DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
EXAMINER’S COMMENT
There does not appear to be any overlapping subject matter requiring a Double Patenting over US Patents 11571247, 10716601, 10034695, 9480504 at this time.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claim(s) 1-4, 10, 12, 14 and 15 is/are rejected on the ground of nonstatutory double patenting as being anticipated by claim(s) 8 and 13 of U.S. Patent No. 12185990. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include many more elements and are thus much more specific as shown below (note that underlined and/or bolded sections indicate comparable elements):
Invention 18975518
US Patent 12185990
1. A system, comprising: a spinal fixation construct configured to couple to a first vertebra and a second vertebra in a patient, the spinal fixation construct comprising: a first pedicle screw including a first shank coupled to a first rod housing, a second pedicle screw including a second shank coupled to a second rod housing, and a spinal rod configured to engage the first and second rod housings; and a first guide assembly configured to couple to the first pedicle screw; a second guide assembly configured to couple to the second pedicle screw; and a spinal alignment frame configured to align the first and second vertebra, the spinal alignment frame comprising: an elongate rack, a first coupler configured to couple to the elongate rack and the first guide assembly, and a second coupler configured to couple to the elongate rack and the second guide assembly a first locking cap configured to lock the spinal rod within the first rod housing of the first pedicle screw; and a second locking cap configured to lock the spinal rod within the second rod housing of the second pedicle screw.
Claim 8. A system, comprising a spinal fixation construct configured to couple to a first vertebra and a second vertebra in a patient, the spinal fixation construct comprising: a first pedicle screw including a first shank coupled to a first rod housing, a second pedicle screw including a second shank coupled to a second rod housing, and a spinal rod configured to engage the first and second rod housings; and a first guide assembly configured to couple to the first pedicle screw; a second guide assembly configured to couple to the second pedicle screw; and a spinal alignment frame configured to align the first and second vertebra, the spinal alignment frame comprising: an elongate rack, a first coupler configured to couple to the elongate rack to the first guide assembly and comprising a first attachment ring configured to receive the first guide assembly therein, a first ring shaft configured to couple to the first attachment ring, wherein the first attachment ring is configured to rotate about a first longitudinal axis of the first ring shaft, and a first indicator arm configured to couple to the first ring shaft, and a second coupler configured to couple to the elongate rack to the second guide assembly and comprising a second attachment ring configured to receive the second guide assembly therein, a second ring shaft configured to couple to the second attachment ring, wherein the second attachment ring is configured to rotate about a second longitudinal axis of the second ring shaft, and a second indicator arm configured to couple to the second ring shaft; a first attachment block configured to couple to the first coupler; a second attachment block configured to couple to the second coupler; a first housing configured to couple the first attachment block to the elongate rack; and a second housing configured to couple the second attachment block to the elongate rack; wherein spinal fixation construct comprises: a first locking cap configured to lock the spinal rod within the first rod housing of the first pedicle screw; and a second locking cap configured to lock the spinal rod within the second rod housing of the second pedicle screw.
2. The system of claim 1, wherein the first coupler comprises: a first attachment ring configured to receive the first guide assembly therein; a first ring shaft configured to couple to the first attachment ring, wherein the first attachment ring is configured to rotate about a first longitudinal axis of the first ring shaft; and a first indicator arm configured to couple to the first ring shaft.
Claim 8- see bolded sections in claim 8 above
3. The system of claim 2, wherein the second coupler comprises: a second attachment ring configured to receive the second guide assembly therein; a second ring shaft configured to couple to the second attachment ring, wherein the second attachment ring is configured to rotate about a second longitudinal axis of the second ring shaft; and a second indicator arm configured to couple to the second ring shaft.
Claim 8- see bolded sections in claim 8 above
4. The system of claim 3, wherein the spinal alignment frame comprises: a first attachment block and a second attachment block configured to couple to the first and second couplers, respectively; and a first housing and a second housing configured to couple the first and second attachment blocks to the elongate rack, respectively.
Claim 8- see bolded sections in claim 8 above
10. The system of claim 4, wherein the first attachment block is configured to translate along a length of the elongate rack.
Claim 8- see underlined section and note that this is a functional recitation
12. The system of claim 1, wherein the first guide assembly and the second guide assembly are configured to position the spinal rod within the first rod housing and the second rod housing, respectively.
Claim 8- see underlined section and note that this is a functional recitation
14. A method for aligning spinal vertebrae and installing a spinal fixation construct in a patient, the method comprising: anchoring a first pedicle screw of the spinal fixation construct to a first vertebra, the first pedicle screw having a first shank coupled to a first rod housing; anchoring a second pedicle screw of the spinal fixation construct to a second vertebra, the second pedicle screw having a second shank coupled to a second rod housing; coupling a first guide assembly to the first pedicle screw; coupling a second guide assembly to the second pedicle screw; and coupling a spinal alignment frame to the first guide assembly and the second guide assembly to align the first vertebra and the second vertebra; and coupling a spinal rod of the spinal fixation construct to the first and second rod housings of the first and second pedicle screws, respectively, an elongate rack; a first coupler configured to couple to the elongate rack and the first guide assembly, wherein the first coupler comprises a first attachment ring configured to receive the first guide assembly therein, a first ring shaft configured to couple to the first attachment ring, and a first indicator arm configured to couple to the first ring shaft, wherein the first attachment ring is configured to rotate about a first longitudinal axis of the first ring shaft; a second coupler configured to couple to the elongate rack and the second guide assembly, measuring a first angle between a longitudinal axis of the first attachment ring and a longitudinal axis of the elongate rack; and adjusting the first attachment ring from the first angle to a second angle.
Claim 13. A method for aligning spinal vertebrae and installing a spinal fixation construct in a patient, the method comprising: anchoring a first pedicle screw of the spinal fixation construct to a first vertebra, the first pedicle screw having a first shank coupled to a first rod housing; anchoring a second pedicle screw of the spinal fixation construct to a second vertebra, the second pedicle screw having a second shank coupled to a second rod housing; coupling a first guide assembly to the first pedicle screw; coupling a second guide assembly to the second pedicle screw; and coupling a spinal alignment frame to the first guide assembly and the second guide assembly to align the first vertebra and the second vertebra; and coupling a spinal rod of the spinal fixation construct to the first and second rod housings of the first and second pedicle screws, respectively, wherein the spinal alignment frame comprises: an elongate rack; a first coupler configured to couple to the elongate rack and the first guide assembly, wherein the first coupler comprises a first attachment ring configured to receive the first guide assembly therein, a first ring shaft configured to couple to the first attachment ring, and a first indicator arm configured to couple to the first ring shaft, and the first attachment ring is configured to rotate about a first longitudinal axis of the first ring shaft; a second coupler configured to couple to the elongate rack and the second guide assembly, wherein the second coupler comprises a second attachment ring configured to receive the second guide assembly therein, a second ring shaft configured to couple to the second attachment ring, and a second indicator arm configured to couple to the second ring shaft, and the second attachment ring is configured to rotate about a second longitudinal axis of the second ring shaft; a first attachment block configured to couple to the first coupler; a second attachment block configured to couple to the second coupler; a first housing configured to couple to the first attachment block to the elongate rack; and a second housing configured to couple the second attachment block to the elongate rack; measuring a first angle between a longitudinal axis of the first attachment ring and a longitudinal axis of the elongate rack; and adjusting the first attachment ring from the first angle to a second angle.
15. The method of claim 14, wherein the spinal alignment frame comprises: wherein the second coupler comprises a second attachment ring configured to receive the second guide assembly therein, a second ring shaft configured to couple to the second attachment ring, and a second indicator arm configured to couple to the second ring shaft, wherein the second attachment ring is configured to rotate about a second longitudinal axis of the second ring shaft; a first attachment block and a second attachment block configured to couple to the first and second couplers, respectively; and a first housing and a second housing configured to couple the first and second attachment blocks to the elongate rack, respectively.
Claim 13- see bolded sections in claim 13 above
Thus, the invention of US Patent 12185990, claims 8 and 13, respectively, are in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
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 –
(a) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim(s) 1 and 11-13 is/are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Nayet (US 20120191143).
With respect to claim 1, Nayet discloses a system (402, see fig. 10 below, para. 45), comprising: a spinal fixation construct (e.g., 402, see fig. 10 below) configured to couple to a first vertebra (416) and a second vertebra (414) in a patient, the spinal fixation construct comprising: a first pedicle screw (422b) including a first shank (422a) coupled to a first rod housing (tulip/receiver), a second pedicle screw (42b) including a second shank (424a) coupled to a second rod housing (tulip/receiver), and a spinal rod (connecting element) configured to engage the first and second rod housings (see para. 45); and a first guide assembly (426b) configured to couple to the first pedicle screw; a second guide assembly (426a) configured to couple to the second pedicle screw; and a spinal alignment frame (210) configured to align the first and second vertebra, the spinal alignment frame comprising: an elongate rack (224), a first coupler (300) configured to couple to the elongate rack (via 214) and the first guide assembly (see fig. 10 below, also fig. 7-8), and a second coupler (252) configured to couple to the elongate rack (via 212) and the second guide assembly (see fig. 10 below, also fig. 7-8); a first locking cap (e.g., set screw) configured to lock the spinal rod within the first rod housing of the first pedicle screw (see last 7 lines of para. 45); and a second locking cap (e.g., set screw) configured to lock the spinal rod within the second rod housing of the second pedicle screw (see last 7 lines of para. 45).
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As for claim 11, Nayet further discloses the system of claim 1, wherein the first guide assembly comprises a body having a distal end configured to couple to the first rod housing of the first pedicle screw (see fig. 10 above and para. 45), and wherein the second guide assembly comprises a body having a distal end configured to couple to the second rod housing of the second pedicle screw (see fig. 10 above and para. 45).
As for claim 12, Nayet further discloses the system of claim 1, wherein the first guide assembly and the second guide assembly are configured to position the spinal rod within the first rod housing and the second rod housing, respectively (see fig. 10 above and para. 45).
As for claim 13, Nayet further discloses the system of claim 1, wherein the first coupler comprises a locking mechanism (e.g., 274) configured to selectively inhibit translation of the first coupler along a length of the elongate rack in at least one direction (see para. 39-40).
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.
Claim 2-10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nayet (US 20120191143), as applied to claim 1 above, in view of Walters (US 20140107659).
As for claims 2-3, Nayet further teaches wherein the first coupler comprises: a first attachment ring (note that 300 is a ring) configured to receive the first guide assembly therein (see fig. 7 below); a first ring shaft (302) configured to couple to the first attachment ring (see fig. 7 and note they are integrally attached), wherein the first attachment ring is configured to rotate about a first longitudinal axis of the first ring shaft (see fig. 7 below); wherein the second coupler comprises: a second attachment ring (note that 252 is a ring) configured to receive the second guide assembly therein (see fig. 7 below and fig. 8 and also fig. 10 above); a second ring shaft (254) configured to couple to the second attachment ring (they are integrally attached), wherein the second attachment ring is configured to rotate about a second longitudinal axis of the second ring shaft (see fig. 7 below).
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Nayet does not teach a first indicator arm configured to couple to the first ring shaft; and a second indicator arm configured to couple to the second ring shaft.
Walters, also drawn to spinal alignments frames, teaches respective first and second indicator arms (120a, 120b) fixedly attached to the first and second attachment couplers (123, 123) that contain measurement scales in order to provide the surgeon with the capability of an angular measurement of the positioning of bone screw assemblies relative to the elongate rack of the alignment frame (see para. 28, fig. 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Nayet to include a first indicator arm fixedly attached to the first ring shaft, and a second indicator arm fixedly attached to the second ring shaft, in view of Walters, in order to in order to provide the surgeon with the capability of an angular measurement of the positioning of bone screw assemblies relative to the elongate rack of the alignment frame.
As for claim 4, Nayet, as modified by Walters, further teaches the system of claim 3, wherein the spinal alignment frame comprises: a first attachment block (e.g., 214) and a second attachment block (e.g., 212) configured to couple to the first and second couplers, respectively (see fig. 7 above); and a first housing (e.g., 276) and a second housing (e.g., 230) configured to couple the first and second attachment blocks to the elongate rack, respectively (see fig. 7 above and fig. 8).
As for claim 5, Nayet, as modified by Walters, further teaches the system of claim 4, wherein the first attachment block comprises a first aperture (e.g., 298) configured to receive the first ring shaft therein and a second aperture (e.g., 296) configured to receive a first set screw therein (see fig. 7 above, note that the set screw is not positively recited and this device is capable of performing this function), and wherein the second attachment block comprises a first aperture (250) configured to receive the second ring shaft therein and a second aperture (248) configured to receive a second set screw therein (see fig. 7 above, note that the set screw is not positively recited and this device is capable of performing this function).
As for claims 7-9, Nayet further teaches wherein the first coupler comprises: a first attachment ring (note that 300 is a ring) configured to receive the first guide assembly therein (see fig. 7 above); a first ring shaft (302) configured to couple to the first attachment ring (see fig. 7 above and note they are integrally attached), wherein the first attachment ring is configured to rotate about a first longitudinal axis of the first ring shaft (see fig. 7 above); wherein the second coupler comprises: a second attachment ring (note that 252 is a ring) configured to receive the second guide assembly therein (see fig. 7 above and fig. 8 and also fig. 10 above); a second ring shaft (254) configured to couple to the second attachment ring (they are integrally attached), wherein the second attachment ring is configured to rotate about a second longitudinal axis of the second ring shaft (see fig. 7 above); wherein the spinal alignment frame comprises: a first attachment block (e.g., 214) and a second attachment block (e.g., 212) configured to couple to the first and second couplers, respectively (see fig. 7 above); and a first housing (e.g., 276) and a second housing (e.g., 230) configured to couple the first and second attachment blocks to the elongate rack, respectively (see fig. 7 above and fig. 8).
Nayet does not teach a first indicator arm configured to couple to the first ring shaft; and a second indicator arm configured to couple to the second ring shaft; wherein the spinal alignment frame comprises: a first readout arm configured to couple to the first attachment block, the first readout arm comprising a first indicator scale distributed in a plane orthogonal to the first longitudinal axis of the first ring shaft, wherein the first readout arm is rotationally fixed relative to the elongate rack and configured to indicate a relative rotational position of the first indicator arm about the first longitudinal axis; wherein the spinal alignment frame comprises: a second readout arm configured to couple to the second attachment block, the second readout arm comprising a second indicator scale distributed in a plane orthogonal to the second longitudinal axis of the second ring shaft, wherein the second readout arm is rotationally fixed relative to the elongate rack and configured to indicate a relative rotational position of the second indicator arm about the second longitudinal axis; and wherein the first indicator arm is configured to rotate with the first attachment ring and indicates an angle of rotation of a longitudinal axis of the first guide assembly relative to a longitudinal axis of the elongate rack.
Walters, also drawn to spinal alignments frames, teaches respective first and second indicator arms (127, 127) fixedly attached to the first and second attachment couplers (123, 123) that contain measurement scales (see fig. 1); wherein the spinal alignment frame comprises: a first readout arm (e.g. 125) configured to couple to the first attachment block, the first readout arm comprising a first indicator scale distributed in a plane orthogonal to the first longitudinal axis of the first ring shaft, (see fig. 1) wherein the first readout arm is rotationally fixed relative to the elongate rack and configured to indicate a relative rotational position of the first indicator arm about the first longitudinal axis (see fig. 1); wherein the spinal alignment frame comprises: a second readout arm (125) configured to couple to the second attachment block, the second readout arm comprising a second indicator scale distributed in a plane orthogonal to the second longitudinal axis of the second ring shaft (see fig. 1), wherein the second readout arm is rotationally fixed relative to the elongate rack and configured to indicate a relative rotational position of the second indicator arm about the second longitudinal axis (see fig. 1); and wherein the first indicator arm is configured to rotate with the first attachment ring and indicates an angle of rotation of a longitudinal axis of the first guide assembly relative to a longitudinal axis of the elongate rack (see fig. 1, para. 28-29) in order to provide the surgeon with the capability of an angular measurement of the positioning of bone screw assemblies relative to the elongate rack of the alignment frame (see para. 28, fig. 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Nayet to include a first indicator arm fixedly attached to the first ring shaft, and a second indicator arm fixedly attached to the second ring shaft; wherein the spinal alignment frame comprises: a first readout arm configured to couple to the first attachment block, the first readout arm comprising a first indicator scale distributed in a plane orthogonal to the first longitudinal axis of the first ring shaft, wherein the first readout arm is rotationally fixed relative to the elongate rack and configured to indicate a relative rotational position of the first indicator arm about the first longitudinal axis; wherein the spinal alignment frame comprises: a second readout arm configured to couple to the second attachment block, the second readout arm comprising a second indicator scale distributed in a plane orthogonal to the second longitudinal axis of the second ring shaft, wherein the second readout arm is rotationally fixed relative to the elongate rack and configured to indicate a relative rotational position of the second indicator arm about the second longitudinal axis; and wherein the first indicator arm is configured to rotate with the first attachment ring and indicates an angle of rotation of a longitudinal axis of the first guide assembly relative to a longitudinal axis of the elongate rack, in view of Walters, in order to in order to provide the surgeon with the capability of an angular measurement of the positioning of bone screw assemblies relative to the elongate rack of the alignment frame.
As for claim 10, Nayet, as modified by Walters, further teaches the system of claim 4, wherein the first attachment block is configured to translate along a length of the elongate rack (see fig. 7 above and note that this device is capable of performing this function).
Reasons for Allowance
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and its dependent claim 5. In particular, none of the cited references teach or suggest wherein the first set screw advances into a groove of the first ring shaft to retain the first ring shaft within the first attachment block, and wherein the second set screw advances into a groove of the second ring shaft to retain the second ring shaft within the second attachment block, as required by claim 6.
The claims in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 14. In particular, none of the cited references teach or suggest the method including a first indicator arm configured to couple to the first ring shaft, wherein the first attachment ring is configured to rotate about a first longitudinal axis of the first ring shaft; measuring a first angle between a longitudinal axis of the first attachment ring and a longitudinal axis of the elongate rack; and adjusting the first attachment ring from the first angle to a second angle, as required by claims 14-18.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Allowable Subject Matter
Claims 16-18 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 7981115; US 6409728.
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/TARA ROSE E CARTER/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773