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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claims 35-54 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception in the form of mental processes without significantly more. Claims 35 and 48 recite “determine a catheter deployment location based on the image data by the imaging device.” The limitation is capable of being performed in the mind or with a pen and paper, as the operator merely needs to assess the catheter deployment location in the image data. This judicial exception is not integrated into a practical application because the system and method display a virtual visualization of the target structure and graphical indicator identifying the catheter deployment location. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no other elements, besides the generic computer component of a processor in Claim 35 are included. The additional elements merely specify that a processor/computer is used as a tool to perform the abstract ideas.
Dependent Claims 36-47 and 49-54 do not add significantly more, or integrate into a practical application, or they simply recite additional abstract ideas consistent with those identified in the independent claims.
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.
Claim 35-44 and 48-53 are rejected under 35 U.S.C. 103 as being obvious over Zhao et al. (US 20140187949).
The applied reference has a common applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). The instant application is obvious over Zhao as Zhao teaches each and every limitation of the claims.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding Claim 35, Zhao teaches a medical system, (Fig. 1 and [0025] “a teleoperated interventional system for use in, for example, surgical, diagnostic, therapeutic, or biopsy procedures, is generally indicated by the reference numeral 100.”), comprising:
a) a catheter ([0036] “The system 200 may be incorporated into a teleoperated interventional system, such as system 100. Alternatively, the system 200 may be used for exploratory procedures or in procedures involving traditional manually operated interventional instruments, such as laparoscopic instruments. The system 200 includes a catheter system 202 (e.g., part of the instrument 104)”); and
b) a processor, ([0028] “control system 116”), configured to:
i) receive image data captured by an imaging device, ([0028] “An optional visualization system 110 may include an endoscope system such that a concurrent (real-time) image of the interventional site is provided to surgeon console C. […] The visualization system 110 may be implemented as hardware, firmware, software, or a combination thereof, which interacts with or is otherwise executed by one or more computer processors, which may include the processor(s) of a control system 116.”), the imaging device provided by the catheter and positioned within a patient anatomy, ([0025] “interventional instrument 104” and Fig. 4), the image data including a target structure within the patient anatomy, (Fig. 4 and [0049] “target location within the anatomy”), the image data associated with an image reference frame ([0028] “An optional visualization system 110 may include an endoscope system such that a concurrent (real-time) image of the interventional site is provided to surgeon console C. The concurrent image may be, for example, a two- or three-dimensional image captured by an endoscopic probe positioned within the interventional site” and [0046] “The flexible body 216 may optionally house one or more image capture probes 226 that transmit captured image data to the imaging system(s) 212.”);
ii) transform a location of the target structure in the image reference frame to an updated location in a model reference frame, the model reference frame associated with an anatomic model of the patient anatomy (Fig. 10b, [0064] “The image capture probe 226 is operated to determine if the target structure 302 is in the expected position relative to the target confirmation location. If the target structure 302 is not found or not in the expected position, the flexible body and image capture probe can be moved around until the target structure is located. When the target structure is located, the location of the distal end of the flexible body 309 or image capture probe is recorded at a new location 322. The navigation planning module 211 then updates the location of the target structure 302'. With the new location of the target structure identified, the operational capability information for the interventional instrument is used to identify a revised planned deployment location 324,” and [0068] “Data associated with the location of the target structure PI in the image frame of reference is transformed to the catheter coordinate system or the patient coordinate system (that has been registered with the catheter coordinate system) as PP.”);
iii) determine a catheter deployment location based on the image data captured by the imaging device (Fig. 7 and [0061] “At 408, a planned deployment location for the interventional instrument is located.”); and
iv) display a virtual visualization image, ([0064] “virtual image 300”), including:
1) an image of the target structure at the updated location ([0064] “The navigation planning module 211 then updates the location of the target structure 302'.”); and
2) a graphical indicator identifying the catheter deployment location (Figs. 4 and 6 and [0064] “the navigation planning module may use the difference between locations 312 and 322 to update location 314 to location 322 and to update the location of the target structure 302 to 302'.”).
Regarding Claim 36, Zhao teaches all limitations of Claim 35, as discussed above. Furthermore, Zhao teaches wherein the virtual visualization image further includes an image of the anatomic model of the patient anatomy ([0050] “Software is used to convert the recorded images into a two dimensional or three dimensional model of a partial or an entire anatomical organ or anatomical region. The model describes the various locations and shapes of the passageways and their connectivity. The images used to generate the model may be recorded preoperatively or intra-operatively during a clinical procedure. In an alternative embodiment, a virtual visualization system may use standard models (i.e., not patient specific) or hybrids of a standard model and patient specific data.”).
Regarding Claim 37, Zhao teaches all limitations of Claim 36, as discussed above. Furthermore, Zhao teaches wherein the image of the anatomic model is a three-dimensional image of the anatomic model ([0050] “Software is used to convert the recorded images into a two dimensional or three dimensional model of a partial or an entire anatomical organ or anatomical region. The model describes the various locations and shapes of the passageways and their connectivity. The images used to generate the model may be recorded preoperatively or intra-operatively during a clinical procedure. In an alternative embodiment, a virtual visualization system may use standard models (i.e., not patient specific) or hybrids of a standard model and patient specific data.”).
Regarding Claim 38, Zhao teaches all limitations of Claim 36, as discussed above. Furthermore, Zhao teaches wherein the anatomic model includes a plurality of anatomic passageways, ([0050] “Virtual navigation using the virtual visualization system is based upon reference to an acquired dataset associated with the three dimensional structure of the anatomical passageways.”), and wherein displaying the virtual visualization image comprises displaying a relative position of the target structure with respect to the plurality of anatomic passageways based on the updated location of the target structure in the model reference frame ([0050] “The model describes the various locations and shapes of the passageways and their connectivity” and [0064] “the virtual image 300 of target structure 302 and nearby anatomic passageways 304 is again depicted.”).
Regarding Claim 39, Zhao teaches all limitations of Claim 38, as discussed above. Furthermore, Zhao teaches wherein the virtual visualization image is from a perspective within a first anatomic passageway of the plurality of anatomic passageways (Figs. 4 and 6 and [0053] “a virtual image 300 of […] nearby anatomic passageways 304 is depicted.”).
Regarding Claim 40, Zhao teaches all limitations of Claim 39, as discussed above. Furthermore, Zhao teaches wherein the virtual visualization image further includes a virtual image of the catheter in the first anatomic passageway of the plurality of anatomic passageways (Figs. 4 and 6 and [0053] “An interventional instrument with a flexible body 309 (substantially similar to flexible body 216) and an extended interventional tool 310 are shown.”).
Regarding Claim 41, Zhao teaches all limitations of Claim 35, as discussed above. Furthermore, Zhao teaches wherein the imaging device includes an ultrasound probe (Claim 17 “the imaging probe”).
Regarding Claim 42, Zhao teaches all limitations of Claim 35, as discussed above. Furthermore, Zhao teaches wherein the image of the target structure displayed in the virtual visualization image is a three-dimensional image of the target structure ([0050] “Software is used to convert the recorded images into a two dimensional or three dimensional model of a partial or an entire anatomical organ or anatomical region. The model describes the various locations and shapes of the passageways and their connectivity. The images used to generate the model may be recorded preoperatively or intra-operatively during a clinical procedure. In an alternative embodiment, a virtual visualization system may use standard models (i.e., not patient specific) or hybrids of a standard model and patient specific data.”).
Regarding Claim 43, Zhao teaches all limitations of Claim 35, as discussed above. Furthermore, Zhao teaches wherein the virtual visualization image further includes an image of a tool extending from a distal end of the catheter (Figs. 4 and 6 and [0053] “extended interventional tool 310”).
Regarding Claim 44, Zhao teaches all limitation of Claim 35, as discussed above. Furthermore, Zhao teaches wherein determining the catheter deployment location is further based on a plurality of sequential images of the image data captured when the imaging device is at a plurality of different locations within an anatomic passageway of the patient anatomy ([0053] The navigation planning module generates or allows the clinician to select a planned deployment location within an anatomical passageway for parking a distal end of the interventional instrument to conduct the interventional procedure” and [0058] “The model is formed from two or three dimensional images of the interventional site recorded and/or modeled preoperatively or interoperatively using imaging technology”).
Regarding Claim 48, Zhao teaches a method, (Abstract “A method of deploying an interventional instrument is performed by a processing system.”), comprising:
a) receiving image data captured by an imaging device, ([0028] “An optional visualization system 110 may include an endoscope system such that a concurrent (real-time) image of the interventional site is provided to surgeon console C. […] The visualization system 110 may be implemented as hardware, firmware, software, or a combination thereof, which interacts with or is otherwise executed by one or more computer processors, which may include the processor(s) of a control system 116.”), the imaging device provided by a catheter and positioned within a patient anatomy, ([0025] “interventional instrument 104,” [0036] “The system 200 may be incorporated into a teleoperated interventional system, such as system 100. Alternatively, the system 200 may be used for exploratory procedures or in procedures involving traditional manually operated interventional instruments, such as laparoscopic instruments. The system 200 includes a catheter system 202 (e.g., part of the instrument 104),” and Fig. 4), the image data including a target structure within the patient anatomy, (Fig. 4 and [0049] “target location within the anatomy”), the image data associated with an image reference frame ([0028] “An optional visualization system 110 may include an endoscope system such that a concurrent (real-time) image of the interventional site is provided to surgeon console C. The concurrent image may be, for example, a two- or three-dimensional image captured by an endoscopic probe positioned within the interventional site” and [0046] “The flexible body 216 may optionally house one or more image capture probes 226 that transmit captured image data to the imaging system(s) 212.”);
b) transforming a location of the target structure in the image reference frame to an updated location in a model reference frame, the model reference frame associated with an anatomic model of the patient anatomy (Fig. 10b, [0064] “The image capture probe 226 is operated to determine if the target structure 302 is in the expected position relative to the target confirmation location. If the target structure 302 is not found or not in the expected position, the flexible body and image capture probe can be moved around until the target structure is located. When the target structure is located, the location of the distal end of the flexible body 309 or image capture probe is recorded at a new location 322. The navigation planning module 211 then updates the location of the target structure 302'. With the new location of the target structure identified, the operational capability information for the interventional instrument is used to identify a revised planned deployment location 324,” and [0068] “Data associated with the location of the target structure PI in the image frame of reference is transformed to the catheter coordinate system or the patient coordinate system (that has been registered with the catheter coordinate system) as PP.”);
c) determining a catheter deployment location based on the image data captured by the imaging device (Fig. 7 and [0061] “At 408, a planned deployment location for the interventional instrument is located.”); and
d) displaying a virtual visualization image, ([0064] “virtual image 300”), including:
i) an image of the target structure at the updated location ([0064] “The navigation planning module 211 then updates the location of the target structure 302'.”); and
ii) a graphical indicator identifying the catheter deployment location (Figs. 4 and 6 and [0064] “the navigation planning module may use the difference between locations 312 and 322 to update location 314 to location 322 and to update the location of the target structure 302 to 302'.”).
Regarding Claim 49, Zhao teaches all limitations of Claim 48, as discussed above. Furthermore, Zhao teaches wherein the virtual visualization image further includes an image of the anatomic model of the patient anatomy ([0050] “Software is used to convert the recorded images into a two dimensional or three dimensional model of a partial or an entire anatomical organ or anatomical region. The model describes the various locations and shapes of the passageways and their connectivity. The images used to generate the model may be recorded preoperatively or intra-operatively during a clinical procedure. In an alternative embodiment, a virtual visualization system may use standard models (i.e., not patient specific) or hybrids of a standard model and patient specific data.”).
Regarding Claim 50, Zhao teaches all limitations of Claim 48, as discussed above. Furthermore, Zhao teaches wherein the anatomic model includes a plurality of anatomic passageways, ([0050] “Virtual navigation using the virtual visualization system is based upon reference to an acquired dataset associated with the three dimensional structure of the anatomical passageways.”), and wherein displaying the virtual visualization image comprises displaying a relative position of the target structure with respect to the plurality of anatomic passageways based on the updated location of the target structure in the model reference frame ([0050] “The model describes the various locations and shapes of the passageways and their connectivity” and [0064] “the virtual image 300 of target structure 302 and nearby anatomic passageways 304 is again depicted.”).
Regarding Claim 51, Zhao teaches all limitations of Claim 48, as discussed above. Furthermore, Zhao teaches wherein the virtual visualization image further includes an image of a tool extending from a distal end of the catheter (Figs. 4 and 6 and [0053] “extended interventional tool 310”).
Regarding Claim 52, Zhao teaches all limitation of Claim 48, as discussed above. Furthermore, Zhao teaches wherein determining the catheter deployment location is further based on a plurality of sequential images of the image data captured when the imaging device is at a plurality of different locations within an anatomic passageway of the patient anatomy ([0053] The navigation planning module generates or allows the clinician to select a planned deployment location within an anatomical passageway for parking a distal end of the interventional instrument to conduct the interventional procedure” and [0058] “The model is formed from two or three dimensional images of the interventional site recorded and/or modeled preoperatively or interoperatively using imaging technology”).
Regarding Claim 53, Zhao teaches all limitations of Claim 48, as discussed above. Furthermore, Zhao teaches wherein the virtual visualization image is from a perspective within a first anatomic passageway of the plurality of anatomic passageways (Figs. 4 and 6 and [0053] “a virtual image 300 of […] nearby anatomic passageways 304 is depicted.”), and wherein the virtual visualization image further includes a virtual image of the catheter in the first anatomic passageway of the plurality of anatomic passageways (Figs. 4 and 6 and [0053] “An interventional instrument with a flexible body 309 (substantially similar to flexible body 216) and an extended interventional tool 310 are shown.”).
Claims 45-47 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (US 20140187949) as applied to Claims 35 and 48 above, and further in view of Manzke et al. (US 20140142422).
Regarding Claim 45, Zhao teaches all limitations of Claim 35, as discussed above. However, Zhao does not explicitly teach wherein the processor is further configured to: determine a respective target structure surface area measurement of each sequential image of a plurality of sequential images of the image data captured by the imaging device.
In an analogous endoscopy field of endeavor, Manzke teaches a medical system, ([0001] “This disclosure relates to medical procedures and systems, and more particularly to guided injection systems”), wherein the processor is further configured to: determine a respective target structure surface area measurement of each sequential image of a plurality of sequential images of the image data captured by the imaging device ([0043] “In block 302, characteristics of interest are measured […] from a 3D heart surface reconstructed from 3D medical imaging study (CT, MRI, ultrasound (US), etc.).”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Zhao with the determination of a respective target structure surface area measurement of Manzke because the modification provides target structure pathology, as taught by Manzke in [0003], which makes it easier for a determination of how to move the imaging probe in to be positioned properly to image or to deliver treatment effectively.
Regarding Claim 46, the modified system of Zhao teaches all limitations of Claim 45, as discussed above. Furthermore, Manzke teaches wherein each target structure surface area measurement is a ratio of a number of target structure pixels to a total number of pixels in each sequential image ([0045] “In block 310, registration is provided, and feature associations with each pixel in the visual image may be made. For example, wall thickness of a heart may be established in every pixel of the endoscope image using the measured characteristics and the transformation.”).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Zhao with the teachings of Manzke because the modification provides distinguishing characteristics for the clinician to complete treatment planning or treat the target area effectively.
Regarding Claim 47, the modified system of Zhao teaches all limitations of Claim 46, as discussed above. Furthermore, Manzke teaches wherein the processor is further configured to: determine a pose of the imaging device that maximizes the target structure surface area measurement, wherein determining the catheter deployment location is further based on the pose of the imaging device that maximizes the target structure surface area measurement ([0049] “If an area of interest 506 is not visible in a current endoscope view, the endoscope 502 may be steered by the robot 504 using surface information provided in the maps or preoperative images and known geometrical relationships between the heart surface and the robot, derived from the previously described registration. Additionally, the robot 504 can be steered using a visual servicing method where regions of wall thickness or ischemic/scar/pathologic tissue can be identified on pre-operative images and through registration and employed to maneuver the robot 504 to a desired location.” Where Zhao teaches that the catheter contains the imaging device, as discussed above.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Zhao with the teachings of Manzke because the modification provides target structure pathology, as taught by Manzke in [0003], which makes it easier for a determination of how to move the catheter in to be positioned properly to image or deliver treatment efficiently.
Regarding Claim 54, the modified method of Zhao teaches all limitations of Claim 48, as discussed above. However, the modified method of Zhao does not explicitly teach determining a respective target structure surface area measurement of each sequential image of a plurality of sequential images of the image data captured by the imaging device; and determining a pose of the imaging device that maximizes the target structure surface area measurement, wherein determining the catheter deployment location is further based on the pose of the imaging device that maximizes the target structure surface area measurement.
In an analogous endoscopy field of endeavor, Manzke teaches a method, ([0001] “This disclosure relates to medical procedures and systems, and more particularly to guided injection systems”), comprising:
a) determining a respective target structure surface area measurement of each sequential image of a plurality of sequential images of the image data captured by the imaging device ([0043] “In block 302, characteristics of interest are measured […] from a 3D heart surface reconstructed from 3D medical imaging study (CT, MRI, ultrasound (US), etc.).”); and
b) determining a pose of the imaging device that maximizes the target structure surface area measurement, wherein determining the catheter deployment location is further based on the pose of the imaging device that maximizes the target structure surface area measurement ([0049] “If an area of interest 506 is not visible in a current endoscope view, the endoscope 502 may be steered by the robot 504 using surface information provided in the maps or preoperative images and known geometrical relationships between the heart surface and the robot, derived from the previously described registration. Additionally, the robot 504 can be steered using a visual servicing method where regions of wall thickness or ischemic/scar/pathologic tissue can be identified on pre-operative images and through registration and employed to maneuver the robot 504 to a desired location.” Where Zhao teaches that the catheter contains the imaging device, as discussed above.).
It would have been obvious to one of ordinary skill in the art at the time of applicant’s filing to modify Zhao with the teachings of Manzke because the modification provides target structure pathology, as taught by Manzke in [0003], which makes it easier for a determination of how to move the catheter in to be positioned properly to image or deliver treatment efficiently and allows the clinician to complete treatment planning or treat the target area effectively.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CHRISTINA TALTY whose telephone number is (571)272-8022. The examiner can normally be reached M-Th 8:30-5:30 EST.
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/MARIA CHRISTINA TALTY/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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