Prosecution Insights
Last updated: August 16, 2026
Application No. 19/183,905

ALIGNMENT GUIDE APPARATUS, METHODS AND SYSTEMS

Non-Final OA §103§112§DP
Filed
Apr 20, 2025
Priority
Dec 28, 2012 — provisional 61/746,928 +7 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 11m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants 82% — above average
82%
Career Allowance Rate
962 granted / 1172 resolved
+22.1% vs TC avg
Moderate +13% lift
Without
With
+13.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
31 currently pending
Career history
1200
Total Applications
across all art units

Statute-Specific Performance

§101
3.6%
-36.4% vs TC avg
§103
45.3%
+5.3% vs TC avg
§102
25.3%
-14.7% vs TC avg
§112
14.8%
-25.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1172 resolved cases

Office Action

§103 §112 §DP
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 The claims are currently directed to multiple inventions and/or species. However, the claims to different inventions and/or species does not currently present too large a search burden for the examiner. The examiner reserves the right to restrict the inventions and/or species if the claims are amended such that the search burden for the examiner is increased. 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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,436,995. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-20 of the current application and the invention of claims 1-18 of the patent lies in the fact that the invention of claims 1-18 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-18 of the patent is in effect a "species" of the "generic" invention of claims 1-20 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 1-20 are anticipated by claims 1-18, claims 1-20 are not patentably distinct from claims 1-18. Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,327,829. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-7 of the current application and the invention of claims 1-13 of the patent lies in the fact that the invention of claims 1-13 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-13 of the patent is in effect a "species" of the "generic" invention of claims 1-7 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 1-7 are anticipated by claims 1-13, claims 1-7 are not patentably distinct from claims 1-13. Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,395,691. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-7 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 1-7 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 1-7 are anticipated by claims 1-11, claims 1-7 are not patentably distinct from claims 1-11. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,779,382. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-20 of the current application and the invention of claims 1-17 of the patent lies in the fact that the invention of claims 1-17 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-17 of the patent is in effect a "species" of the "generic" invention of claims 1-20 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 1-20 are anticipated by claims 1-17, claims 1-20 are not patentably distinct from claims 1-17. Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,295,633. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claims 1-20 of the current application and the invention of claims 1-19 of the patent lies in the fact that the invention of claims 1-19 of the patent includes more elements and is thus more specific. Thus the invention of claims 1-19 of the patent is in effect a "species" of the "generic" invention of claims 1-20 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 1-20 are anticipated by claims 1-19, claims 1-20 are not patentably distinct from claims 1-19. 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. Claims 10, 12, and 18-20 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. Claim 10 recites the limitation "the compression slot" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 10 will be interpreted as depending from claim 9 for examination purposes. Claim 12 recites the limitation “the at least one opening between the first end and the second end” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 12 will be interpreted as depending from claim 8 for examination purposes. Claim 18 recites the limitation “the incision” in line 23. There is insufficient antecedent basis for this limitation in the claim. 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. Claims 1-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Frigg (EP0468192) in view of Lorenzo (U.S. Patent 2,526,959). Regarding claims 1-4 and 6: Frigg discloses a device (for example see Figure 1) comprising: (claim 1) a body including (claim 1) an arm including (claim 1) a first end (claim 1) an attachment portion (22) at the first end (claim 1) a second end (claim 1) an alignment portion (20) at the second end (claim 3) wherein the alignment portion comprises at least one through hole configured to receive a guide pin (see Figure 1) (claim 1) a fixation insert (21) (claim 1) wherein the fixation insert is configured to pass through the attachment portion (claim 2) wherein the attachment portion comprises a through hole configured to receive the fixation insert (claim 4) wherein the fixation insert includes (claim 4) a knob portion (the hex head) (claim 4) a shaft portion extending away from the knob portion (claim 5) wherein the shaft portion includes (claim 5) an alignment portion (the portion of the shaft that engages the hole in element 22) (claim 5) a threaded section (the portion of the shaft that engages threaded hole 8) (claim 1) a screw (30) including (claim 6) a first end (claim 6) a head portion at the first end (claim 6) a second end (claim 6) a shaft portion extending away from the head portion to the second end Frigg fails to disclose the device further comprising a guide pin, the screw includes a through hole configured to engage a guide pin, and the shaft portion of the screw having a smooth portion and a threaded portion. Regarding the device further comprising a guide pin and the screw including a through hole configured to engage a guide pin, Lorenzo teaches a device comprising a screw, wherein the device further comprises a guide pin (25) and the screw further includes a through hole for receiving the guide pin in order to ease implantation of the screw into a bone. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Frigg further comprising a guide pin and the screw having a through hole for receiving the guide pin in view of Lorenzo in order to accurately implant the screw into a bone. Regarding the shaft portion of the screw having a smooth portion and a threaded portion, Lorenzo teaches a device comprising a screw (1) including a head (2) and a shaft, wherein the shaft includes a smooth portion (37) and a threaded portion (4) in order to compress two portions of bone together. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Frigg wherein the shaft portion of the screw includes a smooth portion and a threaded portion in view of Lorenzo in order to compress two portions of bone together. Regarding claim 8: Frigg discloses a device (for example see Figure 1) comprising: (claim 8) a bone plate (10) including (claim 8) a first end (claim 8) at least one through hole (3; the hole closest to element 5) in the first end (claim 8) a second end (claim 8) at least one through hole (the hole that receives element 8) in the second end (claim 8) an intermediate portion connecting the first end and the second end (claim 8) at least one hole (3; any of the holes in the middle of element 10) between the first end and the second end (claim 8) a bone plate alignment guide including (claim 8) a body having (claim 8) an arm with (claim 8) a first end (claim 8) an attachment portion (22) at the first end (claim 8) a second end (claim 8) an alignment portion (20) at the second end (claim 8) a fixation insert (8) (claim 8) wherein the fixation insert is configured to pass through the attachment portion (claim 8) wherein the fixation insert coupled to at least one opening of the bone plate (claim 8) a screw (30) (claim 8) at least one first fastener for insertion through the at least one through hole on the first end of the bone plate and into a first portion of a bone (a fastener configured to be inserted into an element 3 near element 5) (claim 8) at least one second fastener for insertion through the at least one through hole of the second end of the bone plate and into a second portion of a bone (a fastener configured to be inserted into an element 3 near element 8) Frigg fails to disclose the device further comprising a guide pin, the screw having a through bore for engaging the guide pin, and the shaft portion of the screw having a smooth portion and a threaded portion. Regarding the device further comprising a guide pin and the screw including a through hole configured to engage a guide pin, Lorenzo teaches a device comprising a screw, wherein the device further comprises a guide pin (25) and the screw further includes a through hole for receiving the guide pin in order to ease implantation of the screw into a bone. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Frigg further comprising a guide pin and the screw having a through hole for receiving the guide pin in view of Lorenzo in order to accurately implant the screw into a bone. Regarding the shaft portion of the screw having a smooth portion and a threaded portion, Lorenzo teaches a device comprising a screw (1) including a head (2) and a shaft, wherein the shaft includes a smooth portion (37) and a threaded portion (4) in order to compress two portions of bone together. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Frigg wherein the shaft portion of the screw includes a smooth portion and a threaded portion in view of Lorenzo in order to compress two portions of bone together. Claims 1-3, 6-8, 12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hilgendorff (EP 1 273 271) in view of Lorenzo (U.S. Patent 2,526,959). Regarding claims 1-3, 6, 7, and 17: Hilgendorff discloses a device (for example see Figures 1-5) comprising: (claim 1) a body including (claim 1) an arm (18) including (claim 1) a first end (claim 1) an attachment portion (16) at the first end (claim 1) a second end (claim 1) an alignment portion (the end with bore 120) at the second end (claim 3) wherein the alignment portion comprises at least one through hole configured to receive a guide pin (120) (claim 7) wherein the arm is configured to position the through hole of the attachment portion generally perpendicular to the at least one through hole of the alignment portion (claim 1) a fixation insert (14) (claim 1) wherein the fixation insert is configured to pass through the attachment portion (claim 2) wherein the attachment portion comprises a through hole (60) configured to receive the fixation insert (claim 1) a screw (33; for example see Figure 1) including (claim 6) a first end (claim 6) a head portion at the first end (claim 6) a second end (claim 6) a shaft portion extending away from the head portion to the second end (claim 6) wherein the shaft portion includes a smooth portion and a threaded portion (for example see Figure 1) Hilgendorff fails to disclose the device further comprising a guide pin and the screw having a through bore for engaging the guide pin. Regarding the device further comprising a guide pin and the screw including a through hole configured to engage a guide pin, Lorenzo teaches a device comprising a screw, wherein the device further comprises a guide pin (25) and the screw further includes a through hole for receiving the guide pin in order to ease implantation of the screw into a bone. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Hilgendorff further comprising a guide pin and the screw having a through hole for receiving the guide pin in view of Lorenzo in order to accurately implant the screw into a bone. Regarding claims 8 and 12: Hilgendorff discloses a device (for example see Figures 1-5) comprising: (claim 8) a bone plate (12) including (claim 8) a first end (claim 8) at least one through hole (34) in the first end (claim 8) a second end (claim 8) at least one through hole (37) in the second end (claim 8) an intermediate portion connecting the first end and the second end (claim 8) at least one opening between the first end and the second end (claim 12) wherein the at least one opening includes a first opening (35) and a second opening (36) (claim 8) a bone plate alignment guide including (claim 8) a body having (claim 8) an arm (18) with (claim 8) a first end (claim 8) an attachment portion (16) at the first end (claim 8) a second end (claim 8) an alignment portion (the end with bore 120) at the second end (claim 8) a fixation insert (14) (claim 8) wherein the fixation insert is configured to pass through the attachment portion (for example see Figure 1) (claim 8) wherein the fixation insert coupled to at least one opening (74; see paragraph 30) of the bone plate (claim 8) a screw (33) (claim 8) at least one first fastener (32) for insertion through the at least one through hole on the first end of the bone plate and into a first portion of a bone (claim 8) at least one second fastener (38) for insertion through the at least one through hole of the second end of the bone plate and into a second portion of a bone Hilgendorff fails to disclose the device further comprising a guide pin and the screw having a through bore for engaging the guide pin. Regarding the device further comprising a guide pin and the screw including a through hole configured to engage a guide pin, Lorenzo teaches a device comprising a screw, wherein the device further comprises a guide pin (25) and the screw further includes a through hole for receiving the guide pin in order to ease implantation of the screw into a bone. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Hilgendorff further comprising a guide pin and the screw having a through hole for receiving the guide pin in view of Lorenzo in order to accurately implant the screw into a bone. Allowable Subject Matter Claims 18-20 are allowable over the prior art. However, claims 18-20 have been rejected under non-statutory double patenting and under 35 U.S.C. 112(b) as discussed above. Claim 10 would be allowable over the prior art if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. However, claim 10 has been rejected under non-statutory double patenting as discussed above. The following is a statement of reasons for the indication of allowable subject matter: Regarding claims 18-20: Frigg (EP0468192) discloses a device comprising: (claim 18) a body including (claim 18) an arm including (claim 18) a first end (claim 18) an attachment portion (22) at the first end (claim 18) a second end (claim 18) an alignment portion (20) at the second end (claim 18) a fixation insert (21) (claim 1) wherein the fixation insert is configured to engage the attachment portion (claim 18) a screw (30) Frigg further discloses a method of using the device comprising: (claim 18) providing the device discussed above (claim 18) aligning a bone plate on a plate (claim 18) attaching the device to the bone plate in a desired position relative to the bone (claim 18) securing the bone plate to the bone (claim 18) removing the device from the bone plate (claim 18) closing an incision of a patient Frigg fails to disclose the method further comprising preparing a joint, aligning the bone plate on the joint, inserting at least one first temporary fixation pin to secure the bone plate to a first bone of the joint, inserting at least one second temporary fixation pin to secure the bone plate to a second bone of the joint, aligning the bone plate in a desired position relative to the joint, inserting the guide pin across the joint through the alignment portion of the body, inserting the screw over the guide pin to move the joint, and securing the bone plate to the first bone and the second bone of the joint. The examiner was unable to find a reference or a combination of references that disclose and/or teach the limitations of claim 18 as presented. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-289 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. 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
Jul 24, 2026
Non-Final Rejection mailed — §103, §112, §DP (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
82%
Grant Probability
95%
With Interview (+13.2%)
3y 3m (~1y 11m remaining)
Median Time to Grant
Low
PTA Risk
Based on 1172 resolved cases by this examiner. Grant probability derived from career allowance rate.

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