Prosecution Insights
Last updated: October 04, 2026
Application No. 19/183,866

BONE FIXATION SYSTEM, ASSEMBLY, IMPLANTS, DEVICES, ALIGNMENT GUIDES, AND METHODS OF USE

Non-Final OA §102§DOUBLEPATENT
Filed
Apr 20, 2025
Priority
Mar 30, 2017 — provisional 62/478,984 +4 more
Examiner
WOODALL, NICHOLAS W
Art Unit
Tech Center
Assignee
Paragon 28 Inc.
OA Round
1 (Non-Final)
82%
Grant Probability
Favorable
1-2
OA Rounds
1y 10m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants 82% — above average
82%
Career Allowance Rate
967 granted / 1179 resolved
+22.0% vs TC avg
Moderate +13% lift
Without
With
+13.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
27 currently pending
Career history
1206
Total Applications
across all art units

Statute-Specific Performance

§101
3.5%
-36.5% vs TC avg
§103
45.5%
+5.5% vs TC avg
§102
25.0%
-15.0% vs TC avg
§112
14.9%
-25.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1179 resolved cases

Office Action

§102 §DOUBLEPATENT
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 . Election/Restrictions Applicant's election with traverse of Group I in the reply filed on July 15th, 2026 is acknowledged. The traversal is on the ground(s) that there would not be a serious search burden for the examiner to search both inventions. This is not found persuasive because as discussed in the restriction the method claims do not require any of the specifics of the apparatus claims, for example claim 1 includes the alignment wire comprising a spherical member which is not required by the method claim. The requirement is still deemed proper and is therefore made FINAL. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on July 15th, 2026. Applicant’s election without traverse of Species B in the reply filed on July 15th, 2026 is acknowledged. Drawings The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: reference number 212 appears to be missing from the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. Claims 6-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,918,431. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 6-19 of the current application and the invention of claims 1-11 of the patent lies in the fact that the invention of claims 1-11 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-11 of the patent is in effect a "species" of the "generic" invention of claims 6-19 of the current application. It has been held that the generic invention is “anticipated” by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 6-19 are anticipated by claims 1-11, claims 6-19 are not patentably distinct from claims 1-11. U.S. Patent 10,918,431 Current Application 1 6,7,8,9 2 10 3 11,12 4,6 13,14 8 15 9 16 10 17 11 18,19 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 1-4, 6, and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ralph (U.S. Publication 2003/0083667). Regarding claims 1-4: Ralph discloses a device (for example see Figures 1a-2b) comprising: (claim 1) an alignment guide (100) including (claim 1) a first end (102a, 106a, etc.) (claim 1) a second end (108) (claim 1) an alignment wire rotatably coupled to the first end of the alignment guide including (claim 1) a first end (206a) (claim 1) a tip (304a) (claim 1) a spherical member (210; the flange has a spherical shape) position between the first end and the tip of the alignment wire (claim 1) a cylindrical protrusion (302a) positioned between the spherical member and the tip of the alignment wire (claim 1) a coupling member (210a) slidingly engaging a first portion of the alignment guide near the first end (claim 2) an extension member (310a) configured to couple to a portion of a bone plate (element 310a is coupled to a bone plate via element 112a) (claim 3) wherein the coupling member is capable of translating in a proximal-distal direction along the first portion of the alignment guide (elements 200a and 300a are capable of translating in a proximal-distal direction along the first portion of the alignment guide) (claim 4) wherein rotation of the alignment guide on the alignment wire is capable of rotating the coupling member (when element 302a is threaded tightly into element 200a; rotation of element 100 is capable of rotating the coupling member due to the friction between elements 106a and 210a) Regarding claims 6 and 7: Ralph discloses a system (for example see Figures 1a-2b) comprising: (claim 6) a targeting guide assembly including (claim 7) an alignment guide (100) including (claim 7) a first end (102a, 106a, etc.) (claim 7) a second end (108) (claim 7) an alignment wire (200a, 202a, etc.) rotatably coupled to the first end of the alignment guide (claim 7) a coupling member (210a) slidingly engaging a first portion of the alignment guide near the first end (claim 6) a bone plate (400) removably coupled to the targeting guide assembly Allowable Subject Matter Claims 5 and 8-19 are objected to as being dependent upon a rejected base claim, but would be allowable over the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims. However, claims 8-19 are rejected under non-statutory double patenting as discussed above. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, 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 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. /NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775
Read full office action

Prosecution Timeline

Apr 20, 2025
Application Filed
Aug 18, 2026
Non-Final Rejection mailed — §102, §DOUBLEPATENT (current)

Precedent Cases

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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
82%
Grant Probability
95%
With Interview (+13.3%)
3y 3m (~1y 10m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1179 resolved cases by this examiner. Grant probability derived from career allowance rate.

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