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 .
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.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mickiewicz et al. (US 2019/0069934 A1).
Claim 1. Mickiewicz discloses a rod reduction device comprising:
a body (locking member 204) including a housing (locking member 204) defining a cavity (central opening 250);
a first member (pivoting arm 206a) and a second member (pivoting arm 206b), each of the first and second members extending distally from the housing (see Fig. 2A; note that the claim does not require that the first and second members be directly connected to the housing);
a first finger assembly (distal end of pivoting arm 206a including finger 274a) and a second finger assembly (distal end of pivoting arm 206b including finger 274b) being secured to respective distal ends of the first member and the second member, wherein the first finger assembly and the second finger assembly are configured to, collectively, releasably engage a vertebral anchor therebetween (see para. 0099); and
a screw assembly (housing 202 and proximal portion 304 of reducer shaft 300) defining a longitudinal axis, at least a portion of the screw assembly being positioned within the cavity of the housing (see Fig. 7F), wherein the screw assembly comprises:
an inner shaft (proximal portion 304 of reducer shaft 300) having exterior threading (exterior thread 316); and
an outer shaft (housing 202) having interior threading (threaded surface 218t) and circumscribing the inner shaft, wherein at least a portion of the outer shaft is rotatably coupled to the housing, wherein the exterior threading of the inner shaft is threadably engaged with the interior threading of the outer shaft, and wherein the inner shaft is movable along the longitudinal axis upon rotation of the outer shaft and configured to reduce a spinal rod into the vertebral anchor (Figs. 2A-10H).
Claim 2. Mickiewicz discloses a reduction carriage (distal portion 306) connected to a distal end of the inner shaft (Figs. 2A-10H).
Claim 3. Mickiewicz discloses wherein the reduction carriage is fixedly connected to the distal end of the inner shaft (via coupling 318; see para. 0117) (Figs. 2A-10H).
Claim 4. Mickiewicz discloses wherein the reduction carriage is rotationally connected to the distal end of the inner shaft (see para. 0117) (Figs. 2A-10H).
Claim 5. Mickiewicz discloses wherein the reduction carriage is configured to urge a spinal rod into the vertebral anchor (see Figs. 8C-8D) (Figs. 2A-10H).
Claim 6. Mickiewicz discloses wherein the reduction carriage is movable between a retracted position (see Fig. 8C) and a reduced position (see Fig. 8D) (Figs. 2A-10H).
Claim 7. Mickiewicz discloses wherein the outer shaft further comprises a knob (handle 402), wherein the knob is fixedly connected to a proximal end of the outer shaft (via reducer shaft 300; note that the claim does not require a direct connection between the knob and the outer shaft nor does the claim require that actuation of the knob have an effect on the outer shaft) (Figs. 2A-10H).
Claim 8. Mickiewicz discloses wherein the outer shaft is not translatable relative to the housing along the longitudinal axis (due to pins 244; see para. 0096) (Figs. 2A-10H).
Claim 9. Mickiewicz discloses wherein the first member and the second member collectively define a channel (see Fig. 8C, which shows that spinal rod 106 is located between pivoting arms 206a and 206b and thus in a channel defined by pivoting arms 206a and 206b) configured to receive a spinal rod (Figs. 2A-10H).
Claim 10. Mickiewicz discloses wherein the first and second finger assemblies comprise a first finger (finger 274a) and a second finger (finger 274b), respectively, each of the first and second fingers having a finger tip (see Fig. 5, which shows that fingers 274a and 274b each include a projection) at a distal end thereof (Figs. 2A-10H).
Claim 11. Mickiewicz discloses wherein the finger tip of each of the first and second fingers is configured to engage opposite sides of the vertebral anchor (see para. 0152) (Figs. 2A-10H).
Claim 12. Mickiewicz discloses wherein the finger tip of each of the first and second fingers is configured to snap into pockets on the opposite sides of the vertebral anchor (see para. 0152) (Figs. 2A-10H).
Allowable Subject Matter
Claims 13-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed September 17, 2025 have been fully considered but they are not persuasive. Applicant argues that Mickiewicz fails to disclose that the inner shaft is movable along the longitudinal axis upon rotation of the outer shaft and configured to reduce a spinal rod into the vertebral anchor because reducer shaft 300 is rotated to effect distal movement of itself instead of housing 202 being rotated to effect distal movement of reducer shaft 300 (see pgs. 2-4). The Examiner disagrees. As noted by Applicant, Mickiewicz states that “at least a portion of the reducer shaft 300 can rotate relative to the instrument body 200 about the axis A1 to advance the reducer shaft 300 distally relative to the instrument body and a bone anchor 100 secured thereto, thereby urging a rod towards a rod seat of the bone anchor” (see para. 0113). Furthermore, it is noted that housing 202 is part of instrument body 200 (see para. 0073). Thus, in operation as described by Mickiewicz, holding housing 202 steady while rotating reducer shaft 300 results in distal movement of reducer shaft 300 relative to housing 202. However, claim 1 is directed to an apparatus, not a method, and thus the device of Mickiewicz need not be explicitly disclosed as functioning as recited in claim 1 but must instead be capable of such use. In the instant case, holding reducer shaft 300 steady and rotating housing 202 would result in housing 202 moving proximally relative to reducer shaft 300, which would also necessarily result in reducer shaft 300 moving distally relative to housing 202 as recited in claim 1. Furthermore, such movement is capable of occurring when the first and second finger assemblies are engaged with a vertebral anchor to result in the reduction of a spinal rod into the vertebral anchor. Accordingly, the device of Mickiewicz is capable of functioning as recited in claim 1 and therefore Mickiewicz anticipates claim 1.
Conclusion
THIS ACTION IS MADE FINAL. 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 JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773