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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-5, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell et al. (US 2008/0177390 A1) in view of Muhanna et al. (US 2007/0112429 A1).
Claim 1. Mitchell discloses an anterior cervical discectomy and fusion (ACDF) implant (endoprosthesis 100) comprising:
a proximal end portion (end portion adjacent plate 104) and a distal end portion (end portion adjacent distractor 140); and
a first surface (surface 120) opposite a second surface (surface 130), the first surface including one or more teeth (spikes 122, 124, 126, and 128) or ridges and the second surface being arcuate, curved or dome shaped, each of said surfaces extending between the proximal and distal end portions,
wherein the shape of the second surface allows a vertebral body to rotate at a correct center of rotation (para. 0036 states that endoprosthesis 100 is for disk replacement; it is well-known in the art that the purpose of disk replacement is to restore the natural range of motion of the spinal segment), and
wherein the second surface is configured to engage a surface of a vertebra (Figs. 1A-1D and 3A-3D; paras. 0036-0045 and 0055-0059).
Claim 3. Mitchell discloses wherein the proximal end portion further comprises an integrated anterior fixation plate (plate 104) extending from the proximal end portion (Figs. 1A-1D and 3A-3D; paras. 0036-0045 and 0055-0059).
Claim 4. Mitchell discloses wherein the anterior fixation plate further comprises at least one opening (holes 110 and 112) configured to receive a fixation device (see para. 0038) (Figs. 1A-1D and 3A-3D; paras. 0036-0045 and 0055-0059).
Claim 5. Mitchell discloses the fixation device, wherein the fixation device is a screw (see para. 0038) (Figs. 1A-1D and 3A-3D; paras. 0036-0045 and 0055-0059).
Claim 16. Mitchell discloses wherein the anterior fixation plate further comprises two openings (holes 110 and 112) configured to receive a fixation device (see para. 0038) (Figs. 1A-1D and 3A-3D; paras. 0036-0045 and 0055-0059).
Mitchell fails to disclose wherein the first surface is a superior surface, the second surface is an inferior surface, and the inferior surface is configured to engage a superior surface of a vertebra (claim 1).
Muhanna teaches an ACDF implant (disc 100) comprising: a first surface (surface from which anchor 150 extends) opposite a second surface (surface 133), the first surface including one or more teeth or ridges (anchor 150) and the second surface being arcuate, curved or dome shaped, wherein the shape of the second surface allows a vertebral body to rotate at a correct center of rotation (see para. 0030), and wherein the second surface is configured to engage a surface of a vertebra (Figs. 1-7; paras. 0024-0030). Muhanna also states that the inferior endplate of the upper vertebra may not be suitable as an articulating surface due to a variety of reasons, including anatomical variations (see para. 0032).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Mitchell such that the first surface is a superior surface, the second surface is an inferior surface, and the inferior surface is configured to engage a superior surface of a vertebra (claim 1) as doing so would be one of a limited number of configurations when the inferior endplate of the upper vertebra is not be suitable as an articulating surface due to a variety of reasons, including anatomical variations, as acknowledged by Muhanna.
Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Mitchell et al. (US 2008/0177390 A1) in view of Muhanna et al. (US 2007/0112429 A1) and Balderston (US 2008/0077137 A1).
Claim 6. Mitchell discloses a system for correction of spine deformation, the system comprising:
an anterior cervical discectomy and fusion (ACDF) implant (endoprosthesis 100), the implant comprising:
a proximal end portion (end portion adjacent plate 104) and a distal end portion (end portion adjacent distractor 140); and
a first surface (surface 120) opposite a second surface (surface 130), the first surface including one or more teeth (spikes 122, 124, 126, and 128) or ridges and the second surface being arcuate, curved or dome shaped, each of said surfaces extending between the proximal and distal end portions,
wherein the shape of the second surface allows a vertebral body to rotate at a correct center of rotation (para. 0036 states that endoprosthesis 100 is for disk replacement; it is well-known in the art that the purpose of disk replacement is to restore the natural range of motion of the spinal segment); and
wherein the second surface is configured to engage a surface of a vertebra (Figs. 1A-1D and 3A-3D; paras. 0036-0045 and 0055-0059).
Mitchell fails to disclose wherein the first surface is a superior surface, the second surface is an inferior surface, and the inferior surface is configured to engage a superior surface of a vertebra (claim 6), a posterior cervical fixation system to compress a first and second lamina, thereby correcting the spine deformation (claim 6), wherein the posterior cervical fixation system comprises a laminar hook and rod, or a hook and wire, or a spinous process wiring and fixation device (claim 8).
Muhanna teaches an ACDF implant (disc 100) comprising: a first surface (surface from which anchor 150 extends) opposite a second surface (surface 133), the first surface including one or more teeth or ridges (anchor 150) and the second surface being arcuate, curved or dome shaped, wherein the shape of the second surface allows a vertebral body to rotate at a correct center of rotation (see para. 0030), and wherein the second surface is configured to engage a surface of a vertebra (Figs. 1-7; paras. 0024-0030). Muhanna also states that the inferior endplate of the upper vertebra may not be suitable as an articulating surface due to a variety of reasons, including anatomical variations (see para. 0032).
Balderston teaches a system for correction of spine deformation comprising: an implant (disc 102); and a posterior cervical fixation system (member 104) in the form of a hook (see para. 0035) and rod (tubes 600(1) and 600(2) in combination); wherein the implant and posterior cervical fixation system share a common center of rotation (COR), and wherein the posterior cervical fixation system limits extension (see para. 0041) and flexion (see para. 0040) (Figs. 1-6; paras. 0029-0058).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant of Mitchell such that the first surface is a superior surface, the second surface is an inferior surface, and the inferior surface is configured to engage a superior surface of a vertebra (claim 6) as doing so would be one of a limited number of configurations when the inferior endplate of the upper vertebra is not be suitable as an articulating surface due to a variety of reasons, including anatomical variations, as acknowledged by Muhanna. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Mitchell by providing a posterior cervical fixation system to compress a first and second lamina, thereby correcting the spine deformation (claim 6), wherein the posterior cervical fixation system comprises a laminar hook and rod, or a hook and wire, or a spinous process wiring and fixation device (claim 8), as suggested by Balderston, as such can be configured to limit extension and flexion, thereby preventing over-extension and over-flexion of the spine.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Mitchell et al. (US 2008/0177390 A1) in view of Muhanna et al. (US 2007/0112429 A1) and Balderston (US 2008/0077137 A1) as applied to claim 6 above, and further in view of Peterman et al. (US 2018/0228619 A1).
Mitchell, Muhanna, and Balderston fail to teach one or more surgical instruments to access the cervical facet joint and perform either an osteotomy (partial removal of bone) or a facetectomy (total removal of the facet joint) in order to provide space to move the spinal column and correct kyphotic deformity (claim 9).
Peterman teaches system for correction of spine deformation comprising: an ACDF implant (device 30; see para. 0028); and one or more surgical instruments (see “tools” in para. 0025) to access the cervical facet joint and perform either an osteotomy (partial removal of bone) (see Figs. 3A-4D) or a facetectomy (total removal of the facet joint) in order to provide space to move the spinal column and correct kyphotic deformity (see para. 0060) and to allow the surgeon to address variations among patient anatomies or between levels of the vertebral column (see para. 0060) (Figs. 3A-6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Mitchell by providing one or more surgical instruments to access the cervical facet joint and perform either an osteotomy (partial removal of bone) or a facetectomy (total removal of the facet joint) in order to provide space to move the spinal column and correct kyphotic deformity (claim 9), as suggested by Peterman, in order to allow the surgeon to address variations among patient anatomies or between levels of the vertebral column.
Claims 10, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Muhanna et al. (US 2007/0112429 A1) in view of Peterman et al. (US 2018/0228619 A1) and Balderston (US 2008/0077137 A1).
Claim 10. Muhanna discloses a method for correction of spine deformation comprising:
advancing, from an anterior direction (see Fig. 5), an anterior cervical discectomy and fusion (ACDF) implant (disc 100) into a disc space between an upper and lower vertebrae (vertebrae 110 and 110’), the space created in an ACDF procedure, where the ACDF implant comprises:
a proximal end portion (end portion to the right as shown in Fig. 4B) and a distal end portion (end portion to the left as shown in Fig. 4B); and
a first surface (surface from which anchor 150 extends) opposite a second surface (surface 133), the first surface including one or more teeth or ridges (anchor 150) and the second surface being arcuate, curved or dome shaped, each of said surfaces extending between the proximal and distal end portions,
wherein the shape of the second surface allows a vertebral body to rotate at a correct center of rotation (see para. 0030); and
fixing the implant to the lower vertebra (vertebra 110’) thereby allowing the implant to slide or rotate in a controlled manner on a surface of the upper vertebra (vertebra 110) following said vertebra’s instantaneous center of rotation during a subsequent posterior reduction osteotomy (see para. 0030) (Figs. 1-7; paras. 0024-0030).
Claim 12. Muhanna discloses removing a lateral mass (key-hole 128’) of the upper and/or lower vertebrae (Figs. 1-7; paras. 0024-0030).
Muhanna fails to disclose wherein the first surface is a superior surface and the second surface is an inferior surface (claim 10), fixing the implant to the upper vertebra thereby allowing the implant to slide or rotate in a controlled manner on a surface of the lower vertebra (claim 10), compressing a first lamina toward a second lamina with a compression and fixation system or posterior cervical fixation system to compress the first and second lamina, thereby correcting the kyphotic deformity (claim 10), that the removal is with an access and bone removal device (claim 12), and wherein the compression and fixation system is a spinous process wiring/fixation device or a laminar hook/rod, or hook/wire (claim 14).
However, Muhanna notes that the inferior endplate of the upper vertebra may not be suitable as an articulating surface due to a variety of reasons, including anatomical variations (see para. 0032).
Peterman teaches method for correction of spine deformation comprising: advancing an implant (device 30; see para. 0028) into a disc space between an upper and lower vertebrae; and compressing a first lamina toward a second lamina (see Fig. 4D) to compress the first and second lamina, in order to correct kyphotic deformity and achieve a desired range of motion and/or spinal alignment (see para. 0060) (Figs. 3A-6).
Balderston teaches a system for correction of spine deformation comprising: an implant (disc 102); and a posterior cervical fixation system (member 104) in the form of a hook (see para. 0035) and rod (tubes 600(1) and 600(2) in combination), wherein the posterior cervical fixation system limits extension (see para. 0041) and flexion (see para. 0040) (Figs. 1-6; paras. 0029-0058).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Muhanna such that the first surface is a superior surface and the second surface is an inferior surface (claim 10) and by fixing the implant to the upper vertebrae thereby allowing the implant to slide or rotate in a controlled manner on a surface of the lower vertebrae (claim 10) as doing so would be one of a limited number of configurations when the inferior endplate of the upper vertebra is not be suitable as an articulating surface due to a variety of reasons, including anatomical variations. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Muhanna such that the removal is with an access and bone removal device (claim 12), as it is well-known in the art to use bone removal devices, such as drills or other cutting tools, to remove portions of vertebral bodies in preparation for receiving implants. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the system of Muhanna by compressing a first lamina toward a second lamina with a compression and fixation system or posterior cervical fixation system to compress the first and second lamina, thereby correcting the kyphotic deformity (claim 10), wherein the compression and fixation system is a spinous process wiring/fixation device or a laminar hook/rod, or hook/wire (claim 14), as suggested by Peterman and Balderston, in order to correct kyphotic deformity and achieve a desired range of motion and/or spinal alignment and to limit extension and flexion, thereby preventing over-extension and over-flexion of the spine.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Muhanna et al. (US 2007/0112429 A1) and Peterman et al. (US 2018/0228619 A1) and Balderston (US 2008/0077137 A1) as applied to claim 10 above, and further in view of Brennan (US 2014/0046445 A1).
Muhanna and Peterman fail to teach moving the patient to the prone position (claim 11).
Brennan teaches a method comprising: advancing an anterior implant (device 58) into a disc space between an upper and lower vertebrae (vertebral bodies 41); moving the patient to a prone position (see para. 0072); and securing a posterior fixation system (rod 160) to the vertebrae (Figs. 4 and 24-31).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Muhanna by moving the patient to the prone position (claim 11), as suggested by Brennan, to enable securing of a posterior fixation system to the vertebrae, thereby providing additional stabilization to the spinal segment.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Muhanna et al. (US 2007/0112429 A1) and Peterman et al. (US 2018/0228619 A1) and Balderston (US 2008/0077137 A1) as applied to claim 14 above, and further in view of Shima (US 5,534,029 A).
Muhanna and Peterman fail to teach wherein the first lamina is C5 and the second lamina is C7 (claim 15).
Shima teaches that it is sometimes necessary to stabilize a spinal segment comprising more than two vertebral bodies, such as a spinal segment extending from the fifth to seventh cervical vertebrae (see col. 5, ll. 9-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Muhanna such that the first lamina is C5 and the second lamina is C7 (claim 15), as suggested by Shima, as it is sometimes necessary to stabilize a spinal segment comprising more than two vertebral bodies.
Response to Arguments
Applicant's arguments filed July 30, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments regarding Mitchell (see pg. 5) and Balderston (see pg. 7) failing to teach an implant having an arcuate inferior surface configured to engage a superior surface of a vertebra are not persuasive as neither Mitchell nor Balderston were relied upon to teach such a limitation.
Applicant’s arguments regarding Muhanna (see pg. 6) failing to teach an implant having an arcuate inferior surface configured to engage a superior surface of a vertebra because Muhanna teaches the opposite orientation are not persuasive. The Examiner notes that Applicant has not addressed Muhanna’s statement that the inferior endplate of the upper vertebra may not be suitable as an articulating surface due to a variety of reasons, including anatomical variations (see pgs. 4-5 of the Non-Final Rejection citing to para. 0032 of Muhanna). Nor has Applicant addressed the obviousness rationale incorporating the aforementioned statement by Muhanna (see pg. 5 of the Non-Final Rejection). Accordingly, the rejections in view of Muhanna are being maintained.
Applicant’s arguments regarding Peterman (see pg. 7) are not persuasive. First of all, it is unclear whether Applicant’s arguments are referring to the rejection of claim 9 or the rejection of claims 10 and 14 as none of those rejections refer to removal of the pedicle. Because Peterman was not relied upon for any bone removal with respect to claims 10 and 14, the Examiner will assume that Applicant’s arguments are in reference to claim 9. With respect to claim 9, the Examiner notes that Applicant has not addressed Peterman’s statement that the purpose of the bone removal is to allow the surgeon to address variations among patient anatomies or between levels of the vertebral column (see pg. 7 of the Non-Final rejection citing to para. 0060 of Peterman). Nor has Applicant addressed the obviousness rationale incorporating the aforementioned statement by Peterman (see pg. 7 of the Non-Final Rejection). Accordingly, the rejections in view of Peterman are being maintained.
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 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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
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