Prosecution Insights
Last updated: May 29, 2026
Application No. 18/486,611

ROBOTIC SYSTEMS AND METHODS FOR DISTRACTION IN INTERVERTEBRAL DISC PROSTHESIS IMPLANTATION

Non-Final OA §102
Filed
Oct 13, 2023
Priority
Sep 24, 2018 — provisional 62/735,710 +2 more
Examiner
BOLES, SAMEH RAAFAT
Art Unit
3775
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Simplify Medical Pty Ltd.
OA Round
1 (Non-Final)
70%
Grant Probability
Favorable
1-2
OA Rounds
9m
Est. Remaining
95%
With Interview

Examiner Intelligence

Grants 70% — above average
70%
Career Allowance Rate
685 granted / 979 resolved
At TC average
Strong +25% interview lift
Without
With
+24.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
20 currently pending
Career history
1007
Total Applications
across all art units

Statute-Specific Performance

§101
0.5%
-39.5% vs TC avg
§103
67.2%
+27.2% vs TC avg
§102
21.3%
-18.7% vs TC avg
§112
2.4%
-37.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 979 resolved cases

Office Action

§102
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 . According to the Amendment filed on 4/8/26, Claims 1-16 are amended. Claim Objections Claims 2-16 were objected to because of the following informalities: the limitations of “A robotic system of claim” in line 1 should read as “The robotic system of claim”. Applicant has amended the claims 2-16 to read as “The robotic system of claim”. The claim objections of claims 2-16 are withdrawn. 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)(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) 1-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lavallee (US 20070219561 A1). Lavallee discloses a robotic system figs 1-2 capable for being used in distraction of a disc space for implantation of an intervertebral disc prosthesis, the system comprising: a 3D modeling system (para. 12, 69) capable for being used in the following “creating a 3D model of first and second vertebra adjacent the disc space and identifying positions of the first and second vertebrae and generating and storing position data for the positions of the first and second vertebrae”; a robotic distraction system 200, fig. 2 capable to: determine a size (para. 36) of an intervertebral disc prosthesis to be implanted between the first and second vertebrae; and precisely capable to open fig. 2 the disc space just large enough to receive a selected intervertebral disc; and a computing system 30, fig. 1 capable for storing and processing the 3D model and the positions of the first and second vertebrae before and after distraction, further comprising a surgeon interface 32 on the computing system 30 capable to allow the surgeon to select an intervertebral disc prosthesis to be implanted and a desired distraction distance to be achieved or a desired distraction force to be applied by the robotic distraction system, wherein the computing system is capable to be with a maximum distraction force and the robotic distraction system is controlled to not exceed the maximum distraction force, wherein the surgeon interface 32 is capable to allow the surgeon to set the maximum distraction force, wherein the robotic distraction system 200 and the computing system are capable to independently control distraction of anterior and posterior edges of the disc space fig. 2, wherein the 3D modeling system comprises a plurality of radiopaque markers 100, 110 capable to be secured to the first and second vertebrae via at least one of screws, pins, and adhesive, wherein the plurality of radiopaque markers comprises a single radiopaque marker secured to each bones 110, 100, fig. 1, wherein the plurality of radiopaque markers 102, 112 comprises a plurality of radiopaque marker secured to each of the bones, wherein the plurality of radiopaque markers secured to each of the first and second vertebrae comprises a set of three small radiopaque balls 102, 112 arranged in a triangular configuration fig. 1, wherein the 3D modeling system comprises a plurality of infrared reflected fiducials secured to the bone via at least one of screws, pins 104, fig. 1, wherein the robotic distraction system comprises hydraulically (para. 52, 99) operated telescoping distractors which are supplied with a fluid through at least one tube 460, (para. 53, 58,60), wherein the 3D modeling system or the robotic distraction system is capable to track the location of the first and second vertebrae during distraction, wherein the 3D modeling system is capable to update the 3D model of the first and second vertebrae during distraction, wherein the 3D modeling system is capable continuously verify the positions of the first and second vertebrae during distraction, wherein the robotic distraction system is capable to insert distractor pins into the first and second vertebrae, wherein the robotic distraction system is capable to distract two lateral sides of the disc space independently fig. 2. Response to Arguments Applicant's arguments filed with respect to claims have been fully considered but they are not persuasive. Applicant argues that “ The rejection should be withdrawn because Lavallee fails to teach or suggest "determine a size of an intervertebral disc prosthesis to be implanted between the first and second vertebrae" as claimed. Lavallee teaches joint distraction, and more specifically, knee joint distraction. ( [0002].) Lavallee provides no teaching or suggestion that its distraction device may be used to distract an intervertebral space, let alone "determine a size of an intervertebral disc prosthesis to be implanted between the first and second vertebrae." Accordingly, Lavallee fails to teach or suggest "determine a size of an intervertebral disc prosthesis to be implanted between the first and second vertebrae" as claimed. “ Examiner respectfully disagrees, since the robotic system for distraction of Lavallee is capable of being used in distracting an intervertebral space, and capable to determine a size of an intervertebral disc prosthesis to be implanted between the first and second vertebrae. Also, it is noted that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). And A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). 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 SAMEH RAAFAT BOLES whose telephone number is (571)270-5537. The examiner can normally be reached 9-5 pm. 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. /SAMEH R BOLES/Primary Examiner, Art Unit 3775
Read full office action

Prosecution Timeline

Oct 13, 2023
Application Filed
Dec 08, 2025
Non-Final Rejection (signed) — §102
Jan 08, 2026
Non-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

1-2
Expected OA Rounds
70%
Grant Probability
95%
With Interview (+24.7%)
3y 4m (~9m remaining)
Median Time to Grant
Low
PTA Risk
Based on 979 resolved cases by this examiner. Grant probability derived from career allowance rate.

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