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Patent Application 18284939 - SYSTEM AND METHOD FOR CORRECTION OF SPINE - Rejection

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Patent Application 18284939 - SYSTEM AND METHOD FOR CORRECTION OF SPINE

Title: SYSTEM AND METHOD FOR CORRECTION OF SPINE DEFORMATION

Application Information

  • Invention Title: SYSTEM AND METHOD FOR CORRECTION OF SPINE DEFORMATION
  • Application Number: 18284939
  • Submission Date: 2025-05-22T00:00:00.000Z
  • Effective Filing Date: 2023-09-29T00:00:00.000Z
  • Filing Date: 2023-09-29T00:00:00.000Z
  • National Class: 606
  • National Sub-Class: 247000
  • Examiner Employee Number: 84619
  • Art Unit: 3773
  • Tech Center: 3700

Rejection Summary

  • 102 Rejections: 1
  • 103 Rejections: 6

Cited Patents

The following patents were cited in the rejection:

Office Action Text


    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 .

Drawings
The drawings are objected to under 37 CFR 1.83(a).  The drawings must show every feature of the invention specified in the claims.  Therefore, the spinous process wiring and fixation device (claim 8) and the spinous process wiring/fixation device (claim 14) must be shown or the feature(s) canceled from the claim(s).  No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.

Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 10 is objected to because of the following informalities: “upper vertebrae” should be “upper vertebra” (line 12) and “lower vertebrae” should be “lower vertebra” (line 13).  Appropriate correction is required.

Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):

(b)  CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.

The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:

The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.

Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.  Independent claims 1, 6, and 10 all include an anterior cervical discectomy and fusion (ACDF) implant.  It is commonly understood in the art that fusion implants fuse adjacent vertebrae to immobilize that segment of the spine.  However, claims 1, 6, and 10 then recite that the shape of the second surface of the implant allows a vertebral body to rotate at a correct center of rotation, which seems to indicate that the implant is designed to preserve motion between adjacent vertebrae.  It is unclear how an implant can be both a fusion implant and a motion preserving implant.  As such, claims 1, 6, and 10 are indefinite.  Claims 1-5, 7-9, and 11-15 depend from claims 1, 6, and 10 and are therefore also indefinite.
Claims 3-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.  Claim 3 recites the limitation "the end portion" in line 2.  This limitation is indefinite as claim 1 recites both a proximal end portion and a distal end portion.  Because claim 3 recites “the proximal end portion” in line 1, the Examiner is interpreting “the end portion” as “the proximal end portion.”  Claims 4 and 5 are rejected because they depend from claim 3.
Claims 4 and 5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.  Regarding claim 4, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.  See MPEP § 2173.05(d).  Claim 5 is rejected because it depends from claim 4.
Claims 10-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.  Claim 10 recites the limitation "the segment’s" in line 2 of the last paragraph.  There is insufficient antecedent basis for this limitation in the claim.  Claims 11-15 are rejected because they depend from claim 10.
Claims 13-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA  35 U.S.C. 112, the applicant), regards as the invention.  Claim 13 recites the limitation "the kyphotic deformity" in lines 3-4.  There is insufficient antecedent basis for this limitation in the claim.  Claims 14 and 15 are rejected because they depend from claim 13.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.

The following is a quotation of pre-AIA  35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA  35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.

Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA  35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.  Claim 5 fails to further limit claim 4 because claim 4 does not positively recite the fixation device.  Thus, specifying that the fixation device is a screw is not further limiting.  Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.

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 1-6 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) (Figs. 1A-1D and 3A-3D; paras. 0036-0045 and 0055-0059).
Claim 2. Mitchell discloses 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 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), and preferably two openings, 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 wherein the fixation device is a screw (see para. 0038) (Figs. 1A-1D and 3A-3D; paras. 0036-0045 and 0055-0059).
Claim 6. Mitchell discloses a system for correction of spine deformation 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).

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 7 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).
Mitchell fails to disclose a posterior cervical fixation system to compress a first and second lamina, thereby correcting the spine deformation (claim 7), 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 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 7), 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 Peterman et al. (US 2018/0228619 A1).
Mitchell fails to disclose 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 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 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Muhanna et al. (US 2007/0112429 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 the segment'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) and that the removal is with an access and bone removal device (claim 12).
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).
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Muhanna et al. (US 2007/0112429 A1) as applied to claim 10 above, and further in view of Brennan (US 2014/0046445 A1).
Muhanna fails 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.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Muhanna et al. (US 2007/0112429 A1) as applied to claim 12 above, and further in view of Peterman et al. (US 2018/0228619 A1).
Muhanna fails to teach 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 13), wherein the compression and fixation system is a laminar hook/rod, or hook/wire, or a spinous process wiring/fixation device (claim 14).
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 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 13), wherein the compression and fixation system is a laminar hook/rod, or hook/wire, or a spinous process wiring/fixation device (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 13 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 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.

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.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773


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