DETAILED ACTION
This action is in response to applicant’s amendment received on September 3rd, 2026.
Terminal Disclaimer
The terminal disclaimer filed on September 3rd, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 12,318,303 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Applicant is advised that should claim 10 be found allowable, claim 14 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 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, 12-13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ainsworth (U.S. Patent 8,088,147).
Ainsworth discloses a method of using a device (for example see Figure 3) comprising:
(claim 1) providing a spinal implant (see Figure 3) including
(claim 1) a body (450, 460, etc.)
(claim 1) wherein the body comprises a plurality of braided strands (column 24 lines 1-15; for example Figure 26)
(claim 12) wherein the body is flexible such that the body stretches and lengthens when a tensile force is applied to the first fitting or the second fitting (the body is disclosed as semi-compliant and is capable of stretching and lengthening when put in tension)
(claim 13) wherein the body is flexible such that the body is self-expanded when a compression force is applied to the first fitting or the second fitting (the body is disclosed as semi-compliant and is capable of expanding outwards when compressed)
(claim 1) a first fitting (340)
(claim 1) wherein the plurality of braided strands converge at a first end of the body and are secured by the first fitting (the body is disclosed as a woven body, i.e. a plurality of braided strands, wherein the middle of the body converges to a first end of the body that is secure to the first fitting)
(claim 1) a second fitting (344)
(claim 1) wherein the plurality of braided strands converge at a second end of the body and are secured by the second fitting (the body is disclosed as a woven body, i.e. a plurality of braided strands, wherein the middle of the body converges to a second end of the body that is secure to the first fitting)
(claim 4) wherein a width or a diameter of a middle portion of the spinal implant, such as the thickness of the woven structure can be interpreted as a width, is less than a width or a diameter of a first end of the spinal implant, such as the diameter of the portion of the body inserted into element 340.
(claim 1) embedding the first fitting of the spinal implant in a first vertebral body
(claim 1) embedding the second fitting of the spinal implant in a second vertebral body (for example see Figure 2)
(claim 2) applying a coating to the spinal implant
(claim 3) wherein the coating provides an impervious barrier to liquids from entering an interior cavity of the body (column 24 line 24 to column 25 line 17)
(claim 15) removably coupling the first fitting to a delivery instrument (threads 2313 of delivery tool 2300 engage internal thread of element 340)
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ainsworth (U.S. Patent 8,088,147).
Ainsworth discloses the invention as claimed, see above, except for the diameter of the first end of the spinal implant being the same diameter of the second end of the spinal implant. As discussed above, Ainsworth discloses a method of using a device including a first end having a first diameter (the end including element 340) and a second end having a second diameter (the end including element 344) meeting the general conditions of the claim, wherein the first diameter and the second diameter are not the same. It has been held that where the only different between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently that the prior art device, the claimed device was not patentably distinct from the prior art device. In re Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to perform the method of Ainsworth wherein the first diameter and the second diameter on the spinal implant are the same.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ainsworth (U.S. Patent 8,088,147) in view of Hewitt (U.S. Publication 2016/0249934).
Ainsworth discloses the invention as claimed, see above, except for the plurality of braided strands being made from nitinol. Hewitt teaches a method of using spinal implant comprising a body (40), a first fitting (66), and a second fitting (68), wherein the body includes a plurality of braided strands (for example see abstract) made from nitinol (paragraph 18). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the invention of Ainsworth wherein the plurality of braided strands are made from nitinol in view of Hewitt, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ainsworth (U.S. Patent 8,088,147) in view of Lee (U.S. Publication 2005/0015150).
Ainsworth discloses the invention as claimed, see above, except for the body having an hourglass shape. Lee teaches a method of using a device including a body (200), wherein the body has an hourglass shape (for example see abstract). It would have been an obvious matter of design choice to one skilled in the art at the time the invention was filed to perform the method of Ainsworth wherein the body has an hourglass shape in view of Lee, since applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing a body of a spinal implant. In re Dailey and Eilers, 149 USPQ 47 (1966).
Allowable Subject Matter
Claims 16-20 are allowed. See the reasons for allowance discussed in the non-final office action mailed on June 12th, 2026.
Response to Arguments
Applicant's arguments filed September 3rd, 2026 have been fully considered but they are not persuasive. The applicant’s arguments are directed to the amendments which are discussed in the new grounds of rejection provided above.
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 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
