning claim 5, wherein the bottom portion of the locking member comprises a plurality of locking tabs (see Fig. 4 above) that define an expandable aperture.
Concerning claim 6, wherein each of the locking tabs are defined and spaced apart by a groove (see Fig. 4 above) that enables expansion of the expandable aperture.
Concerning claim 15, Baynham discloses a pedicle screw tulip head assembly, comprising: a tulip member (see Fig. 4, element 84); a locking member (40) comprising a top portion formed with a drive feature (see Fig. 4 below, i.e., threads) configured to receive a driver tool (see par. 0028); and a collet (70) member formed with an opening to provide a path for the driver tool to engage with the drive feature of the locking member.
[AltContent: arrow][AltContent: textbox (Groove)][AltContent: textbox (Locking Tabs)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Drive Feature)][AltContent: arrow]
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Concerning claim 17, further comprising a locking member socket (see Fig. 2 below) formed in the tulip member, wherein the top portion of the locking member rotates polyaxially within the locking member socket.
[AltContent: arrow][AltContent: textbox (Socket)]
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Concerning claim 18, further comprising a set screw (see Fig. 4, element 90) configured to engage with a threaded portion (see Fig. 4, element 94) of the tulip member, wherein threading the set screw to the tulip member presses the collet member (70) toward the locking member (40) to fix the locking member within the locking member socket.
Concerning claim 19, wherein a bottom portion of the locking member is an expandable aperture configured with a plurality of locking tabs (see Fig. 4 above).
Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jackson (U.S. 2010/0211114 A1).
Concerning claim 1, Jackson discloses a pedicle screw device, comprising: a bone screw member (see Fig. 44, element 504) having a head portion (537); and a head assembly comprising: a tulip member (510), and a locking member (512) having a bottom portion configured to engage with the head portion of the bone screw, wherein the locking member is disposed in the tulip member and is configured to enable polyaxial movement between the tulip member and the locking member.
Concerning claim 7, further comprising a plurality of protruding tabs (538) extending from a neck portion (534) of the bone screw member, wherein the protruding tabs are positioned between the head portion (537) and a threaded bone portion (506) of the bone screw.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Richelsoph (EP 0 836 835 A2).
Concerning claim 8, Richelsoph discloses a pedicle screw device (see Fig. 3 below), comprising: a bone screw member having threaded head portion (see below), a plurality of protruding tabs (see below), and a threaded bone portion (see below), wherein the protruding tabs extend from a neck portion (see below) that is between the threaded head portion and the threaded bone portion; and a head assembly comprising: a tulip member (see below); a locking member (see below) formed with internal threads configured to engage with the threaded head portion of the bone screw member.
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Concerning claim 9, wherein the plurality of protruding tabs (see Fig. 3 above) are spaced apart and aligned around a circumference of the neck portion of the bone screw member.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited art relates to polyaxial locking between the tulip and screw head, and the connection between a screw head and locking member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. 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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/ELLEN C HAMMOND/ Primary Examiner, Art Unit 3773