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 Objections
Claim 10 is objected to because of the following informalities: “upper vertebrae” should be “upper vertebra” (line 11), “lower vertebrae” should be “lower vertebra” (line 12), and “said vertebrae’s” should be “said vertebra’s” (line 13). Appropriate correction is required. Note that Applicant has used the plural “vertebrae” when referring to a single vertebra.
Claim Rejections - 35 USC § 112
The previous rejections of claims 1-15 is withdrawn in view of Applicant’s remarks.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 8 has been amended to recite “a spinous process wiring and fixation device selected from the group consisting of a laminar hook and rod, or a hook and wire.” Such a recitation constitutes new matter as the specification does not state that the spinous process wiring and fixation device is either a laminar hook and rod or a hook and wire. Instead, the specification states that the spinous process wiring and fixation device is an alternative to a laminar hook and rod and a hook and wire (see paras. 0007, 0008, 0022, and 0023). Accordingly, claim 8 contains new matter. For examination purposes, the Examiner is interpreting claim 8 as not including “a spinous process wiring and fixation device selected from the group consisting of.”
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 14 has been amended to recite “a spinous process wiring/fixation device selected from the group consisting of a laminar hook/rod, or a hook/wire.” Such a recitation constitutes new matter as the specification does not state that the spinous process wiring/fixation device is either a laminar hook/rod or a hook/wire. Instead, the specification states that the spinous process wiring/fixation device is an alternative to a laminar hook/rod and a hook/wire (see paras. 0007, 0008, 0022, and 0023). Accordingly, claim 14 contains new matter. For examination purposes, the Examiner is interpreting claim 14 as not including “a spinous process wiring/fixation device selected from the group consisting of.”
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.
Claims 1, 3-5, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitchell et al. (US 2008/0177390 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 the first and second 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 an inferior surface configured to engage a superior surface of a vertebra (if so desired, endoprosthesis 100 could be used in such a manner as claimed) (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).
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 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 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 the first and second 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) (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 spinous process wiring and fixation device selected from the group consisting of a laminar hook and rod, or a hook and wire (claim 8).
Balderston teaches a system for correction of spine deformation comprising: an ACDF 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 ACDF 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 spinous process wiring and fixation device selected from the group consisting of a laminar hook and rod, or a hook and wire (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) and Peterman et al. (US 2018/0228619 A1).
Claim 10. Muhanna discloses a method for correction of spine deformation comprising:
advancing the 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 the first and second 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 vertebrae (vertebra 110’) thereby allowing the implant to slide or rotate in a controlled manner on a surface of the upper vertebrae (vertebra 110) following said vertebrae’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 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), 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 selected from the group consisting of 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 ACDF 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) with a compression and fixation system or posterior cervical fixation system (fastener 68) 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).
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 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 selected from the group consisting of a laminar hook/rod, or hook/wire (claim 14), as suggested by Peterman, in order to correct kyphotic deformity and achieve a desired range of motion and/or spinal alignment. It is noted that claim 10 does not require a compression and fixation system (see “compression and fixation system or posterior cervical fixation system”), and thus because Peterman was relied upon to teach a posterior cervical fixation system, the combination of Muhanna and Peterman satisfy claim 14.
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) 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) 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 September 22, 2025 have been fully considered but they are not persuasive.
Regarding Mitchell, Applicant argues that Mitchell teaches the opposite orientation from the claimed implant and therefore does not anticipate claim 1 (see pg. 7). The Examiner disagrees. As stated in the rejection above, Mitchell discloses the structure of the implant recited in claim 1. The limitation that “the second surface is an inferior surface configured to engage a superior surface of a vertebra” is an intended use statement. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. If so desired, endoprosthesis 100 of Mitchell could be used in such a manner as recited and therefore meets the limitations of claim 1.
Regarding Balderston, Applicant argues Balderston is not concerned with correcting a spine deformation and thus the combination of Mitchell and Balderston fails to teach the claimed system (see pg. 8). The Examiner disagrees. Balderston states that disc replacement corrects problems with the disc caused by trauma, stress, and degenerative wear (see paras. 0004-0006). It is well-known in the art that trauma, stress, and degenerative wear cause spinal deformities due to the damage to the disc. Furthermore, the system of Balderston necessarily includes both the implant and the posterior cervical fixation system in order for the system to function as desired. Thus, it would be readily apparent to one of ordinary skill in the art that Balderston is concerned with correcting a spine deformation even if not explicitly stated as such.
Regarding Peterman, Applicant argues that Peterman does not compress a first lamina towards a second lamina (see pgs. 8-9). The Examiner disagrees. As stated by Peterman in para. 0060, which is cited in the rejection, the implant and system are used to correct kyphosis. As is well known, kyphosis is an excessive curvature of the spine leading to a hunchback appearance. Correcting such a deformity would necessarily involve compressing the first lamina towards the second lamina as the lamina are located on the posterior side of the vertebrae.
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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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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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773