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 Group II, claims 22-24, drawn to a group comprising an apparatus, kit and method involving in each instance a geared dual-axis hinge comprising four gears and hinge-rods coupled to one or more of the four gears (Fig. 32), in the reply filed on 16 February 2026, is acknowledged. It is noted that there was no species requirement made in the Office action mailed 16 December 2025.
Claims 1-21 were withdrawn by Applicant in the response filed 16 February 2026.
Drawings
The drawings are objected to because of the following informalities.
Figures 10, 11A, 11C, 12A, 12B, 18A, 18B, 20, 21, 22, 23, 24, 27A, 27B, 28A, 28B, 32 and 33 contain extraneous text that should be replaced with a corresponding reference number or removed where a reference number is already present.
Figures 29, 30 and 31 are illegible.
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.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 22-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claim 22, line 9, “the first unipolar clamp” lacks antecedent basis.
Claim 23, line 10, “the first unipolar clamp” lacks antecedent basis.
Claim 24, line 10, “the first unipolar clamp” lacks antecedent basis.
Appropriate correction is required.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (2009/0198279; cited by Applicant) in view of Doose et al. (2017/0231664).
Regarding claim 22, Zhang et al. disclose a uniplanar clamp hinge for spinal surgery (see annotated Fig. 11, below) comprising:
a hinge comprising, a first hinge-rod coupled to the hinge, a second hinge-rod coupled to the hinge;
a first uniplanar clamp movably coupled to the first hinge-rod and a second uniplanar clamp movably coupled to the second hinge-rod;
a stabilizing rod movably coupled to the first uniplanar clamp and the second uniplanar clamp; and
a first provisional spine rod 34 movably coupled to the first uniplanar clamp and a second provisional spine rod 34 movably coupled to the second uniplanar clamp.
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Zhang et al. do not disclose a geared dual-axis hinge comprising four gears; the first hinge-rod coupled to one or more of the four gears; the second hinge-rod coupled to one or more of the four gears; and a plurality of locking screws to lock the four gears at a desired angle.
Doose et al. disclose a uniplanar clamp hinge (Figs. 5A, 5B, 9 and 10; para. 0035) for spinal surgery (para. 0003), comprising a geared dual-axis hinge 20 (e.g., a hinge characterized by at least two axes of rotation; here, the axis of rotation of the worm gear 200 and the axis of rotation about axle 230; para. 0035; Figs. 5A, 5B) comprising at least three gears: 200, 210, 235 (id.). A first hinge-rod 10 is coupled to all of the gears and most directly to gear 200 (id.). A second hinge-rod 30 is coupled to all of the gears and most directly to gear 235 (id.). A locking screw 270 locks the gears at a desired angle (para. 0037). The uniplanar clamp hinge is actuated magnetically in a simple manner by an instrument 285 (para. 0040) without requiring contact or physical effort by a surgeon (paras. 0010, 0011, 0013, 0040).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the uniplanar clamp hinge of Zhang et al. to comprise a geared dual-axis hinge comprising at least three gears; the first hinge-rod coupled to one or more of the gears; the second hinge-rod coupled to one or more of the gears; and a locking screw to lock the gears at a desired angle, in view of Doose et al., to allow the hinge to be actuated magnetically in a simple manner by an instrument without requiring contact or physical effort by a surgeon. It would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide a fourth gear, e.g., to provide a desired gear ratio or rotational direction. Likewise, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide a plurality of the locking screws, e.g., to ensure that the gears do not move and the rods maintain stability.
Regarding claim 23, Zhang et al. disclose a uniplanar clamp hinge kit for spinal surgery comprising a uniplanar clamp hinge (see annotated Fig. 11, above) comprising:
a hinge comprising, a first hinge-rod coupled to the hinge, a second hinge-rod coupled to the hinge;
a first uniplanar clamp movably coupled to the first hinge-rod and a second uniplanar clamp movably coupled to the second hinge-rod;
a stabilizing rod movably coupled to the first uniplanar clamp and the second uniplanar clamp; and
a first provisional spine rod 34 movably coupled to the first uniplanar clamp and a second provisional spine rod 34 movably coupled to the second uniplanar clamp; and
a tool such as a handle to increase leverage (para. 0082).
Zhang et al. do not disclose a geared dual-axis hinge comprising four gears; the first hinge-rod coupled to one or more of the four gears; the second hinge-rod coupled to one or more of the four gears; and a plurality of locking screws to lock the four gears at a desired angle.
Doose et al. disclose a uniplanar clamp hinge (Figs. 5A, 5B, 9 and 10; paras. 0035 and 0040) for spinal surgery (para. 0003), comprising a geared dual-axis hinge 20 (e.g., a hinge characterized by at least two axes of rotation; here, the axis of rotation of the worm gear 200 and the axis of rotation about axle 230; para. 0035; Figs. 5A, 5B) comprising at least three gears: 200, 210, 235 (id.). A first hinge-rod 10 is coupled to all of the gears and most directly to gear 200 (id.). A second hinge-rod 30 is coupled to all of the gears and most directly to gear 235 (id.). A locking screw 270 locks the gears at a desired angle (para. 0037). The uniplanar clamp hinge is actuated magnetically in a simple manner by a tool 285 (para. 0040) without requiring contact or physical effort by a surgeon (paras. 0010, 0011, 0013, 0040).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the uniplanar clamp hinge kit of Zhang et al. to comprise a geared dual-axis hinge comprising at least three gears; the first hinge-rod coupled to one or more of the gears; the second hinge-rod coupled to one or more of the gears; a locking screw to lock the gears at a desired angle, and an actuation tool to manipulate the uniplanar clamp hinge in view of Doose et al., to allow the hinge to be actuated magnetically in a simple manner by the tool without requiring contact or physical effort by a surgeon. It would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide a fourth gear, e.g., to provide a desired gear ratio or rotational direction. Likewise, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide a plurality of the locking screws, e.g., to ensure that the gears do not move and the rods maintain stability.
Regarding claim 24, Zhang et al. disclose a method of using a uniplanar hinge clamp comprising:
providing a uniplanar hinge clamp (see annotated Fig. 11, above) comprising:
a hinge comprising, a first hinge-rod coupled to the hinge, a second hinge-rod coupled to the hinge;
a first uniplanar clamp movably coupled to the first hinge-rod and a second uniplanar clamp movably coupled to the second hinge-rod;
a stabilizing rod movably coupled to the first uniplanar clamp and the second uniplanar clamp; and
a first provisional spine rod 34 movably coupled to the first uniplanar clamp and a second provisional spine rod 34 movably coupled to the second uniplanar clamp; and
performing spinal surgery using the uniplanar hinge clamp (para. 0010).
Zhang et al. do not disclose a geared dual-axis hinge comprising four gears; the first hinge-rod coupled to one or more of the four gears; the second hinge-rod coupled to one or more of the four gears; and a plurality of locking screws to lock the four gears at a desired angle.
Doose et al. disclose a uniplanar clamp hinge (Figs. 5A, 5B, 9 and 10; para. 0035) for spinal surgery (para. 0003), comprising a geared dual-axis hinge 20 (e.g., a hinge characterized by at least two axes of rotation; here, the axis of rotation of the worm gear 200 and the axis of rotation about axle 230; para. 0035; Figs. 5A, 5B) comprising at least three gears: 200, 210, 235 (id.). A first hinge-rod 10 is coupled to all of the gears and most directly to gear 200 (id.). A second hinge-rod 30 is coupled to all of the gears and most directly to gear 235 (id.). A locking screw 270 locks the gears at a desired angle (para. 0037). The uniplanar clamp hinge is actuated magnetically in a simple manner by an instrument 285 (para. 0040) without requiring contact or physical effort by a surgeon (paras. 0010, 0011, 0013, 0040).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to perform the method of Zhang et al. including to configure the uniplanar clamp hinge of Zhang et al. to comprise a geared dual-axis hinge comprising at least three gears; the first hinge-rod coupled to one or more of the gears; the second hinge-rod coupled to one or more of the gears; and a locking screw to lock the gears at a desired angle, in view of Doose et al., to allow the hinge to be actuated magnetically in a simple manner by an instrument without requiring contact or physical effort by a surgeon. It would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide a fourth gear, e.g., to provide a desired gear ratio or rotational direction. Likewise, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide a plurality of the locking screws, e.g., to ensure that the gears do not move and the rods maintain stability.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (see attached PTO-892).
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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DAVID C. COMSTOCK
Examiner
Art Unit 3773
/DAVID C COMSTOCK/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773