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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d).
Information Disclosure Statement
As an initial matter, Applicant is reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this application.
The IDSs filed in the parent claims should be filed in for this application.
Drawings
The drawings filed on August 18, 2025 are accepted.
Claim Objections
Claims 1, 3-8 and 12 are objected to because of the following informalities:
Claims 1, 3, 4, 10, 11 and 20: “the following steps”, “the step” and “the steps” should be corrected to –following steps--, --step--, --steps--.
Appropriate correction is required.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2 and 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Csavoy et al., US 2008/0269602 A1, hereinafter Csavoy, in view of Vesely, US 5,868,673, hereinafter Vesely, further in view of Razzaque et al., US 2009/0226069 A1, hereinafter Razza que .
Claim 1. Csavoy teaches a navigation system for tracking the position of a work target located inside a body, the navigation system comprising:
a trackable device including a frame configured to be secured adjacent to the work target, the frame supporting a plurality of tracking points ([0075]: FIG.3: a flexible sheet or member 120 can include one or more fibers 122. The fiber 122 can include woven fibers; [0077]: the tracking device 124 associated with the sheet 120; FIG.3: multiple tracking device 124 on the sheet 120; and [0076]: the sheet 120 can include a plurality of the tracking devices 124 that can be positioned at selected points) - a frame resulted from the most outer fibers as illustrated in FIG.3; and
a computer-implemented tracking system that is adapted to remotely track the positions of each of the plurality of tracking points relative to a coordinate system ([0079]: the plurality of tracked points can provide information relating to the position of each of the tracking devices 124 on the patient 14; [0031]: the navigation computer and/or processor controller or work station 28) – it is well-known in the art that the information relating to the position is related to a coordinate system.
Csavoy further teaches that the computer processor in the computer-implemented tracking system is adapted to perform the step of
“sensing deformation of the trackable device” ([0087]: the sheets 120, 140 can be flexible enough to substantially conform to a surface contour of the patient 14; and [0079]: the plurality of tracked points can provide information relating to the position of each of the tracking devices 124 on the patient 14. The information can be used for tracking the patient 14, determining the contour of the patient 14) – as the surface of the patient deforms, the sheets would deform accordingly. As the position of each of the tracking devices is obtained, such a system therefore senses a deformation of the trackable device.
Csavoy does not teaches the remaining claimed features associated with the implementation of a navigation routine.
However, in an analogous tracking device configuration and implementation field of endeavor, Vesely explicitly teaches that:
the computer-implemented tracking system (1010) including a computer processor arrangement adapted to implement a navigation routine that includes the following steps:
receiving a preoperative image scan data set of the trackable device (Col.4, ll.55-60: imaging modality system 1014 acquires 2-D, 3-D or 4-D image data sets from an imaging source…to provide a template through or against which th shape, position and movement of instrument being tracked can be displayed),
creating an initial model of the trackable device based on initial locations of a set of the plurality of tracking points in the preoperative image scan data set, the initial model having an initial shape (Col.4, ll.28-31: 3-D tracking system 1012 transforms the multiple distance measurements between all of the transducers 1032, 1034 into XYZ coordinates relative to a referenced axis, as described in detail above; and Col.5, line 18, the original image data set; and Col.6, line 7, the original radiograms),
creating a refined model of the trackable device based on sensed locations of the set of the plurality of tracking points, the refined model having a deformed shape different from the initial shape (Col.5, ll.16-19: Accordingly, warp system 1018 is typically comprised of a matrix transformation routine that maps the deformed geometry onto the original image data set, and distorts it appropriately; Col.4, ll.53-54: XYZ coordinates can be calculated, in reference to some transducer as the origin; and Col.7, ll.1-3: [the external reference transducer 20] will set up a new, changing coordinate frame regardless to what extent the breast tissue is manipulated),
sensing deformation of the trackable device between the initial shape and the deformed shape (Col.5, ll.13-16: a deformation that has occurred in the reference frame between the time that the image data set were acquired and the time that the procedure is to be implemented during surgery), and
calculating a current position of the work target based on the refined model in response to the deformation falling within a maximum error threshold for the work target (Col.4, ll.47-49: A mathematical coordinate transformation can be used to specify exactly how to correct the image set and account for the warping).
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Csavoy employ such features associated with the navigation routine as taught in Vesely for the advantage of “provides a system for performing stereotactic surgery with improved accuracy and comfort”, as suggested in Vesely, Col.2, ll.5-7.
Neither Csavoy nor Vesely teaches that an interoperative image scan data set of the trackable device secured adjacent to the work target is obtained, and based on which the refined model is created.
However, in an analogous deformable model-based tracking and navigation field of endeavor, Razzaque teaches
receiving an interoperative image scan data set of the trackable device secured adjacent to the work target; and creating a refined model of the trackable device based on sensed locations of the set of the plurality of tracking points in the interoperative image scan data set ([0004]: obtaining a first set of imaging data related to the anatomical site and tracking units at the anatomical site and, obtaining a second set of imaging data related to the anatomical site. A deformed version fo the first set of imaging data is then determined based on the relative arrangements of one or more of the tracking units at the time when the first set of imaging data is obtained and when the second set of imaging data is obtained; and [0018]: the image guidance unit 130 may take in the emplacements, such as positions and orientations, of the tracking unit and from that determine an updated model…imaging guidance unit may produce images based on the current ultrasound image data coming from imaging unit and also based on an updated model determined based on the emplacement of tracking unit 145) – to determine an updated model is to “create a refined model” as claimed.
Therefore, it would have been obvious to one of the ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Csavoy and Vesely combined employ such features associated with “receiving an interoperative image scan data set of the trackable device secured adjacent to the work target; and creating a refined model of the trackable device based on sensed locations of the set of the plurality of tracking points in the interoperative image scan data set” as taught in Razzaque for the advantage of “for the surgeon to appropriately utilize the pre-operative data during the operation while avoid massive computational strain required by the registration technique”, as suggested in Razzaque, [0002] and [0003].
Claim 2. Razzaque further teaches
a navigation sensor configured to measure positions of the set of tracking points of the trackable device relative to the navigation sensor; and wherein the navigation routine includes one or more of: determining the initial locations of the set of the plurality of tracking points with the navigation sensor, and determining the sensed locations of the set of the plurality of tracking points with the navigation sensor ([0014]: the position sensing units 110 and 140 may be combined and track all relevant tracking units 145 and movable imaging units 155; and [0016]: the second position sensing unit 140 is coupled to one or more tracking units 145. The second position sensing unit 140 and tracking units 145 may together comprise a magnetic tracking system, an optical tracking system, or any other appropriate tracking system).
Claim 12. Csavoy further teaches that
the plurality of tracking points of the trackable device include at least one of an LED, a reflective surface, a reflective pattern, a magnetic coil, and an optically identifiable geometric shape that uniquely defines position and orientation ([0077]: the tracking devices can be any appropriate type of tracking device. For example, optical tracking devices, including active optical or passive optical members, can be used as tracking devices with the tracking system. The active optical members, including light emitting diodes (LEDs)…Passive optical members including reflectors).
Claim 13. Csavoy further teaches that
the frame of the trackable device has a closed or semi-closed profile defining a window in a central portion of the trackable device ([0075]: FIG.3: a flexible sheet or member 120 can include one or more fibers 122. The fiber 122 can include woven fibers; [0077]: the tracking device 124 associated with the sheet 120; FIG.3: multiple tracking device 124 on the sheet 120; and [0076]: the sheet 120 can include a plurality of the tracking devices 124 that can be positioned at selected points) - as illustrated in FIG.3, a closed frame resulted from the most outer fibers is shown, and a window resulted from the weaving is located in the central portion of the sheet.
Claim 14. Csavoy further teaches that
the navigation system is a surgical navigation system adapted for use in a surgical operating room (FIG.1: a surgical operating room); wherein
the frame comprises a flexible substrate ([0075]: a flexible sheet or member 120; [0077]: the tracking device 124 associated with the sheet 120; FIG.3: multiple tracking device 124 on the sheet 120; and [0076]: the sheet 120 can include a plurality of the tracking devices 124 that can be positioned at selected points); and wherein
the trackable device is adapted to be attached to the skin of a surgical patient and to extend around a surgical area on the surgical patient without covering the surgical area (FIG.3 and FIG.5; and [0084]: the sheet 140 can be pierced or cut for access to a particular location. The sheet 140 can also include a flap that can be moved or removed to gain access through a portal 144 to a selected region; and [0075]: the flexible sheet 120 can include woven fibers and sized with any appropriate dimensions to cover a selected portion of the anatomy).
Claim 15. Csavoy further teaches that
the frame comprises a flexible substrate configured to be secured to a distortable outer surface of the body ([0075]: a flexible sheet or member 120; [0077]: the tracking device 124 associated with the sheet 120; FIG.3: multiple tracking device 124 on the sheet 120; and [0076]: the sheet 120 can include a plurality of the tracking devices 124 that can be positioned at selected points).
Claim 16. Csavoy further teaches that
the frame is in the shape of one of a rectangle, a square, a circle, a semi-circle, an oval, a U, and an H defining the window in the central portion of the trackable device ([0075]: FIG.3: a flexible sheet or member 120 can include one or more fibers 122. The fiber 122 can include woven fibers) – as illustrated in FIG.3, the frame resulted from the most outer fibers is in the shape of a rectangle or a square.
Claims 17-18. Csavoy further teaches that
the trackable device comprises a plurality of separate substrates, each of the plurality of separate substrates configured to be secured to the distortable outer surface of the body in a location spaced apart from the other substrates of the plurality of separate substrates, wherein each substrate of the plurality of separate substrates carries at least two of the plurality of tracking points ([0075]: a flexible sheet or member 120; [0077]: the tracking device 124 associated with the sheet 120; FIG.3: multiple tracking device 124 on the sheet 120; and [0076]: the sheet 120 can include a plurality of the tracking devices 124 that can be positioned at selected points separated by any appropriate dimension. The plurality of tracking device 124 comprise at least two).
Claims 19-20. Csavoy further teaches
a work piece adapted to be tracked by the computer-implemented tracking system ([0076]: the localizer device 48); and wherein
the computer-implemented tracking system is adapted to track the position of the work piece relative to the coordinate system ([0076]: the tracking devices 124 can sense a strength of a field, such as an electromagnetic field produced by the localizer device 48), wherein the navigation routine further comprises the step of:
calculating the position of the work piece relative to the position of the work target based on a tracked position of the work piece and the calculated current position of the work target ([0076]: the sheet 120 including the plurality of the tracking devices 124 can provide a plurality of traced positions relative to whatever the sheet 120 is placed over. The tracking devices can be tracked relative to the patient 14) – as the tracking device can sense the field produced by the localizer device 48 and can provide tracked position, it indicates that the position of the work piece (the localizer device) relative to the positive of the work target (where the sheet is placed over) can be calculated to reveal the current position of the work target (tracking relative to the patient).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Csavoy in view of Vesely and Razzaque, as applied in claim 1, further in view of Umezawa et al., US 2014/0316236 A1, hereinafter Umezawa.
Claim 10: Csavoy, Vesely and Razzaque combined teaches all the limitations of claim 1.
Csavoy further teaches
“sensing the deformation of the trackable device” ([0087]: the sheets 120, 140 can be flexible enough to substantially conform to a surface contour of the patient 14; and [0079]: the plurality of tracked points can provide information relating to the position of each of the tracking devices 124 on the patient 14. The information can be used for tracking the patient 14, determining the contour of the patient 14) – as the surface of the patient deforms, the sheets would deform accordingly. As the position of each of the tracking devices is obtained, such a system therefore senses a deformation of the trackable device.
Neither of Csavoy, Vesely and Razzaque teaches the remaining features.
However, Umezawa explicitly teaches
“estimating an expected error of the current position of the work target calculated from the initial model and the deformation of the trackable device” [0101]: in step S2, coordinates of the feature points in a state before the start of the measurement is acquired; [0102]: in step S3, a plurality of feature points acquired in step S2 is tracked, and the motion vector connecting the corresponding feature points between an original frame and a frame generated after a predetermined frame is calculated; and [0103]: in step S4, whether the shift of the object is within the threshold or not is determined); and
“providing an indication to a user when the expected error exceeds a pre-defined maximum error threshold for the current position of the work target, wherein the indication optionally includes at least one of a warning message and ending the navigation routine” ([0107]: in step s8, notification to an operator is performed by a voice, a lamp, a screen display; and [0057]: The notification unit 23 is an interface for notifying the operator that the change detection unit 22 detected a position shift. The change detection unit 22 and the notification unit 23 correspond to the notification unit in the present invention. In this embodiment, the notification unit 23 is a lamp that can emit a plurality of colors of light (e. g. normally green, which turns red when a position shift occurs), but may display a message to inform an operator that a position shift occurred, including details on the position shift, on a display or display panel.
Therefore, it would have been obvious for one of ordinary skilled in the art before the effective filing date of the claimed invention to have the system of Csavoy, Vesely and Razzaque combined employ the feature of “estimating an expected error of the current position of the work target calculated from the initial model and the deformation of the trackable device; and providing an indication to a user when the expected error exceeds a pre-defined maximum error threshold for the current position of the work target, wherein the indication optionally includes at least one of a warning message and ending the navigation routine” as taught in Umezawa for the advantage of “provide an object information apparatus that can notify the operator of a shift in the position of the object during the measurement” to “ensure that a correct image can be acquired”, as suggested in Umezawa, [0006]-[0008].
Allowable Subject Matter
Claims 3-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The limitations recited in claim 3 in regard to the features of “calculating a spatial deviation of at least one tracking point of the set of the plurality of tracking points, wherein the spatial deviation is based on a distance between the initial location of the at least one tracking point and the sensed location of the same at least one tracking point after the deformation of the trackable device", in combination with the other claimed elements, is/are not taught or disclosed in the prior arts.
Dependent claims 4-10 are allowed at least by virtue of their respective dependency upon an allowable claim.
The limitations recited in claim 11 in regard to the features of “registering the refined model of the trackable device with an initial interoperative position of the work target in an image of the interoperative image scan data set", in combination with the other claimed elements, is/are not taught or disclosed in the prior arts.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YI-SHAN YANG whose telephone number is (408) 918-7628. The examiner can normally be reached Monday-Friday 8am-4pm PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal M Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YI-SHAN YANG/Primary Examiner, Art Unit 3798
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