Prosecution Insights
Last updated: July 17, 2026
Application No. 18/907,097

ORTHOPEDIC IMPLANTS AND INSTRUMENTS

Final Rejection §102
Filed
Oct 04, 2024
Priority
Apr 06, 2022 — provisional 63/362,569 +1 more
Examiner
WAGGLE, JR, LARRY E
Art Unit
3775
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Paragon 28 Inc.
OA Round
2 (Final)
81%
Grant Probability
Favorable
3-4
OA Rounds
1y 0m
Est. Remaining
98%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allowance Rate
668 granted / 829 resolved
+10.6% vs TC avg
Strong +18% interview lift
Without
With
+17.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 9m
Avg Prosecution
30 currently pending
Career history
860
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
68.9%
+28.9% vs TC avg
§102
14.0%
-26.0% vs TC avg
§112
12.9%
-27.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 829 resolved cases

Office Action

§102
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the amendments received after a Non-Final Rejection on 16 March 2026. Claims 1-21 are currently pending. 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 1-10 and 13-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson (U.S. Patent 9,636,236). Regarding claims 1-10, Anderson discloses (as to claim 1) an orthopedic implant system (i.e. system defined by 100 and 115) comprising an insertion instrument (100) comprising an upper portion (102); a lower portion (113) coupled to (i.e. coupled at 106) the upper portion; an actuator (130) extending laterally from a side (i.e. side defining 128) of the lower portion; an extension portion (i.e. extension defined between 118 and 128) connecting the lower portion and the actuator to form a pivot point (i.e. point defined adjacent 128, see column 5, lines 55-65 and claims 1 and 17); and a retention mechanism (i.e. mechanism defined by 116 and 118); and an orthopedic implant (115) capable of releasably coupling with (i.e. via 124) the retention mechanism of the insertion instrument and, upon manipulation of the actuator, decouple from the insertion instrument (see column 4, lines 12-32), wherein (as to claim 2) the upper and lower portions are integral with one another (see Figure 1), wherein (as to claim 3) the actuator is integral with (i.e. via the extension) the lower portion of the insertion instrument (see Figure 1), wherein (as to claim 4) the actuator, the lower portion, and the extension portion of the insertion instrument each have the same width (i.e. there is nothing in the disclosure indicating that the components of the instrument have different widths, see Figure 1), wherein (as to claim 5) the retention mechanism extends from the lower portion of the insertion instrument (extension as best seen in Figure 1) and comprises a pair of retainers (i.e. pegs 124), wherein (as to claim 6) each retainer of the pair of retainers are positioned at an opposite side (i.e. sides defined by 116 and 118) of a bottom portion (i.e. portion defining 122) of the insertion instrument, wherein (as to claim 7) the insertion instrument comprises a volume (i.e. volume receiving 115 as best seen in Figure 2) defined vertically by the lower portion of the insertion instrument and laterally by each of the retainers, wherein (as to claim 8) each of the retainers comprises a substantially curved geometry (i.e. substantially curved geometry of peg as best seen in Figure 1), wherein the curved geometry extends toward the volume (extension as best seen in Figure 1), wherein (as to claim 9) the volume is capable of receiving and retaining at least a portion of the implant therein (see Figure 2), and wherein (as to claim 10) manipulation of the actuator is capable of manipulating at least one of the retainers (i.e. retainer defined by 118) so as to couple and decouple the implant from the insertion instrument (see paragraph 0253) (see Figures 1-3, and column 3, line 31 – column 6, line 6). Regarding claims 13-17, Anderson discloses (as to claim 13) a surgical instrument (100) comprising an upper portion (102); a lower portion (113) integral with and opposite the upper portion, the lower portion comprising an actuator (130) extending laterally from (lateral extension as best seen in Figure 111) a side (i.e. side defining 128) of the lower portion; an extension portion (i.e. extension defined between 118 and 128) coupling the lower portion and the actuator, wherein the actuator pivots relative to the lower portion of the instrument at the extension portion (see column 5, lines 55-65 and claims 1 and 17); and a pair of retainers (i.e. instances of 124 defined by 116 and 118) extending from a bottom portion (i.e. portion defining 122) of the lower portion toward the upper portion (see Figure 1), wherein each retainer of the pair of retainers comprises a substantially curved geometry (i.e. substantially curved geometry of pegs as best seen in Figure 1) with a curvature pointing toward a midline (108) of the instrument, wherein (as to claim 14) the instrument further comprises a first volume (see annotated Figure below) defined at least partially by a lateral surface (e.g. lateral surface defined by 102) of the instrument and a lateral surface (e.g. lateral surface defined by 130) of the actuator, wherein (as to claim 15) the actuator is manipulatable such that at least a portion of the actuator occupies at least a portion of the first volume (see annotated Figure below), wherein (as to claim 16) as the actuator pivots towards the lower portion of the instrument (i.e. as 130 moves toward 102, it is moved towards 113), at least one retainer (i.e. retainer defined by 118) of the pair of retainers is manipulated away from the lower portion (see Figure 3), wherein (as to claim 17) manipulation of the actuator (i.e. via moving 130 towards 102) alters a lateral dimension (i.e. a dimension defined from left-to-right as best seen in Figure 3) of a second volume (i.e. a volume defined between 124/116 and 124/118) defined laterally by the retainers (see Figures 1-3, and column 3, line 31 – column 6, line 6).). PNG media_image1.png 510 258 media_image1.png Greyscale Claims 1 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martin (International Publication WO 2008/129061). Martin discloses (as to claim 1) an orthopedic implant system (i.e. system defined by 1 and 2) comprising an insertion instrument (1) comprising an upper portion (13); a lower portion (i.e. portion defining 12) coupled to the upper portion; an actuator (6) extending laterally from a side (i.e. side defining 11/12) of the lower portion; an extension portion (17) connecting the lower portion and the actuator to form a pivot point (i.e. point defined by 17); and a retention mechanism (i.e. mechanism defined by 10 and 15); and an orthopedic implant (2) capable of releasably coupling with (i.e. via 10 and 15) the retention mechanism of the insertion instrument and, upon manipulation of the actuator, decouple from the insertion instrument (see page 5, line 32 – page 6, line 3), wherein (as to claim 11) the implant comprises an orthopedic staple (see page 4, lines 14-17) (see Figures 1-7, and page 4, line 14 – page 6, line 19). Claims 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biedermann et al. (U.S. Patent 11,278,278). Biedermann et al. disclose (as to claim 18) an orthopedic staple implant (2301) comprising a bridge (2302) including a top surface (2322) comprising a central portion (i.e. portion defined between each instance of 2354); and lateral portions (2354) disposed symmetrically on opposing sides (i.e. sides defining 2354) of the central portion and having substantially semi-circular shapes (i.e. shape defined by 2351 and 2352, see Figure 20b), wherein the lateral portions each are tapered from the central portion to a side portion (i.e. portions defined by 29 and 29’) of the bridge; a pair of legs (3 and 4) extending from a bottom surface (2324) of the bridge, wherein each of the legs comprise a texture (7) on an inner surface (i.e. surface defining 7) thereof and comprise a terminal end (6 and 6’), wherein (as to claim 19) the implant is movable between a first position (i.e. position as best seen in Figure 20c) comprising the bridge in a substantially curved configuration (i.e. configuration as best seen in Figure 20c), and a second position (i.e. position as best seen in Figure 20d) comprising the bridge in a substantially linear configuration (i.e. configuration as best seen in Figure 20d), wherein (as to claim 20) each of the legs extend from the bottom surface of the bridge at a point between a midline (i.e. midline defined through center of 2302, see Figure 20d) of the bridge and a terminal end point (i.e. point defined by 29 and 29’) of the bridge, and wherein (as to claim 21) each of the legs is capable of comprising a tapered thickness (i.e. thickness defined by tapering of 6 and 6’), wherein said thickness is greater at a point adjacent the bridge than at a point adjacent the terminal end of the legs (see column 8, line 50 – column 9, line 2) (see Figures 20a-20d, column 8, line 50 – column 9, line 2, and column 17, line 49 – column 18, line 15). Allowable Subject Matter Claim 12 is 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. Claim 12 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, in combination with the limitations required by claims 1 and 11, no prior art reference could be found disclosing or making obvious wherein the staple comprises a bridge portion comprising a pair of shoulders disposed at opposite ends of the bridge portion; and a pair of legs extending from the bridge portion, with each leg positioned between one of the shoulders and a midline of the bridge portion. Response to Arguments The applicant’s arguments with respect to claims 1-11 and 13-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. 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 LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm). 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, Kevin Truong can be reached at 571-272-4705. 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. /LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775
Read full office action

Prosecution Timeline

Oct 04, 2024
Application Filed
Nov 14, 2025
Non-Final Rejection mailed — §102
Mar 16, 2026
Response Filed
Jun 09, 2026
Final Rejection mailed — §102 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
81%
Grant Probability
98%
With Interview (+17.6%)
2y 9m (~1y 0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 829 resolved cases by this examiner. Grant probability derived from career allowance rate.

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