Prosecution Insights
Last updated: July 17, 2026
Application No. 18/899,825

Spinal Implant And Methods Of Use Thereof

Final Rejection §103
Filed
Sep 27, 2024
Priority
Oct 11, 2016 — provisional 62/406,455 +3 more
Examiner
COMSTOCK, DAVID C
Art Unit
3773
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
K2M Inc.
OA Round
2 (Final)
86%
Grant Probability
Favorable
3-4
OA Rounds
1y 0m
Est. Remaining
78%
With Interview

Examiner Intelligence

Grants 86% — above average
86%
Career Allowance Rate
1305 granted / 1510 resolved
+16.4% vs TC avg
Minimal -8% lift
Without
With
+-8.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
22 currently pending
Career history
1537
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
55.6%
+15.6% vs TC avg
§102
19.3%
-20.7% vs TC avg
§112
3.0%
-37.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1510 resolved cases

Office Action

§103
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 . Drawings The drawings filed on 03 February 2026 are accepted. Claim Rejections - 35 USC § 103 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 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. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Woods et al. (2007/0016197; cited by Applicant) in view of Palmer et al. (2016/0157896; cited by Applicant). Regarding claim 1, Woods et al. disclose an assembly 10 (annotated Fig. 1, below, and Fig. 2) comprising: a first arm assembly (id.) including a first base portion (id.); a second arm assembly (id.) selectively adjustable (para. 0026) with respect to the first arm assembly, the second arm assembly including a second base portion (id.); and a bone anchor, i.e., rod(s) 24/34 and bone screws for attaching the rods (para. 0012). PNG media_image1.png 304 732 media_image1.png Greyscale Thus, Woods et al. disclose the claimed invention except for the first base portion defining a fixation channel and a band extending through the fixation channel. Palmer et al. teach that a base portion (clamp) 10 (annotated Fig. 3A, below) can comprise fixation channels 16, 19 (id.) (i.e., at least a fixation channel) dimensioned to receive a band 60 to pass therethrough “to advantageously provide a number of different options for securing the clamp to bone” (see paras. 0052-0054). It is noted that Palmer et al. also teach various features to accomplish the clamping, including an anvil 28, a screw opening 14, a screw 25 cooperating with the anvil, and a bore (annotated Fig. 3A, below). Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to configure the base portions of Woods et al. with fixation channels and a band passing therethrough, and to include an anvil, bore, a screw configured to cooperate with the anvil, and the screw opening configured for the screw, in view of Palmer et al., to advantageously provide a number of different options for securing the clamp to bone (e.g., for additional and more secure fixation by the band where desired) and to accomplish the clamping of the band. It is noted that the arrangement also secures the spinal rod to the base portion as the band surrounds the rod and is clamped about the rod (see Fig. 3A). PNG media_image2.png 336 718 media_image2.png Greyscale Regarding claim 2, the band 60 is positioned around the bone anchor, i.e., around the rod 24/30 portion of the bone anchor (i.e., the rod and bone screws together; supra; Woods et al., Fig. 1 and para. 0012) of the assembly of the combination of Woods et al. and Palmer et al (annotated Fig. 3A, supra, and paras. 0052-0054). Regarding claim 3, the band 60 is positioned around the spinal rod 24/30 (id.). Regarding claim 4, in use, the band 60 is positioned around a portion of a patient (i.e., around a bone of a patient). It is noted that this limitation is interpreted as a statement of intended use for which the assembly of the combination is capable. Regarding claim 5, the bone anchor comprises a rod and pedicle screw system (supra), i.e., rods 24/34 (Woods et al. Fig. 1) and screws for attaching the rods (Woods et al., para. 0012). Regarding claim 6, the base of the combined assembly further comprises a band clamp comprising screw opening 14 (annotated Fig. 3A, supra), anvil 28 (id.), and bore 18 continuing in front of the anvil (id.). The band clamp includes the bore (id.) and is configured to receive any desired portions of the band 60, including the end portions thereof (Palmer et al., para. 0053). Regarding claim 7, the band clamp further includes a screw opening 14 configured to threadably receive a screw 25 (annotated Fig. 3A, supra). Regarding claim 8, the screw opening 14 is orthogonal to the bore 18 (id., see dashed line). Regarding claim 9, the band 60 is clamped with an anvil 28 disposed in the bore 18 (id.). Regarding claim 10, the fixation channel 16/19 of the assembly of the combination is a first fixation channel, and wherein the second base portion defines a second fixation channel 16/19 (supra; i.e., identical to the fixation channel of the first base portion). Regarding claim 11, the band 60 is a first band 60 and the bone anchor is a first bone anchor (supra, i.e., rod 24/34 and bone screws for attaching the rod; Woods et al., Fig. 1 and para. 0012), and further comprising a second band 60 extending through the second fixation channel 16/19 and around a second bone anchor (id.). Regarding claim 12, the first base portion (annotated Fig. 1, supra) comprises an extension member (id.) and an engagement housing 28 (id.), the extension member being monolithic with the first base portion (id.). Regarding claim 13, the second base portion (annotated Fig. 1, supra) is monolithic with an elongate member 20 (id.) configured to be selectively received in the engagement housing 28 (id.). Regarding claim 14, a fastener 70 (Woods et al., Figs. 2 and 3) is configured to be received in the engagement housing 28 to secure the elongate member 20 thereto (id.). Regarding claim 15, the first base portion (annotated Fig. 1, supra) comprises a first hook portion 14 (id.), the first hook portion being monolithic with the first base portion (id.). Regarding claim 16, the second base portion (annotated Fig. 1, supra) comprises a second hook portion 12, the first hook portion 14 and second hook portion 12 are capable of engaging anatomical structure of the vertebra (e.g., due to the size and/or proximity to vertebra) and are therefore considered to be configured for the same. Regarding claim 17, the first hook portion 14 extends longitudinally along the extension member (annotated Fig. 1, supra). Regarding claim 18, Woods et al. disclose an assembly 10 (annotated Fig. 1, above) comprising: a first arm assembly (id.) including a first base portion (id.); a second arm assembly (id.) selectively adjustable (para. 0026) with respect to the first arm assembly, the second arm assembly including a second base portion (id.); and a rod 24/30 (id.). Thus, Woods et al. disclose the claimed invention except for the first base portion defining a fixation channel and a band extending through the fixation channel and around the rod. Palmer et al. teach that a base portion (clamp) 10 (annotated Fig. 3A, supra) can comprise fixation channels 16, 19 (id.) (i.e., at least a fixation channel) dimensioned to receive a band 60 to extend therethrough and around the rod “to advantageously provide a number of different options for securing the clamp to bone” (see paras. 0052-0054). It is noted that Palmer also teaches various features to accomplish the clamping, including an anvil 28, a screw opening 14, a screw 25 cooperating with the anvil, and a bore (annotated Fig. 3A, below). Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to configure the base portions of Woods et al. with fixation channels and a band passing therethrough and around the rod, and to include an anvil, bore, a screw configured to cooperate with the anvil, and the screw opening configured for the screw, in view of Palmer et al., to advantageously provide a number of different options for securing the clamp to bone, e.g., for enhanced fixation by the band where desired, and to accomplish the clamping of the band. It is noted that the arrangement also secures the spinal rod to the base portion as the band surrounds the rod and is clamped about the rod (cf. annotated Fig. 3A and Palmer et al. para. 0053). Regarding claim 19, the band 80 of the assembly of the combination is compressed with a screw 25 configured to clamp any desired portions of the band 60, including clamping opposite ends of the band together (Palmer et al., para. 0053). Regarding claim 20, Woods et al. disclose an assembly 10 (annotated Fig. 1, above) comprising: a first arm assembly (id.) including a first base portion (id.); a second arm assembly (id.) selectively adjustable (para. 0026) with respect to the first arm assembly, the second arm assembly including a second base portion (id.); and a rod 24/30 (id.). Woods et al. disclose the claimed invention except for: the first base portion defining a fixation channel and a band extending through the fixation channel and around the rod; a band extending through the fixation channel, the band including two end portions; a band clamp having a bore, a screw opening orthogonal to the bore, and an anvil disposed within the bore, the band received within the bore; and a screw threadedly engaged with the screw opening, the screw imparting a force on the anvil, the anvil being in contact with at least one of the end portions of the band. Palmer et al. teach that a base portion (clamp) 10 (annotated Fig. 3A, supra) can comprise fixation channels 16, 19 (id.) (i.e., at least a fixation channel) dimensioned to receive a band 60 to extend therethrough and around the rod “to advantageously provide a number of different options for securing the clamp to bone” (see paras. 0052-0054). Palmer also teaches various features to accomplish the clamping, including the band 60 (including its two end portions; para. 0053), a band clamp comprising a bore (annotated Fig. 3A, supra), a screw opening 14 orthogonal to a bore (id.), and an anvil 28 (id.) disposed within the bore, the band 60 received within the bore (cf. para. 0053); and a screw 25 threadedly engaged with the screw opening 14, the screw 25 imparting a force on the anvil, the anvil being in contact with a desired portions of the band including the ends (para. 0053). Therefore, it would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to configure the base portions of Woods with fixation channels and a band passing therethrough and around the rod, and to include the first base portion (annotated Fig. 1, supra) defining a fixation channel and a band extending through the fixation channel and around the rod; a band extending through the fixation channel, the band including two end portions; a band clamp having a bore, a screw opening orthogonal to the bore, and an anvil disposed within the bore, the band received within the bore; and a screw threadedly engaged with the screw opening, the screw imparting a force on the anvil, the anvil being in contact with at least one of the end portions of the band; in view of Palmer et al., to advantageously provide a number of different options for securing the clamp to bone (e.g., for additional and more secure fixation by the band where desired) and to accomplish the clamping of the band. It is noted that this arrangement also secures the spinal rod to the base portion as the band surrounds the rod and is clamped about the rod (cf. annotated Fig. 3A and Palmer et al. para. 0053). Response to Arguments Applicant's arguments filed 03 February 2026 have been fully considered but they are not persuasive. The amendments made by Applicant overcome the previously outstanding claim objections and 112 rejections. The rejection under 35 U.S.C. 103 of the claims, as currently presented, has been maintained for the following reasons. First, the motivation to combine the bone securement mechanism of Palmer et al. with the base portions of Woods et al. is stated in Palmer and in the Office action: to secure the clamp to bone (Palmer et al. paras. 0052-0054). Palmer et al. show a base portion (clamp) 10 and a rod 80, and teach securing the clamp and rod to the bone with the securement mechanism (band) 60 (see Fig. 1A, below). PNG media_image3.png 372 572 media_image3.png Greyscale Likewise, Woods has a base portion (clamp) (see annotated Fig. 1, below) securing a rod, but do not have a securement mechanism (band) securing the clamp and rod to bone. Palmer et al. teach advantageously securing the clamp to bone (and providing different options for doing so): “to advantageously provide a number of different options for securing the clamp to bone.” Therefore, the motivation to combine is present and clearly set forth in the action. PNG media_image1.png 304 732 media_image1.png Greyscale The argument that Woods et al. teach away from such a modification because Woods et al. seeks a smooth contour and low-profile is unpersuasive. The argument does not explain why the resulting modification allegedly would not be smooth or low-profile, but rather merely states a conclusion that the modification would not result in the intended smooth contour. Examiner maintains that a smooth contour and low profile would result because the necessary modification involves providing the internal fixation channels/bore (e.g., 16, 18 and 19) and the anvil 29, with the low-profile set screw already being present on Woods et al. (Fig. 2). There is no structure to make the device of the combination any less low-profile or the contour of the upper surface any less smooth. Therefore, the argument that Woods et al. teach away from such a modification is unpersuasive. Finally, the argument that the features in Palmer et al. (curved contact surfaces 29, first opening 14, third opening 18, and set screw 25) are configured to secure the elastic member, and not as alternative options for clamping to the bone, is not persuasive. Palmer et al. teach that those features “advantageously provide a number of different options for securing the clamp to bone” (Palmer, paras. 0052-0054). Therefore, the express reason is to provide alternative options for clamping to the bone. Within this statement is the teaching that it is advantageous to secure the clamp to bone and to have multiple ways to do so with the securement mechanism (band) 60. For these reasons, the rejection of the claims, as currently presented, under 35 U.S.C. 103 has been maintained. Conclusion THIS ACTION IS MADE FINAL. 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 DAVID C COMSTOCK whose telephone number is (571)272-4710. The examiner can normally be reached M-F 9:00-5:00 PST. 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, the examiner’s supervisor, Eduardo Robert can be reached 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DAVID C COMSTOCK/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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Prosecution Timeline

Sep 27, 2024
Application Filed
Dec 18, 2025
Non-Final Rejection mailed — §103
Feb 03, 2026
Response Filed
Jun 04, 2026
Final Rejection mailed — §103
Jul 15, 2026
Applicant Interview (Telephonic)
Jul 15, 2026
Examiner Interview Summary

Precedent Cases

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Prosecution Projections

3-4
Expected OA Rounds
86%
Grant Probability
78%
With Interview (-8.4%)
2y 9m (~1y 0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 1510 resolved cases by this examiner. Grant probability derived from career allowance rate.

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