Prosecution Insights
Last updated: July 15, 2026
Application No. 18/720,957

MODULAR INSERTS FOR NAVIGATED SURGICAL INSTRUMENTS

Final Rejection §103§112
Filed
Jun 17, 2024
Priority
Dec 17, 2021 — provisional 63/290,709 +1 more
Examiner
JACOB, OOMMEN
Art Unit
3797
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Smith & Nephew plc
OA Round
2 (Final)
79%
Grant Probability
Favorable
3-4
OA Rounds
9m
Est. Remaining
96%
With Interview

Examiner Intelligence

Grants 79% — above average
79%
Career Allowance Rate
708 granted / 898 resolved
+8.8% vs TC avg
Strong +18% interview lift
Without
With
+17.6%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
27 currently pending
Career history
932
Total Applications
across all art units

Statute-Specific Performance

§101
0.2%
-39.8% vs TC avg
§103
90.2%
+50.2% vs TC avg
§102
3.5%
-36.5% vs TC avg
§112
4.6%
-35.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 898 resolved cases

Office Action

§103 §112
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 with respect to claims 1-4, 7-11, 14-18 have been considered but are moot in view of new grounds of rejection. 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 1-4, 7-11, 14-18 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. Claims 1, 8 recite “the common axis relative to the handle portion” it is not understood what is this common axis. There are many axes that can be common to tow components. Also note the lack of antecedent basis. Examiner interprets as a common coaxial axis for the handle portion and instrument body. Claims 2-4, 7, 9-11, 14-18, are rejected in view of the dependency to the claims 1, 8. 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, 7-8, 14-18 rejected under 35 U.S.C. 103 as being unpatentable over Belson [US 20130066304 A1] in view of Houser [US 20120116388 A1]. As per claim 1, Belson teaches a surgical instrument assembly (Belson Fig 40) comprising: a plurality of modular inserts (Belson Figs 6-20 working tips configured for different applications like magnetic connection, threaded connection, optical, cables etc. Other types of tips shown in the application includes but not limited to mechanical, electro-mechanical, grasper needle holder, etc.. for e.g. as shown in Figs 40-60), wherein each of the plurality of modular inserts is configured to engage with one of a plurality of components associated with the surgical instrument assembly (Belson Figs 6-20, 40-60, different working tips configured to engage with different components for different applications), a surgical instrument body configured to interchangeably receive one of the plurality of modular inserts (Belson ¶0033 “the current shaft may connect to different tips”, ¶0120 “a shaft 102 may have a plurality of connection points for attaching and operating a plurality of working tips 130 with a single shaft 102” Shaft 120 corresponds to the surgical instrument body, and interchangeability is a capability that the device in Belson has)and a handle portion coaxially coupled to the surgical instrument body (Belson Fig 40 handle of a manually operated system), wherein the handle portion and the surgical instrument body are configured to allow the surgical instrument body to be rotated about the common axis relative to the handle portion (Belson ¶0014 “enable transfer of rotation force from the shaft to the tip while also controlling the tip's position in space and moving it around.” ¶0039 “in a manually operated version … a handle connected to the proximal end of the shaft will be controlled by the operator directly allowing the operator to actuate the working tip, as well as to control the tip's position in space and move it around.”, implies shaft is rotating relative to the handle). Belson does not expressly teach the stroked out limitations, including wherein the plurality of modular inserts comprises different diameters corresponding to the respective plurality of components, and the handle portion and the surgical instrument body comprise complementary teeth. Firstly, as discussed in Belson, different working tips for different applications have been disclose. For e.g. magnetic connection, threaded connection, optical, cables etc. Other types of tips shown in the application includes but not limited to mechanical, electro-mechanical, grasper needle holder, etc.. for e.g. as shown in Figs 40-60. Different applications have been further discussed in ¶0091. For e.g. Fig 6 shows different diameters for magnetic coupling, tapering item 106, optical connector 174, suction mechanism as in Fig 19 etc.…and different shapes as in Figs 56-60. Further, each working tip comprises different components, which are obviously not the same as per the drawings. For e.g. items 30, 61, 110, components / spaces inside 64, 70 for accommodating shaft, etc. Hence, before the effective filing date, it would have been obvious to a person of ordinary skill that these working tips comprises different diameters (cross sectional areas / sizes /shapes) so that the working tips can be implemented for various applications as described. Secondly, Houser, in a related field of endoscopic surgical instruments, teaches handle portion and the surgical instrument body comprise complementary teeth (Houser Figs 11A, 11B, ¶0093 “. Rotation knob (914) of the present example includes teeth that are complementary to those of gear (916) and that are formed in a cylindrical recess of rotation knob (914) such that gear (916) is insertable therein and engages rotation knob (914) when end effector assembly (910) is coupled to handle assembly (940)”). Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Belson by integrating a rotation knob with complementary teeth as in Houser. As per MPEP 2143.I., example of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results. In the instant case, the claim is only directed to incorporate the rotation knob of Houser into the handles of manually operated systems of Belson. The predictable result is that it provides for the engagement and manual rotation of shafts of the system with the handle. As per claim 7, Belson in view of Houser further teaches wherein the surgical instrument body is freely rotatable relative to the handle portion (Houser teaches complementary teeth as in parent claim and hence the combination would be freely rotatable, similar to the claimed invention). As per claims 8, 14 have limitations similar to claims 1, 4 and is rejected for same reaons. Belson teaches different working tips corresponding to the first and second modular inserts as claimed. As per claims 15, 17, Belson in view of Houser further teaches wherein Belson ¶0139 “For example, pull wires, pushrods, rotating shafts and/or pneumatic or hydraulic channels in the shaft 102 may be used to operate the end effector 160.” See Figs 13, 15, 53), the channel comprising a diameter corresponding to the respective plurality of components (Implied if the components are connected and operated as described). As stroked through above, Belson in view of Houser not disclose the features in each insert. However, as per MPEP 2144.04,VI.B, mere duplication of parts has no patentable significance unless a new and unexpected result is produced. In this case, the claim is directed to providing features of Belson to more than one or all the inserts. Hence it is duplication of parts and an obvious modification. As per claims 16, 18, Belson in view of Houser further teaches wherein the channel is oriented at a known pose with respect to the surgical instrument body (In Belson Figs 13, 15, 53 the channels are part of the device and hence oriented at known pose along the axis of the shaft). Claims 2-4, 9-11, rejected under 35 U.S.C. 103 as being unpatentable over Belson in view of Houser as applied to claims 1, 8 above, and further in view of Ebbitt [US 20190231447 A1]. As per claims 2-4, 9-11 Belson in view of Houser does not expressly teach wherein the plurality of components comprises a drill bit or nosepiece or a tracking array coupled to the surgical instrument body. Ebbitt, in a related field of Surgical robotic systems teaches a drill bit or nosepiece (Ebbitt Fig 5A, items 44 corresponds to drill and 50 corresponds to a nosepiece since it provides additional and/or different functionality as described by applicant), or a tracking array coupled to the surgical instrument body (Ebbitt Fig 1 items 62, ¶0147 “trackers 62 to track correspondingly multiple objects within the localizer coordinate system LCLZ”). Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify the apparatus in Belson Houser in view of by integrating components as recited in the claims. As per MPEP 2143.I., example of rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results. In the instant case, the modifications of drill bit, nosepiece or tracking array would have been obvious modifications since they provide the predictable result of performing surgical actions or tracking. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00. 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, ANNE M KOZAK can be reached at 571-270-0552. 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. /Oommen Jacob/Primary Examiner, Art Unit 3797
Read full office action

Prosecution Timeline

Jun 17, 2024
Application Filed
Feb 26, 2026
Non-Final Rejection mailed — §103, §112
Apr 13, 2026
Response Filed
May 19, 2026
Final Rejection mailed — §103, §112
Jul 07, 2026
Request for Continued Examination
Jul 14, 2026
Response after Non-Final Action

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Prosecution Projections

3-4
Expected OA Rounds
79%
Grant Probability
96%
With Interview (+17.6%)
2y 10m (~9m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 898 resolved cases by this examiner. Grant probability derived from career allowance rate.

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