Prosecution Insights
Last updated: August 06, 2026
Application No. 18/486,611

ROBOTIC SYSTEMS AND METHODS FOR DISTRACTION IN INTERVERTEBRAL DISC PROSTHESIS IMPLANTATION

Non-Final OA §102§103
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
3 (Non-Final)
70%
Grant Probability
Favorable
3-4
OA Rounds
7m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 70% — above average
70%
Career Allowance Rate
690 granted / 985 resolved
At TC average
Strong +24% interview lift
Without
With
+24.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
32 currently pending
Career history
1008
Total Applications
across all art units

Statute-Specific Performance

§101
2.6%
-37.4% vs TC avg
§103
46.4%
+6.4% vs TC avg
§102
33.0%
-7.0% vs TC avg
§112
10.2%
-29.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 985 resolved cases

Office Action

§102 §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 . A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after the final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 7/21/26 has been entered. Accordingly, claim 1 is amended. 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) 1-8, 12-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McAfee (US 20180125598 A1). McAfee discloses a robotic system (para. 17) for distraction of an intervertebral disc space figs 7-8 for implantation of an intervertebral disc prosthesis, the system comprising: a 3D modeling system (Integrated real time three dimensional mapping, para. 15, 44, 47) capable for creating a 3D model fig. 29 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, having a first pin 20, fig. 4 configured to be inserted into an upper vertebral body and a second pin 24 configured to be inserted into a lower vertebral body, the robotic distraction system capable to: determine a size of an intervertebral disc prosthesis to be implanted between the first and second vertebrae; and precisely open the disc space just large enough to receive a selected intervertebral disc figs 8, 13; and a computing system (para. 66) 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 on the computing system 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 (para. 69), wherein the computing system is capable with a maximum distraction force and the robotic distraction system is controlled to not exceed the maximum distraction force, wherein the surgeon interface is capable to allow the surgeon to set the maximum distraction force, wherein the robotic distraction system and the computing system are capable to independently control distraction of anterior and posterior edges of the disc space, wherein the 3D modeling system comprises a plurality of radiopaque markers secured to the first and second vertebrae via at least one of screws, pins, and adhesive, wherein the plurality of radiopaque markers 23, 27, 31 comprises a single radiopaque marker secured to each of the first and second vertebrae (para. 40, 47), wherein the plurality of radiopaque markers comprises a plurality of radiopaque marker secured to each of the first and second vertebrae figs. 4-6, wherein the robotic distraction system comprises hydraulically operated telescoping distractors fig. 16, 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 configured to insert distractor pins into the first and second vertebrae fig. 4-6, wherein the robotic distraction system is capable to distract two lateral sides of the disc space independently. 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. Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over McAfee (US 20180125598 A1) in view of Lavallee (US 20070219561 A1). McAfee fails to teach that the plurality of radiopaque markers secured to each of the first and second vertebrae comprises a set of three small radiopaque balls arranged in a triangular configuration, wherein the 3D modeling system comprises a plurality of infrared reflected fiducials secured to the first and second vertebrae via at least one of screws, pins, and the hydraulically operated telescoping distractors which are supplied with a fluid through at least one tube. Lavallee teaches that 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). It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the plurality of radiopaque markers of McAfee to comprises a set of three small radiopaque balls arranged in a triangular configuration, or to comprise a plurality of infrared reflected fiducials secured to the bone via at least one of screws, pins in view of Lavallee in order to providing an effective surgical navigation system. Also, It would have been obvious to a person of ordinary skill in the art at the time of the invention was made to modify the hydraulically operated telescoping distractors of McAfee to be supplied with a fluid through at least one tube in view of Lavallee in order to providing an effective distraction mechanism. Response to Arguments Applicant’s arguments with respect to claim(s) 1-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Conclusion 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, §103
Jan 08, 2026
Non-Final Rejection mailed — §102, §103
Apr 08, 2026
Response Filed
Apr 21, 2026
Final Rejection mailed — §102, §103
Jul 21, 2026
Request for Continued Examination
Jul 24, 2026
Response after Non-Final Action
Jul 27, 2026
Non-Final Rejection mailed — §102, §103 (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

3-4
Expected OA Rounds
70%
Grant Probability
94%
With Interview (+24.3%)
3y 4m (~7m remaining)
Median Time to Grant
High
PTA Risk
Based on 985 resolved cases by this examiner. Grant probability derived from career allowance rate.

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