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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 01/08/2026 has been entered.
Claims 2 and 4-18 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/08/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 12-14 are objected to because of the following informalities:
In claim 12, in line 1, change “an” to –a--; in line 2, delete “distal” and “of the first anchor arm”; in line 3, change “an” to –a—and delete “distal”; in line 4 delete “of the second anchor arm.”
In claim 13, line 1, delete “of the first anchor arm”; and in line 2 delete “of the second anchor arm.”
In claim 14, line 1, delete “of the first anchor arm”; in lines 2-3, delete “of the second anchor arm.”
Appropriate correction is required.
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.
Claim(s) 2, 4, 7-8, 10-12 and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gleason (U.S. 11,439,515 B2) as cited in the IDS filed 01/08/2026. It is noted that Michelson (U.S. 2001/0010002 A1) is referenced to support the position that saw teeth on the outer surface of a fusion endplate penetrate the adjacent vertebral bodies.
Concerning claim 2, Gleason discloses a method of anchoring an expandable mesh implant to a patient's anatomy, comprising: providing an anchor (see below) having an elongated body, a first anchor arm (see below), and a second anchor arm (see below), wherein the elongated body extends lengthwise between a distal end and a proximal end, wherein the elongated body includes an interior aperture (see below) and a lateral aperture (see below), and wherein the interior aperture extends lengthwise from the proximal end, and wherein the lateral aperture is disposed in the elongated body at a position between the distal end and the proximal end of the elongated body and the lateral aperture is in communication with the interior aperture; securing the expandable mesh implant to the elongated body of the anchor while the expandable mesh implant is in an unexpanded state (see col. 2, lines 42-60);
placing the expandable mesh implant secured to the elongated body in the unexpanded state in an intervertebral space located between a superior vertebrae and an inferior vertebrae (see col. 2, lines 42-60); securing the first anchor arm (see below) to the elongated body at a first end of the first anchor arm
while extending an opposing second end (see below) of the first anchor arm at least partially into the superior vertebrae (see col. 5, lines 13-18); and securing the second anchor arm (see below) to the elongated body at a first end of the second anchor arm while extending an opposing second end (see below) of the second anchor arm at least partially into the inferior vertebrae.
[AltContent: connector][AltContent: textbox (Head Portion )][AltContent: arrow][AltContent: textbox (Lateral Aperture)][AltContent: arrow][AltContent: textbox (Interior Aperture)][AltContent: arrow][AltContent: textbox (Anchor)]
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[AltContent: connector][AltContent: textbox (Opposing Second End of 2nd Anchor Arm)][AltContent: connector][AltContent: textbox (1st End of 2nd Anchor Arm)][AltContent: connector][AltContent: textbox (Opposing Second End of 1st Anchor Arm)][AltContent: connector][AltContent: textbox (1st End of 1st Anchor Arm)][AltContent: arrow][AltContent: arrow][AltContent: textbox (2nd Anchor Arm)][AltContent: textbox (1st Anchor Arm)]
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Regarding the recitation that the second ends of the 1st and 2nd anchor arms are extended at least partially into the vertebrae, it is noted that the outer surfaces of the 1 and 2nd anchor arms can be saw tooth – as shown in Figs. 18 and 19 below (see col. 5, lines 13-18). Upon expansion of the anchor arms the second ends are extended at least partially into the vertebrae due to the sharp saw teeth engaging and breaking through bone surface. To further illustrate the extension as described, Applicant’s attention is directed below to Figs. 30 and 32 of Michelson. Michelson discloses a spinal implant having saw teeth on the outer surfaces thereof. The saw teeth break through the bone and extend at least partially into the vertebrae during implantation. It is noted that Applicant is not claiming a how much, or at what angle the extension of the arms into the vertebrae occurs. Applicant merely claims “at least partially.”
[AltContent: arrow][AltContent: arrow][AltContent: textbox (At least partially into the vertebra)]
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[AltContent: arrow][AltContent: textbox (Saw Teeth of Gleason)][AltContent: arrow][AltContent: textbox (Saw Teeth of Michelson)]
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Concerning claim 4, wherein the first end of the first anchor arm is secured to the elongated body adjacent to the proximal end of the elongated body, and the first end of the second anchor arm is secured to the elongated body adjacent to the proximal end of the elongated body (see Fig. 13 above).
Concerning claim 7, wherein the first anchor arm and the second anchor arm are disposed on opposite sides of the elongated body (see Fig. 14).
Concerning claim 8, wherein the elongated body includes a head portion (see Fig. 3, near element 114) contiguous with the proximal end, and the first end of the first anchor arm is secured to the head portion (see above), and the first end of the second anchor arm is secured to the head portion (see above).
Concerning claim 10, wherein the first anchor arm has a curved configuration between the first end of the first anchor arm and the second end of the first anchor arm (see Fig. 6 below), and the second anchor arm has a curved configuration between the first end of the second anchor arm and the second end of the second anchor arm (see Fig. 6 below).
[AltContent: arrow][AltContent: textbox (Curved Configuration between 1st and 2nd Ends)][AltContent: arrow]
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Regarding claim 11, Gleason discloses a method of anchoring an expandable mesh implant to a patient's anatomy, comprising: providing an anchor (see Fig. 3 above) having an elongated body, a first anchor arm (see Fig. 14 above), and a second anchor arm (see Fig. 14 above), wherein the elongated body extends lengthwise between a distal end and a proximal end, wherein the elongated body includes an interior aperture (see Fig. 3 above) and a lateral aperture (see Fig. 3 above), and wherein the
interior aperture extends lengthwise from the proximal end, and wherein the lateral aperture is
disposed in the elongated body at a position between the distal end and the proximal end of the elongated body and the lateral aperture is in communication with the interior aperture; removing the first anchor arm and the second anchor arm from the elongated body (see Fig. 3 above); securing the expandable mesh implant to the elongated body of the anchor while the expandable mesh implant is in an unexpanded state (see col. 5, lines 30-34); placing the expandable mesh implant secured to the elongated body in the unexpanded state in an intervertebral space located between a superior vertebrae and an inferior vertebrae (see col. 5, lines 35-40); attaching the first anchor arm and the second anchor arm to the elongated body (see Fig. 13); securing the first anchor arm to the superior vertebrae and securing the second anchor arm to the inferior vertebrae (occurs with expansion as the teeth break into the adjacent vertebral bone); and filling the expandable mesh implant with a filler material (see col. 5, lines 39-40). It is noted that the claim language does not explicitly or implicitly require a specific sequence for the steps of removing the first anchor arm and the second anchor arm from the elongated body, or attaching the first anchor arm and the second anchor arm to the elongated body.
Concerning claim 12, wherein the first anchor arm (FAA) extends between a FAA first end and a FAA second end (see above), and the FAA first end is secured to the elongated body adjacent to the proximal end of the elongated body (see above); and wherein the second anchor arm (SAA) extends between a SAA first end and a SAA second end, and the SAA first end is secured to the elongated
body adjacent to the proximal end of the elongated body (see above).
Concerning claim 15, wherein the first anchor arm has a curved configuration between the FAA first end and the FAA second end, and the second anchor arm has a curved configuration between the SAA first end and the SAA second end (see above).
Concerning claim 16, wherein the first anchor arm and the second anchor arm are disposed on opposite sides of the elongated body (see above).
Concerning claim 17, wherein the elongated body includes a head portion contiguous with the proximal end, and the first anchor arm is secured to the head portion, and the second anchor arm is secured to the head portion (see above).
Allowable Subject Matter
Claims 5, 6, 9, 13-14 and 18 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 ELLEN HAMMOND whose telephone number is (571)270-3819. The examiner can normally be reached Monday-Friday 8 - 4 PM .
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo C. Robert, 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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/ELLEN C HAMMOND/Primary Examiner, Art Unit 3773