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 1-20 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.
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.
Claims 1, 3, 6, 8, 13-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu (US20130237811) and further in view of Ryan (US20180168740), and Downey (US20090093715).
Regarding claims 1 and 6, Mihailescu discloses a method of tracking a medical instrument (Title – “Methods and systems for tracking and guiding sensors and instruments”), the method comprising: [claim 1]
a system for tracking a medical instrument (Title – “Methods and systems for tracking and guiding sensors and instruments”), the system comprising: [claim 6]
an ultrasound probe configured to capture ultrasound data ([0150] – “the 2-dimensional images created by the ultra-sound scanner”, [0174] – “FIGS. 11A-11C show examples of ultrasound imaging probes”);
a camera coupled to the ultrasound probe (Figs. 10A-12B, [0174] – “FIGS. 11A-11C show examples of ultrasound imaging probes with tracking capability using ranging cameras mechanically registered to the ultrasound probe”), the camera configured to capture image data ([0016] – “an image captured by the camera”);
a […] marker […] coupled to the medical instrument ([0072] – “fiducial markers placed on instruments”)[…]; and
a computing device ([0176] – “computing and visualization units”) configured to:
dewarp the image data ([0113] – “the image frames have to be rectified to correct for the distortion of the optics and to account for the response of the camera to points at various positions in space”);
search for the […] marker in the dewarped image data (Fig. 6 step 602 which is the identification of the fiducial object occurs after the image is rectified in step 601, [0104] – “An example of an application using this setup is the intraoperative use of an ultrasound scanner along other surgical instruments. The ultrasound scanner and the surgical instruments can each of them be fitted with computer vision camera systems, or some of the components can comprise elements which act as fiducial elements”, therefore the fiducials are placed on instruments which can include surgical instruments, one with ordinary skill in the art would find it obvious to provide a sterile surgical environment by providing single-use disposable fiducials);
extract an identification from the face portion of the […] marker ([0109] – “Each rigid piece can have a pattern similar to the QR or AR codes, but optimized for pose estimate determination. An example of such a fiduciary is shown in FIG. 5”, [0111] – “The middle pattern 509 will comprise a distinct binary code that will uniquely identify the corners 505, 506, 507, and 508, as well as the fiducial type, index, and the relative position of the pattern within the whole fiducial”, therefore the coded information would be extracted which includes the fiducial type identification, the portion of the fiduciary with the pattern can be considered the face portion);
compare fiducials with a known geometry ([0098] – “A perspective n-point algorithm can be used on the computer 305 to process the apparent shape of the fiducial as seen by the light sensor 302 to determine the relative translation and rotation of a coordinate system 312”);
determine a pose ([0114] – “identifies the fiducial object or fiducial marker in the field of view, and uses its apparent shape to determine the position and orientation of the computer vision camera in respect to that fiducial object in the following pose estimator step 603”);
determine a location of the medical instrument relative to the ultrasound probe ([0173] – “track and spatially register the ultrasound probe in respect to the patient and other instruments”);
Conversely Mihailescu does not teach a disposable marker comprising a face portion and a base portion, the base portion comprising a connector coupled to the medical instrument, wherein the face portion is directly coupled to the base portion and extends away from the base portion to form a space that has an angle of at least 20 degrees and less than 90 degrees between the base portion and the face portion;
overlay a three-dimensional projection of the medical instrument onto the ultrasound data.
However Ryan discloses a disposable marker comprising a face portion and a base portion, the base portion comprising a connector coupled to the medical instrument, wherein the face portion is directly coupled to the base portion and extends away from the base portion to form a space that has an angle of at least 20 degrees and less than 90 degrees between the base portion and the face portion (As seen in Figs. 11 and 12 the marker can be removed from the tool therefore it is disposable, As seen in Fig. 12 reproduced below the marker 1104 has a face portion that contains fiducials and a base portion comprising a connector portion [post 1200] that connects to the medical instrument, it can be seen in Fig. 12 that the face portion is directly coupled to the base portion and extends away from the base portion to form a space and although it is not explicitly disclosed it can be seen that the angle is 90 degrees or close to 90 degrees);
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Ryan is an analogous art considering it is in the field of using a marker for tracking a medical instrument.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system of Mihailescu to incorporate the marker of Ryan to achieve the same results. One would have motivation to combine because as seen in Fig. 24 it would allow the camera to have a good view of the fiducials from the working position of the tool to determine the pose of the tool.
Conversely Mihailescu, Ryan do not teach overlay a three-dimensional projection of the medical instrument onto the ultrasound data.
However Downey overlay a three-dimensional projection of the medical instrument onto the ultrasound data ([0097] – “(a) a 3D display of all relevant information with superimposed planned needle trajectory before needle insertion”).
Downey is an analogous art considering it is in the field of tracking the location of an instrument.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system of Mihailescu to incorporate the projection overlay of Downey to achieve the same results. One would have motivation to combine because it provides guidance to targeted locations.
Regarding claims 3 and 8, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claims 1 and 6.
Mihailescu further discloses wherein the computing device is further configured to locate one or more fiducials ([0114] – “The second computer vision analysis step 602 identifies the fiducial object or fiducial marker in the field of view”).
Regarding claim 13, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claim 6.
Mihailescu further discloses wherein the computing device is configured to determine the pose based on a position of one or more points of the […] marker (Fig. 4B, [0108] – “In FIG. 4B, the fiducial object includes a frame 403 that supports four spherical objects 402. These spherical objects can be either devices actively emitting light, such as light emitting diodes (LEDs), or can be objects made from a material that is efficient at diffusely reflecting the IR or visual radiation”, [0114] – “step 602 identifies the fiducial object or fiducial marker in the field of view, and uses its apparent shape to determine the position and orientation of the computer vision camera in respect to that fiducial object in the following pose estimator step 603” therefore the points [spheres] of the fiducial object of Fig. 4B would be used to determine the pose).
Conversely Mihailescu does not teach the disposable marker,
However Ryan discloses the disposable marker (As seen in Figs. 11 and 12 the marker can be removed from the tool therefore it is disposable, [0109] – “optical marker 1104 attaches to the impactor 1106 in a reproducible way by insertion of an indexed post 1200 into an indexed hole 1202”),
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system of Mihailescu to incorporate the marker of Ryan to achieve the same results. One would have motivation to combine because as seen in Fig. 24 it would allow one to detach the marker after use to provide sterility.
Regarding claim 14, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claim 6.
Mihailescu further discloses further comprising a second camera coupled to the ultrasound probe (Fig. 11C, [0175] – “FIG. 11C shows a front view of an embodiment with two cameras”).
Regarding claim 15, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claim 6.
Mihailescu does not explicitly teach wherein the second camera is disposed on a face of the ultrasound probe that is perpendicular to the camera.
As cited above Mihailescu discloses a second camera coupled to the probe. It would be obvious for one with ordinary skill in the art to provide the second camera on a face of the probe that is perpendicular to the first camera because it would provide a larger field of view around the circumference of the probe and therefor provide tracking for multiple sides of the probe.
Regarding claim 16, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claim 6.
Conversely Mihailescu doesn’t explicitly teach wherein the disposable marker includes a connector.
However Ryan discloses wherein the disposable marker includes a connector ([0109] – “the optical marker 1104 attaches to the impactor 1106 in a reproducible way by insertion of an indexed post 1200 into an indexed hole 1202”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system of Mihailescu to incorporate the marker of Ryan to achieve the same results. One would have motivation to combine because as seen in Fig. 24 it would allow one to detach the marker after use to provide sterility.
Regarding claim 20, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claims 6 and 16.
Conversely Mihailescu doesn’t explicitly teach wherein the disposable marker is coupled to the medical instrument via the connector.
However Ryan discloses wherein the disposable marker is coupled to the medical instrument via the connector (Figs. 11 and 12, [0109] – “the optical marker 1104 attaches to the impactor 1106 in a reproducible way by insertion of an indexed post 1200 into an indexed hole 1202”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system of Mihailescu to incorporate the marker of Ryan to achieve the same results. One would have motivation to combine because as seen in Fig. 24 it would allow one to detach the marker after use to provide sterility.
Claims 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu (US20130237811), Ryan (US20180168740), and Downey (US20090093715) as applied to claims 1 and 6 above, and further in view of Mountney (US20120296202).
Regarding claims 2 and 7, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claims 1 and 6.
Conversely Mihailescu does not teach wherein the computing device is configured to determine the pose by translating the disposable marker in a three-dimensional space based on a position of fiducials represented in the image data.
However Ryan discloses the disposable marker (As seen in Figs. 11 and 12 the marker can be removed from the tool therefore it is disposable, [0109] – “optical marker 1104 attaches to the impactor 1106 in a reproducible way by insertion of an indexed post 1200 into an indexed hole 1202”),
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system of Mihailescu to incorporate the marker of Ryan to achieve the same results. One would have motivation to combine because as seen in Fig. 24 it would allow one to detach the marker after use to provide sterility.
Conversely Mihailescu and Ryan do not teach wherein the computing device is configured to determine the pose by translating the […] marker in a three-dimensional space based on a position of fiducials represented in the image data.
However Mountney discloses wherein the computing device is configured to determine the pose by translating the […] marker in a three-dimensional space based on a position of fiducials represented in the image data (Abstract – “A 2D location of an ultrasound probe is detected in the fluoroscopic image. A 3D pose of the ultrasound probe is estimated based on the detected 2D location of the ultrasound probe in the fluoroscopic image”).
Mountney is an analogous art considering it is in the field of determining a pose of a medical device within an image.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system of Mihailescu to incorporate the pose determination using a translation to a 3D space of Mountney to achieve the same results. One would have motivation to combine because it provides a three dimensional position of a device which could provide better a better navigation of the device.
Claims 4 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu (US20130237811), Ryan (US20180168740), and Downey (US20090093715) as applied to claims 1 and 6 above, and further in view of Bracken (US20170079600).
Regarding claims 4 and 9, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claims 1 and 6.
Conversely Mihailescu does not teach wherein the computing device is configured to determine the location of the medical instrument by using a known three-dimensional model of the medical instrument.
However Bracken discloses wherein the computing device is configured to determine the location of the medical instrument by using a known three-dimensional model of the medical instrument ([0021] – “In an example, the model provision unit is further configured to provide a 3D model of the TEE probe. The 3D model of the TEE probe can be e.g. 3D CAD model. For example, a computer model of the TEE probe head geometry is used to locate the position and orientation of the TEE probe in the live X-ray image”).
Bracken is an analogous art considering it is in the field of determining a position of a medical device within an image.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system of Mihailescu to incorporate the determination of a location using a model of the instrument of Bracken to achieve the same results. One would have motivation to combine because it provides a more accurate determination of the position of the instrument when combined with the identification of fiducial markers.
Claims 5 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu (US20130237811), Ryan (US20180168740), and Downey (US20090093715) as applied to claims 1 and 6 above, and further in view of Schmoll (US20130006270).
Regarding claims 5 and 10, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claims 1 and 6.
Conversely Mihailescu does not teach wherein the computing device is configured to retrieve the known geometry from a look up table.
However Schmoll discloses wherein the computing device is configured to retrieve the known geometry from a look up table ([0047] – “the marker data can then be used to ascertain a geometry of markers, in particular the positions of markers relative to one another (their specific geometric arrangement) when used in the marker device. By comparing the determined geometry of the markers with the identity data in the look-up table, the marker device and preferably also the object connected to it can be identified”).
Schmoll is an analogous art considering it is in the field of determining a position of a medical device using markers.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method and system of Mihailescu to incorporate the retrieval of a known geometry from a look up table of Schmoll to achieve the same results. One would have motivation to combine because it provides a quick way for the computer to determine the known geometry of the marker and possible additional information about the marker and the instrument attached to the marker when may provide useful information during the procedure.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu (US20130237811), Ryan (US20180168740), and Downey (US20090093715) as applied to claim 6 above, and further in view of Stopp (US20200193622).
Regarding claim 11, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claim 6.
Conversely Mihailescu does not teach wherein the identification includes an instrument manufacturer, an instrument model, or both.
However Stopp discloses wherein the identification includes an instrument manufacturer, an instrument model, or both ([0276] – “tracking markers of at least one of the groups form a pattern providing a predetermined code for the properties of the device”, [0282] – “the code based on the above features may be a biunique code assigned to a single specific instrument or device. On the other hand, the code may give an indication as to specific properties of the instrument or device, such as manufacturer, type, length, material etc.”).
Stopp is an analogous art considering it is in the field of using coded markers to track a device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Mihailescu to incorporate the identification including information about the instrument of Stopp to achieve the same results. One would have motivation to combine because it would readily provide information that may be useful in the procedure for navigation purposes.
Regarding claim 12, Mihailescu, Ryan, Downey and Stopp disclose all the elements of the claimed invention as cited in claims 6 and 11.
Conversely Mihailescu does not teach wherein the computing device is configured to determine a length of the medical instrument based on the instrument manufacturer, the instrument model, or both.
However Stopp discloses wherein the computing device is configured to determine a length of the medical instrument based on the instrument manufacturer, the instrument model, or both ([0276] – “tracking markers of at least one of the groups form a pattern providing a predetermined code for the properties of the device”, [0282] – “the code based on the above features may be a biunique code assigned to a single specific instrument or device. On the other hand, the code may give an indication as to specific properties of the instrument or device, such as manufacturer, type, length, material etc.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Mihailescu to incorporate the identification including information about the instrument of Stopp to achieve the same results. One would have motivation to combine because it would readily provide information that may be useful in the procedure for navigation purposes.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu (US20130237811), Ryan (US20180168740), and Downey (US20090093715) as applied to claim 6 above, and further in view of Kohli (US20190223958).
Regarding claim 17, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claims 6 and 16.
Conversely Mihailescu does not teach wherein the connector is a luer lock connector.
However Kohli discloses wherein the connector is a luer lock connector (Figs. 12E and 12F, [0160] – “FIGS. 12E and 12F illustrate various embodiments of optical markers attached to Luer lock mechanisms, to attach to and track needles”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Mihailescu to incorporate the marker including a luer lock connector of Kohli to achieve the same results. One would have motivation to combine because it would allow one to provide a secure attachment of the markers to the tool while also providing means to detach the marker to provide sterile markers or to replace markers.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu (US20130237811), Ryan (US20180168740), and Downey (US20090093715) as applied to claim 16 above, and further in view of Tillett (US20200155238).
Regarding claim 18, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claims 6 and 16.
Conversely Mihailescu does not teach wherein the connector is a snap connector.
However Tillett discloses wherein the connector is a snap connector ([0034] – “The marker device 219 may be locked to the cannula 201 using a suitable attachment mechanism, such as…a snap-fit connector”).
Tillett is an analogous art considering it is in the field of using markers to track a device.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Mihailescu to incorporate the marker including a snap-fit connector of Tillett to achieve the same results. One would have motivation to combine because it would allow one to provide a secure attachment of the markers to the tool while also providing means to detach the marker to provide sterile markers or to replace markers.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Mihailescu (US20130237811), Ryan (US20180168740), and Downey (US20090093715) as applied to claim 16 above, and further in view of Malackowski (US20150025367).
Regarding claim 19, Mihailescu, Ryan, and Downey disclose all the elements of the claimed invention as cited in claims 6 and 16.
Conversely Mihailescu does not teach wherein the connector is a slip fit connector.
However Malackowski discloses wherein the connector is a slip fit connector ([0190] – “Marker head 458 is formed with two diametrically opposed, outwardly extending ears 470. Marker ears 470 are dimensioned to slip fit into shaft slots 468”).
Malackowski is an analogous art considering it is in the field of markers used for position tracking.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Mihailescu to incorporate the marker including a slip-fit connector of Malackowski to achieve the same results. One would have motivation to combine because it would allow one to provide a secure attachment of the markers to the tool while also providing means to detach the marker to provide sterile markers or to replace markers.
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 RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Koharski can be reached on 571-272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797