DETAILED ACTION
This office action is responsive to the amendment filed December 14, 2025. By that amendment, claim 1 was amended; claims 2-6 were canceled; and claims 7-10 were newly presented. Claims 1 and 7-10 are pending.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
The outstanding objections to claims 3-6 were overcome by cancellation of the claims.
The outstanding rejection of claim 6 under 35 USC 112(b) was overcome by cancellation of the claim.
The outstanding rejection of claim 1 under 35 USC 102(b) in view of Blain (US 2005/0177240 A1) was overcome by the amendment to claim 1. Arguments related thereto are considered moot since the reference is no longer used in making a rejection.
The outstanding rejection of claim 1 under 35 USC 102(b) in view of Malek is maintained. Examiner does not find that the amendments to claim 1 overcame the rejection of record. No arguments were presented related to the Malek reference.
A rejection of claim 1 in view of Malek (among other claims) is presented below, modified to correlate to the amended claim language.
A new rejection in view of Pavlov et al. (US 2006/0064099 A1) is also presented.
Drawings/Specification/Priority – Claim 9
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o).
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
Therefore, the threads which engage the vertebral facet distractor of claim 9 (or at least threads on the distractor which are capable of engaging the tip) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Consider the following discussion:
Through examination, Examiner has come to believe the claimed embodiment is that of instant figures 11A-C. This embodiment is demonstrated with a hexagonal opening 1114 for interference fit with a tip of a holder. This embodiment is nowhere taught or suggested to have a threaded coupling feature for receipt of a tip of a holder (except at claim 5 presented with this application, now claim 9). Examiner will admit that this limitation is therefore supported (barely) in the claims, but not by the drawings or specification.
However: Examiner suggests that features of distinct embodiments may be being inadvertently combined in the claims. Therefore, in order to remedy this situation, either
1) Examiner requires the claimed subject matter be demonstrated in the figures, and sufficient disclosure added to the specification to correlate, thereto (without entry of new matter). Upon applicant choosing to do so, claim 9 will be noted as having an earliest priority date of the filing of this application (August 5, 2024), since this will be the first disclosure of this subject matter in this embodiment that examiner is aware of; or
2) Applicant can show where the drawings and specification provide support for the limitation, at which time a persuasive showing is presented, the objections will be withdrawn; or
Cancellation of claim 9 will obviate the drawing and specification objections, and overcome any issues related to priority of claim 9.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Amendment to the specification to provide antecedent basis for the claimed limitation is required.
Claim Objections
Claims 7 and 10 are objected to because of the following informalities: at line 11 of claim 7, and line 1 of claim 10, the holder is claimed as being “engaged” with (or “engages”) the distractor. Examiner suggests applicant intended use of “configured to” language at this limitation, rather than a positive recitation of the connection. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1 and 7 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Malek (US 2010/0121378 A1).
Regarding claim 1, Malek teaches a vertebral facet distractor 100 capable of being positioned between first and second articular facets in an articular facet joint [0026] to be capable of providing distraction between the first and second articular facets (depending on anatomy of the patient; placement of 100 into the facet joint is considered to be capable of causing distraction), the vertebral facet distractor comprising:
an elongated generally cylindrical contour (shape of 100, see fig. 1; see further description of a “two dimensional rounded structure” at [0038], such description understood to be a cylindrical contour) including opposed top and bottom surfaces (up and down in fig. 2), a generally cylindrical outer sidewall 105, an inner sidewall 110, and a central lumen that defines an opening in the bottom surface (fenestrations through the cage to connect the inner space to the outer environment [0039]),
wherein the generally cylindrical outer sidewall 105 of the generally cylindrical contour of 100 is provided with a generally cylindrical screw thread to promote bone fusion (connector, shown as 115 in the figure, discussed at [0026], can be in the form of a threading; examiner takes official notice of threadings used in the manner discussed in [0026] being cylindrical; there is no reason that the threading, with an insertion tool removed therefrom, is not capable of promoting bone fusion, as by providing an additional path into the interior space which bone may grow into during fusion) when the vertebral facet distractor 100 is positioned between the first and second articular facets in the articular facet joint.
Regarding claim 7, Malek teaches a system comprising:
the device as recited in claim 1; and
a holder (handle [0026]) that is capable of being engaged with the elongated generally cylindrical contour of the vertebral facet distractor 100 at the connector 115 and described at [0026]) and is adapted to facilitate the insertion of the vertebral facet distractor between the first and second articular facets in the articular facet joint as discussed at [0026].
Claim(s) 1, 7, 8 and 10 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Pavlov et al. (US 2006/0064099 A1).
Regarding claim 1, Pavlov teaches a vertebral facet distractor 1 adapted to be positioned between first and second articular facets in an articular facet joint (see fig. 7 [0047]) to provide distraction between the first and second articular facets (as at [0018], the core diameter of the screw is significantly larger than the gap in the articular facet), the vertebral facet distractor 1 comprising:
an elongated generally cylindrical contour about 1 as seen in fig. 1 including opposed top and bottom surfaces (tip and head 3, respectively), a generally cylindrical outer sidewall of the shaft 2, an inner sidewall inside the opening seen at 6 (and the cannulation through 1), and a central lumen (through 6) that defines an opening in the bottom surface 3 as seen at fig. 1,
wherein the generally cylindrical outer sidewall of the generally cylindrical contour of 2 is provided with a generally cylindrical screw thread as at fig. 1 to promote bone fusion when the vertebral facet distractor is positioned between the first and second articular facets in the articular facet joint as at fig. 7.
Regarding claim 7, Pavlov teaches a system as at figs. 1 and 5, including:
the device of claim 1; and
a holder 21 that is capable of being engaged with the elongated generally cylindrical contour of the vertebral facet distractor as seen in fig. 5 and is adapted to facilitate the insertion of the vertebral facet distractor 1 between the first and second articular facets in the articular facet joint as at fig. 5.
Regarding claim 8, the holder includes an elongated cylindrical body below the enlarged handle and a tip that engages the elongated generally cylindrical contour of the vertebral facet distractor 1 as seen at fig. 5.
Regarding claim 10, the tip of 21 engages the distractor 1 in an interference fit with the opening 6 in the bottom surface 3 of the central lumen of the vertebral facet distractor 1 as seen at figs. 1 and 5.
Claim Rejections - 35 USC § 103
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.
Claims 8 and 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Malek.
Regarding claim 8, the holder includes an elongated body (rod) and a tip that engages the elongated generally cylindrical contour of the vertebral facet distractor 100 (as discussed at [0026]).
Malek does not teach the body of the holder being cylindrical.
Examiner takes the position that cylindrical bodies of rods were old and well-known in the art at the time of the invention. Forming Malek’s rod as described at [0026] to be cylindrical would not change or materially affect use of the device, and cylindrical rods are capable of being handled by a surgeon’s hand. The instant disclosure provides no reason or advantage for use of a cylindrical elongated body. It would have been obvious to one with ordinary skill in the art at the time of the invention to select a cylindrical elongated rod as a matter of design choice.
Regarding claim 9, the tip is provided with screw threads that engage the vertebral facet distractor: The tip can be threaded as described at [0026]. Threaded connections are considered to be a type of interference fitting.
Claim 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pavlov.
Regarding claim 9, Pavlov teaches the limitations of claim 8, as above. However, Pavlov teaches a tip for interacting with structure 6 of device 1, rather than a threaded tip. Examiner takes the position that coupling between structures with different shaped connectors is old and well known in the art. A threaded coupling for a driver in the surgical space is well known. Use of a threaded coupling between the holder 21 and distractor 1 would have been functionally equivalent to use of a hexagonal driver (as suggested by Pavlov) in that both are selectably releasable drivers for rotatably driving a threaded device. It would have been obvious to one with ordinary skill in the art at the time of the invention to select a coupler with a threaded tip, and form Pavlov with a likewise threaded coupling feature for receipt of the tip, therein.
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 David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799