Prosecution Insights
Last updated: July 17, 2026
Application No. 19/045,624

Reference Devices and Methods of Use For External Fixation Frames

Final Rejection §103
Filed
Feb 05, 2025
Priority
Feb 12, 2024 — provisional 63/552,218
Examiner
MATTHEWS, TESSA M
Art Unit
3773
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Stryker Corporation
OA Round
2 (Final)
83%
Grant Probability
Favorable
3-4
OA Rounds
1y 2m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 83% — above average
83%
Career Allowance Rate
419 granted / 504 resolved
+13.1% vs TC avg
Strong +24% interview lift
Without
With
+24.5%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
38 currently pending
Career history
548
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
70.7%
+30.7% vs TC avg
§102
16.2%
-23.8% vs TC avg
§112
9.8%
-30.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 504 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 . Response to Arguments Applicant's arguments filed 04/28/2026 have been fully considered but they are not persuasive. Applicant argues that Sakker does not disclose two structurally distinct members and that the members are functionally equivalent and therefore cannot be static and dynamic. The Office respectfully disagrees. Claim 1 requires “a static member…the static member being fixedly secured to and extending from the mount body” and also requires “a dynamic member…the dynamic member being slidably connected to the mount body”. Sakker discloses two members that may be static or dynamic at different times. The mere fact that a component is capable of a specific movement and/or function at certain times does not prevent it serving a different movement and/or function at other times. The components of Sakker are shown to be structurally different and also have different functional relationships with the mount body/connecting members. Claim 1 requires a static member that is fixedly secured. Once nut ref. 23b is employed with member 23a, member 23a becomes fixedly secured and thus static. Likewise, claim 1 requires a dynamic member that is slidably connected to the mount body. When member 22 is inserted into hole 12 of the mount body it is initially slid in via the smooth neck portion and proceeds to slide axially via rotational movement. Therefore, member 22 is considered dynamic during such motions and has a sliding connection to the mount body. Therefore, the rejection is maintained. It is noted that Sakker does not disclose sliding connection in a direction perpendicular to a longitudinal axis of the dynamic member or that the static member is monolithically formed with the mount body. 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. Claim(s) 1 – 5, 15, and 18 - 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cherkashin et al. (US 2013/0215114 A1) in view of Saklers et al. (US 2010/0191239 A1). Regarding claim 1, Cherkashin discloses a reference assembly connectable to a support ring of an external fixation frame (Abstract), comprising: a reference device (Figs. 1A – 1C, ref. 10 and Figs. 5D, 5E, ref. 650), the reference device having a reference body (ref. 10) and a plurality of reference objects (Figs. 1A – 1C, ref. 14) disposed within the reference body (Figs. 1A – 1C), the reference objects each being made from a radiopaque material, and the reference body being made from a radiolucent material (paragraph [0050]), but is silent regarding a mount device having a mount body, a static member, and a dynamic member, the static member being fixedly secured to and extending from the mount body and being configured to be received within a first hole of the support ring of the external fixation frame, the dynamic member being slidably connected to the mount body and being configured to be received within a second hole of the support ring; and wherein the reference device is connectable to the mount body. It is noted that Cherkashin discloses the reference device being connected to a ring frame, but is silent regarding the means of the connection and further states that the embodiment shown are merely exemplary and may be modified according to various design factors (paragraph [0103]). Saklers teaches a system for correcting bones in the same field of endeavor as Cherkashin, specifically external ring frames (Abstract). Saklers teaches a mounting device (Fig. 2A, ref. 10c) having a mount body (paragraph [0054], refs. 31, 32), a static member (Fig. 2A, ref. 23a), and a dynamic member (Fig. 2A, ref. 22), the static member being fixedly secured to and extending from the mount body and being configured to be received within a first hole (ref. 12) of the support ring of the external fixation frame (Fig. 2B shows the static member being fixedly secured through nut ref. 23b), the dynamic member being slidably connected to the mount body and being configured to be received within a second hole (ref. 12) of the support ring (Fig. 2B shows the dynamic member being slidably connected the rotational threading ). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the connection between the reference device and the support rings of the fixation device such that it comprises a mount device having a mount body, a static member, and a dynamic member, the static member being fixedly secured to and extending from the mount body and being configured to be received within a first hole of the support ring of the external fixation frame, the dynamic member being slidably connected to the mount body and being configured to be received within a second hole of the support ring, as taught by Saklers, for being a known alternative coupling in the same field of endeavor to connect two parts of a system with increased stabilization. Please note that the reference device is fully capable of being connectable to the mount body via openings ref. 25 in the mount body as shown in Fig. 2A of Saklers. Regarding claim 2, Cherkashin in view of Saklers discloses the reference assembly of claim 1, wherein the reference objects include a first reference object having a first cross-sectional dimension, and a second reference object having a second cross-sectional dimension, the first cross-sectional dimension being greater than the second cross-sectional dimension (Cherkashin, paragraph [0051] discloses that the objects have different shapes, opacity or sizes, thus one being greater than another). Regarding claim 3, Cherkashin in view of Saklers discloses the reference assembly of claim 2, wherein the reference objects are each spherical (Cherkashin, Figs. 1A – 1C shows the objects to be spherical). Regarding claim 4, Cherkashin in view of Saklers discloses the reference assembly of claim 1, wherein the refence body includes a base (bottom surface) and a reference column extending from the base (Cherkashin, Figs. 1A-1B show a single column), the reference column including at least a first reference object of the plurality of reference objects and a second reference object of the plurality of reference objects (ref. 14), the first reference object having a larger cross-sectional dimension than the second reference object (Cherkashin, paragraph [0051] discloses that the objects have different shapes, opacity or sizes, thus one being greater than another), but is silent regarding the limitation that the reference body includes a plurality of reference columns extending from the base, each reference column including at least a first reference object and a second reference object. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the reference assemblies to have a plurality of columns, each column having a first and second reference object, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. It is noted that no criticality for the number of columns was found in the application, paragraph [0006] states “The reference body may include four reference columns”. Regarding claim 5, Cherkashin in view of Saklers discloses the reference assembly of claim 4, wherein the first reference object of each reference column is positioned further from the base than the second reference object (the first object is considered the “top” object; thus, the second object will be closer to the base/bottom of the reference body). Regarding claim 15, Cherkashin in view of Saklers discloses the reference assembly of claim 1, wherein the mount body includes a slot, and the dynamic member is slidably disposed within the slot (Saklers, Fig. 2A shows a slot ref. 25 configured to receive the dynamic member ref. 22 in a sliding fashion most notably between refs. 31, 32). Regarding claim 18, Cherkashin in view of Saklers discloses the reference assembly of claim 15, wherein the dynamic member includes a threaded shaft (Saklers, Fig. 2A), Regarding claim 19, Cherkashin discloses an external fixation frame (Figs. 5D-12), comprising: first and second support rings (Fig. 5E, ref. 644, 642), the first support ring having a first inner row of holes and a second outer row of holes (see remarked Fig. 11 below); one or more struts connected to and extending between the first and second support rings (Fig. 5E, ref. 646), each strut having an adjustable length (as shown in Fig. 5E the struts are telescopingly adjustable); and a reference assembly (ref. 650) having a reference device (Figs. 1A-1C, ref. 10), and having a plurality of reference objects each being radiopaque (paragraphs [0050-51, ref. 14]). PNG media_image1.png 469 922 media_image1.png Greyscale Cherkashin is silent regarding the mount device, the mount device having a mount body, a static member, and a dynamic member, the static member being receivable within a hole of the second outer row of holes, the dynamic member being moveable relative to the mount body and being receivable within a hole of the first inner row of holes, and the reference device being connectable to the mount body. It is noted that Cherkashin discloses the reference device being connected to a ring frame, but is silent regarding the means of the connection and further states that the embodiment shown are merely exemplary and may be modified according to various design factors (paragraph [0103]). Saklers teaches a system for correcting bones in the same field of endeavor as Cherkashin, specifically external ring frames (Abstract). Saklers teaches a mounting device (Fig. 2A, ref. 10c) having a mount body (paragraph [0054], refs. 31, 32), a static member (Fig. 2A, ref. 23a), and a dynamic member (Fig. 2A, ref. 22, it is considered dynamic due to the threaded or rotational nature of the member), the static member being receivable within a hole of the second outer row of holes, the dynamic member being moveable relative to the mount body and being receivable within a hole of the first inner row of holes (the rings of holes on the first support ring may be divided into inner and outer or other halves such that the dynamic member and static member bridge the divide, see remarked Fig 2B below). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the connection between the reference device and the support rings of the fixation device such that it comprises a mount device having a mount body, a static member, and a dynamic member, the static member being receivable within a hole of the second outer row of holes, the dynamic member being moveable relative to the mount body and being receivable within a hole of the first inner row of holes, as taught by Saklers, for being a known alternative coupling in the same field of endeavor to connect two parts of a system with increased stabilization. Please note that the reference device is connectable to the mount body via openings in the mount body as shown in Fig. 2A of Saklers. PNG media_image2.png 529 750 media_image2.png Greyscale Regarding claim 20, Cherkashin discloses an external fixation frame (Fig. 5E), comprising: first and second support rings (Fig. 5E, ref. 644, 642), the first support ring having a first inner row of holes and a second outer row of holes (see remarked Fig. 11 below); one or more struts connected to and extending between the first and second support rings, each strut having an adjustable length (Fig. 5E shows struts ref. 646 being adjustable via telescoping adjustment); and a reference assembly (Fig. 5E, ref. 650) having a reference device, the reference device having a first reference object and a second reference object (paragraph [0050], ref. 14, Figs. 1A-1C), the first reference object having a cross-sectional dimension greater than that of the second reference object, and the first and second reference objects being radiopaque (paragraphs [0050-51] disclose the objects may have different sizes and are radiopaque). PNG media_image1.png 469 922 media_image1.png Greyscale Cherkashin is silent regarding the mount device, the mount device having a mount body and being connectable to the first inner row of holes and second outer row of holes, the reference device being connectable to the mount body. It is noted that Cherkashin discloses the reference device being connected to a ring frame, but is silent regarding the means of the connection and further states that the embodiment shown are merely exemplary and may be modified according to various design factors (paragraph [0103]). Saklers teaches a system for correcting bones in the same field of endeavor as Cherkashin, specifically external ring frames (Abstract). Saklers teaches a mounting device (Fig. 2A, ref. 10c) having a mount body (paragraph [0054], refs. 31, 32) configured to connect to holes of a support ring (the mount body is connected through a static member, Fig. 2A, ref. 23a, and a dynamic member, Fig. 2A, ref. 22), the static member being receivable within a hole of a second outer row of holes, the dynamic member being receivable within a hole of the first inner row of holes (the rings of holes on the first support ring may be divided into inner and outer or other halves such that the dynamic member and static member bridge the divide, see remarked Fig 2B below). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the connection between the reference device and the support rings of the fixation device such that it comprises a mount device having a mount body, a static member, and a dynamic member, the static member being receivable within a hole of the second outer row of holes, the dynamic member being moveable relative to the mount body and being receivable within a hole of the first inner row of holes, as taught by Saklers, for being a known alternative coupling in the same field of endeavor to connect two parts of a system with increased stabilization. Please note that the reference device is connectable to the mount body via openings in the mount body as shown in Fig. 2A of Saklers. Cherkashin is also silent that the reference device has a plurality of reference columns, each reference column having a first reference object and a second reference object. It is noted that Figs. 1A – 1B show a single column reference device (ref. 10) and Fig. 1C shows two columns, however the embodiment in Fig 1C only shows a single object. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the reference assemblies to have a plurality of columns, each column having a first and second reference object, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. It is noted that no criticality for the number of columns was found in the application, paragraph [0006] states “The reference body may include four reference columns”. Allowable Subject Matter Claims 6 – 14 and 16 - 17 are 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. 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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm. 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. /TESSA M MATTHEWS/Examiner, Art Unit 3773
Read full office action

Prosecution Timeline

Feb 05, 2025
Application Filed
Feb 26, 2026
Non-Final Rejection mailed — §103
Apr 28, 2026
Response Filed
Jul 02, 2026
Final Rejection mailed — §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
83%
Grant Probability
99%
With Interview (+24.5%)
2y 8m (~1y 2m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 504 resolved cases by this examiner. Grant probability derived from career allowance rate.

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