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 Arguments
Applicant’s arguments with respect to claim(s) 1 - 20 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 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.
Claim(s) 1 - 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by TO et al. (US 2016/0206439 A1).
Regarding clam 1, TO discloses a system for spinal fusion (Abstract) comprising:
a spinal implant (Figs. 5A – 5D) defining a longitudinal axis, the spinal implant including a plurality of spinal implant components (ref. 560, 577, 566), each component configured to be separate prior to implantation (Figs. 5A – 5C show the components being separate) and to nest inside an adjacent one of the plurality of spinal implant components in an implanted position (Fig. 5D); and
a positioning system configured to insert each one of the plurality of spinal implant components into the implanted position (paragraph [0098], Figs. 8A-8D),
wherein the positioning system is configured to rotate the spinal implant to distract an intervertebral disc space (the system is fully capable of rotating the implant, e.g. by a user, and when expanded would distract a space due to the increase in dimensions of the implant).
Regarding clam 2, TO discloses the system of claim 1, wherein each of the plurality of spinal implant components is a spacer having a first dimension in a first plane and a second dimension in a second plane transverse to the first plane, the second dimension larger than the first dimension (Figs. 5A – 5D show the components to be wider than taller).
Regarding clam 3, TO discloses the system of the claim 2, wherein the first and second planes extend parallel to the longitudinal axis, and the first plane is orthogonal to the second plane (the vertical and lateral planes are orthogonal and extend along the axis).
Regarding clam 4, TO discloses the system of claim 2, wherein each spacer is configured to be inserted into the intervertebral disc space and rotated to distract the intervertebral disc space (the spacer is fully capable of functioning in such a manner since one dimension of the spacer is larger than a second dimension).
Regarding clam 5, TO discloses the system of claim 1, wherein the positioning system includes a guidance structure configured to guide each spinal implant component into the implanted position (Fig. 8B-C, ref. 805).
Regarding clam 6, TO discloses the system of claim 5, wherein the guidance structure is a shaft extending along the longitudinal axis, the shaft configured to receive each of the plurality of spinal components such that the spinal components are adapted to be translated along a length of the shaft (Fig. 8A).
Regarding clam 7, TO discloses the system of claim 6, wherein the shaft includes a proximal end (Fig. 8B, ref. 820) adapted to receive a pushing unit (ref. 857), and the shaft includes a distal end adapted to couple to the spinal implant (Fig. 8D).
Regarding clam 8, TO discloses the system of claim 5, wherein the positioning system includes a pushing unit (ref. 857) configured to couple to the guidance structure and translate relative to the guidance structure (Fig. 8C-8D).
Regarding clam 9, TO discloses the system of claim 8, wherein the pushing unit is configured to push each one of the plurality of spinal components into the implanted position (Fig. 8D).
Regarding clam 10, TO discloses the system of claim 8, wherein the pushing unit is configured to detachably couple to the guidance structure such that a rotation of the pushing unit causes a simultaneous rotation of the shaft (because the pushing unit and the guidance structure are two different components that may be independently used, they are fully capable of being used in such a manner).
Regarding clam 11, TO discloses the system of claim 8, wherein the pushing unit is a cannulated tube configured to extend and translate along the longitudinal axis (the pushing unit is cannulated to receive ref. 866).
Regarding clam 12, TO discloses the system of claim 11, wherein the cannulated tube includes a distal end configured to contact the spinal implant components and push the components into the implanted position, and the cannulated tube includes a proximal end coupled to an actuation device (Fig. 8D, where the proximal end is connected to refs. 856 which actuates the pusher).
Regarding clam 13, TO discloses the system of claim 1, wherein the positioning system includes an actuation device configured to rotate the spinal implant about the longitudinal axis (the actuation device is considered to be handles ref. 856 that may be used to rotate the device, e.g. by a surgeon holding the actuation device).
Regarding clam 14, TO discloses the system of claim 13, wherein the actuation device is a gripping tool adapted to extend along a second axis perpendicular to the longitudinal axis when the system is in an assembled condition (ref. 856 extends substantially perpendicular to the axis of the implant).
Regarding clam 15, TO discloses the system of claim 14, wherein the gripping tool is a handle coupled to a proximal end of the positioning system such that a rotation of the handle causes a simultaneous rotation of the positioning system (Fig. 8D, where if the handle is rotated then the implant will also be rotated since both are fixedly coupled).
Regarding clam 16, TO discloses the system of claim 13, wherein the actuation device is adapted to rotate the implant independently of a separate tool of the positioning system for inserting the spinal implant components into the implanted position (the actuation device is separate from component ref. 810 and thus able to act independently).
Allowable Subject Matter
Claims 18 – 20 are allowed.
Claim 17 is 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/TESSA M MATTHEWS/Examiner, Art Unit 3773
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