DETAILED ACTION
This action is in response to applicant’s amendment received on July 27th, 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, 8, 9, 13, 14, and 16-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Overes (U.S. Patent 8,252,059).
Regarding claims 1, 4, and 8:
Overes discloses a device (see Figure 2) comprising:
(claim 1) a first endplate (3)
(claim 1) a second endplate (5)
(claim 1) a first assembly including
(claim 1) a first load-bearing component disposed between the endplates
(claim 1) wherein the first load-bearing component has a height (for example the height of element 10) is at least twice as great as at least one of a width and a length (for example the width of element 10) of the first load-bearing component
(claim 4) the first load-bearing component having
(claims 4 and 5) a first flexure (52)
(claim 4) wherein a portion of the first flexure 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 (for example see Figure 4)
(claim 1) a second assembly including
(claim 1) a second load-bearing component disposed between the endplates
(claim 1) wherein the second load-bearing component has a height (for example the height of element 20) is at least twice as great as at least one of a width and a length (for example the width of element 20) of the second load-bearing component
(claim 1) wherein the first assembly is couple to the second assembly via a coupler (50)
(claim 8) wherein the device has a different degree of flexibility along each of a flexion/extension axis, a lateral bending axis, and a torsion axis (for example see column 5 line 64 to column 6 line 8, column 7 lines 6-16 and, column 7 lines 37-40)
(claim 9) wherein the first load-bearing component and the second load-bearing component having aspect ratios and orientations that cause different levels of flexion/extension, lateral bending, and axial rotation flexibility (for example see column 5 line 64 to column 6 line 8, column 7 lines 6-16, and column 7 lines 37-40)
Regarding claims 13-14 and 16-18:
Overes discloses a device (for example see Figure 2) comprising:
(claim 13) a first flexure assembly including
(claim 13) a first loading region configured to receive a first portion of a compressive force (the portion of element 10 connected to endplate 3)
(claim 13) a second loading region configured to receive a second portion of a compressive force (the portion of element 10’ connected to endplate 3)
(claim 13) a first support (10) associated with the first loading region
(claim 13) a second support (10’) associated with the second loading region
(claim 13) a flexure (30) 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 (the ends of element 30 are being pushed towards element 5 while the middle of element 30 is being pulled up by element 50, therefore there will be portions of element 30 in tension)
(claim 16) wherein at least one of the first support, the second support, and the flexure comprise a curved component (52)
(claim 13) a second flexure assembly (20, 40, etc.)
(claim 13) wherein the second flexure assembly is coupled to the first flexure assembly via a coupler (50)
(claim 17) wherein the coupler comprises a flexible piece of material
(claim 14) wherein the first flexure assembly and the second flexure assembly are configured such that at least a portion of the compressive force is transmitted through the first flexure assembly and the second flexure assembly in series (if the force is applied to one portion of endplate 3, for example the left side, then the force would extend through element 10 of the first flexure assembly before travelling through element 30 to element 50 to element 40 to element 20 of the second flexure assembly)
(claim 15) wherein each of the flexure assemblies are configured to limit the flexibility of the device along at least one axis (for example see column 5 line 64 to column 6 line 8, column 7 lines 6-16, and column 7 lines 37-40)
(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 method of using the device comprising:
(claim 19) obtaining the first flexure assembly including
(claim 19) a first loading region configured to receive a first portion of a compressive force (the portion of element 10 connected to endplate 3)
(claim 19) a second loading region configured to receive a second portion of a compressive force (the portion of element 10’ connected to endplate 3)
(claim 19) a first support (10) associated with the first loading region
(claim 19) a second support (10’) associated with the second loading region
(claim 19) a flexure (30) coupled to the first support and the second support
(claim 19) 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 (the ends of element 30 are being pushed towards element 5 while the middle of element 30 is being pulled up by element 50, therefore there will be portions of element 30 in tension)
(claim 19) obtaining the second flexure assembly
(claim 19) wherein the second flexure assembly is coupled to the first flexure assembly
(claim 19) inserting the implant into an intervertebral space such that the adjacent vertebrae of the spine apply the compressive force to the implant
(claim 20) selecting the flexure to have an aspect ratio configured to provide a patient-specific flexibility along at least one of a flexion/extension axis, lateral bending axis, and torsion axis (for example see column 5 line 64 to column 6 line 8, column 7 lines 6-16, and column 7 lines 37-40)
Regarding claim 21:
Overes disclose a device (for example see Figure 1A) comprising:
(claim 21) a first flexure assembly including
(claim 21) a first loading region (the portion of 10a connected to endplate 3) configured to receive a first portion of a compressive force
(claim 21) a second loading region (the portion of 10b connected to endplate 3) configured to receive a second portion of a compressive force
(claim 21) a first support (10a) associated with the first loading region
(claim 21) a second support (10b) associated with the second loading region
(claim 21) wherein at least one of the first support or the second support includes a curved portion (15) contiguous with the flexure
(claim 21) a flexure (30) coupled to the first support and the second support
(claim 21) 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 and second loading regions (when a force is applied to endplate 3 above elements 10a and/or 10b element 30 acts like a cantilever anchored at the connection to element 52 which will place at least a portion of element 30 into tension)
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 Overes (U.S. Patent 8,252,059).
Overes discloses the invention as claimed, see above, except for the first endplate comprising a flange. Overes teaches a device (for example see Figures 6A-6D) comprising a first endplate (611), a second endplate (612), a first assembly (for example 614, 614’, etc.), and a second assembly (for example 615), wherein the endplates further include a flange (for example see Figure 6D) including a primary fixation passage (640, 642, 644, or 646) configured to receive an anchor (650, 652, 654, or 656) and wherein the flange is closer to the first assembly than the second assembly (for example see Figure 6D which shows the first assembly 614 being closer to the flange than second assembly 615) and wherein at least one of the load bearing components (for example the element extending between the vertical elements of 614) in order to couple 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 further comprising a flange in view of Overes in order to couple the device to a vertebral body.
Claims 9 and 15 are 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 +/- 4 degrees, along the lateral bending axis is 5 degrees +/- 3 degrees, and along the torsion axis is 4 degrees +/- 4 degrees. Overes discloses the device as discussed above wherein the device includes 6 degrees of freedom, i.e. flexion/extension, lateral bending, and axial rotation (see column 7 lines 6-16) 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 +/- 4 degrees, along the lateral bending axis is 5 degrees +/- 3 degrees, and along the torsion axis is 4 degrees +/- 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 routing skill in the art. In re Aller, 105 USPQ 233.
Response to Arguments
Applicant's arguments filed July 27th, 2026 have been fully considered but they are not persuasive. The applicant’s arguments are directed to the new limitations and new claim added in the amendment which are discussed in the new grounds of rejection provided above.
Allowable Subject Matter
Claims 5-7 are 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
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. 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
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