Prosecution Insights
Last updated: April 19, 2026
Application No. 18/477,170

ORTHOPEDIC IMPLANTS AND METHODS

Non-Final OA §102§112
Filed
Sep 28, 2023
Examiner
PRESTON, REBECCA STRASZHEIM
Art Unit
3774
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Paragon 28 Inc.
OA Round
1 (Non-Final)
74%
Grant Probability
Favorable
1-2
OA Rounds
3y 7m
To Grant
99%
With Interview

Examiner Intelligence

Grants 74% — above average
74%
Career Allow Rate
453 granted / 616 resolved
+3.5% vs TC avg
Strong +37% interview lift
Without
With
+37.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 7m
Avg Prosecution
28 currently pending
Career history
644
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
28.7%
-11.3% vs TC avg
§102
33.1%
-6.9% vs TC avg
§112
32.4%
-7.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 616 resolved cases

Office Action

§102 §112
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 . Claim Objections Claim(s) 5-6, 10, 13-14, 18 is/are objected to because of the following informalities: Within claim 5, line 3 (and claim 6, line 5): “the implant” should be replaced with --the first implant component-- (in order to maintain consistent claim terminology throughout the claims). Within claim 10, line 4: “the top and bottom portions” should be replaced with --the top and bottom portions of the second implant-- (in order to maintain consistent claim terminology throughout the claims). Within claim 13, line 3 (and claim 14, line 5): “the implant” should be replaced with --the second implant component-- (in order to maintain consistent claim terminology throughout the claims). Within claim 18, line 10 the clause starting “wherein the first and second” appears to be indented too far. Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claim(s) 6-9, 13-19 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Within claim 6, line 4: Applicant claims, “the engagement feature”; it is unclear, and therefore indefinite which engagement feature is being referred to – the engagement feature of the top portion of the first implant component OR the engagement feature of the bottom portion of the first implant component? Claim(s) 7-9, which depend from claim 6, inherit all the problems associated with claim 6. Claim 6 recites the limitation "the first portion" in line 5. There is insufficient antecedent basis for this limitation in the claim. Within claim 13, line 1: Applicant claims, “the engagement feature”; it is unclear, and therefore indefinite which engagement feature is being referred to – the engagement feature of the top portion of the first implant component OR the engagement feature of the bottom portion of the first implant component OR the engagement feature of the top portion of the second implant component? Within claim 14, line 1: Applicant claims, “the bottom portion”; it is unclear, and therefore indefinite which bottom portion is being referred to – the bottom portion of the first implant component OR the bottom portion of the second implant component? Claim(s) 15-17, which depend from claim 14, inherit all the problems associated with claim 14. Within claim 14, line 4: Applicant claims, “the engagement feature”; it is unclear, and therefore indefinite which engagement feature is being referred to – the engagement feature of the top portion of the first implant component OR the engagement feature of the bottom portion of the first implant component OR the engagement feature of the top portion of the second implant component OR the engagement feature of the bottom portion of the second implant component? Claim 14 recites the limitation "the first portion" in line 5. There is insufficient antecedent basis for this limitation in the claim. Within claim 18, line 8: Applicant claims, “the top portion”; it is unclear, and therefore indefinite, which top portion is being referred to – the top portion of the first component OR the top portion of the second component. Claim(s) 19, which depend from claim 18, inherit all the problems associated with claim 18. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Duggal et al. (US 2011/0166609 A1). With respect to claim 1: Duggal et al. discloses a subtalar joint implant system (two bone anchor system 100a, 100b), as can be seen in fig. 2 (paragraph [0106]), comprising: a first implant component (bone anchor system 100a) (paragraph [0106]); and a second implant component (bone anchor system 100b) (paragraph [0106]). (PLEASE NOTE: Applicant has failed to claim any structure prevents/ excludes the two bone anchor system (100a, 100b), as disclosed by Duggal et al., as being considered a “subtalar joint implant system” as currently claimed.) With respect to claim 2: wherein the first implant component (bone anchor system 100a), as can be seen in figs. 2-3C, comprises: a top portion (compression bolt 104) (paragraph [0108]); and a bottom portion (standoff 102) (paragraph [0107]); wherein the top and bottom portions (compression bolt 104 and standoff 102) are coupled with one another and are configured about a common longitudinal axis, as can be seen in figs. 2-3B. With respect to claim 3: Wherein the top portion (compression bolt 104) and the bottom portion (standoff 102) of the first implant component (bone anchor system 100a) are threadably couplable (via the threaded shaft 130 and internal threads 118) with one another (paragraphs [0107-0108]). With respect to claim 4: Wherein the top portion (compression bolt 104) of the first implant component (bone anchor system 100a) comprises an engagement feature (driving feature 132 of head 128) (paragraph [0108]). With respect to claim 5: Wherein the engagement feature (driving feature 132 of head 128) comprises an interface (shape of driving feature 132) which is configured to engage with one or more instruments (driver) configured to facilitate implantation of the first implant component (bone anchor system 100a) (paragraph [0108]). With respect to claim 6: wherein the bottom portion (standoff 102) comprises: a threading (external threads 120) disposed on at least a portion of an outer surface thereof (paragraph [0107]); and an engagement feature (driver engagement feature 109) disposed on an end portion (first end 108) of the bottom portion (standoff 102) (paragraph [0107]), wherein the engagement feature (driver engagement feature 109) is configured to engage with one or more instruments (driver) configured to facilitate implantation of the bottom portion (standoff 102) of the first implant component (bone anchor system 100a) (paragraph [0107]). With respect to claim 7: Wherein the top portion (compression bolt 104) of the first implant component (bone anchor system 100a) is configured to be (is capable of being) implanted in at least a portion of a talus of a patient (the top portion (compression bolt 104) of the first implant component (bone anchor system 100a) is considered by Examiner to be capable of being implanted in at least a portion of a talus as the first implant component (bone anchor system 100a) as it is a bone anchor that is used in other bones within the ankle). With respect to claim 8: Wherein the bottom portion (standoff 102) of the first implant component (bone anchor system 100a) is configured to be (is capable of being) implanted in at least a portion of a calcaneum of the patient (the bottom portion (standoff 102) of the first implant component (bone anchor system 100a) is considered by Examiner to be capable of being implanted in at least a portion of a calcaneum as the first implant component (bone anchor system 100a) as it is a bone anchor that is used in other bones within the ankle). With respect to claim 9: Wherein the bottom portion (standoff 102) of the first implant component (bone anchor system 100a) is configured to be (is capable of being) implanted in at least a portion of a posterior facet of the calcaneum of the patient (the bottom portion (standoff 102) of the first implant component (bone anchor system 100a) is considered by Examiner to be capable of being implanted in at least a portion of a posterior face of the calcaneum as the first implant component (bone anchor system 100a) as it is a bone anchor that is used in other bones within the ankle). With respect to claim 10: Wherein the second implant component (bone anchor system 100b), as can be seen in figs. 2-3C, comprises: a top portion (compression bolt 104) (paragraph [0108]); and a bottom portion (standoff 102) (paragraph [0107]); wherein the top and bottom portions (compression bolt 104 and standoff 102) are coupled with one another and are configured about a common longitudinal axis, as can be seen in figs. 2-3B. With respect to claim 11: Wherein the top portion (compression bolt 104) and the bottom portion (standoff 102) of the second implant component (bone anchor system 100b) are threadably couplable (via the threaded shaft 130 and internal threads 118) with one another (paragraphs [0107-0108]). With respect to claim 12: Wherein the top portion (compression bolt 104) of the second implant component (bone anchor system 100b) comprises an engagement feature (driving feature 132 of head 128) (paragraph [0108]). With respect to claim 13: Wherein the engagement feature (driving feature 132 of head 128) comprises an interface (shape of driving feature 132) which is configured to engage with one or more instruments (driver) configured to facilitate implantation of the second implant component (bone anchor system 100b) (paragraph [0108]). With respect to claim 14: wherein the bottom portion (standoff 102) comprises: a threading (external threads 120) disposed on at least a portion of an outer surface thereof (paragraph [0107]); and an engagement feature (driver engagement feature 109) disposed on an end portion (first end 108) of the bottom portion (standoff 102) (paragraph [0107]), wherein the engagement feature (driver engagement feature 109) is configured to engage with one or more instruments (driver) configured to facilitate implantation of the bottom portion (standoff 102) of the second implant component (bone anchor system 100b) (paragraph [0107]). With respect to claim 15: Wherein the top portion (compression bolt 104) of the second implant component (bone anchor system 100b) is configured to be (is capable of being) implanted in at least a portion of a talus of a patient (the top portion (compression bolt 104) of the second implant component (bone anchor system 100b) is considered by Examiner to be capable of being implanted in at least a portion of a talus as the second implant component (bone anchor system 100b) as it is a bone anchor that is used in other bones within the ankle). With respect to claim 16: Wherein the top portion (compression bolt 104) of the second implant component (bone anchor system 100b) is configured to be (is capable of being) implanted in at least a portion of a talus of a patient (the top portion (compression bolt 104) of the second implant component (bone anchor system 100b) is considered by Examiner to be capable of being implanted in at least a portion of a talus as the second implant component (bone anchor system 100b) as it is a bone anchor that is used in other bones within the ankle). With respect to claim 17: Wherein the bottom portion (standoff 102) of the second implant component (bone anchor system 100b) is configured to be (is capable of being) implanted in at least a portion of a posterior facet of the calcaneum of the patient (the bottom portion (standoff 102) of the second implant component (bone anchor system 100b) is considered by Examiner to be capable of being implanted in at least a portion of a posterior face of the calcaneum as the second implant component (bone anchor system 100b) as it is a bone anchor that is used in other bones within the ankle). With respect to claim 18: Duggal et al. discloses a subtalar joint implant system (two bone anchor system 100a, 100b), as can be seen in fig. 2 (paragraph [0106]), comprising: a first component (bone anchor system 100a) (paragraph [0106]), comprising: a top portion (compression bolt 104) (paragraph [0108]); and a bottom portion (standoff 102) coupled with the top portion (compression bolt 104) and configured about a first common longitudinal axis (paragraph [0107]), as can be seen in figs. 2-3B; and a second component (bone anchor system 100b) (paragraph [0106]), comprising: a top portion (compression bolt 104) (paragraph [0108]); and a bottom portion (standoff 102) coupled with the top portion (compression bolt 104) and configured about a first common longitudinal axis (paragraph [0107]), as can be seen in figs. 2-3B; and wherein the first and second components (bone anchor systems 100a, 100b) are each configured to couple (capable of being coupled) with at least a portion of a talus and a calcaneum of a patient (the first and second components (bone anchor systems 100a, 100b) are considered by Examiner to be capable of being implanted with at least a portion of a talus and a calcaneum as the first and second components (bone anchor systems 100a, 100b) are bone anchors that is used in other bones within the ankle). With respect to claim 19: Wherein the first component (bone anchor system 100a) is configured to couple (is capable of being coupled) with at least a portion of a posterior facet of the calcaneum of the patient and the second component (bone anchor system 100b) is configured to couple (is capable of being coupled) with at least a portion of a middle facet of the calcaneum of the patient. With respect to claim 20: Duggal et al. discloses a subtalar joint implant system (two bone anchor system 100a, 100b), as can be seen in fig. 2 (paragraph [0106]), comprising: a first component (bone anchor system 100a) (paragraph [0106]), comprising a threading disposed on at least a portion of an exterior surface thereof (external thread 120) (paragraph [0107]); and a second component (bone anchor system 100b) (paragraph [0106]), comprising a threading disposed on at least a portion of an exterior surface thereof (external thread 120) (paragraph [0107]); wherein the first and second components (bone anchor systems 100a, 100b) are each configured to couple (capable of being coupled) with at least a portion of a talus and a calcaneum of a patient; wherein the first component (bone anchor system 100a) is configured to couple (capable of being coupled) with at least a portion of a posterior facet of the calcaneum of the patient and the second component (bone anchor system 100b) is configured to couple (capable of being coupled) with at least a portion of a middle facet of the calcaneum of the patient (the first and second components (bone anchor systems 100a, 100b) are considered by Examiner to be capable of being implanted with at least a portion of a talus and a calcaneum, specifically the posterior or middle facets, as the first and second components (bone anchor systems 100a, 100b) are bone anchors that is used in other bones within the ankle). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA S PRESTON whose telephone number is (571)270-5233. The examiner can normally be reached M, W: 9-5; T, Th, F: 9-1. 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, Jerrah Edwards can be reached at (408)918-7557. 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. /REBECCA S PRESTON/ Examiner, Art Unit 3774
Read full office action

Prosecution Timeline

Sep 28, 2023
Application Filed
Feb 04, 2026
Non-Final Rejection — §102, §112 (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

1-2
Expected OA Rounds
74%
Grant Probability
99%
With Interview (+37.1%)
3y 7m
Median Time to Grant
Low
PTA Risk
Based on 616 resolved cases by this examiner. Grant probability derived from career allow rate.

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