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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 30, 2026 has been entered.
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 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 superior surface (surface 120) opposite an inferior surface (surface 130), the superior surface including one or more teeth (spikes 122, 124, 126, and 128) or ridges and the inferior surface being arcuate, curved or dome shaped, each of said surfaces extending between the proximal and distal end portions,
wherein the shape of the inferior 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) (Figs. 1A-1D and 3A-3D; paras. 0036-0045 and 0055-0059).
Mitchell fails to disclose 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).
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 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 Balderston (US 2008/0077137 A1) as applied to claim 6 above, and further in view of Peterman et al. (US 2018/0228619 A1).
Mitchell 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 March 30, 2026 with respect to Mitchell and claim 1 (see pg. 6) 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.
Applicant's arguments filed March 30, 2026 with respect to Mitchell and Balderston as applied to claim 6 (see pg. 7) have been fully considered but they are not persuasive. With respect to Mitchell, the Examiner notes that the claim does not correlate inferior and superior as applied to the implant with inferior and superior as applied to the vertebrae (contrast with claim 1, which recites that “the inferior surface is configured to engage a superior surface of a vertebra”). Thus, the implant of Mitchell satisfies the claim limitations (consider, for example, flipping Fig. 1A upside down, which would result in surface 130 being an inferior surface and surface 120 being a superior surface). With regard to Balderston, the Examiner notes that Balderston was merely relied upon to teach a posterior cervical fixation system.
Applicant's arguments filed March 30, 2026 with respect to Muhanna and Peterman as applied to claim 10 (see pg. 7) have been fully considered but they are not persuasive. The Examiner notes that Peterman was not relied upon for teaching of insertion direction or removal of a pedicle as Muhanna discloses insertion from the anterior direction. Peterman was merely relied upon to teach compressing the lamina in order to correct a kyphotic deformity.
Conclusion
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.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773
Prosecution Insights