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 .
Response to Arguments
Applicant’s arguments with respect to claims 1 and 16 in Applicant’s responses filed 02/19/2026 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.
Newly found prior art US 20050020909 A1 teaches a display unit for use with a surgical navigation system that includes a body; a screen capable of displaying data; a communications link capable of sending and receiving data to and from the surgical navigation system; and an attachment device to attach the display unit to a body of a surgical instrument to be manipulated relative to a patient's anatomy, a tracking unit associated with the surgical instrument that can be tracked by the surgical navigation system; where the screen can display information received from the surgical navigation system, as can be seen in fig. 10.
Examiner’s response to Applicant’s previous arguments that Singh does not teach that the orientation sensor 340 is removably mountable onto a surgical instrument. As previously noted, paragraph 35 of Singh discloses that According to one embodiment, at least one orientation sensor 340 is attached to or embedded within a portion of an elongated member 310 of a placement tool used during a hip replacement surgery. Hence, Singh clearly teaches that the orientation sensor is attached to the instrument. Paragraph 61 also states, with respect to figs. 7A and 7B that FIGS. 7A and 7B illustrate an embodiment in which a second orientation sensor 340a is coupled to tool 310 (via a slideable connection associated with a first orientation sensor 340b that is coupled to tool 310). Such removable connection simplifies the procedure by allowing the pelvis sensor (second orientation sensor 340a) to be registered to the pelvic coordinate system simultaneously with the registration of first orientation sensor 340b. Hence, the orientation sensor is removably attached to the tool and hence Singh would be modifiable to include the display unit of Barrera.
Therefore, Singh in view of Barrera teaches all the limitations of claims 1 and 16 and the claims stand rejected.
Withdrawn Objections
Pursuant of Applicant’s amendments filed 02/19/2026, the objections made to claims 1 and 16 are hereby withdrawn.
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 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.
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.
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.
Claims 1, 3-4, 7-8, 11, 16-18, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Singh, A., US 20150142372 A1 in view of Moctezuma de la Barrera, J.L., US 20050020909 A1, hereinafter referred to as “Barrera”.
Regarding claim 1, Singh teaches a surgical guidance system for guiding a surgical instrument to a target location during surgery (orientation sensor 340 of [0028] and fig. 3, the orientation operatively coupled to a tool 310) and, the system comprising:
an inertial measurement unit ([0045] discloses that the orientation sensor 340 comprises an inertial measurement unit) for tracking the orientation and movement ([0035] discloses measuring an orientation of the tool 310) of a work piece (impactor 310 with distal end 312 [0024]) at a first end of the surgical instrument relative to a locally defined three-dimensional reference system (reference plane of [0052]) of a surgical field containing the target location ([0045]-[0046] describe components of the orientation sensor 340 as including an inertial measurement unit); and
a microprocessor (microprocessor of [0029]) for interpreting real-time data gathered by the inertial measurement unit ([0029] discloses “process and/or analyze information indicative of placement of a prosthetic component”) and for communicating the real-time data to a visual display to provide positional guidance of the work piece to the target location during the surgery ([0029] indicates that the microprocessor is configured for receiving, processing, and displaying information indicative of the orientation of tool 310 and [0027] indicates that these steps are performed in real time) ,
the inertial measurement unit comprising a micro electrical mechanical system (MEMS) sensor array to track rotation and acceleration in three spatial directions of the work piece ([0046] indicates the determination of orientation and linear motion, or acceleration, of the tool. Examiner notes that [0045]-[0046] includes a plurality of orientation sensors 340, which include microprocessor and MEMS micro-generator power supply ([0048]) and hence at least suggesting that the orientation sensors 340 are MEMS sensor array), the MEMS sensor array comprising a three-axis accelerometer having six or nine degrees of freedom, a gyroscope and a magnetometer sensor ([0046] states that the “inertial measurement unit(s) 340 may contain a 3-axis gyroscope 343, a 3-axis accelerometer 344, and a 3-axes magnetometer 345”),
wherein the surgical guidance system is configured to be mountable onto an exterior surface at a second, opposed end of, and positioned in line with the use of, the surgical instrument (see the positioning of the orientation sensor 340 with respect to the tool 310 in fig. 3, [0007] also stating that the orientation sensor is rigidly coupled to the elongated linear member and configured to detect information indicative of an orientation of the elongated linear member and the prosthetic component attached to it. The orientation sensor 340 is mounted away from a distal end 312 of the tool).
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Singh does not teach that the surgical guidance system is provided separately from the surgical instrument, and configured to be detachable from, and reattachably mountable onto, an exterior surface at a second, opposing terminal of the surgical instrument, such that the surgical guidance system is positioned externally distal to and in line with a working end of the surgical instrument.
However, within the same field of endeavor, Barrera teaches a display unit for use with a surgical navigation system that includes a body; a screen capable of displaying data; a communications link capable of sending and receiving data to and from the surgical navigation system; and an attachment device to attach the display unit to a body of a surgical instrument to be manipulated relative to a patient's anatomy, a tracking unit associated with the surgical instrument that can be tracked by the surgical navigation system; where the screen can display information received from the surgical navigation system (see abstract). Barrera teaches the surgical guidance system is provided separately from the surgical instrument, and configured to be detachable from, and reattachably mountable onto, an exterior surface at a second, opposing terminal of the surgical instrument, such that the surgical guidance system is positioned externally distal to and in line with a working end of the surgical instrument (see figs. 5 and 10 and [0040]).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh such that the surgical guidance system is provided separately from the surgical instrument, and configured to be detachable from, and reattachably mountable onto, an exterior surface at a second, opposing terminal of the surgical instrument, such that the surgical guidance system is positioned externally distal to and in line with a working end of the surgical instrument, as taught by Barrera, to provide a display of the region of interest such that the surgeon can easily see and utilize the information displayed on the display unit without the need to look away from the point of surgery ([0004]).
Regarding claim 3, Singh in view of Barrera teaches all the limitations of claim 1.
Singh further teaches a visual display, wherein the visual display includes at least one user interfaces ([0043] discloses a display which as graphical user interface).
Regarding claim 4, Singh in view of Barrera teaches all the limitations of claim 1.
Singh further teaches wherein the at least one user interface includes a graphical interface ([0043] discloses a graphical user interface (GUI)).
Regarding claim 7, Singh in view of Barrera teaches all the limitations of claim 1.
Singh further teaches wherein the graphical user interface (GUI of [0043]) can be used to guide a change in orientation of the work piece ([0074] discloses that GUI displays the orientations of the instrument).
Regarding claim 8, Singh in view of Barrera teaches all the limitations of claim 1.
Singh further teaches wherein the work piece is used for cutting ([0022] discloses a surgical reamer or reciprocating saw)) and the change of orientation of the work piece dictates an angle of cutting ([0056] discloses “processing system 350 is configured to mathematically transform the raw orientation measurements from orientation sensor 340 of tool 310 to an orientation angle relative to either or both of the first and second virtual planes (Step 960, FIG. 9). When first end 312 of tool 310 is engaged with acetabulum 190 of pelvis 120, the orientation information detected by orientation sensor 340 may be used to estimate the orientation of a prosthetic cup relative to one or more virtual planes associated with the pelvic anatomy of the patient.”).
Regarding claim 11, Singh in view of Barrera teaches all the limitations of claim 1.
Singh further teaches wherein the work piece is one of a screw driver, a blade, a burr or cutting tool ([0022] discloses a surgical reamer (claimed burr) or reciprocating saw (claimed cutting tool)).
Regarding claim 16, Singh teaches a surgical instrument (impactor tool 310 of fig. 3 and [0024]) comprising:
a work piece at a first end of the surgical instrument (distal end 312, which forms the work piece of the impactor 310 [0024]. Also see fig. 3), and a surgical guidance system (orientation sensor 340 of [0028] and fig. 3) mounted on to an exterior surface at a second, opposed end of the surgical instrument surgery (the orientation sensor 340 operatively coupled to a tool 310 at position that is opposite from a distal end 312 of the tool 310) which tracks the work piece in a surgical field ([0035] discloses measuring an orientation of the tool 310);
the surgical guidance system (orientation sensor 340 of [0028] and fig. 3) comprising:
an inertial measurement unit configured to track an orientation and movement of the work piece relative to a locally defined three-dimensional reference system of the surgical field ([0046] indicates the determination of orientation and linear motion, or acceleration, of the tool. Examiner notes that [0045]-[0046] includes a plurality of orientation sensors 340, which include microprocessor and MEMS micro-generator power supply ([0048]) and hence at least suggesting that the orientation sensors 340 are MEMS sensor array),
a microprocessor (microprocessor of [0029]) configured to interpret real-time data gathered by the MEMS sensor ([0029] discloses “process and/or analyze information indicative of placement of a prosthetic component”),
the inertial measurement unit comprising a MEMS sensor array to track rotation and acceleration in three spatial directions of the work piece([0046] indicates the determination of orientation and linear motion, or acceleration, of the tool. Examiner notes that [0045]-[0046] includes a plurality of orientation sensors 340, which include microprocessor and MEMS micro-generator power supply ([0048]) and hence at least suggesting that the orientation sensors 340 are MEMS sensor array), the MEMS sensor array comprising a three-axis accelerometer having six or nine degree of freedom, a gyroscope and a magnetometer sensor ([0046] states that the “inertial measurement unit(s) 340 may contain a 3-axis gyroscope 343, a 3-axis accelerometer 344, and a 3-axes magnetometer 345” that performs the tracking),
wherein the surgical guidance system is configured to be mountable onto an exterior surface at a second, opposed end, of and positioned in line with the use of the surgical instrument (see the positioning of the orientation sensor 340 with respect to the tool 310 in fig. 3, [0007] also stating that the orientation sensor is rigidly coupled to the elongated linear member and configured to detect information indicative of an orientation of the elongated linear member and the prosthetic component attached to it. The orientation sensor 340 is mounted away from a distal end 312 of the tool).
Singh does not teach wherein the surgical guidance system is provided separate from the surgical instrument, and configured to be detachable from, and reattachably mountable onto an exterior surface at a second, opposing terminal of the surgical instrument, such that the surgical guidance system is positioned externally distal to and in line with a working end of the surgical instrument.
However, within the same field of endeavor, Barrera teaches a display unit for use with a surgical navigation system that includes a body; a screen capable of displaying data; a communications link capable of sending and receiving data to and from the surgical navigation system; and an attachment device to attach the display unit to a body of a surgical instrument to be manipulated relative to a patient's anatomy, a tracking unit associated with the surgical instrument that can be tracked by the surgical navigation system; where the screen can display information received from the surgical navigation system (see abstract). Barrera teaches wherein the surgical guidance system is provided separate from the surgical instrument, and configured to be detachable from, and reattachably mountable onto an exterior surface at a second, opposing terminal of the surgical instrument, such that the surgical guidance system is positioned externally distal to and in line with a working end of the surgical instrument (see figs. 5 and 10 and [0040]).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh wherein the surgical guidance system is provided separate from the surgical instrument, and configured to be detachable from, and reattachably mountable onto an exterior surface at a second, opposing terminal of the surgical instrument, such that the surgical guidance system is positioned externally distal to and in line with a working end of the surgical instrument, as taught by Barrera, to provide a display of the region of interest such that the surgeon can easily see and utilize the information displayed on the display unit without the need to look away from the point of surgery ([0004]).
Regarding claim 17, Singh in view of Barrera teaches all the limitations of claim 16.
Singh further teaches wherein the MEMS sensor array is a six or nine degree of freedom sensor ([0046] states that the “inertial measurement unit(s) 340 may contain a 3-axis gyroscope 343, a 3-axis accelerometer 344, and a 3-axes magnetometer 345”).
Regarding claim 18, Singh in view of Barrera teaches all the limitations of claim 16.
Singh further teaches wherein the work piece is one of a screw driver, a blade, a burr or cutting tool ([0022] discloses a surgical reamer or reciprocating saw)).
Regarding claim 25, Singh in view of Barrera teaches all the limitations of claim 1.
Singh further teaches wherein the visual display includes a simulated visual representation of a simulated anatomy ([0067] states that “Patient-specific instruments typically utilize pre-operative 3D imaging of the patient's anatomy. 3D models of the hip joint based on the images are created and a pre-operative surgical plan is created”. The models are represented on the GUI of [0065] and fig. 8).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Singh in view of Barrera, as applied to claim 1 above, and further in view of Diolati, et al., 20110202068.
Regarding claim 2, Singh in view of Barrera teaches all the limitations of claim 1.
Singh in view of Barrera fails to teach an audio command mechanism.
However, Diolati teaches a medical robotic system including an entry guide with articulated instruments extending out of its distal end (see abstract and figure 1) including an audio command mechanism (paragraphs 29 and 41 disclose a voice recognition system 160 used to input voice commands).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh as modified by Barrera, to include an audio command mechanism, as taught by Diolaiti, providing the surgeon with an expansive selection of achieving tasks during the surgical procedure ([0069]) and hence improving patient safety through timely completion of the medical procedure ([0005]), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy of measurements and hence safeguarding improved outcomes for the patient ([0004]-[0005]).
Claims 5-6, 9-10, 12-15, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Singh in view of Barrera, as applied to claim 4 above, and further in view of Inkpen, et al., US 20140148808.
Regarding claim 5, Singh in view of Barrera teaches all the limitations of claim 1.
Singh in view of Barrera fails to teach wherein the graphical user interface includes a two dimensional matrix and a marker corresponding to the location of the work piece over time, and the graphical user interface recommends the orientation through the visual display by tracking the marker on the two dimensional matrix and indicating a desirable location of the marker corresponding to a desirable location of the work piece.
However, Inkpen further teaches wherein the graphical user interface includes a two dimensional matrix and a marker corresponding to the location of the work piece over time (fig. 7a and paragraphs 342-343), and the graphical user interface recommends the orientation through the visual display by tracking the marker on the two dimensional matrix and indicating a desirable location of the marker corresponding to a desirable location of the work piece (paragraphs 342-343).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh as modified by Barrera, such that the graphical user interface includes a two dimensional matrix and a marker responding to the location of the work piece over time, and the graphical user interface recommends the orientation through the display by tracking the marker on the two dimensional matrix and indicating a desirable location of the marker corresponding to a desirable location of the work piece, as taught by Inkpen, to improve the success of directing the instrument toward the intended target (paragraph 334), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy of measurements and more cost effective ([0004]-[0005]).
Regarding claim 6, Singh in view of Barrera and Inkpen teaches all the limitations of claim 5.
Singh in view of Barrera and Inkpen does not teach wherein the two dimensional matrix is represented as a circle, square, or rectangle and the marker is represented a spot.
However, Inkpen further teaches wherein the two dimensional matrix is represented as a circle, square, or rectangle and the marker is represented as a spot (fig. 7a).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh modified by Barrera such that the two dimensional matrix is a circle, square, or rectangle and the marker is a spot, as taught by Inkpen, to improve the success of directing the instrument toward the intended target ([0334]), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy of measurements and more cost effective ([0004]-[0005]).
Regarding claim 9, Singh in view of Barrera teaches all the limitations of claim 4.
Singh in view of Barrera does not teach wherein the graphical user interface indicates a depth of the work piece over time.
However, Inkpen teaches a display where the display includes graphical user interface which indicates the depth of the work piece over time (fig. 18a paragraph 343).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh modified by Barrera such that the display includes graphical user interface which indicates the depth of the work piece over time, as taught by Inkpen, to improve the success of directing the instrument toward the intended target (paragraph 334), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy of measurements and more cost effective ([0004]-[0005]).
Regarding claim 10, Singh in view of Barrera and Inkpen teaches all the limitations of claim 9.
Singh in view of Barrera fails to teach wherein the graphical user interface is a bar graph which acts as a surgical depth guide.
However, Inkpen further teaches wherein the graphical user interface is a bar graph which acts as a surgical depth guide (paragraph 343).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh as modified by Barrera, such that the graphical user interface is a bar graph which acts as a surgical depth guide, as taught by Inkpen, to improve the success of directing the instrument toward the intended target (paragraph 334), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy of measurements and more cost effective ([0004]-[0005]).
Regarding claim 12, Singh in view of Barrera and Inkpen teaches all the limitations of claim 10.
Singh in view of Barrera does not teach wherein the graphical user interface further includes a two dimensional matrix with a marker.
However, Inkpen further teaches wherein the graphical user interface further includes a two dimensional matrix with a marker (fig. 18a and paragraphs 342-343).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh in view of Barrera, such that the graphical user interface further includes a two dimensional matrix with a marker, as taught by Inkpen, to improve the success of directing the instrument toward the intended target (paragraph 334), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy of measurements and more cost effective ([0004]-[0005]).
Regarding claim 13, Singh in view of Barrera teaches all the limitations of claim 1.
Singh teaches wherein the system includes data (paragraph 264) but Singh in view of Barrera fails to teach that the data relates to the desired location of multiple fasteners and the memory records a local coordinate system which is determined by a user during surgery.
However, Inkpen further teaches to teach wherein the system includes a memory (paragraph 276 states “Field generator 7 has an integrated erasable and rewritable memory 620, visible in FIG. 8, which can be used to store information such as calibration factors and serial numbers. Memory 620 may be, for example, a flash-type memory device.”) including data as to the desired location of multiple fasteners (paragraphs 258-259) and the memory (paragraph 276 states “Field generator 7 has an integrated erasable and rewritable memory 620, visible in FIG. 8, which can be used to store information such as calibration factors and serial numbers. Memory 620 may be, for example, a flash-type memory device.”) records a local coordinate system which is determined by a user during surgery (paragraphs 377-378).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh as modified by Barrera such that the graphical user interface is a bar graph which acts as a surgical depth guide, as taught by Inkpen, to improve the success of directing the instrument toward the intended target (paragraph 334), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy of measurements and more cost effective ([0004]-[0005]).
Regarding claim 14, Singh in view of Barrera and Inkpen teaches all the limitations of claim 13.
Singh further teaches wherein the memory ([0038]) includes information as to an anatomy of a specific patient ([0037] indicates storing anatomic registration information).
Regarding claim 15, Singh in view of Barrera and Inkpen teaches all the limitations of claim 13.
Singh further teaches wherein the memory ([0038]) includes information as to an anatomy of a specific surgical procedure ([0037] indicates receiving placement parameters associated with an orthopedic joint 110).
Regarding claim 19, Singh in view of Barrera teaches all the limitations of claim 16.
Singh further teaches wherein the visual display includes a graphical user interface (paragraph 98) but Singh in view of Burroughs fails to teach that the user interface recommends an orientation of the work piece over time.
However, Inkpen teaches apparatus for integrating an electromagnetic navigation system and a tool and aligning the tool with a target are presented, including a sensor tool, a tool, a field generator, a display, and a computer (abstract and fig. 7) including a user interface 6, wherein the graphical user interface (user interface 6) recommends an orientation or vector of the work piece over time (paragraph 334).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh as modified by Barrera such that the graphical user interface recommends an orientation or vector of the work piece over time, as taught by Inkpen, to improve the success of directing the instrument toward the intended target (paragraph 334), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy of measurements and more cost effective ([0004]-[0005]).
Regarding claim 20, Singh in view of Barrera teaches all the limitations of claim 1.
Singh further teaches further being mounted to a guide, a driver or a cutting tool (paragraph 98 notes that the display/user interface is included in the housing 107 of the handpiece 100 which includes a working element 105 of paragraph 97).
Regarding claim 21, Singh in view of Barrera and Inkpen teaches all the limitations of claim 20.
Singh teaches further being mounted to a cutting tool ([0022] discloses a surgical reamer or reciprocating saw)), but Singh in view of Barrera and Inkpen fails to teach that the cutting tool includes a template with a defined entry or exit site.
However, Inkpen further teaches the cutting tool includes a template with a defined entry or exit site (paragraphs 272-273 include determination of entry and exit sites according to a predetermined pattern of the cutting tool).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh in view of Barrera such that the cutting tool includes a template with a defined entry or exit site, as taught by Inkpen, providing the user unobstructed views of the region of interest (paragraph 271) while also providing the user with positional information of the handpiece (paragraph 272), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy of measurements ([0004]-[0005]).
Claims 22-24 and 26-27 rejected under 35 U.S.C. 103 as being unpatentable over Singh in view of Barrera, as applied to claim 1 above, and further in view of Kumar, et al., US 20150201918.
Regarding claim 22, Singh in view of Barrera teaches all the limitations of claim 16.
Singh in view of Barrera does not teach the surgical guidance system further being configured to set a boundary distance for intervention by the work piece as a safety parameter.
However, within the same field of endeavor, Kumar teaches a surgical handpiece 100 of fig. 1 and [0097] comprising position, motion and orientation sensors ([0203]), the handpiece further being configured to set a boundary distance for intervention by the work piece as a safety parameter (“FIG. 30 is a schematic block diagram of one embodiment of a system-level redundancy architecture for an inertial navigation system in which three different sensor groups (Inertial Systems 1, 2, and 3) provide inertial input data to a fault-tolerant control management system” and “In order to achieve fail-operational/fail-safe operation, preferably at least three inertial systems are used.” [0225]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh as modified by Barrera such that the surgical guidance system is further configured to set a boundary distance for intervention by the work piece as a safety parameter, as taught by Kumar, to improve precision control, reliable operation over time and/or predictable failure modes for surgical procedures ([0006]), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy and reliability of measurements ([0004]-[0005]).
Regarding claim 23, Singh in view of Barrera teaches all the limitations of claim 1.
Singh in view of Burroughs does not the surgical guidance system further being configured for optimization of a specific surgical procedure by enabling uploading of information relating to a fracture pattern, relative location of a fastener, or patient specific anatomic information.
However, Kumar further teaches the surgical guidance system further being configured for optimization of a specific surgical procedure by enabling uploading of information relating to a fracture pattern, relative location of a fastener, or patient specific anatomic information ([0211] indicates feedback for precise torque control based on conditions of the handpiece).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh as modified by Barrera such that the surgical guidance system is further configured for optimization of a specific surgical procedure by enabling uploading of information relating to a fracture pattern, relative location of a fastener, or patient specific anatomic information, as taught by Kumar, to improve precision control, reliable operation over time and/or predictable failure modes for surgical procedures ([0006]), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy and reliability of measurements ([0004]-[0005]).
Regarding claim 24, Singh in view of Barrera teaches all the limitations of claim 23.
Singh further teaches wherein the specific surgical procedure is a spinal surgery ([0071] indicates that use of a sensor during a replacement procedure of a patient’s anatomy including a spine).
Regarding claim 26, Singh in view of Barrera teaches all the limitations of claim 1.
Singh in view of Burroughs does not teach the surgical guidance system further comprising at least one linear potentiometer.
However, Kumar further teaches at least one linear potentiometer (“The amount of displacement (and therefore the amount of acceleration) can be electrically measured by, for example, a linear potentiometer 191” [0173]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh as modified by Barrera such that the surgical guidance system further comprises at least one linear potentiometer, as taught by Kumar, to improve precision control, reliable operation over time and/or predictable failure modes for surgical procedures ([0006]), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy and reliability of measurements ([0004]-[0005]).
Regarding claim 27, Singh in view of Barrera teaches all the limitations of claim 16.
Singh Burroughs does not teach the surgical guidance system further comprising at least one linear potentiometer.
However, Kumar further teaches at least one linear potentiometer (“The amount of displacement (and therefore the amount of acceleration) can be electrically measured by, for example, a linear potentiometer 191” [0173]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to configure Singh as modified by Barrera such that the surgical guidance system further comprises at least one linear potentiometer, as taught by Kumar, to improve precision control, reliable operation over time and/or predictable failure modes for surgical procedures ([0006]), with a reasonable expectation of success, as modified Singh is also concerned with providing a system with improved accuracy and reliability of measurements ([0004]-[0005]).
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 Farouk A Bruce whose telephone number is (408)918-7603. The examiner can normally be reached Mon-Fri 8-5pm PST.
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/FAROUK A BRUCE/ Examiner, Art Unit 3793
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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