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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/05/2026 has been entered.
Response to Amendment
This office action is in response to the communications filed on 01/05/2026 and 02/05/2026, concerning Application No. 17/193,570. The amendments to the claims filed on 01/05/2026 are acknowledged. Presently, claims 1-5, 12, 14-15, 17, and 21-29 remain pending.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 12, 14-15, 17, and 21-29 are rejected under 35 U.S.C. 103 as being unpatentable over Mire et al. (US 2004/0171924 A1, of record, hereinafter Mire) in view of Casas et al. (US 2020/0390503 A1, of record, hereinafter Casas), further in view of Hight et al. (US 2017/0000675 A1, of record, hereinafter Hight), and even further in view of Drake (US 2016/0193099 A1, of record, hereinafter Drake).
Regarding independent claims 1, 12, and 27, Mire discloses a method of positioning an emitter and a receiver of an imaging device relative to an area of interest of a patient supported on a surgical frame (see, e.g., Para. [0048], “The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22”, and Para. [0056], “the OR table 56 positioned below the patient 14”), the method comprising:
providing the surgical frame (OR table 56) including: a first end; an opposite second end; and a mid-longitudinal axis extending through the first end and the opposite second end (see, e.g., Para. [0056], “the OR table 56 positioned below the patient 14”, and Fig. 1);
identifying the area of interest of the patient prior to surgery (see, e.g., Para. [0054], “image datasets from hybrid modalities, such as positron emission tomography (PET) combined with CT, or single photon emission computer tomography (SPECT) combined with CT, could also provide functional image data superimposed onto anatomical data to be used to confidently reach target sights within the areas of interest”, and Para. [0009], “The imaging device is operable to image the selected portion of the anatomy prior to the procedure”);
prior to the surgery, placing a fourth optical navigation marker on skin of the patient adjacent the area of interest (see, e.g., Para. [0060], “The dynamic reference frame 54 can be affixed to the patient's skin, by way of a stick-on adhesive patch. The dynamic reference frame 54 may also be removably attachable to fiducial markers 60 also positioned on the patient's body”, and Claim 1, “said imaging device is operable to generate image data of the selected portion of the anatomy prior to the procedure”);
positioning the patient on the surgical frame in the patient-receiving area (see, e.g., Para. [0056], “the OR table 56 positioned below the patient 14”, and Fig. 1, where the patient 14 is shown to be positioned on the OR table 56 when viewing the figure);
accessing an uninterrupted portion of the patient-receiving area on the one lateral side of the patient (see, e.g., Para. [0056], “the OR table 56 positioned below the patient 14”, and Fig. 1, where the patient 14 is shown to be positioned on the OR table 56 when viewing the figure, and where an accessible/uninterrupted portion of the lateral side of the patient 14 is shown where the OR table 56 is not covering that lateral side of the patient 14);
determining ratio(s) between respective distances ("the transmitter coil array 46 may be positioned at the x-ray source 20, within the OR table 56 positioned below the patient 14, on siderails associated with the OR table 56, or positioned on the patient 14 in proximity to the region being navigated, such as by the patient's pelvic area" [0056]; "The tracking system 44 essentially works by positioning the transmitter coil array 46 adjacent to the patient space to generate a low-energy magnetic field generally referred to as a navigation field." [0068]; "the C-arm 18 may move in the direction of arrow 32 or rotate about the long axis of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged." [0049]; as it is interpreted as ratio determined from measured physical distances between the transmitter coils (considered markers or reference points) and a dimension, due to the distance being in an XYZ coordinate system, using capture images in anterior or lateral view);
measuring a first physical distance between two reference points on the surgical frame ("the transmitter coil array 46 may be positioned at the x-ray source 20, within the OR table 56 positioned below the patient 14, on siderails associated with the OR table 56, or positioned on the patient 14 in proximity to the region being navigated, such as by the patient's pelvic area" [0056]; "The tracking system 44 essentially works by positioning the transmitter coil array 46 adjacent to the patient space to generate a low-energy magnetic field generally referred to as a navigation field." [0068]; as it is interpreted as physical distances are being measured using transmitter coil array 46 as points within the tracking system 44. These transmitter coil array 46 may be located on surgical table, which can be considered a patient support or surgical frame);
determining a second physical distance between reference points on the surgical frame and the fourth optical navigation marker based on the determined ratio and the measured first physical distance ("the dynamic reference frame may include a plurality of coils placed in a known geometry and distance from each other" [0066]; "Thus the system may both determine a location of the dynamic reference frame 54 and the relative location of each of the plurality of EM coils in the dynamic reference frame 54." [0066]; "The points that are selected to perform registration are the fiducial arrays or landmarks 60. Again, the landmarks or fiducial points 60 are identifiable on the images and identifiable and accessible on the patient 14." [0069]; as it is interpreted as using measured known physical distance between markers and the tracking system, which can be considered a ratio of the known X, Y, and Z coordinates of the markers, where the location of the reference frame is located);
determining a physical location of the fourth optical navigation marker on the skin of the patient based on the determined second physical distance ("the dynamic reference frame may include a plurality of coils placed in a known geometry and distance from each other" [0066]; "Thus the system may both determine a location of the dynamic reference frame 54 and the relative location of each of the plurality of EM coils in the dynamic reference frame 54." [0066]; "The points that are selected to perform registration are the fiducial arrays or landmarks 60. Again, the landmarks or fiducial points 60 are identifiable on the images and identifiable and accessible on the patient 14." [0069]; as it is interpreted as using measured known physical distance between markers and the tracking system, which can be considered a ratio of the known X, Y, and Z coordinates of the markers, where the location of the reference frame (markers) is located);
moving the emitter and the receiver into position relative to the physical location of the fourth optical navigation marker ("The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22" [0048]; "the C-arm 18 may move in the direction of arrow 32 or rotate about the long axis of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged." [0049]; as it is interpreted as the C-arm, comprising of the emitter and receiver are moved to the area of interest, this is where the reference frame (markers) is located); and
initiating use of an electromagnetic imaging technique using the emitter and the receiver to produce a desired image of the area of interest ("A controller 30 captures the x-ray images received at the receiving section 22 and stores the images for later use." [0049]).
Mire does not specifically disclose [1] a main beam portion having a first arm portion adjacent the first end of the surgical frame that extends in a first transverse direction laterally and downwardly relative to the mid-longitudinal axis, a second arm portion adjacent the opposite second end of the surgical frame that extends in a second transverse direction laterally and downwardly relative to the mid-longitudinal axis, and a single and offset elongated beam portion extending between the first arm portion and the second arm portion; [2] a first vertical support portion for supporting the first arm portion; and a second vertical support portion for supporting the second arm portion; [3] wherein the first arm portion and the second arm portion each including a first end portion and a second end portion, the mid-longitudinal axis extending through the first end portions, the second end portions being spaced from the mid-longitudinal axis, the single and offset elongated beam being attached between the second end portions, and the first arm portion, the second arm portion, and the single and offset elongated beam portion defining a patient-receiving area for receiving a patient and being uninterrupted by the main beam portion along one lateral side of the patient supported on the surgical frame; [4] attaching a first optical navigation marker to the first arm portion; attaching a second optical navigation marker to the second arm portion; attaching a third optical navigation marker to the first vertical support portion; [5] rotating the main beam portion about an axis of rotation extending through the first ends of the first arm portion and the second arm portion by rotating the first arm portion and the second arm portion; [6] capturing a side-elevational view image of the patient positioned on the surgical frame using an optical camera system; [7] measuring a first distance between the first optical navigation marker and the second optical navigation marker in the captured side-elevational view image; [8] measuring a second distance between the third optical navigation marker and fourth optical navigation marker in the captured side-elevational view image; [9] determining a first ratio between the first distance and the second distance in the captured side-elevational view image; [10] measuring the first physical distance that is specifically between the first optical navigation marker and the second optical navigation marker; and [11] determining the second physical distance that is specifically between the third optical navigation marker and the fourth optical navigation marker based on the determined first ratio and the measured first physical distance.
However, in the same field of endeavor, the system of surgical navigation and imaging of Casas teaches a C-arm imaging device (“The tracking system 40 may include an image calibration system and/or a ground truth reference device attached to the imaging device 20” [0046]; See Fig. 1 of Casas provided below), and the method comprising:
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Fig. 1 of Casas: surgery navigation system
capturing a side-elevational view image of the patient positioned on the surgical frame using an optical camera system ("The position sensors 16 may include cameras, such as CCD cameras, CMOS cameras, and/or optical image cameras, magnetic sensors, radio frequency sensors, or any other sensors adapted to detect and/or track the position of the fiducials 14. […] The cameras may be adapted to capture a view of the fiducials 14 from a different position" [0043]; as it is interpreted as the image of the patient captured on surgical frame, in this case to track fiducials of area of interest);
measuring a first distance between the first optical navigation marker and the second optical navigation marker in the captured side-elevational view image; measuring a second distance between the third optical navigation marker and the fourth optical navigation marker in the captured side-elevational view image; and determining a first ratio between the first distance and the second distance in the captured side-elevational view image (“The fiducials 14 may include reflective elements and/or LED active elements for tracking using one or more sensors. For example, the elements may be tracked using stereoscopic infrared sensors, operating in concert, for sensing, storing, processing and/or outputting data relating to (“tracking”) position and orientation of the fiducials 14” [0042]; "The position sensors 16 may include cameras, such as CCD cameras, CMOS cameras, and/or optical image cameras, magnetic sensors, radio frequency sensors, or any other sensors adapted to detect and/or track the position of the fiducials 14." [0043]; as it is interpreted as the images of the patient captured on surgical frame, in this case to track fiducials of area of interest; and as it is interpreted as the tracking of the position and orientation of the respective fiducials 14 corresponds to measuring the claimed first and second distances between the respective fiducials/markers, which can be considered a ratio of such distances).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Mire by including [6] capturing a side-elevational view image of the patient positioned on the surgical frame using an optical camera system; [7] measuring a first distance between the first optical navigation marker and the second optical navigation marker in the captured side-elevational view image; [8] measuring a second distance between the third optical navigation marker and fourth optical navigation marker in the captured side-elevational view image; [9] determining a first ratio between the first distance and the second distance in the captured side-elevational view image, as taught by Casas, in order to enable a more minimally invasive type of procedure to be performed to thereby reduce the overall recovery time and cost of the procedure ([0004] of Mire).
Mire modified by Casas still does not disclose [1] a main beam portion having a first arm portion adjacent the first end of the surgical frame that extends in a first transverse direction laterally and downwardly relative to the mid-longitudinal axis, a second arm portion adjacent the opposite second end of the surgical frame that extends in a second transverse direction laterally and downwardly relative to the mid-longitudinal axis, and a single and offset elongated beam portion extending between the first arm portion and the second arm portion; [2] a first vertical support portion for supporting the first arm portion; and a second vertical support portion for supporting the second arm portion; [3] wherein the first arm portion and the second arm portion each including a first end portion and a second end portion, the mid-longitudinal axis extending through the first end portions, the second end portions being spaced from the mid-longitudinal axis, the single and offset elongated beam being attached between the second end portions, and the first arm portion, the second arm portion, and the single and offset elongated beam portion defining a patient-receiving area for receiving a patient and being uninterrupted by the main beam portion along one lateral side of the patient supported on the surgical frame; [4] attaching a first optical navigation marker to the first arm portion; attaching a second optical navigation marker to the second arm portion; attaching a third optical navigation marker to the first vertical support portion; [5] rotating the main beam portion about an axis of rotation extending through the first ends of the first arm portion and the second arm portion by rotating the first arm portion and the second arm portion; [10] measuring the first physical distance that is specifically between the first optical navigation marker and the second optical navigation marker; and [11] determining the second physical distance that is specifically between the third optical navigation marker and the fourth optical navigation marker based on the determined first ratio and the measured first physical distance.
However, in the same field of endeavor of surgical navigation and imaging, Hight discloses providing the surgical frame (person support apparatus 100/304/324/504) including: a first end; an opposite second end; a mid-longitudinal axis extending through the first end and the opposite second end; and a main beam portion (see, e.g., Fig. 6A for example, where the claimed surgical frame includes a first end corresponding to the disclosed end 304 as shown in the figure, a second end corresponding to the disclosed end 308 as shown in the figure, and a main beam portion corresponding to the disclosed central portion 310 as shown in the figure; also see Figs. 2A-4B and 6B-7B for similar configurations of a surgical frame/table) having a first arm portion adjacent the first end of the surgical frame that extends in a first transverse direction laterally and downwardly relative to the mid-longitudinal axis, a second arm portion adjacent the opposite second end of the surgical frame that extends in a second transverse direction laterally and downwardly relative to the mid-longitudinal axis, and a single and offset elongated beam portion extending between the first arm portion and the second arm portion (see, e.g., Fig. 2A for example, where the main beam portion has a first arm portion that is on one end (such as upper segment 140) of the support apparatus/frame, a second arm portion that is on the other opposite end (such as leg segment 160) of the support apparatus/frame, and an offset beam (such as torso segment 150/repositioning assembly 170) that extends between the two end portions, and Para. [0046-0047], “The support deck 130 is coupled to the longitudinal frame 126 and includes one or more segments that are positioned between the forward column 122 and the rearward column 124 in the longitudinal direction to support a patient on the person support apparatus 100. In the embodiment depicted in FIG. 2A, the support deck 130 includes an upper segment 140 positioned at the head end of the person support apparatus 100 which supports the upper body and/or the head and arms of a patient. The support deck 130 further includes a leg segment 160 positioned at the foot end of the person support apparatus 100 which supports the lower body and/or the legs of a patient. The support deck 130 includes a torso segment 150 that is positioned between the upper segment 140 and the leg segment 160 in the longitudinal direction which supports a torso and/or a mid-section of a patient. […] In some embodiments, the upper segment 140, the torso segment 150, and/or the leg segment 160 may include contoured or shaped surfaces that accommodate a patient”, where the different portions of the support frame may have contoured/shaped surfaces such that the portions extend in different transverse directions laterally and downwardly),
wherein the first arm portion and the second arm portion each including a first end portion and a second end portion; the mid-longitudinal axis extending through the first end portions; the second end portions being spaced from the mid-longitudinal axis; the single and offset elongated beam being attached between the second end portions; and the first arm portion, the second arm portion, and the single and offset elongated beam portion defining a patient-receiving area for receiving a patient and being uninterrupted by the main beam portion along one lateral side of the patient supported on the surgical frame (see, e.g., Para. [0046-0047], and Fig. 2A for example, where the main beam portion has the first arm portion that is on one end (such as upper segment 140) of the support apparatus/frame and the second arm portion that is on the other opposite end (such as leg segment 160) of the support apparatus/frame, and where each of the upper segment 140 and the leg segment 160 have a plurality of sections such that the segments 140, 160 each have a portion that is aligned with the mid-longitudinal axis (i.e., the center portions) and a different portion that is spaced apart from the mid-longitudinal axis (i.e., the side portions), and where the main beam portion has the offset beam (such as torso segment 150/repositioning assembly 170) that extends between the two end portions);
attaching a first optical navigation marker to the first arm portion; attaching a second optical navigation marker to the second arm portion; attaching a third optical navigation marker to the first vertical support portion (“FIG. 6B schematically depicts an example system 320 including an imaging device 322 and a person support apparatus 324. As discussed above with respect to FIGS. 1A and 1B, at least one of the imaging device 322 and the persons support apparatus 324 includes a sensor 326 for detecting one or more optical markers 332 disposed on the person support apparatus 324” [0070], “The person support apparatus 324, in this embodiment, includes one or more optical markers 332 disposed on the apparatus 324. The optical markers 332, for example, may include light reflectors (passive markers such as retroreflectors) or light emitters (active markers such as light emitting diodes (LEDs))” [0073], and Fig. 6B, where markers 332 are shown to be positioned on two opposing ends of the main beam/central portion of the support apparatus/frame; “The imaging device 502 and the person support apparatus 504, in this embodiment, include one or more optical markers 512 disposed on the device 502 and person support apparatus 504. In the particular embodiment shown in FIG. 7A, for example, the optical markers 512 are disposed on a portion of a C-arm of the imaging device 502 and on a central portion 510 of the person support apparatus 504. The optical markers 512, however, may be disposed in other location(s) on the imaging device 502 and/or the person support apparatus 504. The optical markers 512, for example, may include light reflectors (passive markers such as retroreflectors) or light emitters (active markers such as light emitting diodes (LEDs))” [0079], and Fig. 7A, where markers 512 are shown to be positioned on two opposing ends (one positioned toward end 504, and the other positioned toward end 508) of the main beam/central portion 510 of the support apparatus/frame); and
rotating the main beam portion about an axis of rotation extending through the first ends of the first arm portion and the second arm portion by rotating the first arm portion and the second arm portion (“Referring again to FIG. 2A, the actuator 180 moves the rocker members 176 with respect to the at least one guide 178, the actuator 180 rotates the rocker members 176 about the axis 10 with respect to the primary support frame 120. As the first portion 152 and the second portion 154 of the torso segment 150 are coupled to the rocker members 176, when the rocker members 176 rotate about the axis 10 with respect to the primary support frame 120, the first portion 152 and the second portion 154 of the torso segment 150 rotate about the axis 10 with respect to the primary support frame 120” [0056]; “The person support apparatus 100, and in particular the repositioning assembly 170 of the person support apparatus 100, repositions a patient by rotating the first portion 152 and the second portion 154 of the torso segment 150 about axis 10 with respect to the primary support frame 120” [0059]; “Referring to FIG. 3, to reposition the person support apparatus 100 between the first position and the second position, the actuator 180 moves one of the rocker members 176 and the first portion 152 and/or the second portion 154 of the torso segment 150 that are coupled to the rocker members 176. In particular, the actuator 180 rotates the rocker members 176 and the first portion 152 and the second portion 154 about the axis 10. In the embodiment depicted in FIG. 3, the upper segment 140 is coupled to the first portion 152 of the torso segment 150 such that the upper segment 140 rotates about the axis 10 with the first portion 152 of the torso segment 150” [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Mire modified by Casas by including [1] a main beam portion having a first arm portion adjacent the first end of the surgical frame that extends in a first transverse direction laterally and downwardly relative to the mid-longitudinal axis, a second arm portion adjacent the opposite second end of the surgical frame that extends in a second transverse direction laterally and downwardly relative to the mid-longitudinal axis, and a single and offset elongated beam portion extending between the first arm portion and the second arm portion; [3] wherein the first arm portion and the second arm portion each including a first end portion and a second end portion, the mid-longitudinal axis extending through the first end portions, the second end portions being spaced from the mid-longitudinal axis, the single and offset elongated beam being attached between the second end portions, and the first arm portion, the second arm portion, and the single and offset elongated beam portion defining a patient-receiving area for receiving a patient and being uninterrupted by the main beam portion along one lateral side of the patient supported on the surgical frame; [4] attaching a first optical navigation marker to the first arm portion; attaching a second optical navigation marker to the second arm portion; attaching a third optical navigation marker to the first vertical support portion; and [5] rotating the main beam portion about an axis of rotation extending through the first ends of the first arm portion and the second arm portion by rotating the first arm portion and the second arm portion, as disclosed by Hight. One of ordinary skill in the art would have been motivated to make this modification in order to desirably locate an imaging device relative to a patient and/or to a person support apparatus adapted to support a patient during a medical procedure, as recognized by Hight (see [0006] of Hight).
Further, in a case where the first and second optical navigation markers of Hight are included/positioned on the modified surgical frame of Mire in place of ‘the two reference points’ on the surgical frame of Mire (as set forth above), then the method of Mire modified by Casas and Hight can further include [10] measuring the first physical distance that is specifically between the first optical navigation marker and the second optical navigation marker; and [11] determining the second physical distance specifically between the third optical navigation marker and the fourth navigation marker based on the determined first ratio and the measured first physical distance.
Mire modified by Casas and Hight still does not disclose [2] a first vertical support portion for supporting the first arm portion; and a second vertical support portion for supporting the second arm portion.
However, in the same field of endeavor, the system and patient support apparatus of Drake teaches wherein the surgical frame includes: a first vertical support portion for supporting the first arm portion; and a second vertical support portion for supporting the second arm portion (see re-produced Fig. 1 below which includes first and second lift columns 28 and 22; “first set of leg supports 142 located adjacent a first side of beam 140 and a second set of leg supports 144 located adjacent a second side of beam 140.” [0076]).
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Fig 1 of Drake: patient support apparatus
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Mire modified by Casas and Hight and include wherein the surgical frame includes a first vertical support portion for supporting the first arm portion and a second vertical support portion for supporting the second arm portion, as taught by Drake, because of the increase capability to support a patient's legs in a wider variety of positions (see [0004] of Drake).
Regarding claim 2, Mire modified by Casas, Hight, and Drake discloses the method of claim 1, as set forth above. Mire further discloses wherein diagnosing and determining treatment options for the patient is based on radiographic images generated prior to the surgery ("During the preoperative stages, the various images may be achieved by obtaining a plurality of images of a patient" [0164]; "It will be understood that various images may be acquired of the patient to allow for modeling and planning of a selected procedure as discussed herein." [0161]; "Patient registration is the process of determining how to correlate the position of the instrument 52 on the patient 14 to the position on the diagnostic, pre-acquired, or real-time images." [0069]).
Regarding claim 3, Mire modified by Casas, Hight, and Drake discloses the method of claim 1, as set forth above. Mire further discloses wherein the emitter and the receiver are supported by a C-arm assembly ("The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22" [0048]; also see Fig. 1 provided below),
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Fig 1 of Mire: diagram of a navigation system
the method further comprising: moving the emitter and the receiver in an X-direction, a Y-direction, and a Z-direction of an X, Y, and Z coordinate system via a portion of the C-arm assembly ("The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22" [0048]; "C-arm configuration is used to hold and/or move the imaging system 16, the controller 30 may also control the rotation of the C-arm 18, including the imaging system 16. For example, the C-arm 18 may move in the direction of arrow 32 or rotate about the long axis of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged." [0049]; See Fig. 1; as it is interpreted as moving the c-arm system, which comprises emitter and receiver, moves it in one of the dimensions within the XYZ coordinate system.).
Mire does not teach further comprising moving the emitter and the receiver in an X-direction, a Y-direction, and a Z-direction of an X, Y, and Z coordinate system via articulation of portions of the surgical frame.
However, in the same field of endeavor, system and patient support apparatuses of Drake teaches further comprising moving the emitter and the receiver in an X-direction, a Y-direction, and a Z-direction of an X, Y, and Z coordinate system via articulation of portions of the surgical frame ("Patient support frame 102 includes a beam 140 that extends from rail 118 of first section 110" [0075]; as it is interpreted as the extension of the beam is an articulation of the surgical frame).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Mire modified by Casas, Hight, and Drake and include further comprising moving the emitter and the receiver in an X-direction, a Y-direction, and a Z-direction of an X, Y, and Z coordinate system via articulation of portions of the surgical frame, as taught by Drake, because of the increase capability to support a patient's legs in a wider variety of positions [0004 of Drake].
Regarding claims 4 and 14, Mire modified by Casas, Hight, and Drake discloses the method of claims 3 and 12, respectively, as set forth above. Mire further discloses the C-arm assembly ("C-arm configuration is used to hold and/or move the imaging system 16, the controller 30 may also control the rotation of the C-arm 18, including the imaging system 16." [0049]),
movement of the C-arm assembly relative to the translating beam moving the emitter and the receiver in the X-direction ("The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22" [0048]; "the C-arm 18 may move in the direction of arrow 32 or rotate about the long axis of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged." [0049]; The movement of the c-arm, comprising the emitter and receiver, can move in the X-direction as seen in Fig. 1 and paragraph [0049]), and
moving the emitter and the receiver in the Z-direction (Fig. 1 includes C-arm with x-ray source and receiver which can move in a Z-direction).
Mire does not teach wherein the surgical frame includes a translating beam moveably attached relative the first vertical support portion and the second vertical support portion; and the C-arm assembly being moveably attached relative to the translating beam, and movement of the translating beam relative to the first vertical support portion and the second vertical support portion moving the emitter and the receiver in the Z-direction.
However, in the same field of endeavor, the system and patient support apparatus of Drake teaches a translating beam moveably attached relative the first vertical support portion and the second vertical support portion (Fig. 1 includes beam 140; "beam 140 is coupled to rail 118 for pivoting movement about axis 138" [0075]; "beam 140 is pivotable relative to first section 110 of frame 102 about a second axis that is spaced from and parallel with axis 138." [0079]; First set and second set of leg supports 142, 144 are movable relative to beam 140" [0076]),
the C-arm assembly being moveably attached relative to the translating beam (Fig. 1 includes beam 140; as it is interpreted as the translating beam is part of the surgical frame, which is used to be able image all areas of interest, including moving C-arm assembly), and
movement of the translating beam relative to the first vertical support portion and the second vertical support portion moving the emitter and the receiver in the Z-direction ("hip support 136 and beam 140 are both keyed to the pivot shaft to rotate together relative to first section 110 about axis 138." [0075]; as it is interpreted as the beam 140 is moveable relative to the first section, which comprises the first lift column and first and second rails extending parallel with the longitudinal dimension of the patient support apparatus).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Mire modified by Casas, Hight, and Drake and include wherein the surgical frame includes a translating beam moveably attached relative the first vertical support portion and the second vertical support portion; and the C-arm assembly being moveably attached relative to the translating beam, and movement of the translating beam relative to the first vertical support portion and the second vertical support portion moving the emitter and the receiver in the Z-direction, as taught by Drake, because of the increase capability to support a patient's legs in a wider variety of positions (see [0004] of Drake).
Regarding claims 5 and 15, Mire modified by Casas, Hight, and Drake discloses the method of claims 4 and 14, respectively, as set forth above. Mire further discloses wherein the emitter and the receiver are moveably attached relative to portions of the C-arm assembly ("The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22" [0048]; "C-arm configuration is used to hold and/or move the imaging system 16, the controller 30 may also control the rotation of the C-arm 18, including the imaging system 16." [0049]), and
movement of the emitter and the receiver relative to the portions of the C-arm assembly moving the emitter and the receiver in the Y-direction ("The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22" [0048]; "the C-arm 18 may move in the direction of arrow 32 or rotate about the long axis of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged." [0049]; as it is interpreted as the movement of the c-arm, comprising the emitter and receiver, can move in the Y-direction as seen in Fig 1. and paragraph [0049]).
Regarding claim 21, Mire modified by Casas, Hight, and Drake discloses the method of claim 5, as set forth above. Mire further discloses wherein the measured first physical distance and the determined second physical distance are in the X-direction ("the transmitter coil array 46 may be positioned at the x-ray source 20, within the OR table 56 positioned below the patient 14, on siderails associated with the OR table 56, or positioned on the patient 14 in proximity to the region being navigated, such as by the patient's pelvic area" [0056]; "The tracking system 44 essentially works by positioning the transmitter coil array 46 adjacent to the patient space to generate a low-energy magnetic field generally referred to as a navigation field." [0068]; as it is interpreted as physical distances in the X-direction are being measured using transmitter coil array 46 as points within the tracking system 44. These transmitter coil array 46 may be located on surgical table, which can be considered a patient support or surgical frame).
Mire does not specifically disclose wherein the first distance and the second distance are in the X-direction.
However, in the same field of endeavor, Casas further discloses wherein the first distance and the second distance in the captured side-elevational view image of the optical camera system are in the X-direction (“The fiducials 14 may include reflective elements and/or LED active elements for tracking using one or more sensors. For example, the elements may be tracked using stereoscopic infrared sensors, operating in concert, for sensing, storing, processing and/or outputting data relating to (“tracking”) position and orientation of the fiducials 14” [0042]; "The position sensors 16 may include cameras, such as CCD cameras, CMOS cameras, and/or optical image cameras, magnetic sensors, radio frequency sensors, or any other sensors adapted to detect and/or track the position of the fiducials 14." [0043]; as it is interpreted as the images of the patient captured on surgical frame, in this case to track fiducials of area of interest; and as it is interpreted as the tracking of the position and orientation of the respective fiducials 14 corresponds to measuring the claimed first and second distances between the respective fiducials/markers, which can be considered in the X-direction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Mire modified by Casas, Hight, and Drake and include wherein the first distance and the second distance are in the X-direction, as taught by Casas, in order to enable a more minimally invasive type of procedure to be performed to thereby reduce the overall recovery time and cost of the procedure ([0004] of Mire).
Regarding claims 17 and 22, Mire modified by Casas, Hight, and Drake discloses the method of claims 15 and 21, respectively, as set forth above. Mire further discloses wherein moving the emitter and the receiver into the position relative to the surgical frame and the fourth optical navigation marker comprises moving the emitter and the receiver to the determined location by moving the C-arm assembly relative to the translating beam in the X-direction ("The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22" [0048]; "C-arm configuration is used to hold and/or move the imaging system 16, the controller 30 may also control the rotation of the C-arm 18, including the imaging system 16." [0049]; as it is interpreted as the transmitter coil (fixed reference point on surgical frame) and dynamic reference frame (optical navigation marker on patient) can be used to determine the first physical distance, in the X-direction, and the C-arm moves emitter and receiver that first distance to image area of interest), and
moving the emitter and the receiver relative to the portions of the C-arm assembly in the Y-direction ("The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22" [0048]; "the C-arm 18 may move in the direction of arrow 32 or rotate about the long axis of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged." [0049]; as it is interpreted as the movement of the c-arm, comprising the emitter and receiver, can move in the Y-direction as seen in Fig 1. and paragraph [0049]).
Regarding claims 23-24, 25-26, and 28-29, Mire modified by Casas, Hight, and Drake discloses the method of claims 22, 17, and 27, respectively, as set forth above. Mire further discloses determining ratio(s) between respective distances ("the transmitter coil array 46 may be positioned at the x-ray source 20, within the OR table 56 positioned below the patient 14, on siderails associated with the OR table 56, or positioned on the patient 14 in proximity to the region being navigated, such as by the patient's pelvic area" [0056]; "The tracking system 44 essentially works by positioning the transmitter coil array 46 adjacent to the patient space to generate a low-energy magnetic field generally referred to as a navigation field." [0068]; "the C-arm 18 may move in the direction of arrow 32 or rotate about the long axis of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged." [0049]; as it is interpreted as ratio determined from measured physical distances between the transmitter coils (considered markers or reference points) and a dimension, due to the distance being in an XYZ coordinate system, using capture images in anterior or lateral view);
measuring a third/fifth physical distance between two reference points in the Y-direction ("the transmitter coil array 46 may be positioned at the x-ray source 20, within the OR table 56 positioned below the patient 14, on siderails associated with the OR table 56, or positioned on the patient 14 in proximity to the region being navigated, such as by the patient's pelvic area" [0056]; "The tracking system 44 essentially works by positioning the transmitter coil array 46 adjacent to the patient space to generate a low-energy magnetic field generally referred to as a navigation field." [0068]; as it is interpreted as physical distances are being measured using transmitter coil array 46 as points within the tracking system 44. These transmitter coil array 46 may be located on surgical table, which can be considered a patient support or surgical frame);
determining a fourth/sixth physical distance between two reference points in the Y-direction by applying the second ratio to the measured third physical distance ("the dynamic reference frame may include a plurality of coils placed in a known geometry and distance from each other" [0066]; "Thus the system may both determine a location of the dynamic reference frame 54 and the relative location of each of the plurality of EM coils in the dynamic reference frame 54." [0066]; "The points that are selected to perform registration are the fiducial arrays or landmarks 60. Again, the landmarks or fiducial points 60 are identifiable on the images and identifiable and accessible on the patient 14." [0069]; as it is interpreted as using measured known physical distance between markers and the tracking system, which can be considered a ratio of the known X, Y, and Z coordinates of the markers, the location of the reference frame is located); and
moving the emitter and the receiver into the position relative to the third optical navigation marker by moving the emitter and the receiver to a physical location that is the determined fourth physical distance in the Y-direction from the fourth optical navigation marker ("The imaging device 16 may be a fluoroscopic imaging device that is incorporated into a C-arm configuration that includes a moveable C-arm 18, an x-ray source 20, an x-ray receiving section 22" [0048]; "the C-arm 18 may move in the direction of arrow 32 or rotate about the long axis of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged." [0049]; as it is interpreted as the C-arm, comprising of the emitter and receiver are moved to the area of interest, this is where the reference frame (markers) is located).
Mire does not specifically disclose [1] attaching a fourth/fifth optical navigation marker to one of the first vertical support portion and the second vertical support portion adjacent the translating beam; and [2] measuring a third distance between the fourth optical navigation marker and a second one of the first optical navigation marker and the second optical navigation marker in the Y-direction in the captured side-elevational view image, and measuring a fourth distance between the fourth optical navigation marker and the third optical navigation marker in the Y-direction in the captured side-elevational view image to specifically determine a second ratio between the third distance and the fourth distance in the captured side-elevational view image.
However, in the same field of endeavor, Casas discloses measuring distances between respective optical navigation markers in the captured side-elevational view image to specifically determine ratios between the measured distances in the captured side-elevational view image (“The fiducials 14 may include reflective elements and/or LED active elements for tracking using one or more sensors. For example, the elements may be tracked using stereoscopic infrared sensors, operating in concert, for sensing, storing, processing and/or outputting data relating to (“tracking”) position and orientation of the fiducials 14” [0042]; "The position sensors 16 may include cameras, such as CCD cameras, CMOS cameras, and/or optical image cameras, magnetic sensors, radio frequency sensors, or any other sensors adapted to detect and/or track the position of the fiducials 14." [0043]; as it is interpreted as the images of the patient captured on surgical frame, in this case to track fiducials of area of interest; and as it is interpreted as the tracking of the position and orientation of the respective fiducials 14 corresponds to measuring the claimed first and second distances between the respective fiducials/markers, which can be considered a ratio of such distances).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Mire modified by Casas, Hight, and Drake by including [2] measuring distances between respective optical navigation markers in the captured side-elevational view image to specifically determine ratios between the measured distances in the captured side-elevational view image, as taught by Casas, in order to enable a more minimally invasive type of procedure to be performed to thereby reduce the overall recovery time and cost of the procedure ([0004] of Mire).
Mire modified by Casas still does not disclose [1] attaching a fourth/fifth optical navigation marker to one of the first vertical support portion and the second vertical support portion adjacent the translating beam.
However, in the same field of endeavor of surgical navigation and imaging, Hight discloses attaching a fourth/fifth optical navigation marker (optical markers 332/512) to one of the first vertical support portion and the second vertical support portion adjacent the translating beam (“FIG. 6B schematically depicts an example system 320 including an imaging device 322 and a person support apparatus 324. As discussed above with respect to FIGS. 1A and 1B, at least one of the imaging device 322 and the persons support apparatus 324 includes a sensor 326 for detecting one or more optical markers 332 disposed on the person support apparatus 324” [0070], “The person support apparatus 324, in this embodiment, includes one or more optical markers 332 disposed on the apparatus 324. The optical markers 332, for example, may include light reflectors (passive markers such as retroreflectors) or light emitters (active markers such as light emitting diodes (LEDs))” [0073], and Fig. 6B, where markers 332 are shown to be positioned on two opposing ends of the main beam/central portion of the support apparatus/frame; “The imaging device 502 and the person support apparatus 504, in this embodiment, include one or more optical markers 512 disposed on the device 502 and person support apparatus 504. In the particular embodiment shown in FIG. 7A, for example, the optical markers 512 are disposed on a portion of a C-arm of the imaging device 502 and on a central portion 510 of the person support apparatus 504. The optical markers 512, however, may be disposed in other location(s) on the imaging device 502 and/or the person support apparatus 504. The optical markers 512, for example, may include light reflectors (passive markers such as retroreflectors) or light emitters (active markers such as light emitting diodes (LEDs))” [0079], and Fig. 7A, where markers 512 are shown to be positioned on two opposing ends (one positioned toward end 504, and the other positioned toward end 508) of the main beam/central portion 510 of the support apparatus/frame).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Mire modified by Casas, Hight, and Drake by including [1] attaching a fourth/fifth optical navigation marker to one of the first vertical support portion and the second vertical support portion adjacent the translating beam, as disclosed by Hight. One of ordinary skill in the art would have been motivated to make this modification in order to desirably locate an imaging device relative to a patient and/or to a person support apparatus adapted to support a patient during a medical procedure, as recognized by Hight (see [0006] of Hight).
Response to Arguments
Applicant's arguments, see Remarks filed 01/05/2026, have been fully considered but they are not persuasive.
Regarding Mire (US 2004/0171924 A1) in view of Cases (US 2020/0390503 A1), Hight (US 2017/0000675 A1), and Drake (US 2016/0193099 A1), Applicant argues that the Office Action has not established that the cited references disclose each and every feature recited in amended claim 1. Specifically, Applicant argues that the Office Action has not established that the cited references disclose at least: “measuring a first distance between the first optical navigation marker and the second optical navigation marker in the captured side-elevational view image; measuring a second distance between the third optical navigation marker and the fourth optical navigation marker in the captured side-elevational view image; determining a first ratio between the first distance and the second distance in the captured side-elevation view image; measuring a first physical distance between the first optical navigation marker and the second optical navigation marker; determining a second physical distance between the third optical navigation marker and the fourth optical navigation marker based on the determined first ratio and the measured first physical distance; [and] determining a physical location of the fourth optical navigation marker on the skin of the patient based on the determined second physical distance”, as recited in currently amended claim 1.
Examiner respectfully disagrees and emphasizes that the combination of Mire, Cases, Hight, and Drake does disclose each and every feature of the independent claims 1, 12, and 27, as set forth above. Specifically, Examiner emphasizes that:
[1] Mire discloses determining ratio(s) between respective distances ("the transmitter coil array 46 may be positioned at the x-ray source 20, within the OR table 56 positioned below the patient 14, on siderails associated with the OR table 56, or positioned on the patient 14 in proximity to the region being navigated, such as by the patient's pelvic area" [0056]; "The tracking system 44 essentially works by positioning the transmitter coil array 46 adjacent to the patient space to generate a low-energy magnetic field generally referred to as a navigation field." [0068]; "the C-arm 18 may move in the direction of arrow 32 or rotate about the long axis of the patient 14, allowing anterior or lateral views of the patient 14 to be imaged." [0049]; as it is interpreted as ratio determined from measured physical distances between the transmitter coils (considered markers or reference points) and a dimension, due to the distance being in an XYZ coordinate system, using capture images in anterior or lateral view),
measuring a first physical distance between two reference points on the surgical frame ("the transmitter coil array 46 may be positioned at the x-ray source 20, within the OR table 56 positioned below the patient 14, on siderails associated with the OR table 56, or positioned on the patient 14 in proximity to the region being navigated, such as by the patient's pelvic area" [0056]; "The tracking system 44 essentially works by positioning the transmitter coil array 46 adjacent to the patient space to generate a low-energy magnetic field generally referred to as a navigation field." [0068]; as it is interpreted as physical distances are being measured using transmitter coil array 46 as points within the tracking system 44. These transmitter coil array 46 may be located on surgical table, which can be considered a patient support or surgical frame), and
determining a second physical distance between reference points on the surgical frame and the fourth optical navigation marker based on the determined ratio and the measured first physical distance ("the dynamic reference frame may include a plurality of coils placed in a known geometry and distance from each other" [0066]; "Thus the system may both determine a location of the dynamic reference frame 54 and the relative location of each of the plurality of EM coils in the dynamic reference frame 54." [0066]; "The points that are selected to perform registration are the fiducial arrays or landmarks 60. Again, the landmarks or fiducial points 60 are identifiable on the images and identifiable and accessible on the patient 14." [0069]; as it is interpreted as using measured known physical distance between markers and the tracking system, which can be considered a ratio of the known X, Y, and Z coordinates of the markers, where the location of the reference frame is located);
[2] Mire is then modified by Cases, where Casas discloses measuring a first distance between the first optical navigation marker and the second optical navigation marker in the captured side-elevational view image; measuring a second distance between the third optical navigation marker and the fourth optical navigation marker in the captured side-elevational view image; and determining a first ratio between the first distance and the second distance in the captured side-elevational view image (“The fiducials 14 may include reflective elements and/or LED active elements for tracking using one or more sensors. For example, the elements may be tracked using stereoscopic infrared sensors, operating in concert, for sensing, storing, processing and/or outputting data relating to (“tracking”) position and orientation of the fiducials 14” [0042]; "The position sensors 16 may include cameras, such as CCD cameras, CMOS cameras, and/or optical image cameras, magnetic sensors, radio frequency sensors, or any other sensors adapted to detect and/or track the position of the fiducials 14." [0043]; as it is interpreted as the images of the patient captured on surgical frame, in this case to track fiducials of area of interest; and as it is interpreted as the tracking of the position and orientation of the respective fiducials 14 corresponds to measuring the claimed first and second distances between the respective fiducials/markers, which can be considered a ratio of such distances); and
[3] Mire modified by Casas is then further modified by Hight, where in a case where the first and second optical navigation markers of Hight are included/positioned on the modified surgical frame of Mire in place of ‘the two reference points’ on the surgical frame of Mire (as set forth above), then the method of Mire modified by Casas and Hight can further include measuring the first physical distance that is specifically between the first optical navigation marker and the second optical navigation marker; and determining the second physical distance specifically between the third optical navigation marker and the fourth navigation marker based on the determined first ratio and the measured first physical distance.
Conclusion
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798