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, see remarks, filed 11/10/2025, with respect to the rejections under 35 USC 112(b) have been fully considered and are persuasive. The 35 USC 112(b) rejection of claims 7 and 8 has been withdrawn.
Applicant's arguments filed 11/10/2025 have been fully considered but they are not persuasive. The applicant argues that DiCorleto does not teach the limitation that the handheld device comprises fiducial markers and that the fiducial markers are fixed a different component altogether and it would not be obvious to modify the parts. However, DiCorleto does teach in [0029] that the holder 10 may remain fixed to the handle 54. Therefore, if the two pieces remain fixed, then it doesn't matter where the markers are actually attached because everything functions together. Additionally, the applicant argues that the handle 54 of DiCorleto is mapped to the handheld device of the present application, however in the most recent office action, no such mapping is made. The distinction of where the markers are is not patentably significant because the point of the chuck is to hold the instrument in place relative to the handle. There is simply no way for the tracking to be different when it is connected to the chuck piece or the handle itself because functionally, the markers are recording the same data. Additionally, there is no benefit to placing the markers on the handle rather than on the chuck as long as [0029] of DiCorleto is true and everything is held in place.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, and 12,13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DiCorleto et al (US 20190231408 A1); hereinafter DiCorleto (cited previously).
Regarding claim 1, DiCorleto teaches a method comprising:
for each of one or more surgical tools (instrument or tool 52):
placing the surgical tool in a fixation mechanism ([0030] holder 10 or parts thereof including chuck assembly 64 (figs. 2 and 3) to receive the surgical tool specifically in the guide portion 24);
attaching the fixation mechanism to a handheld device to create a surgical tool / fixation mechanism combination (fig 1, [0030] tool engagement portion 16 connects the combination of fixation mechanism (holder 10) and instrument 52 to the handle 54), wherein the handheld device comprises fiducial markers arranged thereon ([0029] holder 10 may remain fixed to handle 54 - if the two pieces remain fixed, then it doesn't matter where the markers are actually attached because everything functions together);
calibrating the handheld device with the fixation mechanism and surgical tool ([0034] tracking devices may be calibrated or registered relative to a portion of the instrument 52);
and storing the calibration information for the tool ([0050] a lookup table or recalling from memory).
It should be noted that Applicant’s definition for “fixation mechanisms” 204 (par [0009], lines 1-2) specifies a ‘chuck’. Therefore, the Examiner’s new interpretation of a “fixation mechanism” including at least elements 10 and 64 appear to meet this limitation.
Regarding claim 2, DiCorleto teaches the method of claim 1, further comprising:
removing the surgical tool / fixation mechanism combination from the handheld device ([0029] the instrument 52' positioned/removed/changed into the tool 54 without moving or changing the tracking device holder).
Regarding claim 3, DiCorleto teaches the method of claim 1, wherein the step of calibrating comprises:
touching the surgical tool to one or more predefined spots such that a position of fiducial markers attached to the handheld device may be read by a tracking system ([0034] calibration may occur with a fiducial or fixed/known point registration procedure as is generally understood in the art, [0050] may then be touched to a known or registerable portion).
Regarding claim 4, DiCorleto teaches a system comprising:
a processor (navigation processor 148); and
software that, when executed by the processor, causes the system to perform the method of claim 2 ([0045] commercially available surgical navigation systems).
Regarding claim 12, DiCorleto teaches a device comprising:
a powered handheld device ([0024] handle is powered) comprising fiducial markers arranged thereon ([0029] holder 10 may remain fixed to handle 54 - if the two pieces remain fixed, then it doesn't matter where the markers are actually attached because everything functions together);
a fixation mechanism ([0030] holder 10), removably attached to the handheld device ([0029] instrument 52 is removed); and
a surgical tool held by the fixation mechanism (fig 1);
wherein one or more combination surgical tools / fixation mechanisms are preoperatively attached to the handheld device and calibrated ([0034] tracking devices may be calibrated or registered relative to a portion of the instrument 52).
Regarding claim 13, DiCorleto teaches the device of claim 12, wherein the combination surgical tool / fixation mechanism attached to the powered handheld device may be dynamically changed during a surgical procedure by disconnecting a first fixation mechanism ([0029] changing an instrument)
containing a first surgical tool and connecting a second fixation mechanism ([0029] tracking device holder 10 may be maintained on the tool 54) containing a second surgical tool to the powered handheld device (second instrument 52').
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiCorleto in view of Ho et al (US 20200008889 A1); hereinafter Ho (cited previously).
Regarding claim 5, DiCorleto teaches the system of claim 4. DiCorleto fails to teach identification of surgical tools and instructions to calibrate said tools. Ho teaches software further causes the system to:
receive an identification of one or more surgical tools to be used during a surgical procedure ([0052] RFID reader on calibration device 1300 and instrument 1200 respectively, so that the RFID reader detects the RFID label). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify DiCorleto with Ho because there is some teaching, suggestion, or motivation to do so. Ho states that identifying the tool using RFID can be useful for “detecting the state of connection between the calibration device 1300 and the instrument 1200” ([0052]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiCorleto in view of Ho et al (US 20200008889 A1); hereinafter Ho and Wang et al (US 20210290336 A1); hereinafter Wang (cited previously).
Regarding claim 6, the combination of DiCorleto and Ho teaches the system of claim 5. Wang further teaches the software further causes the system to:
provide instructions to the user indicating steps required to calibrate each surgical tool ([0069] display a plurality of calibration points, and an instruction for instructing the user to perform a calibration operation with respect to each of the calibration points).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of DiCorleto and Ho with Wang because there is some teaching, suggestion, or motivation to do so. Wang teaches that providing instructions to calibrate the system “to thereby obtain a plurality of screen coordinate sets that are associated respectively with the plurality of calibration points on the display lens and a plurality of calibrated coordinate sets that are associated with the calibration points in the global 3D coordinate system” ([0013]).
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiCorleto in view of Ho and Nixon et al (US 20050251110 A1); hereinafter Nixon (cited previously).
Regarding claim 7, the combination of DiCorleto and Ho teaches the system of claim 5. The combination of DiCorleto and Ho fails to teach identifying calibration procedures for the identified surgical tools and calibrating according to said procedures. Nixon teaches the system of claim 5, wherein the software, in a preoperative phase, further causes the system to:
identify a calibration procedure for the identified surgical tools ([0062] tool type identifier); and
calibrate each identified surgical tool using the identified procedures ([0062] grip calibration procedure).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify the combination of DiCorleto and Ho with Nixon because this allows the processor to be reconfigured so as to allow the surgeon to accurately and safely use tools of different types ([0062]).
Regarding claim 8, the combination of DiCorleto and Ho teaches the system of claim 5. DiCorleto further teaches the software implements calibration procedures for the one or more surgical tools ([0034] registration procedure).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiCorleto in view of Nixon.
Regarding claim 9, DiCorleto teaches the system of claim 4. DiCorleto fails to teach receiving a request to change the tool and prompting the user to identify the next tool. Nixon teaches the software further causes the system to:
receive an interoperative request to change the surgical tool ([0004] tool changes will be performed while a procedure is under way); and
prompt a user to identify the next desired surgical tool ([0011] single element end effector identifying signal).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify DiCorleto and Nixon because there is some teaching, suggestion, or motivation to do so. Nixon teaches that these elements will help avoid and/or minimize any tool-swap related delays to the surgical procedure ([0004]).
Regarding claim 10, the combination of DiCorleto and Nixon teaches the system of claim 9. Nixon further teaches the software further causes the system to:
retrieve and load calibration information for the requested surgical tool ([0012] The calibration may be stored during the procedure in a memory of the processor).
Regarding claim 11, the combination of DiCorleto and Nixon teaches the system of claim 10. Nixon further teaches the software further causes the system to:
instruct the user to connect the requested surgical tool and fixation mechanism to the handheld device ([0064] indicating that a tool has been mounted to holder 408).
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.
/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796