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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-13, 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al (Pub. No.: US 2017/0265774).
Regarding claim 1, Johnson et al disclose a method for illustrating a portion of a procedure, comprising:
tracking an end tip of an instrument while the end tip is moved within a portion of a subject [see 0092, 0142, figs 21A-21D] by disclosing tracking system 100, 300, 600 to precisely determine the position of the tip 624 and the orientation of the shaft 622 while the probe 608A is moved around [see 0092] and the tip of the tool 2024 progresses around the perimeter of the disc [see 0142];
determining a volume in which the end tip of the instrument is moved [see 0139] by disclosing a volume represented as a cylinder of the same radius as the probe tip's radius, capped by hemispherical volumes at each end, also with the radius of the probe tip, would be the assumed space calculated to be clear of matter [see 0139, 0140];
determining a graphical representation of the volume in which the end tip of the instrument is moved for display [see fig 11, 0134, 0139, 0142] by disclosing display the region of the disc that is clear of matter [see 0142].
Regarding claim 3, Johnson et al disclose removing a selected portion of the subject with a resection instrument to create the volume [see 0134-0135, 0139-0140] by disclosing computer system 2002 can extract data sets from the initial representation and the final representation of the targeted anatomical structure 2001 to determine dimensions, such as a thickness, of matter within the targeted anatomical structure 2001. These dimensions can be measured from the traced path of the probe, considering the diameter of the probe's tip and assuming that no volume of matter could share the space occupied by the probe tip [see 0139]
Regarding claim 4, Johnson et al disclose wherein determining the volume includes automatically (via computer system 2002) determining an initiation of the volume based at least on the tracking of the end tip of the instrument [see 0139].
Regarding claim 5, Johnson et al disclose wherein the graphical representation includes a painted (different colors) volume (in this case the volume is bone matter, tissue matter, and vacant space) [see 0134] by disclosing mapping can include a three-dimensional rendering of the targeted anatomical structure, including indications, such as different colors, to represent bone matter, tissue matter, and vacant space. The initial representation of the targeted anatomical structure 2001 can be displayed by a display or screen of the computer system 2002, such as the display 110 or the display 304 described herein [see 0134] and further disclose the volume would be the assumed space calculated to be clear of matter [see 0139] and display the region of the disc that is clear of matter [see 0142].
Regarding claim 6, Johnson et al disclose a method for illustrating a portion of a procedure, comprising:
tracking an instrument while the instrument is moved within a portion
of a subject [see 0092, 0142, figs 21A-21D] by disclosing tracking system 100, 300, 600 to precisely determine the position of the tip 624 and the orientation of the shaft 622 while the probe 608A is moved around [see 0092] and the tip of the tool 2024 progresses around the perimeter of the disc [see 0142];
determining a volume in which the instrument is moved [see 0139, 0142] by disclosing computer system 2002 can extract data sets from the initial representation and the final representation of the targeted anatomical structure 2001 to determine dimensions, such as a thickness, of matter within the targeted anatomical structure 2001. These dimensions can be measured from the traced path of the probe, considering the diameter of the probe's tip and assuming that no volume of matter could share the space occupied by the probe tip [see 0139] and a volume represented as a cylinder of the same radius as the probe tip's radius, capped by hemispherical volumes at each end, also with the radius of the probe tip, would be the assumed space calculated to be clear of matter [see 0139];
determining a real time graphical representation of the volume in which the instrument is moved [see 0142] by disclosing imaging devices 1304 that may be used in conjunction with robot systems 100, 300, 600 to acquire pre-operative, intra-operative, post-operative, and/or real-time image data of patient 210. Any appropriate subject matter may be imaged for any appropriate procedure using the imaging system 1304 [see 0088];
displaying the real time graphical representation of the volume [see 0142] by disclosing imaging devices 1304 that may be used in conjunction with robot systems 100, 300, 600 to acquire pre-operative, intra-operative, post-operative, and/or real-time image data of patient 210. Any appropriate subject matter may be imaged for any appropriate procedure using the imaging system 1304 [see 0088].
Johnson et al disclose the term “representation” as used herein includes any type of imaging (which is in term real-time, emphasis added), mapping, dataset [see 0133].
Regarding claim 7, Johnson et al disclose wherein the volume includes a volume of a spinal disc to remove during a discectomy (inherently disclosed because the procedure performed on a disc is referred to as discectomy) [see 0133, 0142] and disclose the targeted anatomical space 2001 is preferably the disk space in a patient's spine [see 0133].
Regarding claim 8, Johnson et al disclose predetermining the volume in which the instrument is moved in order to predetermine a volume to remove from the subject [see 0134-0135] by disclosing after the initial representation of the targeted anatomical structure 2001 is acquired, the method 1900 includes removing 1920 matter from the targeted anatomical structure 2001. The removal step 1920 is performed by any type of cutting, shaving, or scraping tools [see 0135].
Regarding claim 9, Johnson et al disclose displaying a value of the volume with the real-time graphical representation. [see fig 11, 0134, 0139, 0142] by disclosing display the region of the disc that is clear of matter [see 0142].
Regarding claim 10, Johnson et al disclose wherein the instrument includes an end tip with a known end tip geometry, wherein the end tip is moved within the portion of the subject [see 0094].
Regarding claim 11, Johnson et al disclose wherein the volume includes a volume of the spinal disc to be removed during a discectomy (inherently disclosed because the procedure performed on a disc is referred to as discectomy) [see 0133, 0142] and disclose the targeted anatomical space 2001 is preferably the disk space in a patient's spine [see 0133].
Regarding claim 12, Johnson et al disclose a system for performing a procedure, comprising:
an instrument having an end tip with a known end tip geometry [see 0094];
a tracking device (tracking markers 118) coupled to the instrument and configured to enable
the instrument (608) to be tracked [see 0047, 0061];
a navigation system configured to:
track the instrument within a portion of a subject [see 0061];
determine a volume in which the tracked instrument is moved in the portion of the subject [see 0139, 0142];
determine a graphical representation of the volume in which the tracked instrument is moved for display [see fig 11, 0134, 0139, 0142] by disclosing display the region of the disc that is clear of matter [see 0142].
Regarding claim 13, Johnson et al disclose a display for displaying the determined graphical representation [see fig 11, 0134, 0139, 0142] by disclosing display the region of the disc that is clear of matter [see 0142].
Regarding claim 15, Johnson et al disclose wherein the volume includes a volume of a spinal disc to be removed during a discectomy (inherently disclosed because the procedure performed on a disc is referred to as discectomy) [see 0133, 0142] and disclose the targeted anatomical space 2001 is preferably the disk space in a patient's spine [see 0133].
Regarding claim 16, Johnson et al disclose wherein the graphical representation is a painted (different colors) volume (in this case the volume is bone matter, tissue matter, and vacant space) [see 0134] by disclosing mapping can include a three-dimensional rendering of the targeted anatomical structure, including indications, such as different colors, to represent bone matter, tissue matter, and vacant space. The initial representation of the targeted anatomical structure 2001 can be displayed by a display or screen of the computer system 2002, such as the display 110 or the display 304 described herein [see 0134] and further disclose the volume would be the assumed space calculated to be clear of matter [see 0139] and display the region of the disc that is clear of matter [see 0142].
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.
Claim(s) 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al (Pub. No.: US 2017/0265774) in view of Mire et al (Pub. No.: US 2004/0171924)
Regarding claims 2, 14, Johnson et al disclose indicator can include a percentage of matter remaining in the targeted anatomical structure 2001 [see 0140].
Johnson et al don’t disclose displaying the determined graphical representation including an absolute value of the volume
Nonetheless, Mire et al disclose if it is determined that the nucleus 418 must be removed or replaced, determining the procedure in block 426 may also include determining the volume of the nucleus 418 to be removed and from where. Therefore, if the volume of the nucleus to remove is about 10 cc (which is the absolute value of the volume relied on to be displayed, emphasis added) [see 0175] and disclose Mire et al disclose on the screen, a graphical display of the nucleus 418 may also be shown. Alternatively, the icon 486 may be displayed relative to an acquired image of the patient. In addition, a graphical display of an area removed 488 and a selected area to be yet removed 490 may be illustrated. Therefore, a physician may graphically see which portion of the nucleus 418 has not been removed 490 and which portion has been removed 488 and the boundaries of the nucleus 418 [see 0202].
Therefore, it is obvious to one skilled in the art at the time the invention was filed and would have been motivated to combine Jonhson et al and Mire et al by displaying the determined graphical representation including an absolute value of the volume; so that the selected implant may properly fit within the patient [see 0202, Mire et al].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOEL F BRUTUS whose telephone number is (571)270-3847. The examiner can normally be reached Mon-Sat, 11:00 AM to 7:00 PM.
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/JOEL F BRUTUS/ Primary Examiner, Art Unit 3798