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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-28 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites “the anatomy” in line 15. It is unclear to the Examiner which anatomy is being claimed because “an anatomy of a patient” was recited in lines 5-6 and “a virtual representation of a portion of the anatomy of the patient” was recited in lines 11-12.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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 15-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque et al. (U.S. Patent Application 20170360395) in view of Riedel (U.S. Patent Application 20170329402) and further in view of Jagga (U.S. Patent Application 20180042681).
In regards to claim 15, Razzaque teaches an apparatus [Fig. 1A; e.g. system for image guidance for placement of one or more medical devices at a target location, Abstract], comprising:
a memory [e.g. non-transitory computer-readable medium, 0252];
a processor [e.g. processor, 0252] operatively coupled to the memory, the processor configured to:
determine, based on data associated with an operative plan [e.g. image guidance data, 0020] of a surgical procedure [Fig. 1A; e.g. medical procedure, 0018], a suggested position and orientation [e.g. trajectory indicators, 0049-0050] of a medical device [Fig. 1; e.g. medical device, 0049-0050] in an anatomy of a patient [Fig. 1; e.g. target such as patient’s tissue, 0049-0050, also see 0041], the medical device configured to be used in the surgical procedure [e.g. The healthcare provider uses the medical device such as a ablation needle to drive it into the patient’s tissue, 0048-0050];
determine, based on tracking data associated with the medical device [e.g. based on sensor data from the medical device, 0016, 0026, 0069], an actual position and orientation of the medical device [e.g. position and orientation of the medical device, 0016, 0026, 0069]; and
generate a surgical navigation image [Fig. 1A, 1B; e.g. image prediction information, 0047] including three-dimensional (3D) image [e.g. image in the 3D viewing area, 0024, 0062] including (1) a virtual object indicative of the suggested position and orientation of the medical device [e.g. virtual information and image guidance cues such as trajectory indicators, 0049-0050, 0060], (2) a virtual representation of the medical device [e.g. image of the virtual medical device, 0024], and (3) a virtual representation of a portion of the anatomy of the patient [e.g. virtual image region corresponding to the patient’s tissue, 0032, 0040]; and
a display system [Fig. 1A; e.g. stereoscopic 3D display, 0035] configured to display the surgical navigation image [Fig. 1A; e.g. the image prediction information is displayed on the stereoscopic 3D display, 0035, 0047].
Razzaque does not explicitly teach
a display system configured to display the surgical navigation image on a surface positionable between a head of an operator and a surgical field including the patient anatomy such that the virtual representation of the portion of the anatomy is collocated with the anatomy and the virtual representation of the medical device is overlaid on a portion of the medical device in a field of view of the operator (emphasis added).
However, Riedel teaches
a display system [Fig. 14A, 14B; e.g. immersive, direct interaction stereoscopic display system, 0032, 0066] configured to display the surgical navigation image [e.g. displays the overlaid medical image for surgery planning and intra-operative visualization, 0066] on a surface [Fig. 2; e.g. second beam combiner 104, 0047] positionable between a head of an operator [Fig. 2; e.g. head of the user, 0047] and a surgical field including the patient anatomy [Fig. 14A, 14B; e.g. the environment of the patient including the patient’s head, 0066] such that the virtual representation of the portion of the anatomy [e.g. a virtual model of the internal anatomy of a patient, 0066] is collocated with the anatomy [e.g. actual view of the patient’s head, 0066].
Therefore, it would have been obvious to one of ordinary skill in the art to have modified Razzaque’s apparatus with the features of a display system configured to display the surgical navigation image on a surface positionable between a head of an operator and a surgical field including the patient anatomy such that the virtual representation of the portion of the anatomy is collocated with the anatomy in the same conventional manner as taught by Riedel because Riedel provides a method for simulating reactions between the virtual representation of the hands or objects and the 3D virtual objects or interfaces, which results in the user feeling as though he or she is directly interacting with the virtual environment [0040].
Razzaque as modified by Riedel does not explicitly teach
the virtual representation of the medical device is overlaid on a portion of the medical device in a field of view of the operator.
However, Jagga teaches
the virtual representation of the medical device is overlaid on a portion of the medical device in a field of view of the operator [Fig. 7-8; e.g. the position and orientation of the ghost representation of the surgical tool matches the position and orientation of the surgical tool, 0071-0074].
Therefore, it would have been obvious to one of ordinary skill in the art to have modified the combination of Razzaque’s apparatus and the teachings of Riedel with the features of the virtual representation of the medical device is overlaid on a portion of the medical device in a field of view of the operator in the same conventional manner as taught by Jagga because Jagga provides a method for helping the surgeon to more easily maneuver the tool to the appropriate position and orientation to return to the stored waypoint, simply by matching the actual tool to the depicted ghost representation [0070].
In regards to claim 16, Razzaque teaches the apparatus of claim 15, wherein the virtual representation of the medical device is a first virtual representation of the medical device [e.g. image of the virtual medical device, 0024].
Razzaque as modified by Riedel does not explicitly teach the virtual object is a second virtual representation of the medical device having the suggested position and orientation of the medical device.
However, Jagga teaches the virtual object is a second virtual representation of the medical device having the suggested position and orientation of the medical device [Fig. 7; e.g. ghost representation of the surgical tool having a stored position and orientation of the surgical tool, 0070-0071].
Therefore, it would have been obvious to one of ordinary skill in the art to have modified the combination of Razzaque’s apparatus and the teachings of Riedel with the features of the virtual object is a second virtual representation of the medical device having the suggested position and orientation of the medical device in the same conventional manner as taught by Jagga because Jagga provides a method for helping the surgeon to more easily maneuver the tool to the appropriate position and orientation to return to the stored waypoint, simply by matching the actual tool to the depicted ghost representation [0070].
In regards to claim 17, Razzaque teaches the apparatus of claim 15, wherein the processor is configured to generate the surgical navigation image to further include a set of images depicting different orthogonal [e.g. image slices oriented orthogonally, 0044, 0102] or arbitrary planes [e.g. image slices oriented perpendicularly, 0044, 0102] of the portion of the anatomy.
In regards to claim 18, Razzaque teaches the apparatus of claim 17, wherein the display system is configured to display the surgical navigation image on the surface such that the set of images is displayed at a location next to the 3D image [Fig. 1A; e.g. the image slices of the 2D viewing area are displayed next to the 3D image of the 3D viewing area, 0024, 0044, 0102].
In regards to claim 19, Razzaque teaches the apparatus of claim 17, wherein the display system is configured to adjust the location of the set of images based on a location of the 3D image [Fig. 1A; e.g. As the medical device is moved, the point-of-view location of the 3D image changes along with the perspective view of the image slice, 0040, 0106].
In regards to claim 20, Razzaque teaches the apparatus of claim 17, wherein the display system is configured to display the surgical navigation image on the surface such that the 3D image occupies a larger area of the field of view of the operator than the set of images [Fig. 1A; e.g. the 3D viewing area is larger than the 2D viewing area, 0024].
In regards to claim 21, Razzaque teaches the apparatus of claim 17, wherein the processor is further configured to adapt the set of images of the surgical navigation image based on changes to the actual position and orientation of the medical device [Fig. 1A; e.g. As the medical device is moved, the point-of-view location of the 3D image changes along with the perspective view of the image slice. The movement of the medical device corresponds to a change in position and orientation of the medical device, 0026-0028, 0040, 0106].
In regards to claim 22, Razzaque teaches the apparatus of claim 15, wherein the processor is further configured to adapt the 3D image based on a position and orientation of the head of the operator [e.g. based on the position and orientation of the user’s head, different perspectives of the display objects within a 3D scene can be displayed, 0065, 0072, 0105-0106].
In regards to claim 23, Razzaque as modified by Riedel does not explicitly teach the apparatus of claim 15, wherein the processor is further configured to generate the surgical navigation image to include virtual guidance indicating whether a placement of the medical device is correct based on the suggested position and orientation of the medical device.
However, Jagga teaches the apparatus of claim 15, wherein the processor [Fig. 16; e.g. processor, 0047, 0051] is further configured to generate the surgical navigation image [Fig. 8; e.g. image of the surgical field including navigational information, 0067-0068] to include virtual guidance [Fig. 8; e.g. visual feedback, 0073] indicating whether a placement of the medical device is correct based on the suggested position and orientation of the medical device [e.g. feedback may be provided to indicate that the surgical tool 220 has successfully returned to the waypoint, 0073].
Therefore, it would have been obvious to one of ordinary skill in the art to have modified the combination of Razzaque’s apparatus and the teachings of Riedel with the features of virtual guidance indicating whether a placement of the medical device is correct based on the suggested position and orientation of the medical device in the same conventional manner as taught by Jagga because Jagga provides a method for helping the surgeon to more easily maneuver the tool to the appropriate position and orientation to return to the stored waypoint, simply by matching the actual tool to the depicted ghost representation [0070].
In regards to claim 24, Razzaque as modified by Riedel does not explicitly teach the apparatus of claim 23, wherein the virtual guidance includes an animation.
However, Jagga teaches the apparatus of claim 23, wherein the virtual guidance includes an animation [e.g. a change in color of the ghost representation or a flashing of the ghost representation, 0073].
Therefore, it would have been obvious to one of ordinary skill in the art to have modified the combination of Razzaque’s apparatus and the teachings of Riedel with the features of wherein the virtual guidance includes an animation in the same conventional manner as taught by Jagga because Jagga provides a method for helping the surgeon to more easily maneuver the tool to the appropriate position and orientation to return to the stored waypoint, simply by matching the actual tool to the depicted ghost representation [0070].
In regards to claim 25, Razzaque does not explicitly teach the apparatus of claim 15, wherein the surface is a surface of a see-through mirror, the see-through mirror positionable a first distance from the head of the operator and a second distance from the surgical field, the first distance being less than the second distance.
However, Riedel teaches the apparatus of claim 15, wherein the surface is a surface of a see-through mirror [Fig. 7, 14A, 14B; e.g. first beam combiner 103 is partially transparent mirror, 0055, 0067-0068], the see-through mirror positionable a first distance from the head of the operator and a second distance from the surgical field, the first distance being less than the second distance [Fig. 7, 14A, 14B; e.g. The surgeon’s head would correspond to the glasses 116. Based on the figures 7, 14A, and 14B, the distance from the second beam combiner to the glasses is shorter than the distance from glasses to the patient’s anatomy. The Examiner is interpreting the first and second distances as any value because they are not defined in the claims, 0055-0056, 0066].
Therefore, it would have been obvious to one of ordinary skill in the art to have modified Razzaque’s apparatus with the features of wherein the surface is a surface of a see-through mirror, the see-through mirror positionable a first distance from the head of the operator and a second distance from the surgical field, the first distance being less than the second distance in the same conventional manner as taught by Riedel because Riedel provides a method for simulating reactions between the virtual representation of the hands or objects and the 3D virtual objects or interfaces, which results in the user feeling as though he or she is directly interacting with the virtual environment [0040].
In regards to claim 26, Razzaque does not explicitly teach the apparatus of claim 25, wherein the display system is configured to move such that a location of the see-through mirror can move relative to the head of the operator.
However, Riedel teaches the apparatus of claim 25, wherein the display system is configured to move such that a location of the see-through mirror can move relative to the head of the operator [Fig. 1; e.g. The first beam combiner would move using the adjustment apparatus 112. The movement would be relative to the user’s head based on the user’s needs, 0045].
Therefore, would have been obvious to one of ordinary skill in the art to have modified Razzaque’s apparatus with the features of wherein the display system is configured to move such that a location of the see-through mirror can move relative to the head of the operator in the same conventional manner as taught by Riedel because Riedel provides a method for simulating reactions between the virtual representation of the hands or objects and the 3D virtual objects or interfaces, which results in the user feeling as though he or she is directly interacting with the virtual environment [0040].
In regards to claim 27, Razzaque does not explicitly teach the apparatus of claim 25, wherein the display system includes a 3D display and an arm extending from the 3D display, the arm configured to support the see-through mirror such that the see-through mirror can be positioned between the head of the operator and the surgical field when the 3D display is positioned above the head of the operator.
However, Riedel teaches the apparatus of claim 25, wherein the display system includes a 3D display [Fig. 1; e.g. display panel 101, 0041] and an arm [Fig. 1; e.g. adjustable support arm 111a, 0043] extending from the 3D display, the arm configured to support the see-through mirror such that the see-through mirror can be positioned between the head of the operator and the surgical field when the 3D display is positioned above the head of the operator [Fig. 1; e.g. the adjustable support arm supports the first beam combiner such that the first beam combiner is positioned between the user’s head and the environment containing the patient’s anatomy when the display panel 101 is above the user’s head, 0041, 0043].
Therefore, it would have been obvious to one of ordinary skill in the art to have modified Razzaque’s apparatus with the features of a 3D display and an arm extending from the 3D display, the arm configured to support the see-through mirror such that the see-through mirror can be positioned between the head of the operator and the surgical field when the 3D display is positioned above the head of the operator in the same conventional manner as taught by Riedel because Riedel provides a method for simulating reactions between the virtual representation of the hands or objects and the 3D virtual objects or interfaces, which results in the user feeling as though he or she is directly interacting with the virtual environment [0040].
In regards to claim 28, Razzaque teaches the apparatus of claim 15, wherein the processor is further configured to:
determine, based on tracking data associated with the head of the operator [e.g. tracking sensor data of the healthcare provider’s head, 0056, also see 0029-0031], a position and orientation of the head of the operator [e.g. position and orientation of the healthcare provider’s head, 0056, also see 0029-0031],
the processor configured to generate the surgical navigation image according to a perspective of the operator based on the position and orientation of the head of the operator [e.g. when the head of a user is tracked, the healthcare provider can then move her head to the side, so that she sees the ultrasound image from a different point of view location, 0056].
Claims 29, 31-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque et al. (U.S. Patent Application 20170360395) in view of Jagga (U.S. Patent Application 20180042681).
In regards to claim 29, Razzaque teaches a method [Fig. 5; e.g. method, 0121-0137], comprising:
determining, based on data associated with an operative plan [e.g. image guidance data, 0020] of a surgical procedure [Fig. 1A; e.g. medical procedure, 0018], a suggested position and a suggested orientation [e.g. trajectory indicators, 0049-0050] of a medical device [Fig. 1; e.g. medical device, 0049-0050] in an anatomy of a patient [Fig. 1; e.g. target such as patient’s tissue, 0049-0050, also see 0041], the medical device configured to be used in the surgical procedure [e.g. The healthcare provider uses the medical device such as a ablation needle to drive it into the patient’s tissue, 0048-0050];
receiving, from a tracking system [e.g. position sensing coordinate system, 0056, 0069], tracking data associated with the medical device [e.g. sensor data from the medical device, 0016, 0026, 0069];
determining, based on the tracking data associated with the medical device, an actual position and orientation of the medical device [e.g. position and orientation of the medical device, 0016, 0026, 0069];
generating a three-dimensional (3D) image [Fig. 1A, 1B; e.g. image in the 3D viewing area including image prediction information, 0024, 0062, 0047] including (1) a first virtual guidance clue for indicating the suggested position of the medical device [e.g. virtual information and image guidance cues such as trajectory indicators indicating the position of the medical device, 0049-0050, 0060-0061], (2) a second virtual guidance clue for indicating the suggested orientation of the medical device [e.g. virtual information and image guidance cues such as trajectory indicators indicating the orientation of the medical device, 0049-0050, 0060-0061], and (3) a virtual representation of the medical device associated with the actual position and orientation of the medical device [e.g. image of the virtual medical device, 0024]; and
displaying the 3D image in a field of view of an operator [Fig. 1A; e.g. displaying the image in the 3D viewing area of the user, 0024, 0062].
Razzaque does not explicitly teach
displaying the 3D image in a field of view of an operator such that the virtual representation of the medical device is overlaid on a portion of the medical device in the field of view and the first and second virtual guidance clues show the operator whether the medical device has been placed in the suggested position and the suggested orientation (emphasis added).
However, Jagga teaches
displaying the 3D image in a field of view of an operator such that the virtual representation of the medical device is overlaid on a portion of the medical device in the field of view [Fig. 7-8; e.g. the position and orientation of the ghost representation of the surgical tool matches the position and orientation of the surgical tool, 0071-0074] and the first and second virtual guidance clues show the operator whether the medical device has been placed in the suggested position and the suggested orientation [Fig. 7-8; e.g. The ghost representation corresponds to a stored position and orientation of the surgical tool. Visual feedback may be provided to indicate that the surgical tool 220 has successfully returned to the waypoint, 0073].
Therefore, it would have been obvious to one of ordinary skill in the art to have modified Razzaque’s apparatus with the features of displaying the 3D image in a field of view of an operator such that the virtual representation of the medical device is overlaid on a portion of the medical device in the field of view and the first and second virtual guidance clues show the operator whether the medical device has been placed in the suggested position and the suggested orientation in the same conventional manner as taught by Jagga because Jagga provides a method for helping the surgeon to more easily maneuver the tool to the appropriate position and orientation to return to the stored waypoint, simply by matching the actual tool to the depicted ghost representation [0070].
In regards to claim 31, the claim recites similar limitations as claims 17 and 18. Therefore, the same rationale as claims 17 and 18 are applied.
In regards to claim 32, Razzaque does not explicitly teach the method of claim 31, wherein at least one of the set of images includes one or more additional guidance clues associated with the suggested position or the suggested orientation of the medical device.
However, Jagga teaches the method of claim 31, wherein at least one of the set of images includes one or more additional guidance clues associated with the suggested position or the suggested orientation of the medical device [Fig. 7; e.g. additional ghost representations corresponding to a different stored position and orientation of the surgical tool, 0071-0072].
Therefore, it would have been obvious to one of ordinary skill in the art to have modified Razzaque’s apparatus with the features of wherein at least one of the set of images includes one or more additional guidance clues associated with the suggested position or the suggested orientation of the medical device in the same conventional manner as taught by Jagga because Jagga provides a method for helping the surgeon to more easily maneuver the tool to the appropriate position and orientation to return to the stored waypoint, simply by matching the actual tool to the depicted ghost representation [0070].
In regards to claim 33, the claim recites similar limitations as claim 21. Therefore, the same rationale as claim is applied 21.
In regards to claim 34, the claim recites similar limitations as claims 22 and 28. Therefore, the same rationale as claims 22 and 28 are applied.
Claim 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Razzaque et al. (U.S. Patent Application 20170360395) in view of Jagga (U.S. Patent Application 20180042681) as applied to claim 29 above, and further in view of Riedel et al. (U.S. Patent Application 20170329402).
In regards to claim 30, Razzaque teaches the method of claim 29, wherein the 3D image further includes a virtual representation of a portion of the anatomy of the patient [e.g. virtual image region corresponding to the patient’s tissue, 0032, 0040].
Razzaque does not explicitly teach the 3D image is displayed in the field of view further such that the virtual representation of the portion of the anatomy is collocated with the anatomy.
However, Riedel teaches the 3D image is displayed in the field of view further such that the virtual representation of the portion of the anatomy [e.g. a virtual model of the internal anatomy of a patient, 0066] is collocated with the anatomy [e.g. actual view of the patient’s head, 0066].
Therefore, it would have been obvious to one of ordinary skill in the art to have modified the combination of Razzaque’s apparatus and the teachings of Jagga with the features of the 3D image is displayed in the field of view further such that the virtual representation of the portion of the anatomy is collocated with the anatomy in the same conventional manner as taught by Riedel because Riedel provides a method for simulating reactions between the virtual representation of the hands or objects and the 3D virtual objects or interfaces, which results in the user feeling as though he or she is directly interacting with the virtual environment [0040].
Conclusion
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/ANDREW SHIN/Examiner, Art Unit 2612
/JENNIFER MEHMOOD/Supervisory Patent Examiner, Art Unit 2612