DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6-7, 9, 12, 14 and 15 are rejected under 35 U.S.C. 102(a)(1) or 102 (a)(2) as being anticipated by Berman et al., US 20230210604 A1 ("Berman").
Regarding claim 1 and 9, Berman discloses a first surgical instrument and associated method thereof ([0029] “instrument 40 may be any type of shaft-based medical instrument, including an endoscope (such as a ureteroscope or bronchoscope), catheter (such as a steerable or non steerable catheter), needle, nephroscope, laparoscope, or other type of medical instrument” the instrument associated with second modality/positioning system 380/680 of Fig. 5/6 [0057]/[0079]) comprising a processor ([0032], control system; [0048] - “control circuitry configured to perform certain of the functionality described herein, including the control circuitry 211 of the robotic system 10 and the control circuitry 251 of the control system 50 …The term "control circuitry" is used herein according to its broad and ordinary meaning, and may refer to any collection of processors, processing circuitry ...” ) and an electromagnetic (EM) sensor ([0053] regarding markers and/or sensors 63 comprising one or more conductive coils “configured to generate and/or send sensor position data to another device and/or produce a detectable distortion or signature in an electromagnetic field”, [0065] “a tracked instrument or calibration structure is equipped with two five-degrees-of freedom (DOF) EM sensors/markers”, and/or Fig. 7 and [0081-0084] regarding consolidated marker visible in different modalities including EM) wherein the processor is configured to: sense (i.e., sensing step in claim 9), using the EM sensor , a predicted location of the EM sensor, wherein the predicted location is distorted by an EM field ([0060-0062] or [0079] and illustration Fig. 5/6 - location of EM sensor is predicted by the processor in conjunction with EM positioning system 380/680; [0086] regarding identify areas of deviation between the derived positions in optical space and EM space as indicating electromagnetic distortion), receive (i.e., receiving step in claim 9), from a second surgical instrument, a coordinate system associated with imaging of an area around the EM sensor ([0032],”… imaging/positional information to the physician 5 that is based on certain positioning modalities, such as fluoroscopy, ultrasound, optical/camera imaging, EM field positioning, or other modality”; Fig. 5/6, first modality/positioning system 350/650 of Fig. 5/6 [0059]/[0079] the first modality or imaging system may comprise a fluoroscopic X-ray imaging system or a computed tomography (CT) system associated with a coordinate system, [0063] regarding the positioning system each defining separate reference frames to which markers are detectable within the view field and relating of coordinate system/frame of one positioning system e.g. EM positioning system to another coordinate system/frame of another positioning system e.g. fluoroscopy system); determine (determining step in claim 9) an adjusted location of the EM sensor based on the received coordinate system (e.g., [0068-0070] and illustration Fig. 5 regarding transform “X”); and output the adjusted location of the EM sensor ([0032], [0064] EM-fluoroscopy registration used to update the position of the instrument relative to anatomy/image).
Regarding claims 4 and 12, see discussion in claim 1 above, the first surgical instrument is a laparoscopic probe ([0029] instrument 40 is a laparoscope); the EM sensor is a magnetic tracker ([0023] “Electromagnetic (EM) tracking systems and fiber optic tracking systems can provide real-time instrument tracking. EM tracking generally functions by detecting/ determining the position/orientation of EM sensing coil(s) (i.e., an EM marker/sensor) in a fluctuating magnetic field”, [0053], [0060]); the second surgical instrument is a moveable CT machine ([0056]); the EM field causing distortion of the predicted location is created by proximity of the moveable CT machine to the first surgical instrument ([0086] distortion caused by for example C-arm or other metal structure in vicinity of generated field); and the processor being configured to determine the adjusted location of the EM sensor based on the received coordinate system comprises the processor being configured to align expected anatomy associated with the predicted location with anatomy in the area around the EM sensor associated with the received coordinate system ([0064], [0068-0070]).
Regarding claims 6 and 14, see [0064] regarding “registration, when the EM sensor marker(s) 367 are integrated into a tracked instrument ( e.g., scope) are localized and registered to an image space ( e.g., fluoroscopy image(s)) of the anatomy such that the position of the instrument is determined relative to the anatomical image space, a positionally-accurate representation of the instrument can be provided in the coordinate frame of the anatomical image(s). As the instrument moves through the patient, the tracking information of the marker(s) can be used to update the position of the instrument relative to the anatomy/image such that the representation of the instrument can be displayed moving in real-time in an anatomical image” and discussion regarding monitoring distortion in [0086]. It follows that, an Em device causing distortion would necessarily be within the range of the EM monitoring device (i.., first distance which defines the range wherein EM tracking is possible) and the first instrument must necessarily be at a second distance from the EM device that is less than the distance between the EM monitoring device and the EM sensor (i.e., within range of EM tracking defined by the EM device and EM monitoring device) for tracking purposes and monitoring of distortion as discussed in [0086]. The accounting of distortion would be used to adjust location of EM sensor.
Regarding claims 7 and 15, see [0064] regarding “registration, when the EM sensor marker(s) 367 are integrated into a tracked instrument ( e.g., scope) are localized and registered to an image space ( e.g., fluoroscopy image(s)) of the anatomy such that the position of the instrument is determined relative to the anatomical image space, a positionally-accurate representation of the instrument can be provided in the coordinate frame of the anatomical image(s). As the instrument moves through the patient, the tracking information of the marker(s) can be used to update the position of the instrument relative to the anatomy/image such that the representation of the instrument can be displayed moving in real-time in an anatomical image”, i.e., as the instrument moves, an updated (adjusted) location is redetermined as a result of a change in positional relationship between the first and second surgical instrument during tracking.
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 2-3, 5, 10-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Berman as applied to claim1 or 9 above, and further in view of Graetzel et al., US 20210059766 A1 "Graetzel".
Regarding claims 2-3 and 10-11, as to claims 2 and 10, see [0086] regarding tracking motion of the marker, thus monitoring distortion caused by proximity of a surgical instrument (“Such distortion may be caused by, for example, the presence of a fluoroscopy C-arm or other metal structure in the vicinity of the generated field”, examiner note: distortion is due to proximity and is expected to increase or decrease due to change in position) and adjusting the adjusted location of EM sensor based on reduced distortion is done via either localization computations that account for or cancel out the distortion as discussed in [0086], here, Berman differs with the claimed invention in that Berman in that the marker being tracked is for the first surgical instrument and not the second surgical instrument.
As to claims 3 and 11, see [0064] regarding “registration, when the EM sensor marker(s) 367 are integrated into a tracked instrument ( e.g., scope) are localized and registered to an image space ( e.g., fluoroscopy image(s)) of the anatomy such that the position of the instrument is determined relative to the anatomical image space, a positionally-accurate representation of the instrument can be provided in the coordinate frame of the anatomical image(s). As the instrument moves through the patient, the tracking information of the marker(s) can be used to update the position of the instrument relative to the anatomy/image such that the representation of the instrument can be displayed moving in real-time in an anatomical image”. Berman thus discloses the aspect of receiving registration information of registered elements on a surgical instrument; monitoring positional changes of the surgical instrument based on the registration information; and adjust the adjusted location of the EM sensor based on the monitored positional changes, here, Berman also differs with the claimed invention in that Berman does not explicitly disclose that the surgical instrument is the second surgical instrument.
Attention is directed to Graezel in the same field of endeavor of electromagnetic distortion and compensation ([abstract]), Graezel discloses in [0123] an ultrasound imager (“radial endobronchial ultrasound (REBUS) probe”) used to provide images and can cause local EM distortions that may affect an EM sensor on an instrument. At the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to have applied the ultrasound imager in the form of an ultrasound imaging probe as the second surgical instrument in Berman, to perform the same function of providing a coordinate system associated with an imaging area around the EM sensor while monitoring distortion caused by proximity of the ultrasound imaging probe, to arrive at the claimed invention, because Berman discloses an ultrasound imager as an alternative second surgical instrument and Graezel discloses an ultrasound imaging probe as a known ultrasound imager in the same field of endeavor.
Regarding claims 5 and 13, Berman as discussed above discloses in [0032] “… imaging/positional information to the physician 5 that is based on certain positioning modalities, such as fluoroscopy, ultrasound …” and further in [0041], “… tracking of the position of instrumentation robotically advanced within the patient can be facilitated by the use of a plurality of positioning modalities, including, for example, fluoroscopy, EM field sensing, optical imaging, robotic pose estimation, ultrasound, and the like”, [0056] “… the anatomical space in which the scope 40 or other instrument may be localized … Various positioning/imaging modalities may be implemented to provide images/representations of the anatomical space. Suitable imaging subsystems include, for example, X-ray, fluoroscopy, CT, PET, PET-CT, CT angiography, Cone-Beam CT, 3DRA, single-photon emission computed tomography (SPECT), MRI, Optical Coherence Tomography (OCT), and ultrasound”, i.e., Berman sets forth that the second surgical instrument that provides a coordinate system associated with imaging around the EM sensor could either of the modalities mentioned above, to include ultrasound.
Berman therefore does not explicitly disclose wherein the second surgical instrument is an ultrasound imaging probe [claim 5], however, following the discussion in claim 1 or 9 above, the second surgical instrument is an ultrasound imager (see [0056] positioning/imaging modality is ultrasound, hence an ultrasound imager) and the EM field causing distortion of the predicted location is created by proximity of the ultrasound imager and a medical object ([0086] distortion caused by for example C-arm or other metal structure in vicinity of generated field); and the processor being configured to determine the adjusted location of the EM sensor based on the received coordinate system comprises the processor being configured to align expected anatomy associated with the predicted location with anatomy in the area around the EM sensor associated with the received coordinate system ([0064], [0068-0070]).
Attention is directed to Graezel in the same field of endeavor of electromagnetic distortion and compensation ([abstract]), Graezel discloses in [0123] an ultrasound imager (“radial endobronchial ultrasound (REBUS) probe”) used to provide images and can cause local EM distortions that may affect an EM sensor on an instrument. At the time of filing the claimed invention, it would have been obvious to one of ordinary skill in the art to have applied the ultrasound imager in the form of an ultrasound imaging probe as the second surgical instrument in Berman, to perform the same function of providing a coordinate system associated with an imaging area around the EM sensor, to arrive at the claimed invention, because Berman discloses an ultrasound imager as an alternative second instrument and Graezel discloses an ultrasound imaging probe as a known ultrasound imager in the same field of endeavor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BONIFACE N NGANGA whose telephone number is (571)270-7393. The examiner can normally be reached Mon. - Thurs. 5:30 am - 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANNE M KOZAK can be reached at (571) 270-0552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BONIFACE N NGANGA/Primary Examiner, Art Unit 3797
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