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 § 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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Richelsoph (5,863,293; previously cited by Examiner) in view of Cahill et al. (2012/0303063; previously cited by Examiner).
Regarding claim 1, Richelsoph discloses a bone screw 10 (Fig. 1) for fixation in a vertebral body of a spine, comprising:
an elongated shank 12 having bone engaging threads 36 and defining a longitudinal axis; and
a rod-engaging portion 30 connected directly to one end of said elongated shank (Fig. 1), said rod-engaging portion including an elongated tulip portion (id.) coaxial with said longitudinal axis (id.), said tulip portion defining a channel 16 for receiving a spinal rod 20 therein, wherein said channel is defined at a fixed non-perpendicular angle relative to said longitudinal axis with said longitudinal axis intersecting said channel 16 (col. 3, lines 31-56, describing the shank 12 being angled relative to a longitudinal axis of the body portion 30).
Richelsoph discloses the claimed invention except only that the channel is defined at a fixed non-perpendicular angle relative to the longitudinal axis when the rod-engaging portion 30 is not coaxial (i.e., angled) relative to the longitudinal axis (id.).
However, Cahill et al. disclose also disclose a bone screw and teach that a channel 44a, 44b / 74a, 74b (Figs. 2 and 4) can be defined at a fixed non-perpendicular angle relative to a longitudinal axis of a rod-engaging portion 60 (i.e., coupling member), the rod-engaging portion 60 also being coaxial with a longitudinal axis of an elongated shank 50 (i.e., screw member) (id.), “to advantageously orient a rod member in a desired orientation, without having to adjust the angle or orientation of the coupling member 60 relative to the screw member 50 . . . reduc[ing] the need to expand the size of the incision when inserting the rod member . . . thereby reducing the amount of trauma to the patient” (paras. 0030 and 0037).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the bone screw 10 of Richelsoph with the channel 16 defined at a fixed non-perpendicular angle relative to the longitudinal axis when the rod-engaging portion 30 is coaxial relative to the longitudinal axis, in view of Cahill et al., to advantageously orient a spinal rod in a desired orientation, without having to adjust the angle or orientation of the rod-engaging portion 30 relative to the elongated shank 12, thereby reducing the need to expand the size of an incision when inserting the spinal rod and reducing the amount of trauma to the patient.
Regarding claim 2, the bone screw of the combination of Richelsoph and Cahill et al. discloses the claimed invention except for explicitly disclosing the non-perpendicular angle being between exactly 5 and 45 degrees measured from a line that is perpendicular to the longitudinal axis (cf. Cahill et al., para. 0037 disclosing an angle between about 5 and 50 degrees relative to a horizontal bottom surface).
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date to select the non-perpendicular angle in a desired range, including between 5 and 45 degrees measured from a line that is perpendicular to the longitudinal axis, e.g., to better accommodate the particular shape of a patient’s spine and reduce the amount of trauma to the patient.
Regarding claim 3, the bone screw of the combination of Richelsoph and Cahill et al. includes a kit for forming a spinal construct for correcting a plurality of vertebral levels of a patient's spine, comprising:
a plurality of bone screws according to claim 1 (Richelsoph, col. 3, lines 31-56), each having said channel 16 defined at a different non-perpendicular angle (id., describing “the assemblies can be individually made in various angulations); and
an elongated spinal rod defining a fixed curved contour (id., describing “various angulations between the bone connection surface and the rod 20” and col. 1, lines 18-23, describing anatomy requiring contouring of the rod in at least the sagittal plane) capable of percutaneous introduction along the patient's spine, if desired.
The limitation “said fixed curved contour being non-perpendicular relative to an optimum insertion angle for a bone screw into vertebral bodies at the plurality of vertebral levels, wherein said different non-perpendicular angles of the channels of the plurality of bone screws matches the non-perpendicular fixed curved contour of the elongated spinal rod at each of the different vertebral levels” amounts to a statement of intended use and would depend on each patient’s unique anatomy. However, it is noted that this limitation is satisfied by the bone screws of the combination of Richelsoph and Cahill et al. (supra at claim 1), which provides for angled screws (id.) “adapted to various angulations between the bone connection surface and the rod 20” (Richelsoph, col. 3, lines 31-56), thereby reducing the degree of contouring of the rod that is necessary (Richelsoph, cf. col. 1, lines 18-23).
Regarding claim 4, Cahill et al. further discloses a set screw 138 threadable into a rod-engaging portion 60, the set screw including a tip arranged to directly engage the elongated spinal rod 200 received within said channel to clamp the rod within the rod-engaging portion, wherein the tip is conical and defined at the non-perpendicular angle to directly contact the elongated spinal rod 200 (Fig. 6). This configuration puts more surface area in contact with an offset rod for more secure fixation.
Therefore, it also would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the bone screw of the combination of Richelsoph and Cahill et al. with a set screw 138 threadable into a rod-engaging portion 60, the set screw including a tip arranged to directly engage the elongated spinal rod 200 received within said channel to clamp the rod within the rod-engaging portion, wherein the tip is conical and defined at the non-perpendicular angle to directly contact the elongated spinal rod 200, also in view of Cahill et al., to provide more secure fixation.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Richelsoph (5,863,293; previously cited by Examiner) in view of Cahill et al. (2012/0303063; previously cited by Examiner), as applied to claim 1 above, and further in view of Jacob et al. (2012/0041490; previously cited by Examiner).
Regarding claim 9, the bone screw of the combination of Richelsoph and Cahill et al. includes a kit for forming a spinal construct for correcting a plurality of vertebral levels of a patient's spine, comprising:
a plurality of bone screws according to claim 1 (Richelsoph, col. 3, lines 31-56), each having said channel 16 defined at a different non-perpendicular angle (id., describing “the assemblies can be individually made in various angulations);
and an intermediate portion (annotated Fig. 1, below) disposed between and directly connected to said rod-engaging portion 30 and said elongated shank 12, said intermediate portion having a height along said longitudinal axis from said elongated shank to said channel (id.).
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The kit of the combination of Richelsoph and Cahill et al. does not explicitly recite each of the plurality of bone screws having a different height ranging from 0.5mm to 30mm.
Jacob et al. discloses a kit for forming a spinal construct 100 for correcting a plurality of vertebral levels of a patient's spine (Fig. 2), the kit comprising:
a plurality of bone screws, e.g., 110A/130A, 110B/130B, 110C/130C, each having:
an elongated shank, e.g., 110A, 110B, 110C, having bone engaging threads (Fig. 2), a head 124, and defining a longitudinal axis;
a rod-engaging portion, e.g., upper portion of 130A, 130B, 130C, extending to the bottom 209 of the channel 208, for receiving a spinal rod 120 therein; and
an intermediate portion, e.g., varying height middle portion of 130A, 130B, 130C (cf. Fig. 5-7) disposed between and directly connected to said rod-engaging portion (supra) and the head 124 of the elongated shank 110A, 110B, 110C, the intermediate portion having a height along said longitudinal axis, wherein each of the plurality of bone screws has a different height (cf. Figs. 5-7).
Jacob et al. do not recite the different heights explicitly ranging from 0.5mm to 30mm but do teach that kits can be provided with screws having “nearly any number of heights and dimensions that are adaptable to the anatomy encountered in patients who receive spinal surgery” (para. 0022). Examples of 5mm, 9mm and 13mm are given, which fall within a range of 0.5mm to 30mm (id.).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the kit of the combination of Richelsoph and Cahill et al. with intermediate portions having different heights ranging from 0.5mm to 30mm, further in view of Jacob et al., to provide heights and dimensions readily adaptable to the anatomy of different patients.
Regarding claim 10, the kit of the combination of Richelsoph and Cahill et al. and further in view of Jacob et al. discloses the claimed invention, including a plurality of bone screws provided with “nearly any number of heights and dimensions that are adaptable to the anatomy encountered in patients who receive spinal surgery” (para. 0022), but do not explicitly disclose providing heights at 0.5mm increments.
However, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to provide the bone screws with heights at 0.5mm increments, also in view of Jacob et al., to provide heights and dimensions readily adaptable to the anatomy of different patients.
Regarding claim 11, the kit of the combination of Richelsoph and Cahill et al. and further in view of Jacob et al. discloses an elongated spinal rod defining a fixed curved contour adapted for percutaneous introduction along the patient's spine (Richelsoph, col. 3, lines 31-56, describing “various angulations between the bone connection surface and the rod 20” and col. 1, lines 18-23, describing anatomy requiring contouring of the rod in at least the sagittal plane), said fixed curved contour being offset from the patient's spine by different offsets at different vertebral levels, as would result by the intermediate portions having different heights as taught by Jacob et al; (para. 0022; supra at claim 9), wherein each of the plurality of bone screws has a different height corresponding to each of said different offsets (id.).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Richelsoph (5,863,293; previously cited by Examiner) in view of Cahill et al. (2012/0303063; previously cited by Examiner) and Jacob et al. (2012/0041490; previously cited by Examiner), as applied to claims 9 and 11 above, and further in view of Miller et al. (2010/0004693; previously cited by Examiner).
The kit of the combination discloses the claimed invention including the spinal rod having a total length and necessarily a cranial and caudal portion, but do not explicitly recite the length of the caudal portion being sixty percent (60%) of the total length and in which the caudal and cranial portions are oppositely curved at the same fixed radius to form the fixed curved contour of the elongated spinal rod.
Miller et al. teach that spinal rods can have various shapes including S-shaped (i.e., caudal and cranial portions that are oppositely curved at the same fixed radius) (see para. 0157). Miller et al. further teach that the rods are pre-shaped (i.e., fixed absent any further necessary contouring) (id.). Pre-shaped rods more closely accommodate patient anatomy, reducing or eliminating the need for contouring.
Therefore, it would have been further obvious to a person having ordinary skill in the art before the effective filing date to configure the curved rods of the combination of Richelsoph in view of Cahill et al. and Jacob et al. (supra) as rods having caudal and cranial portions that are oppositely curved at the same fixed radius (i.e., S-shaped), in view of Miller et al., to more closely accommodate patient anatomy and reduce or eliminate the need for contouring.
An S-shape rod necessarily has a percentage of its total length that is cranial and a percentage thereof that is caudal. Miller et al. do not explicitly recite the length of the caudal portion being 60% of the total length.
However, it would have also been obvious to a person having ordinary skill in the art before the effective filing date to configure the kit of the combination with a rod for selection having a caudal length that is 60% of the total length, e.g., to readily accommodate different patient anatomy or vertebral levels to be stabilized.
Regarding claim 13, though not explicitly disclosed by Miller et al., it likewise would have been obvious to a person having ordinary skill in the art before the effective filing date to configure the kit of the combination with a rod for selection wherein the fixed radius is sized so that the anterior displacement of the caudal portion, measured from a line between one end of the rod and the cranial portion, is 9-11% of the total length of the elongated spinal rod, e.g., to readily accommodate different patient anatomy or the curvature of vertebral levels to be stabilized.
Response to Arguments
Applicant’s arguments, see Remarks, page 6, filed 19 November 2025, with respect to the rejection under 35 U.S.C. 102(a)(1) based on Richelsoph (5,863,293), and in light of the amended claims, have been fully considered and are persuasive for the reasons advanced by Applicant. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Richelsoph in view of Cahill et al. (2012/0303063; of record), as set forth above.
Allowable Subject Matter
Claims 17 and 18 are allowed.
Reasons for Allowance
The following is an examiner’s statement of 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 17. In particular, none of the cited references teach or suggest:
determining the T10-S2 distance between the T10 vertebra and the S2 vertebra of the patient's spine;
determining the L1-S2 distance between the L1 vertebra and the S2 vertebra of the patient's spine,
wherein the fixed radius is calculated using the following equation - ((L1-S2 distance)2 / 8A) + A/2, where A is the anterior displacement of the caudal portion, measured from a line between one end of the spinal rod and the cranial portion; and
determining the distance between the caudal portion of the spinal rod and each of the instrumented L1-S1 vertebrae, and the distance between the cranial portion of the spinal rod and each of the instrumented T10-T12 of the patient's spine, as required by claim 17.
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.”
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 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