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 § 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.
Claim(s) 66, 72, 75, 82, and 85 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2011/0134113 to Ma et al. “Ma”, in view of US2013/0322719 to Dekel et al. “Dekel”.
Regarding claim 66, Ma discloses method comprising:
obtaining one or more first images using a first imaging modality (Paragraph 0062, MRI imaging system 106 obtains an MRI image of a tissue of a patient; Paragraph 0063, wherein the MRI image can be reconstructed into a 3D image of the tissue);
determining first coordinates of one or more anatomical markers relative to an anatomy of a patient based on content of the first images (Paragraph 0073, selection of a landmark within the MRI image, such as an internal tissue landmark, external landmark, or a fiducial skin marker, and determine the relative differences between the coordinates of the target in the MRI image, and the co-ordinates of the target in the tracker co-ordinate space, which would infer determining the coordinates of the selected landmark/marker in the MRI image);
obtaining one or more second images using a second imaging modality (image tissue of the patient with the ultrasound imaging system 104, Paragraph 0071);
determining second coordinates of the one or more anatomical markers relative to the medical [device] tool based on content of the second images (Paragraph 0072, the same landmark selected in the MRI image can be located with the ultrasound probe; Paragraphs 0132 and 0133, step 1610, user positions the ultrasound probe 204 so that the field of view 210 can detect the landmark, and the ultrasound image is displayed, step 1612, the user uses standard measurement tools to measure the distance between the landmark in field of view 210 and the upper right and left corners of field of view 210 of ultrasound probe 204. This distance information can be used to determine the co-ordinates of the landmark in the co-ordinate frame of transducer 206; this reads on the claimed second coordinates of the marker being based on content of the second image, i.e. the position of the marker in the second image and determining the second coordinate by measuring the position of the marker to the upper right and left corners of the image).
Further, Ma teaches determining the relationship between the ultrasound coordinate space, tracker coordinate space, and MRI coordinate such that the position of marker from the ultrasound image can be co-registered with the position of the marker in the MRI image (Paragraph 0133, transforming coordinates from ultrasound image to tracker coordinate space; Paragraph 0142, transforming from tracker coordinate space to MRI coordinate space).
However, Ma does not disclose wherein the method is for controlling motion of a medical tool, and the first coordinates of the one or more anatomical markers in the first image is relative to an anatomy of a patient, the second coordinates of the one or more anatomical markers relative to the medical tool based on the second image, and registering the medical tool to the anatomy of the patient based on the first and second coordinates.
Dekel teaches a similar method of accurate and continuous mapping to track the pose of a surgical instrument in a coordinate reference frame (Paragraph 0071) and a navigation system and method for dynamic mapping of an instrument such as a drill to a scanned image of the anatomical region of the human body (Paragraph 0156, 0167)
Dekel teaches first coordinates of the one or more anatomical markers in the first image is relative to an anatomy of a patient (Paragraph 0086, obtaining MRI volumetric images that depict the anatomical region with the fiducial body; Paragraph 0160, wherein the position of each image sample or voxel in the three-dimensional image, such as those of the fiducial body, is determined from the information found in DICOM format, wherein the positions of the voxels of the image, that includes the fiducial body, reads on the first coordinates; also see Paragraph 0013, operating a data processor to map locations in an interior of the anatomical region to corresponding locations in the three-dimensional volume representation of the interior of the anatomical region based on the mapping transformation; Paragraph 0093, determining the pose, i.e. position and orientation, of the fiducial body that contains multiple individual markers; Paragraph 0096, wherein the fiducial body is correlated with the interior of the anatomical region, and the scanning of the three-dimensional image may be done using a CT or MRI scanner).
Dekel further teaches, the second coordinates of the one or more anatomical markers relative to the medical tool based on the second image (Paragraph 0173, dynamically determining a pose of an instrument relative to the fiducial body, by determining the position of markers on the tool handle, and through the use of an optical camera, Fig. 16, Ref. 1625, and Paragraph 0156, correlate the position of the markers on the tool handle, such as Fig. 16, Ref. 1617 with the markers on the fiducial mounted to the anatomy, such as markers 1637, via the coordinate system transformation process as described in Paragraphs 0162, 0173, and Fig. 16; Paragraph 0186, wherein the registration is based on scanned images, and therefore this image based registration using the optical camera, would result in images that would read on the claimed second image).
Dekel teaches registering the medical tool to the anatomy of the patient based on the first and second coordinates (Paragraph 0014, ; Paragraph 0031, dynamically calculate a spatial mapping between the coordinate frame of the fiducial body and the coordinate frame of an instrument located near the anatomical region, then mapping a location in the anatomical region referenced by the instrument to the three-dimensional volume representation of the at least a part of the fiducial body based on the mapping transformation resulting from the registration process; wherein the coordinate frame of the instrument located near the anatomical region is labeled as “H” in Fig. 16, and determined through the optical camera images of the markers on the instrument as discussed in Paragraph 0173, and the coordinate frame of three-dimensional image is labeled as “P” in Figure 16, and is determined from the volumetric image information such as DICOM information, Paragraph 0160). Dekel specifically teaches in Paragraph 0161, mapping the tool tip to the three dimensional volumetric image of the anatomical region, wherein the tool tip is in relationship to structures and target positions visible in the three-dimensional image, which as discussed in Paragraph 0096, includes the fiducial body with markers, using the transformation processes discussed in Paragraph 0162. The process of transforming from coordinate system H, all the way to coordinate system P would read on registering based on the first and second coordinates.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Ma's invention wherein the first coordinates of the one or more anatomical markers in the first image is relative to an anatomy of a patient, the second coordinates of the one or more anatomical markers are relative to the medical tool based on the second image, and the method includes registering the medical tool to the anatomy of the patient based on the first and second coordinates, as taught by Dekel, in order to be able to dynamically measure a pose of an instrument point to locations in the interior of the anatomical region relative to the fiducial body (Dekel, Paragraph 0193).
Regarding claim 72, the modifications of Ma and Dekel disclose all the features of claim 66 above.
Ma teaches wherein the first imaging modality and the second imaging modality are different (Paragraph 0073, MRI and ultrasound).
Regarding claim 75, the modifications of Ma and Dekel disclose all the features of claim 66 above.
Ma teaches adjusting a position and an orientation of an imaging device from which the second images are obtained so that the one or more anatomical markers are within a field of view of the imaging device (Paragraph 0073, the same landmark selected in the MRI image can be located with the ultrasound probe, and upon location, a mechanism can be provided for capturing coordinates of the representation of the target, Paragraph 0073; the user can then manipulate the position and orientation of a tracked ultrasound probe to align the field of view of the ultrasound probe with the selected anatomical plane, Paragraph 0072).
Regarding claim 82, the modifications of Ma and Dekel disclose all the features of claim 66 above.
Dekel teaches wherein the one or more anatomical markers comprises a first anatomical marker and a second anatomical marker (See Fig. 16 and Paragraph 0156, tool handle fiducial/marker 1615 that can further include markers/trackers 1617, and fiducial body 1645 with markers/trackers 1637; As described in Paragraph 0041, the fiducial body, is detectable by MRI, and the markers/trackers are detectable by the optical tracking camera, Paragraph 0156. Therefore, the fiducial body such as 1645 would read on the first anatomical marker, and the markers/tracker 1637 would read on the second anatomical marker.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, wherein the one or more anatomical markers comprises a first anatomical marker and a second anatomical marker, as taught by Dekel, in order to be able to detect the region marked by the fiducial/marker using two different imaging modalities.
Regarding claim 85, the modifications of Ma and Dekel disclose all the features of claim 66 above.
As disclosed in the claim 66 rejection above, Ma teaches wherein the first and second imaging modalities obtain their images without using light in a visible spectrum (Paragraphs 0064, 0073, MRI, and Paragraphs 0066, 0132, Ultrasound).
Claim(s) 67, 68, 73, and 76 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma, in view of Dekel, as applied to claim 66 above, and further in view of US2009/0036902 to DiMaio et al. “DiMaio”.
Regarding claim 67, the modifications of Ma and Dekel disclose all the features of claim 66 above.
However, the modifications of Ma and Dekel do not disclose wherein registering the medical tool is further based on a kinematic model of an arm supporting an imaging device that captures the second images.
DiMaio teaches wherein registering the medical tool to the anatomy of the patient is further based on a kinematic model of an arm supporting an imaging device that captures the second images (Paragraph 0045, ultrasound probe 150, on arm 150 of system 100, Fig. 1; wherein ultrasound images captured by the ultrasound probe are calibrated and registered with a second imaging device using kinematics of the slave arms 121-124 and their joint positions, Paragraph 0052).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, wherein registering the medical tool is further based on a kinematic model of an arm supporting an imaging device that captures the second images, as taught by DiMaio, in order to calibrate the position of the ultrasound, based on the calibration of the robot arm (Paragraphs 0059, 0127).
Regarding claim 68, the modifications of Ma, Dekel, and DiMaio disclose all the features of claim 67 above.
DiMaio further teaches wherein registering the medical tool to is further based on a kinematic model of an arm supporting the medical tool (Fig. 1 and Paragraph 0052, ultrasound images captured by the LUS probe 150, right and left 2D camera images captured by the stereoscopic endoscope 140, and end effector positions and orientations as determined using kinematics of the slave arms 121-124 and their sensed joint positions, are calibrated and registered with each other, wherein the end effectors are tools 138 or 139 on slave arms 121 and 122 as seen in Fig. 1, and would read on the medical tool).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, wherein registering the medical tool is further based on a kinematic model of an arm supporting the medical tool, as taught by DiMaio, in order to calibrate the position of the medical tool based on the calibration of the robot arm (Paragraphs 0059, 0127).
Regarding claim 73, the modifications of Ma and Dekel disclose all the features of claim 66 above.
However, the modifications of Ma and Dekel do not disclose where the second imaging modality is stereoscopic endoscopy.
DiMaio teaches wherein the second imaging modality is stereoscopic endoscopy (Paragraph 0052, stereoscopic endoscope; DiMaio teaches a plurality of imaging modalities, ranging from ultrasound, Paragraph 0045, to optical camera imaging via stereoscopic endoscope, Paragraph 0052; which could be overlaid with magnetic resonance images, Paragraph 0156).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, where the second imaging modality is stereoscopic endoscopy, as taught by DiMaio, in order to obtain live 2D optical images from the camera in the stereoscopic endoscope (DiMaio, Paragraph 0052).
Regarding claim 76, the modifications of Ma and Dekel disclose all the features of claim 66 above.
However, the modifications of Ma and Dekel do not disclose moving one or more joints of an articulated arm to which the medical tool is mounted.
DiMaio teaches moving one or more joints of an articulated arm to which the medical tool is mounted (Paragraphs 0046, the slave arms comprise active joints that are controlled by a motor to manipulate the slave arms; Paragraph 0050, translate and transfer the mechanical motion of master input devices 107 and 108 to their associated slave arms 121 and 122 through control signals over bus 110 so that the surgeon can effectively manipulate their respective tools 138 and 139; Also see Paragraphs 0065, 0066).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, wherein the method includes moving one or more joints of an articulated arm to which the medical tool is mounted, as taught by DiMaio, in order to allow the surgeon to effectively manipulate their respective tools (DiMaio, Paragraph 0050), and the use of motor controlled joints on the arms are routine and conventional (DiMaio, Paragraph 0046).
Claim(s) 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma, in view of Dekel, as applied to claim 66 above, and further in view of US5,469,847 to Zinreich et al. “Zinreich”.
Regarding claim 69, the modifications of Ma and Dekel disclose all the features of claim 66 above.
Ma teaches wherein each of the one or more anatomical markers comprises an imaging material observable by a first and second imaging modality (Paragraph 0073, MRI and Ultrasound).
However, the modifications of Ma and Dekel do not disclose wherein the marker comprises a body comprising a first material observable to the first imaging modality and a second material observable to the second imaging modality, wherein: the first material is different from the second material; and the second material is disposed concentrically around the first material.
Zinreich teaches an anatomical marker ("adhesive surface marker ... The markers provide means for marking patients", Abstract; multi-modality surface marker 10, Col. 3, lines 60-67) a body (See annotated Fig. 2, below; outer casing 20, a membrane 16, a top membrane 28, and plastic disk 26 with gel 12, See Fig. 2 and Fig. 6, and liquid imaging agent, Col. 4, lines 50-61),
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comprising a first material observable to a first imaging modality (gel 12, Col. 3, lines 61-67; "The gel 12 has a mobile phase suitable for MRI imaging by commercial machines and is sufficiently X-Ray-opaque for adequate imaging on CT or X-Ray", Col 3, line 61 - Col 4, line 4) and a second material observable to a second imaging modality (a liquid imaging agent can be injected into the sealed well 18, see Fig. 6, which is sealed by a top membrane 28, and plastic disk 26, Col. 4, lines 50-61, the liquid imaging agent in the sealed well 18 would read on the body comprising the second material; the liquid imaging agent is observable with PET scans, Col. 4, lines 50-61), wherein the first material is different from the second material (as discussed above, the two imaging agents are clearly different).
Additionally, Zinreich discloses the marker is sterile and completely sealed (Col. 5, line 63 - Col. 6, line 5) and that the gel 12 is injectable (Column 4, Paragraph starting at line 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, wherein each of the one or more anatomical markers comprises: a body comprising a first material observable to a first imaging modality and a second material observable to a second imaging modality, wherein: the first material is different from the second material, as taught by Zinreich, in order to provide a marker that is sterilizable and remain consistent in size and shape, (Col. 5, paragraphs starting at lines 55 and 62).
However, Zinreich does not disclose wherein the second material is disposed concentrically around the first material, wherein the second material is for ultrasound.
However, Zinreich does disclose gel imaging agent for ultrasound (Col. 3, paragraph starting at line 3). Zinreich also teaches that the MRI imaging agent could be liquid (Col. 6, Paragraph starting at line 17).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Zinreich’s marker, wherein the second material is disposed concentrically around the first material, wherein the second material is for ultrasound, as taught by Zinreich, since configuring the multimodality marker such that the inner, first portion of the marker is observable under one imaging modality, and an outer, second portion that is concentric to the first portion is visible in fluorescent imaging, is a simple substitution of one known configuration for another to obtain predictable results (ability to observe the marker in fluorescent imaging and at least a second modality such as MRI) (See MPEP 2143).
Claim(s) 70 and 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma, in view of Dekel, and further in view of Zinreich as applied to claim 69 above, and further in view of US20150011861 to Rahmer et al. "Rahmer",
Regarding claim 70, the modifications of Ma, Dekel, and Zinreich disclose all the features of claim 69 above.
Ma discloses wherein the first imaging modality is MRI (Paragraph 0073).
However, the modifications of Ma, Dekel, and Zinreich do not disclose wherein the second imaging modality is fluorescent imaging.
Rahmer teaches a similar multimodality marker (Title, Abstract), wherein the second imaging modality is fluorescent imaging and the second material is disposed concentrically around the first material (fluorescent marker in portion 14, see Figs Fig. 3A and 3B, and Paragraph 0049, used for optical imaging with fluorescence, Paragraphs 0014 and 0049, which would read on fluorescent imaging; wherein portion 14 is concentric around portion 12, and wherein portion 12 contains a first material, magnetically visible material, Paragraph 0036, such as Resovist®, Paragraph 0037, which is observable using a different imaging modality, magnetic particle imaging, Paragraph 0036; examiner notes that Resovist is also a well-known MRI contrast agent).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as disclose by Ma, Dekel, and Zinreich, wherein the second imaging modality is fluorescent imaging and therefore the second imaging agent reactive to fluorescent imaging, as taught by Rahmer, in order to order to make the marker optically visible (Rahmer, Paragraph 0049), and allows localization of the marker in optical fluorescence imaging (Rahmer, Paragraph 0015) which would enhance the multimodal nature of the marker of Zinreich.
Regarding claim 71, the modifications of Ma, Dekel, Zinreich, and Rahmer disclose all the features of claim 70 above.
As disclosed in the claim 66 rejection above, Ma teaches wherein the body is configured to secure to an external surface of an anatomical feature without penetrating the external surface (the fiducial skin marker is located on the surface of the skin, Paragraph 0073), the anatomical feature being internal to a patient (tissue, Paragraph 0074).
Claim(s) 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma in view of Dekel, as applied to claim 66 above, and further in view of US2009/0270678 Scott et al. “Scott”.
Regarding claim 74, the modifications of Ma and Dekel disclose all the features of claim 66 above.
Scott teaches wherein the second imaging modality is stereoscopic fluorescence imaging (Paragraphs 0141, 0191).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, wherein the second imaging modality is stereoscopic fluorescence imaging, as taught by Scott, in order to provide stereoscopic alternate modality images that identify tissue of clinical interest in addition to stereoscopic visible images that a surgeon normally uses when performing a surgical operation using a teleoperated surgical system (Scott, Paragraph 0088).
Claim(s) 77 and 79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma, in view of Dekel, as applied to claim 66 above, and further in view of Zinreich.
Regarding claim 77, the modifications of Ma and Dekel disclose all the features of claim 66 above.
However, the modifications of Ma and Dekel do not disclose determining a desired location for a first anatomical marker of the one or more anatomical markers on the anatomy of the patient; and applying the first anatomical marker to the desired location.
Zinreich teaches determining a desired location for a first anatomical marker of the one or more anatomical markers on the anatomy of the patient; and applying the first anatomical marker to the desired location (Zinreich teaches the marker also has an adhesive 30, with a removable backing 22 (Col. 4, lines 5-23; Fig. 10, Ref. 30 for adhesive, and Ref. 22 for removable backing; remove the marker from the backing 22 and apply it to the desired location on a patient's skin, Col. 4, line 62 - Col. 5, line 3; affixing to the desired location, infers a desired location has been determined).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, wherein the method includes determining a desired location for a first anatomical marker of the one or more anatomical markers on the anatomy of the patient; and applying the first anatomical marker to the desired location, as taught by Zinreich, in order to provide a marker that is sterilizable and remain consistent in size and shape, (Col. 5, paragraphs starting at lines 55 and 62).
Regarding claim 79, the modifications of Ma, Dekel, and Zinreich disclose all the features of claim 77 above.
Zinreich further discloses wherein the shape of the hollow shell has a major axis configured to be aligned with the anatomical feature (See Figs. 1-4, and 6). With the adhesive being on the underside of the marker (Fig. 10, Ref. 30 for adhesive, and Ref. 22 for removable backing) when applied to the patient's skin (Col. 4, line 62 - Col. 5, line 3), the major axis would be aligned with the skin (i.e. anatomical feature).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma, Dekel, and Zinreich, wherein applying the first anatomical marker comprises aligning a major axis of the first anatomical marker with a feature of the anatomy of the patient, as further taught by Zinreich, in order to substantially improved (in both ease and accuracy) through the use of surface markers which create reference points visible to a multiplicity of imaging (Zinreich, Col. 2, top paragraph).
Claim(s) 78 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma, in view of Dekel, and further in view of Zinreich, as applied to claim 77 above, and further in view of US2013/0274596 to Azizian et al. “Azizian”.
Regarding claim 78, the modifications of Ma, Dekel, and Zinreich disclose all the features of claim 77 above.
However, the modifications of Ma, Dekel, and Zinreich do not explicitly disclose wherein the adhesive is a bio-adhesive.
Azizian teaches using a glue to attach the markers (Paragraph 0065), wherein the glue is biocompatible (Paragraph 0072), which reads on a bio-adhesive.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma, Dekel, and Zinreich, wherein the adhesive is a bio-adhesive, as further taught by Azizian, in order to have an adhesive that can be directly applied to bodily tissue (Azizian, Paragraph 0065).
Claim(s) 80 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma, in view of Dekel, and further in view of Zinreich, as applied to claim 77 above, and further in view of US2008/0281335 to “Fell”.
Regarding claim 80, the modifications of Ma, Dekel, and Zinreich disclose all the features of claim 77 above.
However, the modifications of Ma, Dekel, and Zinreich do not disclose wherein applying the first anatomical marker comprises applying the first anatomical marker using an anatomical marker application tool coupled to an articulated arm.
Fell discloses applying the first anatomical marker comprises applying the first anatomical marker using an anatomical marker application tool coupled to an articulated arm (applicator 16 may be controlled with the assistance of a robotic arm, Paragraph 0021; wherein the applicator is associated with markers and anatomical component, See Fig. Ref. 36).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma, Dekel, and Zinreich, wherein the method includes applying the first anatomical marker comprises applying the first anatomical marker using an anatomical marker application tool coupled to an articulated arm, as taught by Fell, in order to add material or deposits to the anatomical components to create a desired shape (Fell, Paragraph 0012).
Claim(s) 81 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma, in view of Dekel, as applied to claim 66 above, and further in view of US2009/0181104 to Rigotti et al. “Rigotti”.
Regarding claim 81, the modifications of Ma and Dekel disclose all the features of claim 66 above.
As disclosed in the claim 66 rejection above, Dekel teaches mapping the one or more anatomical markers based on the first and second coordinates and one or more pre-operative images (Paragraph 0161, compute and constantly update the mapping from the tool tip 1605 with the coordinate system T 1610 to the three-dimensional volumetric image 1675 of the anatomical region of the patient with the coordinate system P 1680, wherein the three-dimensional volumetric image is pre-acquired and reads on the pre-operative image).
However, Ma and Dekel do not disclose mapping to a surgical plan.
Rigotti teaches mapping to a surgical plan (Paragraph 0040; superimposing together the treatment plan and the 3D position of the markers with respect to the model shown on the monitor; wherein the models are formed pre-surgery, Paragraph 0024, pre-operative, Paragraph 0050).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, wherein the mapping includes mapping to a surgical plan, as taught by Rigotti, in order to improved accuracy in transferring the planned points and pathways 292 into the reality of the surgical procedure (Paragraph 0040).
Claim(s) 83 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma, in view of Dekel, as applied to claim 82 above, and further in view of Azizian.
Regarding claim 83, the modifications of Ma and Dekel disclose all the features of claim 82 above.
However, the modifications of Ma and Dekel do not disclose wherein the first anatomical marker is configured to fluoresce in response to a first wavelength of light and the second anatomical marker is configured to fluoresce in response to a second wavelength of light.
Azizian teaches a fluorescent marker comprising fluorescent dyes (Paragraph 0070, 0072). Multiple dyes with excitation/emission at different wavelengths can be used (Paragraph 0064).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, wherein the different markers of Dekel are marked with dyes that fluoresce in response to different wavelengths of light, as further taught by Azizian, in order to be able to detect markers marked with the first material and differentiate it from markers marked with the second material through excitation/emission at different wavelengths.
Claim(s) 84 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ma, in view of Dekel, as applied to claim 66 above, and further in view of US2013/0158565 to Anvari et al. “Anvari”.
Regarding claim 84, the modifications of Ma and Dekel disclose all the features of claim 66 above.
However, the modifications of Ma and Dekel do not disclose controlling motion of the medical tool relative to the anatomy of the patient based on the registration.
Anvari teaches controlling motion of the medical tool relative to the anatomy of the patient based on the registration (using the real-time intra-operative tracking of anatomical landmarks provides a mechanism of incorporating compensatory motion of the robotic arm to accommodate patient movement, Paragraph 0104).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Ma and Dekel, wherein the method includes controlling motion of the medical tool relative to the anatomy of the patient based on the registration, as taught by Anvari, in order to enhance the precision of the robotic task (Paragraph 0104).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 66-68, 72, 74-76, and 85 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-7 of U.S. Patent No. 11,389,268. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 66, ‘268 discloses a method of controlling motion of a medical tool (“control unit”, Claim 1, line 2, for first and second articulated arms, Claim 1, lines 3 and 4, wherein a medical tool is mounted on the second arm, Claim 1, line 8-9, the method comprising:
obtaining one or more first images (Claim 1, line 11) using a first imaging modality (Claim 1, line 13);
determining first coordinates of one or more anatomical markers relative to an anatomy of a patient based on content of the first images (Claim 1, lines 15-16);
obtaining one or more second images using a second imaging modality (Claim 1, lines 19-20);
determining second coordinates of the one or more anatomical markers relative to the medical tool based on content of the second images (Claim 1, lines 22-24); and
registering the medical tool to the anatomy of the patient based on the first and second coordinates (Claim 1, lines 30-31 ).
Regarding Claim 67, ‘268 discloses wherein registering the medical tool to the anatomy of the patient is further based on a kinematic model of an arm supporting an imaging device that captures the second images (Claim 1, lines 6-7, 19-20, and 30-32).
Regarding claim 68, ‘268 discloses wherein registering the medical tool to the anatomy of the patient is further based on a kinematic model of an arm supporting the medical tool (Claim 1, lines 8-9, 30-32).
Regarding claim 72, ‘268 discloses wherein the first imaging modality and the second imaging modality are different (Claim 4 and Claim 5).
Regarding claims 74, ‘268 discloses wherein the second imaging modality is stereoscopic, fluorescence imaging (claim 5).
Regarding claim 75, ‘268 discloses adjusting a position and an orientation of an imaging device from which the second images are obtained so that the one or more anatomical markers are within a field of view of the imaging device (claim 6).
Regarding claim 76, ‘268 discloses moving one or more joints of an articulated arm to which the medical tool is mounted (Claim 1, line 4).
Regarding claim 82, ‘268 discloses wherein the one or more anatomical markers comprises a first anatomical marker and a second anatomical marker (claim 2, “plurality of anatomical markers”).
Regarding claim 85, ‘268 discloses wherein the first and second imaging modalities obtain their images without using light in a visible spectrum (Claim 7).
Claims 69 and 77 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,389,268, in view of US5,469,847 to Zinreich et al. “Zinreich”.
Regarding claim 69, ‘268 discloses all the features of claim 66 above.
‘268 discloses wherein each of the one or more anatomical markers comprises: a body comprising a first material observable to a first imaging modality and a second material observable to a second imaging modality (Claim 1, lines 25-29).
However, ‘268 does not disclose wherein: the first material is different from the second material; and the second material is disposed concentrically around the first material.
Zinreich teaches an anatomical marker ("adhesive surface marker ... The markers provide means for marking patients", Abstract; multi-modality surface marker 10, Col. 3, lines 60-67) comprising a first material observable to a first imaging modality (gel 12, Col. 3, lines 61-67; "The gel 12 has a mobile phase suitable for MRI imaging by commercial machines and is sufficiently X-Ray-opaque for adequate imaging on CT or X-Ray", Col 3, line 61 - Col 4, line 4) and a second material observable to a second imaging modality (a liquid imaging agent can be injected into the sealed well 18, see Fig. 6, which is sealed by a top membrane 28, and plastic disk 26, Col. 4, lines 50-61, the liquid imaging agent in the sealed well 18 would read on the body comprising the second material; the liquid imaging agent is observable with PET scans, Col. 4, lines 50-61), wherein the first material is different from the second material (as discussed above, the two imaging agents are clearly different).
Additionally, Zinreich discloses that the gel 12 is injectable (Column 4, Paragraph starting at line 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘268, wherein the first material is different from the second material, as taught by Zinreich, in order to provide a marker that is sterilizable and remain consistent in size and shape, (Col. 5, paragraphs starting at lines 55 and 62).
However, Zinreich does not disclose wherein the second material is disposed concentrically around the first material, wherein the second material is for ultrasound.
However, Zinreich does disclose gel imaging agent for ultrasound (Col. 3, paragraph starting at line 3). Zinreich also teaches that the MRI imaging agent could be liquid (Col. 6, Paragraph starting at line 17).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Zinreich’s marker, wherein the second material is disposed concentrically around the first material, wherein the second material is for ultrasound, as taught by Zinreich, since configuring the multimodality marker such that the inner, first portion of the marker is observable under one imaging modality, and an outer, second portion that is concentric to the first portion is visible in fluorescent imaging, is a simple substitution of one known configuration for another to obtain predictable results (ability to observe the marker in fluorescent imaging and at least a second modality such as MRI) (See MPEP 2143).
Regarding claim 77, ‘268 discloses all the features of claim 66.
However, ‘268 does not disclose determining a desired location for a first anatomical marker of the one or more anatomical markers on the anatomy of the patient; and applying the first anatomical marker to the desired location.
Zinreich teaches determining a desired location for a first anatomical marker of the one or more anatomical markers on the anatomy of the patient; and applying the first anatomical marker to the desired location (Zinreich teaches the marker also has an adhesive 30, with a removable backing 22 (Col. 4, lines 5-23; Fig. 10, Ref. 30 for adhesive, and Ref. 22 for removable backing; remove the marker from the backing 22 and apply it to the desired location on a patient's skin, Col. 4, line 62 - Col. 5, line 3; affixing to the desired location, infers a desired location has been determined).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘268, wherein the method includes determining a desired location for a first anatomical marker of the one or more anatomical markers on the anatomy of the patient; and applying the first anatomical marker to the desired location, as taught by Zinreich, in order to provide a marker that is sterilizable and remain consistent in size and shape, (Zinreich, Col. 5, paragraphs starting at lines 55 and 62).
Claims 73 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,389,268, in view of US2009/0036902 to DiMaio et al. “DiMaio”.
Regarding claim 73, ‘268 discloses all the features of claim 66 above.
However, ‘268 does not disclose where the second imaging modality is stereoscopic endoscopy.
DiMaio teaches wherein the second imaging modality is stereoscopic endoscopy (Paragraph 0052, stereoscopic endoscope; DiMaio teaches a plurality of imaging modalities, ranging from ultrasound, Paragraph 0045, to optical camera imaging via stereoscopic endoscope, Paragraph 0052; which could be overlaid with magnetic resonance images, Paragraph 0156).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified ‘268, where the second imaging modality is stereoscopic endoscopy, as taught by DiMaio, in order to obtain live 2D optical images from the camera in the stereoscopic endoscope (DiMaio, Paragraph 0052).
There are no double patenting rejections for claims 70-71, 78-81, and 83-84.
Response to Arguments
Applicant’s arguments, see Pages 6-9, filed 01/30/2026, with respect to the rejection(s) of claim(s) 66-85, under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art to Dekel et al. (US2013/0322719), which teaches determining second coordinates of the one or more anatomical markers relative to the medical tool based on content of the second images. Dekel teaches dynamically determining a pose of an instrument relative to the fiducial body, by determining the position of markers on the tool handle, and through the use of an optical camera, Fig. 16, Ref. 1625, and Paragraph 0156, correlate the position of the markers on the tool handle, such as Fig. 16, Ref. 1617 with the markers on the fiducial mounted to the anatomy, such as markers 1637, via the coordinate system transformation process as described in Paragraphs 0162, 0173, and Fig. 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US2012/0071757 to Salcudean et al. “Salcudean” teaches a multimodal fiducial (Fig. 1, Ref. 105) with individual markers that can be detected by ultrasound (Paragraph 0027, Fig. 1, Ref. 115) and also optically (Fig. 1, Ref. 110, Paragraph 0030). Salcudean further teaches a surgical robot with a surgical tool and registering the location of the surgical tool tip to the 3D ultrasound image, taking into account the kinematics (Paragraph 0036), along with the fiducials attached to the surface of the body (Paragraph 0037).
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/MT/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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