DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Terminal Disclaimer
The terminal disclaimer filed on 11 November 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Pat. No. 11,918,207 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claims 2-6 and 10-18 are rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Allain et al. (2009/0105832; cited by Applicant).
Regarding claim 2, Allain et al. disclose a spinal fusion implant 1, 2A (Figs. 1C, 4A-D), comprising:
a first spinal fixation device 1 (Fig. 1C) adapted to penetrate and implant into vertebral material (para. 0026), the first spinal fixation device having a curved geometry with a first body portion ending in a first pointed tip 13 at a first end of the first spinal fixation device, the first pointed tip being configured to penetrate into vertebral material with a first point (e.g., at least the corner of the end of the pointed tip; Fig. 1C);
a second spinal fixation device 1 (Fig. 1C and Fig. 4A; note that connecting support structure 2A utilizes four spinal fixation devices 1 via openings 20) adapted to penetrate and implant into vertebral material (para. 0026), the second spinal fixation device having a curved geometry with a second body portion ending in a second pointed tip 13 at a distal end of the second spinal fixation device, the second pointed tip being configured to penetrate into vertebral material with a second point (e.g., at least the corner of the end of the pointed tip; Fig. 1C); and
a connecting support structure 2A (Figs. 4A, 4B) having a curved outer surface that is curved at multiple portions of the connecting support structure (e.g., the curved upper and lower edge; Fig. 4A), wherein the connecting support structure is adapted to hold the first spinal fixation device with respect to the second spinal fixation device via openings 20 and stop elements 11, 21 (Figs. 1C and 4A-4D; paras. 0024 and 0036), the connecting support structure 2A defining a first opening 20 through which the first spinal fixation device is configured to extend, such that material of the connecting support structure surrounds a first surrounded portion of the first spinal fixation device 1 when the first spinal fixation device extends through the first opening 20 (para. 0024; Fig. 4A and cf. Fig. 8B).
Regarding claim 3, the first spinal fixation device 1 (Fig. 1C) comprises a plurality of predetermined curved angles (para. 0026).
Regarding claim 4, the first spinal fixation device 1 is arcuate such that the first spinal fixation device is continuously curved throughout the first body portion to the first pointed tip 13 (Fig. 1C; para. 0026).
Regarding claim 5, the first pointed tip 13 of the first spinal fixation device 1 comprises a first tapered surface extending from part of the first pointed tip 13 proximal the first body portion to a most distal end of the first pointed tip (Fig. 1C, the tapered length of 13); and
the second pointed tip 13 of the second spinal fixation device 1 comprises a second tapered surface extending from part of the second pointed tip 13 proximal the second body portion to a most distal end of the second pointed tip (id.).
Regarding claim 6, a locking mechanism 14 (Fig. 1C; para. 0037) is provided for fixing the first spinal fixation device 1 and the second spinal fixation device 1 in a deployed configuration.
Regarding claim 10, the first pointed tip 13 of the first spinal fixation device 1 and the second pointed tip 13 of the second spinal fixation device 1 are configured to be implanted into adjacent vertebrae (para. 0026).
Regarding claim 11, the first spinal fixation device 1 is considered to be configured to be deployed into vertebral material by a screw driver tool, if desired, because its configuration includes being formed of a rigid material having a surface suitable for being acted upon by a screwdriver. It is noted that a screwdriver is not positively recited.
Regarding claim 12, the first spinal fixation device 1 comprises a single-piece construct (Fig. 1C) of a biocompatible material (para. 0008; claim 1, “configured for implantation in an intervertebral space between adjacent vertebrae of a spinal column”).
Regarding claim 13, the connecting support structure 2A defines a second opening 20 (Fig. 4A) through which the second spinal fixation device 1 (Fig. 1C and Fig. 4A; note that connecting support structure 2A utilizes four spinal fixation devices 1 via openings 20) is configured to extend, such that material of the connecting support structure 2A surrounds a second surrounded portion of the second spinal fixation device 1 when the second spinal fixation device extends through the second opening 20 (cf. Fig. 4C, showing material of the connecting support structure surrounding the openings 20 through which the spinal fixation devices 1 extend).
Regarding claim 14, all of the openings 20, including a first opening and second opening, are spaced apart from each other (Fig. 4A).
Regarding claim 15, Allain et al. disclose a spinal fusion implant assembly 1, 2A (Figs. 1C, 4A-D) comprising:
a first spinal fixation device 1 (Fig. 1C) comprising a first curved body and a first pointed tip 13, the first spinal fixation device rigidly coupled (e.g., at least when implanted and secured; para. 0024) to a second spinal fixation device 1 (Fig. 1C and Fig. 4A; note that connecting support structure 2A utilizes four spinal fixation devices 1 via openings 20) comprising a second curved body and a second pointed tip 13, the first pointed tip 13 of the first spinal fixation device 1 configured to be deployed into a first vertebral body while the second pointed tip 13 of the second spinal fixation device 1 is configured to be deployed into a second vertebral body (para. 0030 and Figs. 4C and 4D; cf. Fig. 8B);
a third spinal fixation device 1 (as the second; supra) comprising a third curved body and a third pointed tip 13, the third spinal fixation device rigidly coupled (supra) to a fourth spinal fixation device 1 (supra) comprising a fourth curved body and a fourth pointed tip 13, the third pointed tip 13 of the third spinal fixation device 1 configured to be deployed into the first vertebral body (e.g., below the connecting support structure 2A; para. 0024; Figs. 4C and 4D; cf. Fig. 8B) while the fourth pointed tip 13 of the fourth spinal fixation device is configured to be deployed into the second vertebral body (e.g., above the connecting support structure 2A; supra); and
at least one locking mechanism, e.g., 14 (Fig. 1C; para. 0037) for locking at least one of the spinal fixation devices 1 in a deployed configuration (id.);
wherein the first pointed tip 13 of the first spinal fixation device 1 is configured to be oriented opposite to the third pointed tip 13 of the third spinal fixation device 1 when the first pointed tip 13 and the third pointed tip 13 are deployed in the first vertebral body (e.g., see annotated Fig. 4A, below); and
wherein the second pointed tip 13 of the second spinal fixation device 1 is configured to be oriented opposite to the fourth pointed tip 13 of the fourth spinal fixation device 1 when the second pointed tip 13 and the fourth pointed tip 13 are deployed in the second vertebral body (e.g., see annotated Fig. 4A, below). It is noted that the connecting support structure 2A (Fig. 4A) has four openings 20 for four spinal fixation devices 1 (id.), wherein the top two openings 20 extend upward and the bottom two openings 20 extend downward (Fig. 4C). Accordingly, two pairs of openings extend in opposite directions. Thus, the first, second, third and fourth spinal fixation devices 1 can be considered to be those that extend through the openings 20 as set forth below in annotated Fig. 4A.
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Regarding claim 16, the first curved body of the first spinal fixation device 1 (Fig. 1C) comprises a first shape and the second curved body of the second spinal fixation device 1 comprises a second shape (Fig. 1C), wherein the first shape and the second shape are the same (Fig. 1C, showing a single configuration for a spinal fixation device; para. 0024, describing using such an anchoring device in a desired quantity of openings 20; Fig. 4A, showing a configuration with four openings 20 for spinal fixation devices 1).
Regarding claim 17, the first spinal fixation device 1, second spinal fixation device 1, third spinal fixation device 1 and fourth spinal fixation device 1 (id.) comprise a biocompatible material (para. 0008; claim 1, “configured for implantation in an intervertebral space between adjacent vertebrae of a spinal column”).
Regarding claim 18, the first spinal fixation device 1 (Fig. 1C) and the second spinal fixation device 1 (Fig. 1C, supra) are coupled to a first connecting support structure 2A (Fig. 4A) having a curved outer surface that is curved at multiple portions of the first connecting support structure 2A (e.g., at the curved upper edge and curved lower edge; Fig. 4A).
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 (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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 7-9 and 19-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Allain et al. (2009/0105832; cited by Applicant) in view of McDonough et al. (2010/0145460; cited by Applicant).
Regarding claim 7, Allain et al. disclose the claimed invention, as applied to claim 2 above, except for the first spinal fixation device 1 (Fig. 1C) being coupled to the connecting support structure 2A (Fig. 4A) by a threaded screw.
McDonough et al. discloses providing an implant 100 (comprising connecting support structure) with a blocking plate 190 retained by a threaded screw 180 “for covering, contacting and/or interacting with at least a portion of the first or second bone fixation elements” (para. 0080; Fig. 2E). The blocking plate 190 and threaded screw 180 limit the fixation elements from backing out of bone fixation holes (id.).
It would have been obvious to a person having ordinary skill in the art at the time of the invention to have configured the spinal fusion implant 1, 2A (Figs. 1C, 4A; supra) of Allain et al. with a blocking plate and a threaded screw, in view of McDonough et al., for covering, contacting and/or interacting with at least a portion of the spinal fixation devices 1 to limit the spinal fixation devices from backing out of bone fixation holes into which they extend. It is noted that the spinal fixation devices 1 would be coupled by assembly to the connecting support structure 2A by the threaded screw 180 via the blocking plate 190.
Regarding claim 8, the threaded screw 180 of the combination is considered to be configured to deploy the first pointed tip 13 (Fig. 1C) of the first spinal fixation device 1 (id.) into a first vertebrae at least because the threaded screw 180 is configured to be advanced via rotation, and to act upon the blocking plate 190 during such threaded advancement, wherein the blocking plate is configured to interact with the spinal fixation devices (para. 0080; Fig. 2E).
Regarding claim 9, the first opening 20 (Figs. 4A, 4C) of the connecting support structure 2A (id.) is adapted to orient the first spinal fixation device 1 to penetrate and implant into the first vertebrae (para. 0030).
Regarding claim 19, Allain et al. disclose the claimed invention, as applied to claim 15 above, except for the first spinal fixation device 1 and the second spinal fixation device 1 (supra) being coupled to a threaded connecting bar.
McDonough et al. discloses providing an implant 100 (comprising connecting support structure) with a threaded connecting bar 180, 190 (Fig. 2E, para. 0080, i.e., at least retaining portion 180 thereof being threaded) to interact with at least a portion of first and second bone fixation elements and limit them from backing out of bone fixation holes (para. 0080).
It would have been obvious to a person having ordinary skill in the art at the time of the invention to have configured the spinal fusion implant 1, 2A (Figs. 1C, 4A; supra) of Allain et al. with a threaded connecting bar (i.e., 180, 190), in view of McDonough et al., to interact with the spinal fixation devices 1 and limit them from backing out of the bone.
Regarding claim 20, the spinal fusion implant of the combination (supra; cf. Allain et al. Fig. 4A and McDonough et al. Fig. 2E) comprises a threaded screw 180 of the threaded connecting bar 180, 190 configured to couple by assembly the first spinal fixation device 1 to the first connecting support structure 2A (McDonough et al. para. 0080).
Regarding claim 21, the spinal fusion implant of the combination of Allain et al. and McDonough et al. discloses the claimed invention except for explicitly showing a device insertion tool comprising a threaded portion 197 for engaging with the threaded screw 180 coupling the first spinal fixation device 1 to the first connecting support structure 2A (supra).
McDonough et al. disclose providing an insertion tool 195 (Fig. 2A) comprising a threaded portion 197 for engaging, e.g., via common threading and steps of the method, with the threaded screw 180, to facilitate insertion of the implant (para. 0084).
It would have been obvious to a person having ordinary skill in the art at the time of the invention to have provided a tool comprising a threaded portion for engaging with the threaded screw 180 coupling the first spinal fixation device 1 to the first connecting support structure, in view of McDonough et al., to facilitate insertion of the implant.
Response to Arguments
Applicant’s arguments, see Remarks, page 1, filed 11 November 2025, with respect to the rejection(s) of claim(s) 2-21 under 102(e) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Allain et al. (2009/0105832; cited by Applicant) and McDonough et al. (2010/0145460; cited by Applicant), as set forth above.
The double patenting rejection set forth in the Office action mailed 11 September 2025 has been overcome by the terminal disclaimer filed by Applicant on 11 November 2025.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST.
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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773