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 Objections
Claim 4 is objected to because of the following informalities: The amendments state “at least one or” Examiner believes it should read “at least one of”. Appropriate correction is required.
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) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Knobel et al. (US 20090068620) and in view of Avinash (US 20060058604).
Regarding claim 1, Knobel discloses an instrument for a medical or surgical assistance system (Fig. 1, section 0120, a layout of the device according to the invention with a mobile tracking system with a medical instrument including a structure with a pattern in front of a body part with another structure), the instrument comprising: a proximal handling section 9 (Fig. 1, section 0137, the mobile tracking system 2 well, it features a hand grip 9 to which, in this implementation example, an activation mechanism 10 is attached); a distal end section 130 with a distal working point 131 (Fig. 5, section 0150, The medical instrument 130 has an instrument point 131); a first reference system 12, 132 arranged proximally in a predetermined first condition relative to the distal working point 131, the first reference system 12 adapted for determining a position and/or an orientation of the distal end section with the distal working point (Fig. 1, 5, section 0139, 0154, The structure 3 features a first pattern 12 and a first locator. the mobile tracking system 102 can unambiguously determine the geometry of the medical instrument 130 using the different patterns 112, 132); and a second reference system 114, 115 arranged distally in a predetermined second condition relative to the distal working point 131, the second reference system designed as an optical pattern adapted to determine the position and/or orientation of the distal end section with the distal working point (Fig. 1, section 0139A further structure 14 with a second pattern 15 and a bone locator 16 is attached to bone 4. The structures 3 and 14 are three-dimensional bodies onto which the pattern 12 or the pattern 15 are attached. The patterns 12 and 15 allow the mobile tracking system 2 to determine the spatial position of structures 3 and 14).
However, Knobel does not disclose wherein when one of the first and second reference systems is shielded, obscured, or defective, another of the first and second reference systems is still available for tracking the distal working point. Avinash discloses wherein when one of the first and second reference systems is shielded, obscured, or defective, another of the first and second reference systems is still available for tracking the distal working point (section 0064, in a spinal surgery, the surgeon initiates the surgery with optical tracking and when the field of view becomes obscured, for example, a line of sight is no longer possible, the surgeon switches tracking to EM). This allows for the user/surgeon to have an improved location and orientation of the instrument instead of total obliviousness. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of the invention, to modify the device of Knobel by adding when one of the first and second reference systems is shielded, obscured, or defective, another of the first and second reference systems is still available for tracking the distal working point as taught by Avinash in order to facilitate user/surgeon to have an improved location and orientation of the instrument instead of total obliviousness.
Regarding claim 2, Knobel discloses the first reference system 12, 132 is designed as a rigid body 131 with reference bodies arranged in a distributed manner (Fig. 1, 5, section 0142, The mobile tracking system 2 can therefore exactly identify and explicitly allocate the properties of the first pattern 12).
Regarding claim 3, Knobel discloses the second reference system 114, 115 extends along a surface 4 (section 0139, further structure 14 with a second pattern 15 and a bone locator 16 is attached to bone) or surface section of the distal end section to be detected by an optical recording system 5, 6 (Fig. 1, section 0135, The mobile tracking system 2 features a first camera 5 and a second camera 6).
Regarding claim 4, Knobel discloses the optical pattern has at least one of a bar code, a bar grid, or geometries or ruled geometries arranged according to a matrix (Figs. 2-4, sections 0144, Pattern 20, shown in FIG. 2, contains many lines of different widths, circles, ellipses, triangles, and rectangles.).
Regarding claim 5, Knobel discloses the optical pattern is designed in two colors, with maximum contrast (section 2-4, shows black and white contrasting colors).
Regarding claim 6, Knobel discloses the optical pattern is printed or laser-printed (section 0184, The patterns and secondary patterns can also be directly imprinted).
Regarding claim 7, Knobel discloses the instrument is designed as a navigation pointer 131 (Fig.5, section 0150, The medical instrument 130 has an instrument point 131) or an endoscope, or wherein the instrument is designed as a suction tube.
Regarding claim 8, Knobel discloses an optical recording system 5, 6 (Fig. 1, section 0135, The mobile tracking system 2 features a first camera 5 and a second camera) connected to a robot arm (section 0037, 0106, the mobile tracking system is not held and guided only by hand, it is advantageous for the mobile tracking system to have an attachment mechanism to connect it to a movable guidance mechanism, like a manually movable arm and/or a robot arm; The tracking system can, therefore, as already mentioned, be attached to a robot, in particular a robot arm) and adapted to create at least one up-to-date recording of a patient’s surgical intervention area and to provide the at least one up-to-date recording in real time (section 0002, 0106, Common tracking systems acquire a position, with known mathematical methods in real time conduct measurements only on demand); a tracking system 2 adapted to detect at least the first reference system 12, 132 of the instrument 3 (Fig. 1, 5, section 0139, 0154, The structure 3 features a first pattern 12 and a first locator. the mobile tracking system 102 can unambiguously determine the geometry of the medical instrument 130 using the different patterns 112, 132); and a data processing unit adapted to determine at least one of a position or orientation of the distal end section with the distal working point at least based on the first reference system (section 0138, An evaluation and display device 11 is assigned to the mobile tracking system 2 and is connected to the mobile tracking system 2 with a communication connection 11A), wherein: the data processing unit is further adapted to determine at least one of the position or orientation of the distal end section with the distal working point based on an up-to-date recording of the second reference system (section 0142, both the first locator 13 and the bone locator 16 are equipped with retro-reflective spheres 18. The shape of the first structure 3 and the further structure 14 as well as the properties of the first pattern 12 and the second pattern 15 are already defined during the production of structure 3 and the further structure 14. The mobile tracking system 2 can therefore exactly identify and explicitly allocate the properties of the first pattern 12 as well as the second pattern 15), and the instrument 3, 130 being arrangeable as intended at least with the distal end section with the distal working point 131 in a field of view of the optical recording system 2, 5, 6 (Fig. 1, section 0135, The mobile tracking system 2 features a first camera 5 and a second camera 6) defining the at least one up-to-date recording (section 0002, 0106, Common tracking systems acquire a position, with known mathematical methods in real time conduct measurements only on demand).
Regarding claim 9, Knobel discloses the data processing unit is adapted to determine at least one of the position or orientation of the distal end section with the distal working point based on the first reference system and/or the second reference system (Section 0154, the mobile tracking system 102 determines the locator positions of the respective pattern 112, 132 on the medical instrument 130. This has the benefit that the position of the instrument point 131 is known with the measurement of the locators ).
Regarding claim 10, Knobel discloses the data processing unit is adapted to optimally determine at least one of the position or orientation of the distal end section with the distal working point based on the first reference system and the second reference system (Section 0167-0168, A bone structure 714 with a pattern 715 is attached to the bone piece 740 as shown in FIG. 11. In the immediate vicinity of bone piece 740 there is a mobile tracking system 702 with three cameras 705. The orientation and position of the optical scanner 775 and the bone structure 714 is measured by means of the mobile tracking system).
Regarding claim 11, Knobel discloses the tracking system is further adapted to detect the second reference system of the instrument (Section 0167-0168, A bone structure 714 with a pattern 715 is attached to the bone piece 740 as shown in FIG. 11. In the immediate vicinity of bone piece 740 there is a mobile tracking system 702 with three cameras 705. The orientation and position of the optical scanner 775 and the bone structure 714 is measured by means of the mobile tracking system).
Regarding claim 12, Knobel discloses the data processing unit is adapted to determine a condition of the optical recording system based on stored kinematics and at least one detected joint angle of the robot arm, and/or wherein a rigid body detectable by the tracking system is coupled to the optical recording system and the data processing unit is adapted to determine a condition of the optical recording system based on the rigid body (section 0037, it is advantageous for the mobile tracking system to have an attachment mechanism to connect it to a movable guidance mechanism, like a manually movable arm and/or a robot arm. With such an attachment mechanism the attachment of the mobile tracking system onto additional holding mechanisms, like, for example, a holding arm which is movable during the tracking or a robot arm is substantially simplified).
Regarding claim 13, Knobel discloses arranging the instrument at least in sections in a field of view of a recording system; creating an up-to-date recording by the recording system (section 0002, 0106, Common tracking systems acquire a position, with known mathematical methods in real time conduct measurements only on demand); providing the up-to-date recording in real time by the recording system (section 0002, 0106, Common tracking systems acquire a position, with known mathematical methods in real time conduct measurements only on demand); detecting the first reference system 112, 132 of the instrument by a tracking system (Fig. 1, 5, section 0139, 0154, The structure 3 features a first pattern 12 and a first locator. the mobile tracking system 102 can unambiguously determine the geometry of the medical instrument 130 using the different patterns 112, 132); determining at least one of a position or orientation of the distal end section with the distal working point 131 at least based on the first reference system by a data processing unit (Fig. 1, 5, section 0139, 0154, The structure 3 features a first pattern 12 and a first locator. the mobile tracking system 102 can unambiguously determine the geometry of the medical instrument 130 using the different patterns 112, 132); optically detecting the second reference system of the instrument by the up-to-date recording (section 0002, 0106, Common tracking systems acquire a position, with known mathematical methods in real time conduct measurements only on demand); and determining at least one of the position or orientation of the distal end section with the distal working point at least based on the second reference system by machine vision or machine vision of the data processing unit (section 0142, both the first locator 13 and the bone locator 16 are equipped with retro-reflective spheres 18. The shape of the first structure 3 and the further structure 14 as well as the properties of the first pattern 12 and the second pattern 15 are already defined during the production of structure 3 and the further structure 14. The mobile tracking system 2 can therefore exactly identify and explicitly allocate the properties of the first pattern 12 as well as the second pattern 15).
Regarding claim 14, Knobel discloses determining whether the first reference system is adequately detected by the tracking system by the data processing unit (Fig. 1, 5, section 0139, 0154, The structure 3 features a first pattern 12 and a first locator. the mobile tracking system 102 can unambiguously determine the geometry of the medical instrument 130 using the different patterns 112, 132); determining whether the second reference system is adequately detected by the recording system by the data processing unit (section 0142, both the first locator 13 and the bone locator 16 are equipped with retro-reflective spheres 18. The shape of the first structure 3 and the further structure 14 as well as the properties of the first pattern 12 and the second pattern 15 are already defined during the production of structure 3 and the further structure 14. The mobile tracking system 2 can therefore exactly identify and explicitly allocate the properties of the first pattern 12 as well as the second pattern 15); and depending on results of an investigation, determining: a) the at least one of position or orientation of the distal end section with the distal working point based only on the first reference system; or b) determining at least one of the position or orientation of the distal end section with the distal working point based only on the second reference system; or c) determining at least one of the position or orientation of the distal end section with the distal working point based on both reference systems; or d) outputting an error message that no determination can be made (section 0174, Acquired measurement data is sent over a communication connection 1011A to an analysis and display device).
Regarding claim 15, Knobel discloses A non-transitory computer-readable storage medium comprising instructions which, when executed by a computer, cause the computer to perform the steps of the method according to claim 13 (section 0091, This simplification is achieved because on the one hand the tracking system detects a structure and/or a pattern on the respective body part and on the other hand the other imaging systems (C-Arm, CT, MRI and/or another device which identifies bones and teeth three dimensionally using X-rays) detect the patient data and the secondary patterns and process this data as spatial information).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JON ERIC C MORALES whose telephone number is (571)272-3107. The examiner can normally be reached Monday-Friday 830AM-530PM CST.
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/JON ERIC C MORALES/Primary Examiner, Art Unit 3796
/J.C.M/Primary Examiner, Art Unit 3796
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