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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/7/2026 has been entered.
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.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seifert et al. (U.S. Pub. No. 2016/0242927 A1, hereinafter “Seifert”) in view of Bergey (U.S. Pub. No. 2020/0246158 A1, hereinafter “Bergey”).
Seifert discloses, regarding claim 1, a surgical implant system (see Figs. 57-61C), comprising: a surgical implant (see Fig. 59, note spacer 500 and anchors 506) for securing adjacent vertebrae of a spine to each other (see Fig. 59) and having an implant eyelet (see annotated Fig. 57 below); a vertebral anchor (506) configured for insertion through the implant eyelet to fasten the surgical implant to the spine (see Fig. 59), the vertebral anchor including a head (516); an elongate shank (see annotated Fig. 61B below) extending from the head (see Fig. 61B) and including a distally extending tip (see annotated Fig. 61B below), the elongate shank having a first surface and a second surface on an opposite side of the first surface (see annotated Fig. 61B below); and an elongate fin (see annotated Fig. 61B below) extending from the head and along the first surface of the elongate shank (see Fig. 61B), the elongate shank and the elongate fin forming a generally t-shaped cross-section (see Fig. 61B, see para. [0167] “t-shaped”).
PNG
media_image1.png
392
483
media_image1.png
Greyscale
PNG
media_image2.png
368
373
media_image2.png
Greyscale
Regarding claim 2, wherein the elongate shank tip includes sharpened serrations formed on the first surface of the elongate shank proximate the tip (see annotated Fig. 61B above).
Regarding claim 6, wherein the tip of the anchor has a duck bill cross-section to reduce cross-sectional area to initially enter the vertebral body (see Fig. 61A).
Regarding claim 7, wherein the tip of the elongate shank includes a double beveled profile having a first bevel on the first side and a second bevel on the second side (see annotated Fig. 59 below), wherein the first and second bevels meet at an edge (see annotated Fig. 59 below).
PNG
media_image3.png
334
332
media_image3.png
Greyscale
Regarding claim 8, wherein the fin includes a double beveled profile having a first bevel on one side and a second bevel on the other side, wherein the first and second bevels meet at an edge (see annotated Fig. 61B above).
Regarding claim 9, wherein the surgical implant comprises a plurality of moveable actuators configured to move in response to mechanical input to expand the surgical implant (see annotated Fig. 59 above, see also para. [0164]).
Regarding claim 10, wherein the shank comprises a curved profile (see Fig. 61B).
Seifert fails to disclose, regarding claim 1, wherein the head at a proximal end having a pair of three-sided key recesses on opposite sides of each other to receive corresponding curved key guides of an insertion device to prevent rotation of the anchor during deployment, each side of each of the three-sided key recesses extending along a different axis with the vertebral anchor is viewed head-on from the proximal end; regarding claim 3, further comprising a retaining hole interposed between the pair of key recesses for being retained in the insertion device prior to deployment; regarding claim 4, wherein the retaining hole is an elongate recess extending laterally between the pair of key recesses; and regarding claim 5, wherein the key recesses are rectangular recesses.
Bergey discloses a surgical implant system (see Fig. 5), with a spacer (30), vertebral anchor (12), wherein the vertebral anchor head (16) at a proximal end (see annotated Fig. 7B below) having a pair of three-sided key recesses (51a-b, see Fig. 5, see also annotated Fig. 7D below) on opposite sides of each other to receive corresponding curved key guides (see annotated Fig. 5 below) of an insertion device (40, see Fig. 5), each side of each of the three-sided key recesses extending along a different axis when the vertebral anchor is viewed head-on from the proximal end (see annotate Fig. 7B below), further comprising a retaining hole (see annotated Fig. 6B below) interposed between the pair of key recesses (see Fig. 6B), wherein the retaining hole is an elongate recess extending laterally between the pair of key recesses (see annotated Fig. 7D below), wherein the key recesses are rectangular recesses (see Fig. 6B) in order to enable the vertebral anchors to engaged by a tool to impart impact load for insertion (see para. [0107]).
PNG
media_image4.png
366
847
media_image4.png
Greyscale
PNG
media_image5.png
625
806
media_image5.png
Greyscale
PNG
media_image6.png
390
655
media_image6.png
Greyscale
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the head of the vertebral anchor in Seifert to include a pair of three-sided key recesses on opposite sides of each other to receive corresponding curved key guides of an insertion device and to include a retaining hole that is an elongate recess extending laterally between the pair of key recesses in view of Bergey in order to enable the vertebral anchors to engaged by a tool to impart impact load for insertion.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seifert in view of Bergey, as applied to claim 1 above, and in further view of Zappacosta et al. (U.S. Pub. No. 2016/0058564 A1, hereinafter “Zappacosta”).
Seifert in view of Bergey discloses all of the features of the claimed invention, as previously set forth above, except regarding claim 10, wherein a trajectory of the curved profile is between five and fifteen degrees.
Zappacosta discloses a surgical implant system (see Fig. 27), with a spacer (90), vertebral anchor (300 or 400, see para. [0032]), wherein a trajectory of the curved profile is between five and fifteen degrees (see para. [0052] “15 degrees”)in order to provide a shallow angle that reduces insertion force (see para. [0052]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the curved profile of the vertebral anchor in Seifert in view of Bergey to have a trajectory of the curved profile is between five and fifteen degrees in view of Zappacosta and in order to provide a shallow angle that reduces insertion force.
Claim(s) 11-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seifert et al. (U.S. Pub. No. 2016/0242927 A1, hereinafter “Seifert”) in view of Bergey (U.S. Pub. No. 2020/0246158 A1, hereinafter “Bergey”) and in view of Gilbride et al. (U.S. Pub. No. 2019/0000637 A1, hereinafter “Gilbride”).
Seifert discloses, regarding claim 11, a surgical implant system (see Figs. 57-61C), comprising: a surgical implant (see Fig. 59, note spacer 500 and anchors 506) for securing adjacent vertebrae of a spine to each other (see Fig. 59), wherein the surgical implant includes a spacer (500) having at least one implant eyelet (see annotated Fig. 57 above); and at least one vertebral anchor (506) configured for insertion through the at least one implant eyelet to fasten the surgical implant to the spine (see Fig. 59), the vertebral anchor comprising: a head (516); an elongate shank (see annotated Fig. 61B above) extending from the head (see Fig. 61B) and including a distally extending tip (see annotated Fig. 61B above), the elongate shank having a first surface and a second surface on an opposite side of the first surface (see annotated Fig. 61B above); and an elongate fin (see annotated Fig. 61B above) extending from the head and along the first surface of the elongate shank (see annotated Fig. 61B above), the elongate shank and the elongate fin forming a generally t-shaped cross-section (see annotated Fig. 61B, see para. [0167] “t-shaped”).
Regarding claim 12, wherein the elongate shank tip includes sharpened serrations formed on the first surface of the elongate shank proximate the tip (see annotated Fig. 61B above).
Regarding claim 16, wherein the tip of the anchor has a duck bill cross-section to reduce cross-sectional area to initially enter the vertebral body (see Fig. 61A).
Regarding claim 17, wherein the tip of the elongate shank includes a double beveled profile having a first bevel on the first side and a second bevel on the second side, wherein the first and second bevels meet at an edge (see annotated Fig. 59 above).
Regarding claim 18, wherein the fin includes a double beveled profile having a first bevel on one side and a second bevel on the other side, wherein the first and second bevels meet at an edge (see annotated Fig. 61A above).
Regarding claim 19, wherein the surgical implant comprises a plurality of moveable actuators configured to move in response to mechanical input to expand the surgical implant (see annotated Fig. 59 above).
Regarding claim 20, wherein the shank comprises a curved profile (see Fig. 61B).
Seifert fails to disclose, regarding claim 11, wherein the head has an angled face formed via a seventy-five to eighty-five degree flat cut into the head, the angled face configured to sit flush with the at least one implant eyelet after insertion, the head at a proximal end having a pair of three-sided key recesses on opposite sides of each other to receive corresponding curved key guides of an insertion device to prevent rotation of the anchor during deployment, each side of each of the three-sided key recesses extending along a different axis when the vertebral anchor is viewed head-on from the proximal end; regarding claim 13, further comprising a retaining hole interposed between the pair of key recesses for being retained in the insertion device prior to deployment; regarding claim 14, wherein the retaining hole is an elongate recess extending laterally between the pair of key recesses; and regarding claim 15, wherein the key recesses are rectangular recesses.
Bergey discloses a surgical implant system (see Fig. 5), with a spacer (30), vertebral anchor (12), wherein the vertebral anchor head (16) at a proximal end (see annotated Fig. 7B below) having a pair of three-sided key recesses (51a-b, see Fig. 5, see also annotated Fig. 7D below) on opposite sides of each other to receive corresponding curved key guides (see annotated Fig. 5 below) of an insertion device (40, see Fig. 5), each side of each of the three-sided key recesses extending along a different axis when the vertebral anchor is viewed head-on from the proximal end (see annotate Fig. 7B below); further comprising a retaining hole (see annotated Fig. 6B below) interposed between the pair of key recesses (see Fig. 6B), wherein the retaining hole is an elongate recess extending laterally between the pair of key recesses (see annotated Fig. 7D below), wherein the key recesses are rectangular recesses (see Fig. 6B) in order to enable the vertebral anchors to engaged by a tool to impart impact load for insertion (see para. [0107]).
PNG
media_image4.png
366
847
media_image4.png
Greyscale
PNG
media_image7.png
625
806
media_image7.png
Greyscale
PNG
media_image6.png
390
655
media_image6.png
Greyscale
Gilbride discloses a surgical implant (110, see Fig. 3A), with curved anchors (130), wherein the head of the anchor includes an angled face (see annotated Fig. 3A below) relative to the head portion and to match the angle of the opening (240, see Fig. 3A) and is configured to sit flush with the implant (see Fig. 4A, see para. [0096]) in order to enable the anchor to be flush with the surface of the implant while extending fully superiorly / inferiorly to achieve maximum purchase with the bone (see para. [0196]).
PNG
media_image8.png
246
486
media_image8.png
Greyscale
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the head of the vertebral anchor in Seifert to include a pair of three-sided key recesses on opposite sides of each other to receive corresponding curved key guides of an insertion device and to include a retaining hole that is an elongate recess extending laterally between the pair of key recesses in view of Bergey in order to enable the vertebral anchors to engaged by a tool to impart impact load for insertion. And it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the head of the vertebral anchor in Seifert to have an angled face formed via a flat cut into the head in view of Gilbride in order to enable the anchor to be flush with the surface of the implant while extending fully superiorly / inferiorly to achieve maximum purchase with the bone. It is further noted that angle to which the face would need to cut at to maintain a flush relationship with the implant depends on how much the anchor curves for achieving bone purchase. Thus the angle of the face is a result effective variable. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the face to be angled seventy-five to eighty-five degree, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Seifert in view of Bergey and in view of Gilbride, as applied to claim 11 above, and in further view of Zappacosta et al. (U.S. Pub. No. 2016/0058564 A1, hereinafter “Zappacosta”).
Seifert in view of Bergey and in view of Gilbride disclose all of the features of the claimed invention, as previously set forth above, except regarding claim 20, wherein a trajectory of the curved profile is between five and fifteen degrees.
Zappacosta discloses a surgical implant system (see Fig. 27), with a spacer (90), vertebral anchor (300 or 400, see para. [0032]), wherein a trajectory of the curved profile is between five and fifteen degrees (see para. [0052] “15 degrees”) in order to provide a shallow angle that reduces insertion force (see para. [0052]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the curved profile of the vertebral anchor in Seifert in view of Bergey and in view of Gilbride to have a trajectory of the curved profile is between five and fifteen degrees in further view of Zappacosta in order to provide a shallow angle that reduces insertion force.
Response to Arguments
Applicant's arguments filed 1/7/2026 have been fully considered but they are not persuasive.
The Applicant asserts that Bergey fails to teach or suggest, regarding amended claims 1 and 11, “each side of each of the three-sided key recesses extending along a different axis when the vertebral anchor is viewed head-on from the proximal end”. The Applicant asserts Bergeys anchors only have three sides when viewed from the side as interpreted by the examiner in annotated Fig. 7D. The Applicant further asserts that when viewed from the proximal end as now required, Bergey’s key recesses do not have three sides, as is clearly shown in Fig. 7B of Bergey. Instead at best the recesses are two sides connected by a rounded corner.
The Office respectfully disagrees. The key recesses in Bergey have three sides that can be viewed from the side (as can be seen in annotated Fig. 7D), as well as head-on from a proximal end (as can be seen in annotated Fig. 7B), with each side of each of the three-sided key recesses extending along a different axis (see annotated Fig. 7B). In response to the Applicant's argument that Bergey’s sides are at best two sides connected by a rounded corner, the claim does not clearly set forth that the sides must be straight / planar / free of curved corners, rather the claim just requires that the recess is three sided; which can be seen in annotated Figs. 7B and 7D of Bergey.
PNG
media_image4.png
366
847
media_image4.png
Greyscale
PNG
media_image7.png
625
806
media_image7.png
Greyscale
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michelle C. Green whose telephone number is (571)270-7051. The examiner can normally be reached on Monday-Friday between 9am-5pm.
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, 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.C.G/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773