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 .
Election/Restrictions
Applicant's election with traverse of Species D in the reply filed on January 23rd, 2026 is acknowledged. The traversal is on the ground(s) that the examiner would not have a serious burden to search the different species. This is not found persuasive because the different species are mutually exclusive, are not obvious variants, and have a different design.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on January 23rd, 2026.
Claim Rejections - 35 USC § 102
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, 4-10, 13, 14, and 16, 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Overes (U.S. Patent 8,252,059).
Regarding claims 1 and 4-9:
Overes discloses a device (for example see Figure 3) comprising:
(claim 1) a first endplate (3)
(claim 1) a second endplate (5)
(claim 1) a load-bearing component
(claim 1) wherein the load-bearing component is disposed between the first endplate and the second endplate
(claim 1) wherein the load-bearing component includes
(claim 1) a height (for example the height of element 10) that is at least twice a width of the load-bearing component (for example the width of element 50)
(claim 4) a first flexure (10a, 50a, etc.)
(claim 4) wherein a portion of the first flexure (50a) is configured to be placed under tension when a compressive force is applied to at least one of the first endplate and the second endplate
(claim 5) further comprising a flexure assembly including
(claim 5) a first loading region (the area of endplate 3 above element 10a) configured to receive a first portion of the compressive force
(claim 5) a second loading region (the area of endplate 5 below 20a) configured to receive a second portion of the compressive force
(claim 5) the first flexure
(claim 5) a first support (10a and 30a) configured to transfer the first portion of the compressive force to a first end (the end near element 30a) of the first flexure
(claim 5) wherein the first end of the first flexure is opposite the first loading region
(claim 5) a second support (20a and 40a) configured to transfer the second portion of the compressive force to a second end (the end near element 40a) of the first flexure
(claim 5) wherein the second end of the first flexure is positioned opposite the second loading region
(claim 5) wherein a transfer of the compression force from the first loading region and the second loading region causes the first flexure to support the compressive force with an opposite tensile force
(claim 6) further comprising a second flexure assembly (10b’, 50b, etc.)
(claim 6) wherein the second flexure assembly includes a second flexure (50b)
(claim 7) wherein the first flexure is configured to be flexible along a flexion/extension axis and the second flexure is configured to be flexible along a lateral bending axis
(claim 10) wherein the load-bearing component is configured to withstand at least 25% of a compression force applied to the first endplate and the second endplate without buckling and without breaking when the compression force results from compression between a first vertebra and a second vertebra (the device is designed not to break while in use)
(claim 8) wherein the device is flexible along each of a flexion/extension axis, a lateral bending axis, and a torsion axis (for example see column 7 lines 6-16)
(claim 9) wherein the device is configured to stabilize motion to a physiological range along each of the flexion/extension axis, the lateral bending axis, and the torsion axis (for example see column 1 lines 46-49)
Regarding claims 13, 14, 16, 18:
Overes discloses a device (for example see Figure 3) comprising:
(claim 13) a first flexure assembly including
(claim 13) a first loading region (for example the region of endplate 3 above 10a) configured to receive a first portion of a compressive force
(claim 13) a second loading region (for example the region of endplate 5 below 20a) configured to receive a second portion of the compressive force
(claim 13) a first support (10a and 30a) associated with the first loading region
(claim 13) a second support (20a and 40a) associated with the second loading region
(claim 13) a flexure (50a) coupled to the first support and the second support
(claim 13) wherein a portion of the flexure is configured to be placed under tension in response to the compressive force being applied to at least one of the first loading region and the second loading region
(claim 14) wherein at least one of a stiffness of the device along a flexion/extension axis, a stiffness of the device along a lateral bending axis, and a stiffness of the device along a torsion axis is selectably adjustable (column 5 line 64 to column 6 line 8)
(claim 16) a second flexure assembly (10b’, 30a’, 20b, 50b, etc.)
(claim 18) wherein the first flexure assembly has a first orientation and the second flexure assembly has a second orientation different from the first orientation
Regarding claims 19 and 20:
Overes discloses a device as discussed above and a method comprising:
(claim 19) obtaining a first flexure assembly including
(claim 19) a first loading region configured to receive a first portion of a compressive force
(claim 19) a second loading region configured to receive a second portion of a compressive force
(claim 19) a first support associated with the first loading region
(claim 19) a second support associated with the second loading region
(claim 19) a flexure coupled to the first support and the second support
(claim 19) wherein the flexure is configured to be placed under tension in response to the compressive force being applied to at least one of the first loading region and the second loading region
(claim 19) inserting the device into an interbody space of a spine of a patient such that adjacent vertebra of the spine apply the compressive force to the device
(claim 20) configuring at least one of the first support, the second support, and the flexure to provide a patient-specific flexibility along at least one of a flexion/extension axis, a lateral bending axis, and a torsion axis (column 5 line 64 to column 6 line 8; column 10 line 60 to column 11 line 4)
Claim Rejections - 35 USC § 103
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 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Overes (U.S. Patent 8,252,059) in view of Coates (U.S. Patent 6,899,735).
Overes discloses the invention as claimed except for at least one of the endplates comprising a flange. Coates teaches a device comprising a first endplate (upper element 20) and a second endplate (lower element 20), wherein at least one of the endplates includes a flange (30) having a primary fixation passage (32) configured to receive an anchor and a secondary fixation passage (36) configured to receive a locking cap (40b and 37) configured to prevent the anchor from backing out of the primary passage in order to attach the device to a vertebral body. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Overes wherein at least one of the endplates includes a flange in view of Coates in order to attach the device to a vertebral body.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Overes (U.S. Patent 8,252,059).
Overes discloses the invention as claimed, see above, except for the flexibility of the implant along the flexion/extension axis is 7 degrees plus/minus 4 degrees, along the lateral bending axis is 5 degrees plus/minus 3 degrees, and along the torsion axis is 4 degrees plus/minus 4 degrees. Overes discloses the device as discussed above wherein the device is flexible along the flexion/extension axis, the lateral bending axis, and a torsion axis meeting the general conditions of the claim. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Overes wherein the flexibility of the implant along the flexion/extension axis is 7 degrees plus/minus 4 degrees, along the lateral bending axis is 5 degrees plus/minus 3 degrees, and along the torsion axis is 4 degrees plus/minus 4 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Allowable Subject Matter
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775