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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/14/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 12 is 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 12 recites the limitation "the medical needle" in line 8. There is insufficient antecedent basis for this limitation in the claim.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1-3, 5, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bai et al. (Pub. No.: US 2017/0327371) in view of Johnson et al. (Pub. No.: US 2023/0277084) and further in view of Chopra et a. (Pub. No.: US 2022/0008141).
Consider claims 1, 17, Bai discloses an imaging system for use in medical operation involving an operational area of a patient (paragraph [0034], medical instruments 360 may include tracking markers such as tracking spheres that may be recognizable by a tracking camera 307), comprising:
a reference marker adapted to be fixed in a position within the operational area (paragraph [0076], markers affixed to the patient and/or the bed on which the patient is positioned);
a medical device adapted to be moved within the operational area, wherein the medical device comprises a comparison marker (paragraph [0076], affixing the tracking tool 508 to the access port 504 of a medical device);
a camera adapted to observe the position of the reference marker and a position of the comparison marker within the operational area (paragraph [0076], camera 307, may then detect the presence of the tracking markers affixed to the tracking tool 504 and the medical navigation system 205 may then compute the position in space of the access port 504 relative to other markers);
a computer system adapted to define the position of the reference marker within the operational area (paragraph [0049], Fig. 4B, the navigation system computes the registration to reference markers (block 446));
a display system (paragraph [0077], Fig. 3, display 311) in communication with the imaging array and the computer system (paragraph [0076], camera 307, may then detect the presence of the tracking markers affixed to the tracking tool 504 wherein the initial position of the medical device may be displayed on the display, see paragraph [0077]), wherein the display system is adapted to, using the position of the reference marker and the position of the comparison marker, create a display of the three-dimensional model of the operational area and a position of the medical device within the operational area (paragraph [0058], the medical navigation system 205 must acquire and maintain a reference of the location of the tools in use as well as the patient in three dimensional (3D) space wherein an inertial system may generate 3D tracking information and tool trajectory information for display on a display screen, see paragraph [0063]).
Bai does not specifically disclose an imaging array, wherein the imaging array comprises at least two cameras.
Johnson discloses an imaging array, wherein the imaging array comprises at least two cameras (paragraph [0067], tracking devices may be one or more cameras 200, 326).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the camera as disclosed by Bai with the imaging array as taught by Johnson to provide a defined domain or relative orientations of the instrument (Johnson, paragraph [0067]).
The combination of Bai and Johnson does not specifically disclose a computer system adapted to, from two-dimensional X-ray images of the operational area, construct a three-dimensional model of the operational area and define the position of the reference marker within the operational area.
Chopra discloses a computer system adapted to, from two-dimensional X-ray images of the operational area, construct a three-dimensional model of the operational area (paragraph [0112], x-ray image data 382 may be used as part of an integrated image modality to produce a three dimensional (3D)) and define the position of the reference marker within the operational area (paragraph [0116], other position markers may contain or use a local position or coordinate system to establish a three dimensional coordinate system).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the computer system as disclosed by the combination of Bai and Johnson with the computer system as taught by Chopra to establish a three-dimensional coordinate system (Chopra, paragraph [0116]).
Consider claims 2, 5, the combination of Bai and Johnson does not specifically disclose three reference markers adapted to be fixed in three respective positions within the operational area.
Chopra discloses three reference markers adapted to be fixed in three respective positions within the operational area (paragraph [0084], one or more fiducial markers F on or in the patient (FIG. 1D)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the reference markers as disclosed by the combination of Bai and Johnson with the reference markers as taught by Chopra to correlate the visual scan data of the patient (Chopra, paragraph [0084]).
Consider claim 3, the combination of Bai, Johnson, and Chopra discloses wherein each of the three reference markers has a shape which is visually distinguishable from any of the other three reference markers (Chopra, paragraph [0091], fiducial marker may also have one or more sensor detectable devices that can be in various shapes and sizes).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bai et al. (Pub. No.: US 2017/0327371) in view of Johnson et al. (Pub. No.: US 2023/0277084) and further in view of Norton et al. (Pub. No.: US 2023/0255679).
Consider claim 12, Bai discloses a medical device for use alongside an imaging system in a medical operation involving an operational area of a patient (paragraph [0034], medical instruments 360 may include tracking markers such as tracking spheres that may be recognizable by a tracking camera 307), the imaging system comprising a reference marker fixed in a position within an operational area (paragraph [0076], markers affixed to the patient and/or the bed on which the patient is positioned), a camera adapted to observe the operational area (paragraph [0076], camera 307, may then detect the presence of the tracking markers affixed to the tracking tool 504 and the medical navigation system 205 may then compute the position in space of the access port 504 relative to other markers), a computer system adapted to construct a three-dimensional model of the operational area (paragraph [0049], Fig. 4B, the navigation system computes the registration to reference markers (block 446)), and a display system (paragraph [0077], Fig. 3, display 311) in communication with the imaging array and the computer system (paragraph [0076], camera 307, may then detect the presence of the tracking markers affixed to the tracking tool 504 wherein the initial position of the medical device may be displayed on the display, see paragraph [0077]) adapted to create a display of the three-dimensional model of the operational area (paragraph [0058], the medical navigation system 205 must acquire and maintain a reference of the location of the tools in use as well as the patient in the three dimensional (3D) space wherein an inertial system may generate 3D tracking information and tool trajectory information for display on a display screen, see paragraph [0063]).
Bai does not specifically disclose an imaging array.
Johnson discloses an imaging array (paragraph [0067], tracking devices may be one or more cameras 200, 326).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the camera as disclosed by Bai with the imaging array as taught by Johnson to provide a defined domain or relative orientations of the instrument (Johnson, paragraph [0067]).
The combination of Bai and Johnson does not specifically disclose the medical needle comprising:
an elongate element extending from a proximal end to a distal end of the medical device, wherein the elongate element has an increasing stiffness profile from the distal end to the proximal end;
a housing coupled to the proximal end of the elongate element; and
a comparison marker coupled to the housing, wherein the comparison marker is adapted to be observed by the imaging array while the elongate element is within the operational area such that, while the elongate element is within the operational area, the display system is adapted to create the display further comprising a position of the elongate element within the operational area.
Norton discloses the medical needle (paragraph [0106], ablation components of the surgical tool 102, to include a needle as known in the art) comprising:
an elongate element extending from a proximal end to a distal end of the medical device, wherein the elongate element has an increasing stiffness profile from the distal end to the proximal end (paragraph [0107], Fig. 1A, surgical tool 102 extends from a proximal end 104 to a distal end 108 wherein the surgical tool 102 may be passed through a hollow portion of the cannula handle 120 and the cannula tube 124 (as shown in FIG. 1B), see paragraph [0106]);
a housing coupled to the proximal end of the elongate element (paragraph [0106], Fig. 1A, cannula assembly 106); and
a comparison marker coupled to the housing (paragraph [0141], reference markers (e.g., navigation markers) may be placed on the robot 314), wherein the comparison marker is adapted to be observed by the imaging array while the elongate element is within the operational area such that (paragraph [09142], one or more cameras or other sensor(s) for tracking one or more reference markers), while the elongate element is within the operational area, the display system is adapted to create the display further comprising a position of the elongate element within the operational area (paragraph [0146], Fig. 4, imaging devices 312 may be used to capture video, images, or other data associated with the entry of the access tools into the anatomical element 404).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to replace the medical device as disclosed by the combination of Bai and Johnson with the medical needle as taught by Norton to capture video which may be viewed by the surgeon to determine when the access tools have breached the anatomical element (Norton, paragraph [0146]).
Allowable Subject Matter
Claims 4, 6-11, 13-16, and 18-20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GERALD JOHNSON whose telephone number is (571)270-7685. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carey Michael can be reached at (571)270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Gerald Johnson/
Primary Examiner, Art Unit 3797
