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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/30/2025 is being considered by the examiner.
Claim Objections
Claims 4-18 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims have not been further treated on the merits.
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.
Claims 1-2 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kheradpir et al. (US 20180140223 A1), hereinafter Kheradpir, and in view of Tien et al. (US 20110054449 A1), hereinafter Tien, and in further view of Chen et al. (US 20210177520 A1).
Regarding claim 1, Kheradpir teaches a calibration block (Fig. 7, element 600 – calibration block) for calibrating a hand-held surgical tool (Fig. 5, element 500 – tracked instrument, para. 0067 (calibration block 600 may be used to calibrate a medical tool having a tool tracking marker, such as the pointer tool 500 having the tracking markers 510)) coupled to an end effector (Fig. 5, element 504 – shaft, Fig. 5, element 502- tip), the calibration block comprising:
a handle extending along a handle axis (see Fig. 1 below);
a frame coupled to the handle and surrounding the handle axis (Fig. 7, element 602 – frame),
the frame comprising a first frame member (Fig. 7, element 616 – top side) and a second frame member (Fig. 7, element 618 – bottom side) each defining a calibration feature (Fig. 7, element 630 – retaining orifice, Fig. 7, element 606 – divot),
wherein a calibration feature is configured to receive the end effector or be engaged by the end effector (para. 0069 (The tip 502 of the medical tool 500 is insertable into the divot 606 to abut against a floor of the divot 606)),
wherein a calibration feature of the first frame member is oriented in a first direction, and wherein a calibration feature of the second frame member is oriented in a second direction, the first direction being different from the second direction (see Fig. 1 below); and
at least three fiducial markers coupled to the frame (Fig. 7, element 604 – tracking marker, para. 0068 (typically at least three tracking markers 604 will be attached to a same side of the frame 602));
wherein the handle extends in a third direction from the frame, and wherein the at least three fiducial markers extend in a fourth direction from the frame, the fourth direction being opposite from the third direction (see Fig. 1 below).
Kheradpir does not disclose the first frame member and the second frame member comprising a plurality of calibration features.
Tien teaches a calibration block (Fig. 2A, element 32 – calibration block) for calibrating a hand-held surgical tool (Fig. 2A, element 20 – surgical tool) coupled to an end effector (Fig. 2A, element 22 – end), the calibration block comprising:
a frame comprising a first frame member (Fig. 2A, top side of element 32) defining a plurality of calibration features (Fig. 2A, element 324 – tool inserting portion)
wherein a calibration feature of the plurality of calibration features is configured to receive the end effector or be engaged to the end effector (para. 0024 (tool inserting portion 324 to be inserted by a pointed end 22 of the surgical tool 20. Each of the said tool inserting portion 324 is formed as a calibration bore having a different bore diameter));
and a second frame member (Fig. 2A, bottom side of element 32).
Tien does not teach the second frame member comprising a plurality of calibration devices.
Chen teaches a calibration block (Fig. 1, element 100 – calibration device) for calibrating a hand-held surgical tool coupled to an end effector (Fig. 1, element 200 – surgical tool), the calibration block comprising:
a handle extending along a handle axis (Fig. 2, element 110a – grip portion, para. 0032 (grip portion is provided for user to grip);
a frame coupled to the handle and surrounding the handle axis (Fig. 1, element 110 – base), the frame comprising a frame member (Fig. 1, element 120 – instrument holder) defining a plurality of calibration features (Fig. 1, element 122a – insertion hole)
wherein a calibration feature of the plurality of calibration features is configured to receive the end effector or be engaged to the end effector (para. 0030 (at least one insertion hole… surgical instrument is able to be inserted into the insertion hole able to be rotated or swung selectively with the instrument holder 120); and
at least three fiducial markers coupled to the frame (Fig. 1, element 130 – reference frame marker, para. 0030 (reference marker are image sensors or radio frequency components)).
Kheradpir, Tien, and Chen are all considered to be analogous to the claimed invention because they are in the same field of calibrating surgical instruments. Kheradpir teaches a first frame member comprising a calibration feature that holds the surgical tool, as it’s being inserted to the calibration block (Kheradpir, para. 0069). Tien teaches a plurality of calibration features that are calibrations bores, that allow the surgical tool to be inserted to the calibration block (Tien, para. 0024). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kheradpir to incorporate the teachings of Tien and provide a first frame member comprising a plurality of calibration features. Doing so would allow the calibration block to have a plurality of calibration features, that would allow different bore diameters of the end effector of the surgical tool to be calibrated. Such a modification could improve the system by being able to recognize different surgical tool sizes.
Kheradpir teaches a second frame member comprising a divot for calibrating a surgical tool, that has known spatial reference point (Kheradpir, para. 0067). Kheradpir also teaches that the calibration block 600 may further have a second divot 632, formed on the frame 602 for further validating the medical tool 500 dimensions by the medical navigation system, however the second divot lies within the first frame member (Kheradpir, para. 0073). Chen teaches that when a surgical tool is fully inserted into any one of the insertion holes, a coordinate signal is received (Chen, para. 0033-0034). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kheradpir to incorporate the listed teachings of Chen and provide the second frame member comprising a plurality of calibration features. Doing so would allow the calibration block to perform an even increased level of analysis by being able to detect multiple positions of where the surgical tool is being inserted. This can also account for cases where the end effector of the surgical tool may be bent.
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Fig. 1 (from Kheradpir)
Regarding claim 2, Kheradpir (in view of Tien and Chen) further teaches the calibration block comprising the claimed features of any preceding claim. Kheradpir further discloses wherein the plurality of calibration features includes an aperture and/or a divot (para. 0067 (reference point 606 formed on the frame 602. In one example, the reference point may be a divot that is of an appropriate shape for securely receiving the tip 502 of the pointer tool 500)).
Regarding claim 19, Kheradpir teaches a calibration block (Fig. 7, element 600 – calibration block) for calibrating a hand-held surgical tool (Fig. 5, element 500 – tracked instrument, para. 0067 (calibration block 600 may be used to calibrate a medical tool having a tool tracking marker, such as the pointer tool 500 having the tracking markers 510)) coupled to an end effector (Fig. 5, element 504 – shaft, Fig. 5, element 502- tip), the calibration block comprising:
a handle (see Fig. 1 above);
a frame coupled to the handle (Fig. 7, element 602 – frame),
the frame comprising a first frame member (Fig. 7, element 616 – top side) and a second frame member (Fig. 7, element 618 – bottom side) each defining a calibration feature (Fig. 7, element 630 – retaining orifice, Fig. 7, element 606 – divot),
wherein a calibration feature of the plurality of calibration features is configured to be engaged by the end effector (para. 0069 (The tip 502 of the medical tool 500 is insertable into the divot 606 to abut against a floor of the divot 606)),
wherein a calibration feature of the first frame member is oriented in a first direction, and wherein a calibration feature of the second frame member is oriented in a second direction, the first direction being different from the second direction (see Fig. 1 above); and
at least three fiducial markers coupled to the frame (Fig. 7, element 604 – tracking marker, para. 0068 (typically at least three tracking markers 604 will be attached to a same side of the frame 602));
wherein the handle extends in a third direction relative to the frame and wherein the at least three fiducial markers extend in a fourth direction relative to the frame, the fourth direction being opposite from the third direction (see Fig. 1 above).
Kheradpir does not disclose the first frame member and the second frame member comprising a plurality of calibration features.
Tien teaches a calibration block (Fig. 2A, element 32 – calibration block) for calibrating a hand-held surgical tool (Fig. 2A, element 20 – surgical tool) coupled to an end effector (Fig. 2A, element 22 – end), the calibration block comprising:
a frame comprising a first frame member (Fig. 2A, top side of element 32) defining a plurality of calibration features (Fig. 2A, element 324 – tool inserting portion),
wherein a calibration feature of the plurality of calibration features is configured to be engaged to the end effector (para. 0024 (tool inserting portion 324 to be inserted by a pointed end 22 of the surgical tool 20. Each of the said tool inserting portion 324 is formed as a calibration bore having a different bore diameter));
and a second frame member (Fig. 2A, bottom side of element 32).
Tien does not teach the second frame member comprising a plurality of calibration devices.
Chen teaches a calibration block (Fig. 1, element 100 – calibration device) for calibrating a hand-held surgical tool coupled to an end effector (Fig. 1, element 200 – surgical tool), the calibration block comprising:
a handle extending along a handle axis (Fig. 2, element 110a – grip portion, para. 0032 (grip portion is provided for user to grip);
a frame coupled to the handle and surrounding the handle axis (Fig. 1, element 110 – base), the frame comprising a frame member (Fig. 1, element 120 – instrument holder) defining a plurality of calibration features (Fig. 1, element 122a – insertion hole)
wherein a calibration feature of the plurality of calibration features is configured to be engaged to the end effector (para. 0030 (at least one insertion hole… surgical instrument is able to be inserted into the insertion hole able to be rotated or swung selectively with the instrument holder 120); and
at least three fiducial markers coupled to the frame (Fig. 1, element 130 – reference frame marker, para. 0030 (reference marker are image sensors or radio frequency components)).
Kheradpir teaches a first frame member comprising a calibration feature that holds the surgical tool, as it’s being inserted to the calibration block (Kheradpir, para. 0069). Tien teaches a plurality of calibration features that are calibrations bores, that allow the surgical tool to be inserted to the calibration block (Tien, para. 0024). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kheradpir to incorporate the teachings of Tien and provide a first frame member comprising a plurality of calibration features. Doing so would allow the calibration block to have a plurality of calibration features, that would allow different bore diameters of the end effector of the surgical tool to be calibrated. Such a modification could improve the system by being able to recognize different surgical tool sizes.
Kheradpir teaches a second frame member comprising a divot for calibrating a surgical tool, that has known spatial reference point (Kheradpir, para. 0067). Kheradpir also teaches that the calibration block 600 may further have a second divot 632, formed on the frame 602 for further validating the medical tool 500 dimensions by the medical navigation system, however the second divot lies within the first frame member (Kheradpir, para. 0073). Chen teaches that when a surgical tool is fully inserted into any one of the insertion holes, a coordinate signal is received (Chen, para. 0033-0034). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kheradpir to incorporate the listed teachings of Chen and provide the second frame member comprising a plurality of calibration features. Doing so would allow the calibration block to perform an even increased level of analysis by being able to detect multiple positions of where the surgical tool is being inserted. This can also account for cases where the end effector of the surgical tool may be bent.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kheradpir and in view of Tien and in further view of Chen and Bonny et al. (US 20180014888 A1), hereinafter Bonny.
Regarding claim 20, Kheradpir teaches a method (para. 0075 (a method 1400 for verifying and reregistering a medical tool) for calibrating a hand-held surgical tool (para. 0067 (calibration block 600 may be used to calibrate a medical tool having a tool tracking marker, such as the pointer tool 500 having the tracking markers 510)) coupled to an end effector (Fig. 5, element 504 – shaft, Fig. 5, element 502- tip), the method comprising:
providing a calibration block (Fig. 7, element 600 – calibration block),
the calibration block including a handle extending along a handle axis (see Fig. 1 above),
a frame coupled to the handle and surrounding the handle axis (Fig. 7, element 602 – frame),
the frame comprising a first frame member (Fig. 7, element 616 – top side) and a second frame member (Fig. 7, element 618 – bottom side) each defining a calibration feature (Fig. 7, element 630 – retaining orifice, Fig. 7, element 606 – divot), and
at least three fiducial markers coupled to the frame (para. 0068 (typically at least three tracking markers 604 will be attached to a same side of the frame 602));
at least three fiducial markers are within a view of a localizer pose (para. 0076 (surgeon 201 may ensure that the medical tool 500 is placed in the calibration block 600 and that both are clearly visible by the appropriate sensors used by the control and processing unit 300 to see the tool and the calibration block, such as the camera 307 in the case of optical tracking markers));
positioning a surgical device (Fig. 5, element 506 – handle portion) such that at least a portion of the surgical device contacts at least one of the calibration features of the first frame member while the calibration block is in the first pose (para. 0072 (retaining orifice 630 may receive the medical tool such as the pointer tool 500 as the tip 502 of the tool 500 is positioned in the divot 606));
at least a portion of the surgical device contacts at least one of the calibration features of the second frame member while the calibration block (para. 0072 (retaining orifice 630 may serve to hold the tool 500 in an upright position when the tip 502 of the tool 500 rests in the divot 606)).
Kheradpir does not disclose the first frame member and the second frame member comprising a plurality of calibration features, holding the handle of the calibration block with a first hand of a user in a first pose, positioning a surgical device with a second hand of the user, spinning the handle of the calibration block from the first pose to a second pose within the first hand while the fiducial markers of the calibration block remain within the view of a localizer, and positioning the surgical device with a second hand of the user such that at least a portion of the surgical device contacts at least one of the calibration features of the second frame member while the calibration is in the second pose.
Tien teaches a calibration block (Fig. 2A, element 32 – calibration block),
a frame comprising a first frame member (Fig. 2A, top side of element 32) defining a plurality of calibration features (Fig. 2A, element 324 – tool inserting portion)
and a second frame member (Fig. 2A, bottom side of element 32).
Tien does not teach the second frame member comprising a plurality of calibration features, holding the handle of the calibration block with a first hand of a user in a first pose, positioning a surgical device with a second hand of the user, spinning the handle of the calibration block from the first pose to a second pose within the first hand while the fiducial markers of the calibration block remain within the view of a localizer, and positioning the surgical device with a second hand of the user such that at least a portion of the surgical device contacts at least one of the calibration features of the second frame member while the calibration is in the second pose.
Chen teaches a calibration block (Fig. 1, element 100 – calibration device),
the calibration block including a handle extending along a handle axis (Fig. 2, element 110a – grip portion, para. 0032 (grip portion is provided for user to grip);
a frame coupled to the handle and surrounding the handle axis (Fig. 1, element 110 – base), the frame comprising a frame member (Fig. 1, element 120 – instrument holder) defining a plurality of calibration features (Fig. 1, element 122a – insertion hole)
at least three fiducial markers coupled to the frame (Fig. 1, element 130 – reference frame marker, para. 0030 (reference marker are image sensors or radio frequency components));
holding the handle of the calibration block with a first hand of a user in a first pose (para. 0032 (grip portion is provided for user to grip));
positioning a surgical device with a second hand of the user (para. 0005 (insertion of a surgical instrument such that the surgical instrument is able to be rotated or swung selectively on the base))
Kheradpir teaches a first frame member comprising a calibration feature that holds the surgical tool, as it’s being inserted to the calibration block (Kheradpir, para. 0069). Tien teaches a plurality of calibration features that are calibrations bores, that allow the surgical tool to be inserted to the calibration block (Tien, para. 0024). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kheradpir to incorporate the teachings of Tien and provide a first frame member comprising a plurality of calibration features. Doing so would allow the calibration block to have a plurality of calibration features, that would allow different bore diameters of the end effector of the surgical tool to be calibrated. Such a modification could improve the system by being able to recognize different surgical tool sizes.
Kheradpir teaches a second frame member comprising a divot for calibrating a surgical tool, that has known spatial reference point (Kheradpir, para. 0067). Kheradpir also teaches that the calibration block 600 may further have a second divot 632, formed on the frame 602 for further validating the medical tool 500 dimensions by the medical navigation system, however the second divot lies within the first frame member (Kheradpir, para. 0073). Chen teaches that when a surgical tool is fully inserted into any one of the insertion holes, a coordinate signal is received (Chen, para. 0033-0034). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kheradpir to incorporate the listed teachings of Chen and provide the second frame member comprising a plurality of calibration features. Doing so would allow the calibration block to perform an even increased level of analysis by being able to detect multiple positions of where the surgical tool is being inserted. This can also account for cases where the end effector of the surgical tool may be bent.
Kheradpir does not explicitly disclose holding the handle of the calibration block with a first hand of a user in a first pose. Chen teaches a handle that a user is able to grip. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kheradpir to incorporate the teachings of Chen and disclose holding the handle of the calibration block with a first hand of a user in a first pose such that at least fiducial markers are within a view of a localizer. A person of ordinary skill in the art would have known that a hand is needed to hold the calibration device, and that the fiducial markers must remain in view of the localizer for tracking.
Kheradpir It would be obvious to anyone in the art that a hand will need to be used to hold the surgical device as Kheradpir teaches a handle portion of the surgical tool (Fig. 5, element 506 – handle portion). It’s rendered obvious that a portion of the surgical device contacts at least one of the calibration features of the first frame member, while the surgical tool is first inserted, thereby engaging with the first frame calibration feature. positioning a surgical device with a second hand of the user (para. 0005 (insertion of a surgical instrument such that the surgical instrument is able to be rotated or swung selectively on the base))
Kheradpir does not explicitly disclose positioning a surgical device with a second hand of the user. Chen teaches that an insertion of a surgical instrument is able to be rotated or swung (Chen, para. 0005). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kheradpir to incorporate the teachings of Chen and disclose positioning a surgical device with a second hand of the user. A person of ordinary skill in the art would have known that a second hand is needed to hold the hand-held surgical tool while the first hand is holding the calibration device, in order to perform the calibration. Additionally, it’s rendered obvious that in order to perform the calibration, a surgical tool must first pass through the calibration features of the first frame, which leads to a first pose.
Kheradpir does not explicitly disclose spinning the handle of the calibration block from the first pose to a second pose within the first hand while the fiducial markers of the calibration block remain within the view of a localizer. However, it would have been obvious to modify the handle of the calibration block, to allow rotation to access the additional calibration features. A person of ordinary skill in the art would have recognized that continuously rotating the surgical tool to engage with the plurality of calibration features, could lead to the bending and deformation of the surgical tool, which can lead to inaccurate tracking. Therefore, incorporating the handle to spin, would simplify the calibration process, and reduce the likelihood of the surgical tool bending.
Kheradpir does not explicitly disclose positioning the surgical device with a second hand of the user such that at least a portion of the surgical device contacts at least one of the calibration features of the second frame member while the calibration is in the second pose. Chen teaches that an insertion of a surgical instrument is able to be rotated or swung (Chen, para. 0005). It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kheradpir to incorporate the teachings of Chen and disclose positioning a surgical device with a second hand of the user. A person of ordinary skill in the art would have known that a second hand is needed to hold the hand-held surgical tool while the first hand is holding the calibration device, in order to perform the calibration. Additionally, it’s rendered obvious that in order to complete the calibration, the surgical tool must contact the calibration features of the second frame.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kheradpir and in view of Tien and in further view of Chen and Grimm et al. (US 20040153191 A1), hereinafter Grimm.
Regarding claim 3, Kheradpir (in view of Tien and Chen) teaches the calibration block comprising the claimed features of any preceding claim.
Kheradpir (in view of Tien and Chen) does not teach wherein the plurality of calibration features includes at least one of a boss, a groove, a protrusion, and a laser marking.
Grimm teaches wherein the plurality of calibration features includes at least one of a boss, a groove, a protrusion, and a laser marking ((Fig. 2, elements 26, 28, and 30), para. 0025 (tapered slots 26, 28, 30 are formed in body 24), 0036 (the space defined by slots 26, 28, 30 are configured to uniquely engage registration device 20 with each of the differently sized hip stems 46 for which registration device 20 is intended for use)).
Kheradpir, Tien, Chen, and Grimm are all considered to be analogous to the claimed invention because they are in the same field of calibrating medical structures with the use of a navigation system. Kheradpir teaches a calibration feature of apertures and divots, that allows for the calibration of a medical instrument. Grimm teaches a calibration feature of grooves that allow for calibration of a structure to be positioned correctly to track within a system. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kheradpir (in view of Tien and Chen) to incorporate the listed teachings of Grimm and provide a plurality of calibration features including a groove. Doing so would allow the shaft from Kheradpir’s medical instrument to be inserted within a groove of the calibration block, which would help to prevent the shaft from being slightly bent or deformed, which can cause inaccurate tracking within the navigation system (Kheradpir, para. 0064).
Conclusion
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/EILEEN ROBLES/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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