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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 02 February 2026. As directed by the amendment: claims 1, 3, 4, 6, 9, 10, and 17-20 have been amended, and claims 24-30 stand withdrawn. Claims 1-30 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the specification objections listed in the previous action, which are accordingly withdrawn.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are accordingly withdrawn. Further claim objections as necessitated by the claim amendments are presented below.
Response to Arguments
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) and 35 U.S.C. 103 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.
Claim Objections
Claim 18 is objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 18 / line 7: “[[the]] a positional relationship”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20 and 21 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 20, the specification as originally filed does not provide proper support for the limitation that the drive portion of the screw is configured to be engaged by a drive tool to move the staple from a first to a second longitudinal position, which implies a first drive tool is used to move the staple rotationally (claim 20, lines 4-6) and a second drive tool is used to move the staple longitudinally (claim 20, lines 7-9). Only one tool is mentioned, which rotates the staple in a first direction (par. [0099]). Combined with the disclosure of par. [0059], it appears that the drive tool rotates the staple to a deployed rotational position and retracts the staple when rotated further in the same direction. Accordingly, as to claim 21, the specification as originally filed does not provide proper support for the limitation that the second longitudinal position (moved by the drive tool as required by claim 20) comprises an extended longitudinal position, i.e. the specification does not disclose a drive tool that moves the staple to an extended longitudinal position. The specification does not recite how the staple is moved to an extended longitudinal position. Paragraphs [0059] and [0099] appear to indicate that the drive tool moves the staple to a retracted longitudinal position, but confirmation and clarification are required.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20 and 21 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 20, the second recitation of “the drive tool” (lines 7-8) renders the claims indefinite, because it is unclear as to which “drive tool” is being referred, the one in line 4 or the one in line 7. Coupled with the rejection under 35 U.S.C. 112(a) above, it is unclear even if there are two drive tools, or if all of the recitations of the drive tool should refer to the same drive tool. For examination purposes, the limitation will be interpreted as all of the recitations of the drive tool referring to the same drive tool.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-23 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 6,287,308 to Betz et al. (hereinafter, “Betz”).
As to claim 1, Betz discloses an orthopedic implant device (col. 17 / lines 7-20), FIGS. 27-29, comprising: a plate (131) having a proximal end and a distal end; a coupling device (134 and 136); a staple (132) positioned closer to the distal end of the plate than the proximal end of the plate; the coupling device is configured to rotate the staple relative to the plate (the coupling device at shaft 134 is fully capable of rotating the staple 132 relative to the plate 131, since the staple is welded to the shaft so that rotation of the shaft would result in conjoint rotation of the staple); the coupling device comprising a shaft (134) and a nut (136), FIGS. 27 and 29; the nut is configured to mate with the shaft proximal to the staple and distal to the proximal end of the plate (since part of the nut is distally recessed into the proximal end of the plate and thus is distal to the proximal end of the plate); the coupling device, the staple and the plate operably coupled whereby the plate and the staple are configured to be secured to a sidewall of a bone (interpreted as language of intended use; the staple and the plate are fully capable of being secured to a sidewall of a bone if placed adjacently); and whereby the orthopedic implant device is configured to be secured across the bone (interpreted as language of intended use; the device is fully capable of being secured across the bone due to the length of the shaft, e.g. FIG. 26).
As to claim 2, Betz discloses the orthopedic implant device of claim 1 wherein the staple (132) and the plate (131) are configured to secure the orthopedic implant device to the bone with a compressive force (interpreted as language of intended use; fully capable of being secured with a compressive force when the nut 136 is threaded down).
As to claim 3, Betz discloses the orthopedic implant device of claim 1 wherein the sidewall of the bone comprises one or more lateral sidewalls of a vertebral body (interpreted as language of intended use; see e.g. FIG. 26).
As to claim 4, Betz discloses the orthopedic implant device of claim 1 wherein: the sidewall of the bone comprises a first lateral sidewall and a second lateral sidewall of a vertebral body; and the staple is configured to secure the orthopedic implant device to the first lateral sidewall and the plate is configured to secure the orthopedic implant device to the second lateral sidewall (interpreted as language of intended use; see e.g. FIG. 26) whereby the orthopedic implant device is configured to be secured to the vertebral body with a compressive force (interpreted as language of intended use; fully capable of being secured with a compressive force when the nut 136 is threaded down).
As to claim 5, Betz discloses the orthopedic implant device of claim 1 wherein the sidewall of the bone comprises an anterior sidewall and a posterior sidewall of a vertebral body (interpreted as language of intended use; the device is fully capable of being inserted so that the plate and the staple are secured to anterior and posterior sidewalls of a vertebral body).
As to claim 6, Betz discloses the orthopedic implant device of claim 1 wherein: the sidewall of the bone comprises an anterior sidewall and a posterior sidewall of a vertebral body; and the staple is configured to secure the orthopedic implant device to the posterior sidewall and the plate is configured to secure the orthopedic implant device to the anterior sidewall (interpreted as language of intended use; the device is fully capable of being inserted so that the staple and the plate are secured to posterior and anterior sidewalls of a vertebral body) whereby the orthopedic implant device is configured to be secured to the vertebral body with a compressive force (interpreted as language of intended use; fully capable of being secured with a compressive force when the nut 136 is threaded down).
As to claim 7, Betz discloses the orthopedic implant device of claim 1 wherein the sidewall of the bone is an upper portion and a lower portion of a lateral sidewall of a vertebral body (interpreted as language of intended use; the plate and the staple are each fully capable of being secured to upper and lower portions of a lateral sidewall of a vertebral body – the terms upper portion and lower portion are subjective, and even in the position shown for example in FIG. 26, the plate is secured to upper and lower portions, with the upper portion comprising the upper ¼ of the sidewall, and the lower portion comprising the ¼ below that, and the staple is correspondingly secured to upper and lower portions on its side of the sidewall; in another interpretation, one side of the vertebral body is upper and the other is lower, if the patient is positioned on their side).
As to claim 8, Betz discloses the orthopedic implant device of claim 1 wherein the sidewall of the bone comprises a sidewall of a vertebral body in a distal location relative to an insertion location of the orthopedic implant device (interpreted as language of intended use; any portion of the sidewall is in a distal location relative to an insertion location which is at the skin level).
As to claim 9, Betz discloses the orthopedic implant device of claim 1 wherein: the sidewall of the bone comprises a distal sidewall and a proximal sidewall of a vertebral body; the distal sidewall located at a distal location relative to an insertion location of the orthopedic implant device; the proximal sidewall located at a proximal location relative to the insertion location of the orthopedic implant device (interpreted as language of intended use; the distal sidewall is at a distal location relative to the insertion location of at least the portion of the device inserted nearer the proximal location/proximal sidewall); the staple is configured to secure the orthopedic implant device to the distal sidewall; and the plate is configured to secure the orthopedic implant device to the proximal sidewall (interpreted as language of intended use) whereby the orthopedic implant device is configured to be secured to the vertebral body with a compressive force (interpreted as language of intended use; fully capable of being secured with a compressive force when the nut 136 is threaded down).
As to claim 10, Betz discloses the orthopedic implant device of claim 1 wherein the coupling device (at shaft 134) is configured to move the staple from a first position to a second position (interpreted as language of intended use; since the staple is welded to the shaft so that translation of the shaft would result in conjoint translation of the staple from a first position to a second position).
As to claim 11, Betz discloses the orthopedic implant device of claim 1 wherein: the staple is configured to move from a first position to a second position (interpreted as language of intended use; fully capable of moving to different longitudinal positions); the first position is an undeployed position; and the second position is a deployed position (retracted relative to the plate).
As to claim 12, Betz discloses the orthopedic implant device of claim 1 wherein: the staple is configured to move from a first position to a second position (interpreted as language of intended use; fully capable of moving to different rotational positions, as part of the whole device or relative to the rest of the device); the first position is an undeployed position; and the second position comprises a position rotated relative to the undeployed position.
As to claim 13, Betz discloses the orthopedic implant device of claim 1 wherein: the staple is configured to move from a first position to a second position (interpreted as language of intended use; fully capable of moving to different longitudinal positions); the first position is an undeployed position; and the second position comprises an extended position relative to the undeployed position (fully capable of being extended relative to the plate if the shaft and welded staple are pushed further through the plate).
As to claim 14, Betz discloses the orthopedic implant device of claim 1 wherein: the staple is configured to move from a first position to a second position (interpreted as language of intended use; fully capable of moving to different longitudinal and rotational positions, as part of the whole device or relative to the rest of the device); the first position is an undeployed position; and the second position comprises a position both extended and rotated relative to the undeployed position (as above).
As to claim 15, Betz discloses the orthopedic implant device of claim 1 wherein the coupling device is configured to retract the staple relative to the plate (as the nut 136 threads down on the shaft 134 to pull or retract the shaft and attached staple proximally toward the plate).
As to claim 16, Betz discloses the orthopedic implant device of claim 1 further comprising a wedge (133) having an external dimension configured to influence an external surface configuration of the implant device (since the wedge comprises part of the external surface of the implant device) and effect a correction to a vertebral body when the orthopedic implant device is secured across the vertebral body (the wedge effects a correction to a vertebral body that is created by an osteotomy, since the wedge fits within the osteotomy and holds the osteotomy open to maintain the positions of the portions of the vertebral body and effect the desired correction; col. 7 / lines 23-24, col. 9 / lines 29-32).
As to claim 17, Betz discloses the orthopedic implant device of claim 1 wherein: the plate (131) comprises a through bore (141 including chamfer 142) (col. 17 / lines 21-32), FIG. 29; and the coupling device (at nut 136) is received in the through bore to operably couple the plate and the staple, FIG. 29.
As to claim 18, Betz discloses the orthopedic implant device of claim 1 wherein: the shaft comprises a screw (134, col. 17 / lines 13-14); a distal end of the screw coupled to the staple (col. 17 / lines 16-19), FIG. 29; a proximal end of the screw terminating proximal to the staple and distal to the proximal end of the plate (where the proximal end of the screw comprises the threaded end portion of the screw, which has a distal termination point that is proximal to the staple 132 and distal to the proximal end of the plate 131); and the screw is configured to mate with the plate (the parts mate as part of the whole device, with the screw passing through the plate) whereby the screw is configured to adjust the positional relationship of the staple and the plate (interpreted as language of intended use; the screw is fully capable of adjusting the positional relationship of the staple and the plate since the screw and the staple are welded together so that movement of the screw causes movement of the staple, relative to the plate).
As to claim 19, Betz discloses the orthopedic implant device of claim 1 wherein the nut is configured to further secure the implant device across the bone (as part of the secured whole device), FIG. 29.
As to claim 20, Betz discloses the orthopedic implant device of claim 1 wherein: the shaft comprises a screw (134, col. 17 / lines 13-14); the screw having a threaded portion (146) and a drive portion (space between thread sets), FIG. 27; the drive portion of the screw is configured to be engaged by a drive tool (interpreted as language of intended use; fully capable of being engaged by a drive tool of complementary size and shape, such as pliers) whereby the drive tool is configured to rotate the screw and move the staple from a first rotational position to a second rotational position (since the screw and the staple are welded together so that rotating the screw rotates the staple; the drive tool would be fully capable of applying rotational force); the drive portion of the screw is configured to be engaged by a drive tool (interpreted as language of intended use; fully capable of being engaged by a drive tool of complementary size and shape, such as pliers) whereby the drive tool is configured to move the staple from a first longitudinal position to a second longitudinal position (since the screw and the staple are welded together so that moving the screw longitudinally also moves the staple longitudinally; the drive tool would be fully capable of applying push/pull force); the nut having a threaded portion (144) configured to mate with the threaded portion of the screw proximal to the staple and distal to the proximal end of the plate (since part of the nut is distally recessed into the proximal end of the plate and thus is distal to the proximal end of the plate), FIG. 29; and the nut is configured to further secure the implant device across the bone (as part of the secured whole device), FIG. 29.
As to claim 21, Betz discloses the orthopedic implant device of claim 20 wherein: the first rotational position comprises an undeployed rotational position; the second rotational position comprises a deployed rotational position (the second rotational position is at least deployed relative to the first undeployed rotational position); the first longitudinal position comprises an undeployed longitudinal position; and the second longitudinal position comprises an extended longitudinal position (the second longitudinal position is fully capable of being extended relative to the first undeployed longitudinal position).
As to claim 22, Betz discloses the orthopedic implant device of claim 1 wherein the orthopedic implant device comprises an intravertebral implant device configured to alter a relative orientation between a superior endplate surface plane and an inferior endplate surface plane of a vertebral body, FIG. 26.
As to claim 23, Betz discloses the orthopedic implant device of claim 1 wherein the orthopedic implant device comprises an intervertebral implant device (interpreted as language of intended use; fully capable of use between vertebrae as a securing device) configured to join one vertebral body to another vertebral body (interpreted as language of intended use; as shown in other embodiments, e.g. FIGS. 30-32, the device is configured to join one vertebral body to another vertebral body when connected to other devices; the device itself is intervertebral because the vertebra in which the device is positioned is between two other vertebrae).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Betz in view of U.S. Patent No. US 8,273,129 to Baynham et al. (hereinafter, “Baynham”).
Assuming arguendo, Betz is silent as to wherein the orthopedic implant device comprises an intervertebral implant device configured to join one vertebral body to another vertebral body.
Baynham teaches an orthopedic implant device comprises an intervertebral implant device configured to join one vertebral body to another vertebral body (col. 5 / lines 8-10, col. 6 / lines 55-65).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize Betz’s implant device as an intervertebral implant device, since Baynham teaches that an implant device with a wedge can be used to correct an alignment of the spine by being implanted intervertebrally, and combining prior art elements according to known methods to yield predictable results (spinal alignment) is within the ordinary skill in the art. As applied to Betz, the intervertebral implant device would be placed between adjacent vertebral bodies to join them together at a desired angle to correct the spinal alignment, with the prongs on the plate and staple in Betz secured into the superior vertebral body. If required, it would also have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include prongs on both ends of each of the plate and the staple in Betz, to secure into the superior and inferior vertebral bodies, as taught in other embodiments of Betz (FIG. 19A), to provide securement above and below the device for secure fusion of the vertebral bodies, as also taught by Baynham.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775