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 .
Continued Examination Under 37 CFR 1.114
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 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 9th, 2026 has been entered.
Claim Status
Claims 1-27 were pending for examination in Application No. 17/913,604 in the amendments filed June 25th, 2025. In the remarks and amendments received on January 9th, 2026, claims 1, 14, and 27 are amended, no claims are cancelled, and no claims are added. Accordingly, claims 1-27 are currently pending for examination in the application.
Response to Amendment
Applicant’s amendments filed January 9th, 2026, have overcome objection previously set forth in the Final Office Action mailed July 11th, 2026. Accordingly, the objection is withdrawn.
Response to Arguments
Applicant’s arguments filed January 9th, 2026, with respect to the rejection of claim 1, have been fully considered but are moot because the arguments do not apply to the new combination of references, facilitated by Applicant’s newly submitted amendments being used in the current rejection.
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) 1-2, 4-8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US-20170020630-A1) in view of Tolkowsky et al. (US-20210386480-A1) and Isaacs et al. (US-20160117823-A1).
Regarding claim 1, Johnson teaches:
A method for determining a safety criterion during an autonomous manipulation of a surgical tool by a robotic system (“system 300 may provide for automatic movement of vertical column 312, upper arm 306, and lower arm 308 through a user indicating on display 304 (which may be a touchscreen input device) the location of a surgical instrument or component on three dimensional image of the patient's anatomy on display 304,” Para [0046]) to treat an anatomical structure according to a planned trajectory in a 3D image (“the user could use the system to plan a pedicle screw at a particular vertebra on 3D preoperative CT or MRI images and then plan the same pedicle screw on x-rays,” Para [0073]), said 3D image (”3D anatomical feature”) being registered with a patient tracker (“The system may also store a 3D anatomical feature for a first coordinate system,” Para [0081]), and the robotic system being servo- controlled on the movements of the patient tracker (“the tracking markers 118 enable each of the marked objects (e.g. ,… the patient 210…) to be tracked by the robot 102”, Para [0033]), the method comprising:
(a) acquiring at least one 2D X-ray image containing the anatomical structure (Fig. 13, “a single lumbar vertebra (L3)” 1600) and the surgical tool (Fig. 13, “pedicle screw” 1602) by an X-ray imaging system (Fig. 12A and 12B), and for each at least one 2D X-ray acquisition:
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i. synchronously localizing the surgical tool (“placement information of a digital medical object,” Para [0081]) and the patient tracker (“3D anatomical feature,” Para [0081]) to determine the position of the surgical tool relative to said 3D image (“placement information of a digital medical object on both the 3D and 2D images,” Para [0081])
ii. registering the 2D X-ray image with the 3D image (“registers the 3D coordinate system (first coordinate system) with the 2D coordinate system (second coordinate system),” Para [0083]) in a region of interest around the anatomical structure (“image feature of the intra-operative 2D image data,” Para [0083]),
(b) determining a safety criterion (“match”) from a similarity information between each real position and each projected localized position of the surgical tool on the at least one 2D X-ray image (“The 2D anatomical feature is compared with the simulated 2D anatomical feature until a match is reached,” Para [0004]).
Johnson fails to teach the following limitations as further claimed. Isaacs, however, further teaches:
iii. generating a projection onto the 2D X-ray image of a model of the surgical tool (Isaacs, “the projection of the instrument onto that 2D plane can be readily determined,” Para [0074]) in its position relative to the 3D image computed in step (i) (Johnson, “the stored 3D image may undergo a rigid transformation to generate 2D DRR images (simulated 2D images),” Para [0081]), said position of the model of the surgical tool being called 'projected localized position' (Johnson, “ultimately register the 3D image data to the intra-operative 2D image data,” Para [0081]),
iv. determining a real position of the surgical tool on the 2D X-ray image (Isaacs, “if the location and position of the instrument is known from the tracking data and 3D model, then the location and position of the instrument on the 2D image can be corrected,” Para [0074]),
(c) comparing the safety criterion with a threshold (Issacs, “if the new image matches the generated image (both tool and anatomy) within a given tolerance then the surgery can proceed,” Para [0087]), and
(d) if the safety criterion is greater than the threshold (“if the new image matches the generated image (both tool and anatomy)”), determining that there is an error in execution of the planned trajectory (Isaacs, “If the match is poor, the surgery can be stopped (in the case of automated surgery) and/or recalibration can take place,” Para [0087], where the trajectory of the tool can be tracked (see para. [0088] with the “catheter”).
And Tolkowsky teaches:
i. synchronously localizing the surgical tool (“tool”) and the patient tracker (“bone-level entry point 412,” Para [0865]) to determine the position of the surgical tool relative to said 3D image at the time of the 2D X-ray image acquisition (“a 2D x-ray image acquired intra-procedurally… The 2D x-ray image is registered with the 3D image data such that the planning data is projected upon the 2D X-Ray image. FIG. 32C demonstrates that a tool 416 inserted (seen as a dark elongated shaft) corresponds in its direction to planned insertion line,” Para [0865]).
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Isaacs is considered to be analogous to the claimed invention because they are in the same field of planned autonomous surgeries. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Isaacs into Johnson for the benefits of accurate object location in multiple dimensions.
Tolkowsky is considered to be analogous to the claimed invention because they are in the same field of planned surgery using 2D and 3D image registration. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the teachings of Tolkowsky into Johnson for the benefit of improved correspondence between the planned (3D) image data and the current, intra-op image data.
Regarding claim 2, the rejection of claim 1 is incorporated herein. Johnson in view of Isaacs and Tolkowsky teach the method of claim 1, and Johnson further teaches wherein steps (a) and (b) are repeated several times all along the autonomous manipulation of the surgical tool by the robotic system (“system may then use the object locations in different coordinate systems (e.g., both the CT (or MM) and x-ray coordinate systems) to determine areas of interest on the images so that the iterative process starts on and focuses within this region in attempting to match simulated and actual images,” Para [0074]).
Regarding claim 4, the rejection of claim 1 is incorporated herein. Johnson in view of Isaacs and Tolkowsky teach the method of claim 1, and Johnson further teaches wherein the localization of the surgical tool in step (i) is determined by a tracker rigidly fixed to said surgical tool (“Instrument tool 608 may be attached to a tracking array 612 including one or more tracking markers (such as markers 118) and have an associated trajectory 614,” Para [0047]).
Regarding claim 5, the rejection of claim 1 is incorporated herein. Johnson in view of Isaacs and Tolkowsky teach the method of claim 1, and Johnson further teaches wherein the localization of the surgical tool in step (i) is determined by a tracker rigidly fixed to a part of the robotic system (“The robotic surgical system 100 can comprise one or more tracking markers 118,” Para [0033]) and a known kinematic model of the robotic system between said tracker and the surgical tool at the time of localization (“system 100 can use tracking information collected from each of the marked objects to calculate the orientation and location, for example,… the end effector 112… and the relative position of the patient 210,” Para [0033]).
Regarding claim 6, the rejection of claim 1 is incorporated herein. Johnson in view of Isaacs and Tolkowsky teach the method of claim 1, and Johnson further teaches wherein step (a) comprises computing at least one optimal orientation of the X-ray imaging system relative to either the surgical tool or the anatomical structure (“Parameters of the cost function that could be adjusted between iterations may include the position and orientation of… the x-ray source, angles of x-ray paths relative to the 3D volume,” Para [0004]) and acquiring the at least one 2D X-ray image with said at least one optimal orientation of the X-ray imaging system (“The DRRs are generated iteratively until they match the actual 2D x-ray images; that is, until the features or intensity characteristics of the bone structures on the DRRs and actual radiographs overlap within some tolerance,” Para [0004]).
Regarding claim 7, the rejection of claim 1 is incorporated herein. Johnson in view of Isaacs and Tolkowsky teach the method of claim 1, and Johnson further teaches wherein each one of steps (a) through (b) (“iterative process”) involves at least two 2D X-ray images (“The system may then use the object locations in different coordinate systems (e.g., both the CT (or MM) and x-ray coordinate systems) to determine areas of interest on the images so that the iterative process starts on and focuses within this region in attempting to match simulated and actual images,” Para [0074]) and step (b) comprises computing a global safety criterion (“match”) as a function of each similarity information computed for each 2D X-ray image (“the iterative process starts on and focuses within this region in attempting to match simulated and actual images,” Para [0074]).
Regarding claim 8, the rejection of claim 1 is incorporated herein. Johnson in view of Isaacs and Tolkowsky teach the method of claim 1, and Johnson further teaches wherein said function is a maximum function (“the positioning of one or more tracking markers 118 on end effector 112 can maximize the accuracy of the positional measurements by serving to check or verify the position of end effector 112,” Para [0034]).
Regarding claim 13, the rejection of claim 1 is incorporated herein. Johnson in view of Isaacs and Tolkowsky teach the method of claim 1, and Isaacs further teaches wherein the at least one 2D X-ray acquisition is performed with a collimation of the x-ray beam (using a “collimator”) on the region of interest around the anatomical structure (“a collimator may be used to limit the field of exposure to the area 300 which presumably contains the critical anatomy to be visualized by the surgeon or medical personnel,” Para [0094]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Isaacs into Johnson and Tolkowsky for the benefits of reduced incident radiation dosage to the patient.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US-20170020630-A1) in view of Tolkowsky et al. (US-20210386480-A1) and Isaacs et al. (US-20160117823-A1) as applied to claim 1, and further in view of Crawford et al. (US-20130345718-A1).
Regarding claim 3, the rejection of claim 1 ais incorporated herein. Johnson in view of Isaacs and Tolkowsky teach the method according to claim 15, but fail to teach the following limitations as further claimed.
Crawford teaches wherein wherein step (a) and (b) are first applied to at least two 2D X-ray images (“two images”), and then applied to only one 2D X-ray image (“the x-axis, y-axis, and z-axis coordinates of the markers 730 can be found on the two images, and the positions of the anatomy and planned trajectories relative to these reference points can be related to these reference positions,” Para [0401]).
Crawford is considered to be analogous to the claimed invention because they are in the same field autonomous robot surgery. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Crawford into Johnson, Tolkowsky, and Isaacs for the benefits of quickening the matching (safety criterion) process of medical imaging images.
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US-20170020630-A1) in view of Tolkowsky et al. (US-20210386480-A1) and Isaacs et al. (US-20160117823-A1) as applied to claim 1, and further in view of Hayashi (US-20040081271-A1).
Regarding claim 9, the rejection of claim 1 is incorporated herein. Johnson in view of Isaacs and Tolkowsky teach the limitations of claim 1, but fail to teach the following limitations as further claimed. Hayashi, however, further teaches wherein the registration process in step (ii) is initiated by a known estimation of a position (using a “rotary encoder”) of the X-ray imaging system (“C-arm”; “An arm stand 22 is equipped with… a position sensor, such as a rotary encoder, that detects the position of the C-arm 21,” (Para [0035]).
Hayashi is considered to be analogous to the claimed invention because they are in the same field of x-ray image systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Hayashi into Johnson, Tolkowsky, and Isaacs for the benefits of knowing the precise location of the imaging system in relation to the patient.
Regarding claim 10, the rejection of claim 9 is incorporated herein. Hayashi in the combination teaches the method of claim 9, and further teaches wherein said position of the X-ray imaging system is determined (using a “rotary encoder”) by a tracker rigidly attached to said X-ray imaging system (“An arm stand 22 is equipped with… a position sensor, such as a rotary encoder, that detects the position of the C-arm 21,” Para [0035], where the arm stand 22 is a part of the imaging system 10 (Fig 1).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Hayashi into Johnson, Tolkowsky, and Isaacs for the benefits of knowing the precise location of the imaging system in relation to the patient.
Regarding claim 11, the rejection of claim 9 is incorporated herein. Hayashi in the combination teaches the method of claim 9, and further teaches wherein the X-ray imaging system is motorized (“C-arm”), and said position of said motorized X-ray imaging system is determined by its motor encoders values (C-arm imaging systems are well known in the art to be moveable; “An arm stand 22 is equipped with… a position sensor, such as a rotary encoder, that detects the position of the C-arm 21,” Para [0035], where the arm stand 22 is a part of the imaging system 10 (Fig 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Hayashi into Johnson, Tolkowsky, and Isaacs for the benefits of knowing the precise location of the imaging system in relation to the patient.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US-20170020630-A1) in view of Tolkowsky et al. (US-20210386480-A1) and Isaacs et al. (US-20160117823-A1) as applied to claim 1, and further in view of Hussain et al. (US-20180064497-A1).
Regarding claim 12, the rejection of claim 1 is incorporated herein. Johnson in view of Isaacs and Tolkowsky teach the method of claim 1, but fail to teach the following limitations as further claimed. Hussain, however, further teaches (Fig. 15C) wherein the similarity information is a distance (Fig. 15C,
D
F
) between the longitudinal axis corresponding to the real position of the surgical tool (Fig. 15C, 1016) and the longitudinal axis corresponding to its projected localized position on a plane perpendicular to a predetermined point of interest along the planned trajectory of the surgical tool (Fig. 15C, 616) (“when a detected distance DD from tool centerline 616 to single marker 1018 matches the known fixed distance DF from the guide tube centerline 1016 to the single marker 1018,” Para [0118]).
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Hussain is considered to be analogous to the claimed invention because they are both in the same field of autonomous robot surgery. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Hussain into Johnson, Tolkowsky, and Isaacs for the benefits of lack of error from the surgical tool during an autonomous surgery.
Allowable Subject Matter
Claims 14-27 are allowable on account of the prior art failing to anticipate or render obvious the limitations of the allowable subject matter. The primary reason of allowance for claim 14 is the specific implementation of the 2D/2D x-ray image registration method for finding a safety criterion between the two 2D x-ray images in combination with the determination of a safety criterion between a 2D x-ray image and 2D image projection from a 3D planned trajectory. 2D/2D x-ray image registration in surgery is not a new technique, such as in US Patent Application US-20150125033-A1 (Murphy et al.), but in combination with other claimed elements, the technique is a novel method. Claims 15-26 depend on claim 14 and are thus allowable. Claim 27 is a corresponding claim to claim 14, which is thus allowable.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Gou et al. (US-20220218298-A1) teaches a method for 2D-2D image registration in the context of surgery, where one of the 2D images was converted from 3D.
Popovic (US-20120294498-A1) teaches real-time tracking of surgical tools relative to pre-operative and intra-operative image registration.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL A OMETZ whose telephone number is (571)272-2535. The examiner can normally be reached 6:45am-4:00pm ET Monday-Thursday, 6:45am-1:00pm ET every other Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vu Le can be reached at 571-272-7332. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rachel Anne Ometz/Examiner, Art Unit 2668 2/10/26
/VU LE/Supervisory Patent Examiner, Art Unit 2668