DETAILED ACTION
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 statements filed 2/2/2026 and 10/2/2025 fail to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
The information disclosure statements filed 10/2/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
The Applicant has submitted four information disclosure statements (IDSs), comprising over 500 references, which is excessive for any Examiner to have to consider at any level beyond a cursory review. In accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), stating that forcing the Examiner to find "a needle in a haystack" is "probative of bad faith." Id. [The Molins] case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references. Likewise, the instant application’s IDSs include more references than even the Molins case, and these particularly long IDSs do not include any concise explanation of the relevance of any of the listed references nor cite any pages, columns, and lines (or paragraph numbers) where relevant passages or relevant figures appear. According to MPEP Section 2004 “Aids to Compliance With Duty of Disclosure [R-08.2012]”, “It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to Applicant’s attention and/or are known to be of most significance.” Additionally, per MPEP Section 609.04(a)(III): “applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability.” See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v.Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
As such, even though these IDSs have been placed in the application file with the lists of references marked as considered, and the compilation of those listed PG Publications and Patent references have at least been key-word searched and/or classification searched for relevant prior art, the information referred to therein for each individual reference has admittedly not been fully considered beyond a cursory review. If Applicant wishes to have one or more references fully considered, the Examiner requests resubmitting the IDSs with a reasonable number of references that are known to be pertinent for the determination of patentability as defined by 37 C.F.R. § 1.56, along with the concise explanations as to relevance and citations explaining the locations of relevant passages or figures, as per 37 CFR 1.98(a)(3) and 37 CFR § 1.105.
Claim Objections
Claim 20 is objected to because of the following informalities: Claim 20 appears to contain typographical errors, and Examiner believes claim 20 should read as follows:
20. The surgical system of claim 16,
wherein the one or more controllers are configured to .
Appropriate correction is required.
Claim Interpretation
Applicant claims a “localizer” throughout the claims (see at least “a localizer configured to track a surgical site using a first tracking modality” in claim 1). A localizer appears to be a common class of devices well-known and understood in the art. A localizer shall be interpreted as a class of camera devices used in conjunction with tracking means (such as optical markers placed on patient anatomy) to establish and track patient anatomy relative to a coordinate system. Among others, Bowling and Malacklowski (cited in the rejections to follow), for example, utilize the term “localizer” to refer to this class of device. If Applicant intends “localizer” to be interpreted differently, Examiner requests appropriate clarification as to the intended meaning. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
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 therefor, subject to the conditions and requirements of this title.
Claims 1-15 rejected under 35 U.S.C. 101 because claimed invention is directed to an abstract idea without significantly more.
101 Analysis – Step 1
Claim 1 is directed to a surgical tracking system (i.e., a machine). Therefore, claim 1 is within at least one of the four statutory categories.
101 Analysis – Step 2A, Prong I
Regarding Prong I of the Step 2A analysis in the 2019 PEG, the claims are to be analyzed to determine whether they recite subject matter that falls within one of the follow groups of abstract ideas: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
Independent claim 1 includes limitations that recite an abstract idea (emphasized below) and will be used as a representative claim for the remainder of the 101 rejection. Claim 1 recites:
A surgical tracking system comprising:
a localizer configured to track a surgical site using a first tracking modality;
a vision device configured to track the surgical site using a second tracking modality different from the first tracking modality; and
one or more controllers coupled to the localizer and the vision device,
the one or more controllers being configured to:
determine, based on tracking data from the localizer, a first positional relationship between the localizer and the surgical site;
determine, based on tracking data from the vision device, a second positional relationship between the vision device and the surgical site;
compare the first and second positional relationships to identify a discrepancy wherein the second positional relationship fails to match the first positional relationship;
evaluate the discrepancy to identify an object presents an obstacle at the surgical site; and
generate a response to account for the obstacle.
The examiner submits that the foregoing bolded limitation(s) constitute a “mental process” because under its broadest reasonable interpretation, the claim covers performance of the limitation in the human mind. Specifically, the limitations of “track a surgical site… ” and “determine, based on tracking data… a … positional relationship” encompass an observer taking note of various vantage points and determining relative positions or distances between the area observed and the vantage point. Even accounting for the differing modalities (which will be discussed below), the limitation may encompass measuring these relative positions via different measuring means which may be done mentally (e.g. measuring stick and “eyeballing” the distance intuitively). The limitations of “compare the first and second positional relationships to identify a discrepancy …” encompasses noting a difference in the measurements from the previous step. The limitations of “evaluate the discrepancy to identify an object presents and obstacle … and generate a response” encompasses noting a difference during the above comparison step due to an obstruction in the measuring process, and responding accordingly by removing the obstruction so that the process may be repeated. Accordingly, the claim recites at least one abstract idea.
101 Analysis – Step 2A, Prong II
Regarding Prong II of the Step 2A analysis in the 2019 PEG, the claims are to be analyzed to determine whether the claim, as a whole, integrates the abstract into a practical application. As noted in the 2019 PEG, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
In the present case, the additional limitations beyond the above-noted abstract idea are as follows (where the underlined portions are the “additional limitations” while the bolded portions continue to represent the “abstract idea”):
A surgical tracking system comprising:
a localizer configured to track a surgical site using a first tracking modality;
a vision device configured to track the surgical site using a second tracking modality different from the first tracking modality; and
one or more controllers coupled to the localizer and the vision device,
the one or more controllers being configured to:
determine, based on tracking data from the localizer, a first positional relationship between the localizer and the surgical site;
determine, based on tracking data from the vision device, a second positional relationship between the vision device and the surgical site;
compare the first and second positional relationships to identify a discrepancy wherein the second positional relationship fails to match the first positional relationship;
evaluate the discrepancy to identify an object presents an obstacle at the surgical site; and
generate a response to account for the obstacle.
For the following reason(s), the examiner submits that the above identified additional limitations do not integrate the above-noted abstract idea into a practical application.
Regarding the additional limitations of “a localizer … using a first tracking modality,” the examiner submits that these limitations are an attempt to generally link additional elements to a technological environment. In particular, the tracking is recited at a high level of generality and merely automates the tracking step, therefore acting as a generic computer to perform the abstract idea. The localizer is claimed generically (see Claim Interpretation above) and is operating in its ordinary capacity and does not use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. The additional limitation is no more than mere instructions to apply the exception using a computer (the localizer). The same argument may be applied vis-à-vis to the limitation “a vision device … using a second tracking modality different from the first tracking modality.” The claimed “one or more controllers” are also claimed generically, and merely automate the determining, comparing, evaluating, and generating steps.
Thus, taken alone, the additional elements do not integrate the abstract idea into a practical application. Further, looking at the additional limitation(s) as an ordered combination or as a whole, the limitation(s) add nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (MPEP § 2106.05). Accordingly, the additional limitation(s) do/does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
101 Analysis – Step 2B
Regarding Step 2B of the Revised Guidance, representative independent claim 1 does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of localizer, vision device, and controllers amounts to nothing more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Hence, the claim is not patent eligible.
Independent claim 15 recites substantially similar subject matter to claim 1, and is rejected for by the same rationale. Dependent claim(s) 2-14 do not recite any further limitations that cause the claim(s) to be patent eligible. Rather, the limitations of dependent claims are directed toward additional aspects of the judicial exception and/or well-understood, routine and conventional additional elements that do not integrate the judicial exception into a practical application [provide concise explanation]. Therefore, dependent claims 2-14 are not patent eligible under the same rationale as provided for in the rejection of claim 1.
Claims 2-3 specify the types of modalities used and do not incorporate the abstract idea into a practical application.
Claims 4-7 introduce additional abstract ideas (determine and compare), which specify conditions under which a third positional relationship is determined and do not incorporate the abstract idea into a practical application.
Claim 8 specifies that the tracking is carried out relative to anatomical objects, which does not change the interpretation discussed with respect to claim 1.
Claim 9 introduces additional abstract ideas (identify, generate).
Claims 10-11 introduce additional generic computing devices (display) and insignificant extra solution activity (display notifications, display position of object).
Claims 12-14 introduce additional abstract ideas (generate virtual boundary).
EXAMINER NOTE: Claim 16 integrates the above abstract ideas into a practical application by incorporating a step of using a controller to control a surgical tool to account for the obstacle. If the above claims were amended to include a similar limitation, the above rejections may be overcome.
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(s) 1-10 and 12-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casas (US-20160191887-A1) in view of Bowling (US-20140276943-A1).
Claim 1
Casas teaches
a localizer configured to track a surgical site using a first tracking modality;
(Casas - [0071] In embodiments, the stereoscopic camera system 114 is composed of three or more cameras,)
a vision device configured to track the surgical site using a second tracking modality different from the first tracking modality; and
(Casas - [0078] … In embodiments, a 3D scanner system 110 may be composed of one or more devices capable of capturing shapes of objects (and sometimes its appearance, e.g. color), usually outputting a point cloud as a data file, allowing for the construction of three-dimensional surface models of the object scanned. For example, a 3D scanner system 110 may include a laser scanner, a time-of-flight 3D laser scanner, a structured-light 3D scanner, hand-held laser scanner, a time-of-flight camera, a depth camera, or a combination of these or other devices.
[0079] The 3D scanner 110 may be moved around the target portion of the patient 118 to obtain a precise 3D surface image of it through surface reconstruction 112. For example, computer means 100 may receive a dense 3D point cloud provided by the 3D scanning process, that represents the surface of the target portion of the patient 118 by a point cloud construction algorithm, … )
one or more controllers coupled to the localizer and the vision device,
(Casas - [0179] In embodiments, the above described methods and processes may be tied to a computing system including one or more computers. Examples of such computing systems may include, but are not limited to, imaging devices 102, 104, computing system 100, 3D scanner system 110, stereo camera system 114, tracking means 136, stereo display 126. In particular, the methods and processes described herein may be implemented as a computer application, computer service, computer API, computer library, and/or other computer program product.)
EXAMINER NOTE: See also Fig. 1. The 3D scanner and stereo camera pair are coupled to the computer.
the one or more controllers being configured to:
determine, based on tracking data from the localizer, a first positional relationship between the localizer and the surgical site;
(Casas - [0078] … In embodiments, a 3D scanner system 110 may be composed of one or more devices capable of capturing shapes of objects (and sometimes its appearance, e.g. color), usually outputting a point cloud as a data file, allowing for the construction of three-dimensional surface models of the object scanned. For example, a 3D scanner system 110 may include a laser scanner, a time-of-flight 3D laser scanner, a structured-light 3D scanner, hand-held laser scanner, a time-of-flight camera, a depth camera, or a combination of these or other devices.
[0079] The 3D scanner 110 may be moved around the target portion of the patient 118 to obtain a precise 3D surface image of it through surface reconstruction 112. For example, computer means 100 may receive a dense 3D point cloud provided by the 3D scanning process, that represents the surface of the target portion of the patient 118 by a point cloud construction algorithm, e.g. by the intersection of two lines emanating from the camera center, or from the midpoint of a line perpendicular to these two lines …)
compare the first and second positional relationships to identify a discrepancy wherein the second positional relationship fails to match the first positional relationship;
(Casas - [0080] In embodiments, the point cloud obtained is used directly for registration purposes, e.g. by comparing it with point clouds used to represent volumetric data from preoperative 104 or intraoperative imaging 106.
[0170] … With such information, real-time video images 116 may be compared with the preoperative images 104, 108 or the graphical representation of them (e.g. 3D volume) to determine whether the observed surgical images match expected surgical images based upon the patient condition information. Further, notifications may be generated and output based upon such comparisons. For example, in embodiments, the 3D surface may be compared to such data used to determine whether a surgery is performed on a correct body part or side. As a more specific example, the 3D volume-3D surface registration acquired during surgery may be analyzed to determine that a surgeon 128 is operating on a particular limb of a patient 118, on the correct vertebra or bone within the target portion of the patient 118. Such information may be compared to condition-related information to determine whether the procedure is being performed on the correct limb, target portion or level of the portion of the patient 118.)
evaluate the discrepancy to identify an object presents an obstacle at the surgical site; and
(Bowling - [0082] … In other words, the two fields of view may be matched or otherwise correlated such that if an object can be seen in video images streamed from the video camera, the objects are also within the field of view of the camera unit 36. A coordinate system of the video camera can also be transformed into the localizer coordinate system LCLZ or vice versa so that positions and/or orientations of objects shown in the video images streamed from the video camera are known in the localizer coordinate system LCLZ. Video images from the video camera can be streamed to the displays 28, 29 and the user can then identify on the displays 28, 29, using an input device, such as a mouse or touch screen, virtual constraint boundaries to delineate zones to be avoided by the instrument 22.)
generate a response to account for the obstacle.
(Bowling - [0056] The created models are used as virtual constraint boundaries to guide movement of the surgical instrument 22. The models may be displayed on displays 28, 29 to show the locations of the objects and/or information relating to the models can be forwarded to the manipulator controller 54 to guide the manipulator 56 and corresponding movement of the surgical instrument 22 relative to these virtual constraint boundaries to prevent the object from being contacted by the surgical instrument 22.
[0081] … The navigation system 20 communicates with the control system of the hand held surgical cutting instrument. The navigation system 20 communicates position and/or orientation data to the control system. The position and/or orientation data is indicative of a position and/or orientation of the instrument 22 relative to the anatomy. This communication provides closed loop control to control cutting of the anatomy such that the cutting occurs within a predefined boundary (the term predefined boundary is understood to include predefined trajectory, volume, line, other shapes or geometric forms, and the like))
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Casas's surgical registration system with Bowling's suggestion to utilize multiple views to identify obstacles to be avoided. Bowling's suggestion serves to prevent unwanted contact of objects with the surgical instrument.
Claim 2
The combination of Casas and Bowling teaches the limitations of claim 1 as outlined above. Regarding the limitations of
wherein the first tracking modality comprises one or more of:
non-visible light tracking, infrared tracking, electromagnetic tracking, ultrasound tracking, fluoroscopy-based tracking, and inertial tracking.
Casas discloses the use of optical markers as tracking means used in conjunction with the stereo cameras
(Casas - [0113] In embodiments, the stereoscopic display 126 is composed of a virtual reality device, and the stereoscopic camera system 114 is composed of fixed cameras, or cameras that do not move with the head of the surgeon 128, so that the stereoscopic view displayed to the virtual reality device moves as the head of the surgeon 128 moves, using its own tracking means 136 (e.g. optical marker-based tracking), without the need to change the position of the cameras 114 to change the view. )
Casas does not specify the spectrum in which the optical markers operate. However, as evidenced by Bowling, it is common in the art to utilize optical trackers operating in the infrared spectrum. Bowling therefore teaches
wherein the first tracking modality comprises one or more of:
non-visible light tracking, infrared tracking, electromagnetic tracking, ultrasound tracking, fluoroscopy-based tracking, and inertial tracking.
(Bowling - [0023] A localizer 34 communicates with the navigation computer 26. In the embodiment shown, the localizer 34 is an optical localizer and includes a camera unit 36 (one example of a sensing device). The camera unit 36 has an outer casing 38 that houses one or more optical position sensors 40. In some embodiments at least two optical sensors 40 are employed, preferably three. The optical sensors 40 may be three separate charge-coupled devices (CCD). In one embodiment three, one-dimensional CCDs are employed. It should be appreciated that in other embodiments, separate camera units, each with a separate CCD, or two or more CCDs, could also be arranged around the operating room. The CCDs detect infrared (IR) signals.
[0033] The optical sensors 40 of the localizer 34 receive light signals from the trackers 44, 46, 48. In the illustrated embodiment, the trackers 44, 46, 48 are active trackers. … The active markers can be, for example, light emitting diodes or LEDs 50 transmitting light, such as infrared light. )
Claim 3
The combination of Casas and Bowling teaches the limitations of Claim 2 as outlined above. Casas further teaches
wherein the second tracking modality comprises one or more of: depth map generation tracking, structured light projection tracking, time-of-flight tracking, or laser range finding.
(Casas - [0078] … In embodiments, a 3D scanner system 110 may be composed of one or more devices capable of capturing shapes of objects (and sometimes its appearance, e.g. color), usually outputting a point cloud as a data file, allowing for the construction of three-dimensional surface models of the object scanned. For example, a 3D scanner system 110 may include a laser scanner, a time-of-flight 3D laser scanner, a structured-light 3D scanner, hand-held laser scanner, a time-of-flight camera, a depth camera, or a combination of these or other devices.)
Claim 4
The combination of Casas and Bowling teaches the limitations of Claim 1 as outlined above. Casas further teaches
wherein the one or more controllers are configured to:
determine a third positional relationship between the localizer and the vision device; and
further utilize the third positional relationship to compare the first and second positional relationships to identify the discrepancy.
(Casas - [0101] … The relative locations may be used by the computer 211 to automatically select the position of virtual cameras for stereoscopic views of the 3D surface, according to the precise position of the cameras 201, 202 relative to the coordinate system used by the 3D scanner 203)
Claim 5
The combination of Casas and Bowling teaches the limitations of Claim 4 as outlined above. Casas further teaches
the localizer is fixed to the vision device; and
the third positional relationship is predetermined.
(Casas - [0101] In the exemplary embodiment described above in FIG. 2, the stereoscopic cameras 201, 202 and the 3D scanner 203 are closely arranged in a precise fixed and known relative position to each other, so that the precise relative location (x.sub.1,y.sub.1,z.sub.1) and orientation angle (α.sub.1,φ.sub.1,θ.sub.1) of the first camera 201 with respect to the 3D scanner 203, and the relative location (x.sub.2,y.sub.2,z.sub.2) and orientation angle (α.sub.2,φ.sub.2,θ.sub.2) of the second camera 202 with respect to the 3D scanner 203 are known. )
(Casas - [0105] In embodiments, the device or devices composing the 3D scanner system 110 include one or more cameras (e.g. time-of-flight cameras). The camera or cameras may form part of the stereoscopic camera system 114. Registration of 3D surface and stereoscopic video 122 is therefore done directly within the coordinate system of the device.)
Claim 6
The combination of Casas and Bowling teaches the limitations of Claim 4 as outlined above. Casas further teaches
the localizer is movable relative to the vision device; and
the third positional relationship is variable.
(Casas - [0103] In embodiments, the 3D scanner 206 is separated from the stereoscopic cameras 201, 202. … In embodiments,… they are mobile, and their relative orientation angle is determined e.g. by IMUs attached to all devices, which show their orientation relative to each other. )
Claim 7
The combination of Casas and Bowling teaches the limitations of Claim 4 as outlined above. Casas further teaches
a tracker is coupled to the vision device;
the localizer is configured to detect the tracker to track a pose of the vision device; and
the one or more controllers determine the third positional relationship based on tracked pose of the vision device.
(Casas - [0103] In embodiments, the 3D scanner 206 is separated from the stereoscopic cameras 201, 202. … In embodiments,… they are mobile, and their relative orientation angle is determined e.g. by IMUs attached to all devices, which show their orientation relative to each other. )
Claim 8
The combination of Casas and Bowling teaches the limitations of Claim 1 as outlined above. Casas further teaches
the localizer tracks an anatomical object at the surgical site using the first tracking modality;
the vision device tracks the anatomical object at the surgical site using the second tracking modality; and
the one or more controllers:
determine the first positional relationship between the localizer and the anatomical object at the surgical site; and
determine the second positional relationship between the vision device and the anatomical object at the surgical site.
(Casas -[0108] In embodiments, once the initial 3D volume-3D surface registration 120 and stereoscopic video-3D surface registration 122 are done, the tracked location and orientation angles of the two-dimensional cameras 114 with respect to the portion of the patient 118 (e.g. tracking the selected anatomic landmarks of the patient 118) are used as the location and orientation parameters for the virtual cameras defined for capturing the 3D volume images.)
EXAMINER NOTE: The first and second modalities and determination of relationships have been discussed above with respect to claim 1. Each device tracks patient anatomy.
Claim 9
The combination of Casas and Bowling teaches the limitations of Claim 1 as outlined above. Casas alone may not explicitly teach the following limitations in combination. However, Bowling further teaches
wherein the one or more controllers are configured to:
identify the object as presenting the obstacle to a surgical trajectory defined by a surgical plan; and
generate the response to account for the obstacle by being configured to modify the surgical plan.
(Bowling - [0059] … The manipulator controller 54 may also continuously track movement of the virtual constraint boundary and continuously adjust a path and/or orientation of the surgical instrument 22 as the virtual constraint boundary moves, to avoid the virtual constraint boundary.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify Casas with Bowling's suggestion to modify the surgical plan to account for obstacle to ensure that surgical instruments do not make unwanted contact with objects in the surgical site.
Claim 10
The combination of Casas and Bowling teaches the limitations of Claim 1 as outlined above. Casas further teaches
further comprising a display device,
(Casas - [0112] In embodiments, the display 126 may be a simple stereoscopic video display, or alternatively it may be a stereoscopic virtual reality display, that allows for interaction of the surgeon 128 or other users with the virtual environment created by computer means 100, e.g. through motion tracking and gesture recognition. In embodiments, as shown in FIG. 2, the stereoscopic display 214 is head-mounted 213, and it may include headphones 219 and a microphone, to receive information in audio format and be able to communicate with other users.)
Casas alone may not explicitly teach the following limitations in combination. However, as discussed above with respect to claim 1 (and further elaborated below), Bowling teaches
and wherein the one or more controllers generate the response to account for the obstacle by being configured to present, on the display device, a notification informing of the obstacle.
(Bowling - [0061] Models of the objects being tracked may be displayed on displays 28, 29 to show the location of the objects. Representations of the virtual boundaries and the anatomy being treated may also be shown on displays 28, 29. )
Claim 12
The combination of Casas and Bowling teaches the limitations of claim 1 as outlined above. In the cited combination, Bowling also teaches
wherein the one or more controllers generate the response to account for the obstacle by being configured to
generate a virtual boundary that is associated with the object,
wherein the virtual boundary provides a constraint on motion of a surgical tool.
(Bowling - [0059] … The manipulator controller 54 may also continuously track movement of the virtual constraint boundary and continuously adjust a path and/or orientation of the surgical instrument 22 as the virtual constraint boundary moves, to avoid the virtual constraint boundary.
[0061] Models of the objects being tracked may be displayed on displays 28, 29 to show the location of the objects. Representations of the virtual boundaries and the anatomy being treated may also be shown on displays 28, 29. )
Claim 13
The combination of Casas and Bowling teaches the limitations of claim 12 as outlined above. In the cited combination, Bowling also teaches
wherein the one or more controllers generate the virtual boundary based on a virtual model of the object.
(Bowling - [0055] … As more points on the surface are touched by the tip and their positions calculated by the navigation system 20, models of the object can be created to define a position and orientation of the object in the localizer coordinate system LCLZ. Such models can be created using conventional surface mapping tools and the like.
[0056] The created models are used as virtual constraint boundaries to guide movement of the surgical instrument 22. )
Claim 14
The combination of Casas and Bowling teaches the limitations of claim 12 as outlined above. In the cited combination, Bowling also teaches
wherein the one or more controllers generate the virtual boundary based on a geometry of the object determined by the vision device.
(Bowling - [0005] Typically, virtual cutting boundaries are created prior to surgery. Virtual cutting boundaries are often created in a model of a patient's bone and fixed with respect to the bone so that when the model is loaded into the navigation system, the navigation system can track movement of the virtual cutting boundary by tracking movement of the bone.)
Claim 15
Casas teaches
a localizer for tracking a surgical site using a first tracking modality,
(Casas - [0071] In embodiments, the stereoscopic camera system 114 is composed of three or more cameras,)
a vision device for tracking the surgical site using a second tracking modality different from the first tracking modality, and
(Casas - [0078] … In embodiments, a 3D scanner system 110 may be composed of one or more devices capable of capturing shapes of objects (and sometimes its appearance, e.g. color), usually outputting a point cloud as a data file, allowing for the construction of three-dimensional surface models of the object scanned. For example, a 3D scanner system 110 may include a laser scanner, a time-of-flight 3D laser scanner, a structured-light 3D scanner, hand-held laser scanner, a time-of-flight camera, a depth camera, or a combination of these or other devices.
[0079] The 3D scanner 110 may be moved around the target portion of the patient 118 to obtain a precise 3D surface image of it through surface reconstruction 112. For example, computer means 100 may receive a dense 3D point cloud provided by the 3D scanning process, that represents the surface of the target portion of the patient 118 by a point cloud construction algorithm, … )
one or more controllers coupled to the localizer and the vision device,
(Casas - [0179] In embodiments, the above described methods and processes may be tied to a computing system including one or more computers. Examples of such computing systems may include, but are not limited to, imaging devices 102, 104, computing system 100, 3D scanner system 110, stereo camera system 114, tracking means 136, stereo display 126. In particular, the methods and processes described herein may be implemented as a computer application, computer service, computer API, computer library, and/or other computer program product.)
EXAMINER NOTE: See also Fig. 1. The 3D scanner and stereo camera pair are coupled to the computer.
the method comprising
the one or more controllers performing the following steps:
determining, based on tracking data from the localizer, a first positional relationship between the localizer and the surgical site;
(Casas - [0054] At operation 330, orientation tracking data of each of the cameras that form the stereoscopic camera system may be obtained. The obtained orientation tracking data may be used in combination with the appropriate tracking means 136 for location.
[0055] At operation 332, a view of the 3D surface may be displayed to the surgeon, wherein the view corresponds to the precise position of each camera in the common coordinate system.)
determining, based on tracking data from the vision device, a second positional relationship between the vision device and the surgical site;
(Casas - [0078] … In embodiments, a 3D scanner system 110 may be composed of one or more devices capable of capturing shapes of objects (and sometimes its appearance, e.g. color), usually outputting a point cloud as a data file, allowing for the construction of three-dimensional surface models of the object scanned. For example, a 3D scanner system 110 may include a laser scanner, a time-of-flight 3D laser scanner, a structured-light 3D scanner, hand-held laser scanner, a time-of-flight camera, a depth camera, or a combination of these or other devices.
[0079] The 3D scanner 110 may be moved around the target portion of the patient 118 to obtain a precise 3D surface image of it through surface reconstruction 112. For example, computer means 100 may receive a dense 3D point cloud provided by the 3D scanning process, that represents the surface of the target portion of the patient 118 by a point cloud construction algorithm, e.g. by the intersection of two lines emanating from the camera center, or from the midpoint of a line perpendicular to these two lines …)
comparing the first and second positional relationships for identifying a discrepancy wherein the second positional relationship fails to match the first positional relationship;
(Casas - [0080] In embodiments, the point cloud obtained is used directly for registration purposes, e.g. by comparing it with point clouds used to represent volumetric data from preoperative 104 or intraoperative imaging 106.
[0170] … With such information, real-time video images 116 may be compared with the preoperative images 104, 108 or the graphical representation of them (e.g. 3D volume) to determine whether the observed surgical images match expected surgical images based upon the patient condition information. Further, notifications may be generated and output based upon such comparisons. For example, in embodiments, the 3D surface may be compared to such data used to determine whether a surgery is performed on a correct body part or side. As a more specific example, the 3D volume-3D surface registration acquired during surgery may be analyzed to determine that a surgeon 128 is operating on a particular limb of a patient 118, on the correct vertebra or bone within the target portion of the patient 118. Such information may be compared to condition-related information to determine whether the procedure is being performed on the correct limb, target portion or level of the portion of the patient 118.)
Casas alone may not explicitly teach the following limitations in combination. However, Bowling teaches
evaluating the discrepancy for identifying an object that presents an obstacle at the surgical site; and
(Bowling - [0082] … In other words, the two fields of view may be matched or otherwise correlated such that if an object can be seen in video images streamed from the video camera, the objects are also within the field of view of the camera unit 36. A coordinate system of the video camera can also be transformed into the localizer coordinate system LCLZ or vice versa so that positions and/or orientations of objects shown in the video images streamed from the video camera are known in the localizer coordinate system LCLZ. Video images from the video camera can be streamed to the displays 28, 29 and the user can then identify on the displays 28, 29, using an input device, such as a mouse or touch screen, virtual constraint boundaries to delineate zones to be avoided by the instrument 22.)
generating a response to account for the obstacle.
(Bowling - [0056] The created models are used as virtual constraint boundaries to guide movement of the surgical instrument 22. The models may be displayed on displays 28, 29 to show the locations of the objects and/or information relating to the models can be forwarded to the manipulator controller 54 to guide the manipulator 56 and corresponding movement of the surgical instrument 22 relative to these virtual constraint boundaries to prevent the object from being contacted by the surgical instrument 22.
[0081] … The navigation system 20 communicates with the control system of the hand held surgical cutting instrument. The navigation system 20 communicates position and/or orientation data to the control system. The position and/or orientation data is indicative of a position and/or orientation of the instrument 22 relative to the anatomy. This communication provides closed loop control to control cutting of the anatomy such that the cutting occurs within a predefined boundary (the term predefined boundary is understood to include predefined trajectory, volume, line, other shapes or geometric forms, and the like))
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Casas's surgical registration system with Bowling's suggestion to utilize multiple views to identify obstacles to be avoided. Bowling's suggestion serves to prevent unwanted contact of objects with the surgical instrument.
Claim 16
Casas teaches
a localizer configured to track the surgical site using a first tracking modality;
(Casas - [0071] In embodiments, the stereoscopic camera system 114 is composed of three or more cameras,)
a vision device configured to track the surgical site using a second tracking modality different from the first tracking modality; and
(Casas - [0078] … In embodiments, a 3D scanner system 110 may be composed of one or more devices capable of capturing shapes of objects (and sometimes its appearance, e.g. color), usually outputting a point cloud as a data file, allowing for the construction of three-dimensional surface models of the object scanned. For example, a 3D scanner system 110 may include a laser scanner, a time-of-flight 3D laser scanner, a structured-light 3D scanner, hand-held laser scanner, a time-of-flight camera, a depth camera, or a combination of these or other devices.
[0079] The 3D scanner 110 may be moved around the target portion of the patient 118 to obtain a precise 3D surface image of it through surface reconstruction 112. For example, computer means 100 may receive a dense 3D point cloud provided by the 3D scanning process, that represents the surface of the target portion of the patient 118 by a point cloud construction algorithm, … )
one or more controllers coupled to the surgical tool, the localizer and the vision device,
(Casas - [0179] In embodiments, the above described methods and processes may be tied to a computing system including one or more computers. Examples of such computing systems may include, but are not limited to, imaging devices 102, 104, computing system 100, 3D scanner system 110, stereo camera system 114, tracking means 136, stereo display 126. In particular, the methods and processes described herein may be implemented as a computer application, computer service, computer API, computer library, and/or other computer program product.)
EXAMINER NOTE: See also Fig. 1. The 3D scanner and stereo camera pair are coupled to the computer.
the one or more controllers being configured to:
determine, based on tracking data from the localizer, a first positional relationship between the localizer and the surgical site;
(Casas - [0054] At operation 330, orientation tracking data of each of the cameras that form the stereoscopic camera system may be obtained. The obtained orientation tracking data may be used in combination with the appropriate tracking means 136 for location.
[0055] At operation 332, a view of the 3D surface may be displayed to the surgeon, wherein the view corresponds to the precise position of each camera in the common coordinate system.)
determine, based on tracking data from the vision device, a second positional relationship between the vision device and the surgical site;
(Casas - [0078] … In embodiments, a 3D scanner system 110 may be composed of one or more devices capable of capturing shapes of objects (and sometimes its appearance, e.g. color), usually outputting a point cloud as a data file, allowing for the construction of three-dimensional surface models of the object scanned. For example, a 3D scanner system 110 may include a laser scanner, a time-of-flight 3D laser scanner, a structured-light 3D scanner, hand-held laser scanner, a time-of-flight camera, a depth camera, or a combination of these or other devices.
[0079] The 3D scanner 110 may be moved around the target portion of the patient 118 to obtain a precise 3D surface image of it through surface reconstruction 112. For example, computer means 100 may receive a dense 3D point cloud provided by the 3D scanning process, that represents the surface of the target portion of the patient 118 by a point cloud construction algorithm, e.g. by the intersection of two lines emanating from the camera center, or from the midpoint of a line perpendicular to these two lines …)
compare the first and second positional relationships to identify a discrepancy wherein the second positional relationship fails to match the first positional relationship;
(Casas - [0080] In embodiments, the point cloud obtained is used directly for registration purposes, e.g. by comparing it with point clouds used to represent volumetric data from preoperative 104 or intraoperative imaging 106.
[0170] … With such information, real-time video images 116 may be compared with the preoperative images 104, 108 or the graphical representation of them (e.g. 3D volume) to determine whether the observed surgical images match expected surgical images based upon the patient condition information. Further, notifications may be generated and output based upon such comparisons. For example, in embodiments, the 3D surface may be compared to such data used to determine whether a surgery is performed on a correct body part or side. As a more specific example, the 3D volume-3D surface registration acquired during surgery may be analyzed to determine that a surgeon 128 is operating on a particular limb of a patient 118, on the correct vertebra or bone within the target portion of the patient 118. Such information may be compared to condition-related information to determine whether the procedure is being performed on the correct limb, target portion or level of the portion of the patient 118.)
Casas alone may not explicitly teach the following limitations in combination. However, Bowling teaches
evaluate the discrepancy to identify an object that presents an obstacle at the surgical site;
(Bowling - [0082] … In other words, the two fields of view may be matched or otherwise correlated such that if an object can be seen in video images streamed from the video camera, the objects are also within the field of view of the camera unit 36. A coordinate system of the video camera can also be transformed into the localizer coordinate system LCLZ or vice versa so that positions and/or orientations of objects shown in the video images streamed from the video camera are known in the localizer coordinate system LCLZ. Video images from the video camera can be streamed to the displays 28, 29 and the user can then identify on the displays 28, 29, using an input device, such as a mouse or touch screen, virtual constraint boundaries to delineate zones to be avoided by the instrument 22.)
control the surgical tool to account for the obstacle.
(Bowling - [0056] The created models are used as virtual constraint boundaries to guide movement of the surgical instrument 22. The models may be displayed on displays 28, 29 to show the locations of the objects and/or information relating to the models can be forwarded to the manipulator controller 54 to guide the manipulator 56 and corresponding movement of the surgical instrument 22 relative to these virtual constraint boundaries to prevent the object from being contacted by the surgical instrument 22.
[0081] … The navigation system 20 communicates with the control system of the hand held surgical cutting instrument. The navigation system 20 communicates position and/or orientation data to the control system. The position and/or orientation data is indicative of a position and/or orientation of the instrument 22 relative to the anatomy. This communication provides closed loop control to control cutting of the anatomy such that the cutting occurs within a predefined boundary (the term predefined boundary is understood to include predefined trajectory, volume, line, other shapes or geometric forms, and the like))
Regarding the limitations of
a surgical tool configured to manipulate a surgical site;
Casas's teachings primarily relate to a non-robotic surgical system. However, Casas indicates that their teachings apply equally to a fully automated robotic device.
(Casas - [0176] The same principles described above are used in case of a fully automated robotic device, where the surgeon 128 may operate without physically being in the same room as the patient 118.)
Bowling illustrates an exemplary robot, and thus teaches
(Bowling - [0051] As a result, coordinate transformer 102 generates data indicating the position and orientation of the working end of the surgical instrument 22 relative to the tissue (e.g., bone) against which the instrument working end is applied. Image signals representative of these data are forwarded to displays 28, 29 enabling the surgeon and staff to view this information. In certain embodiments, other signals representative of these data can be forwarded to the manipulator controller 54 to guide the manipulator 56 and corresponding movement of the surgical instrument 22.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Casas by implementing Bowling's surgical robot in order to allow the surgeon to operate without physically being in the same room (see Casas - [0176], cited above). Additionally, Bowling's suggestion to utilize multiple views to identify obstacles to be avoided serves to prevent unwanted contact of objects with the surgical instrument.
Claim 17
The combination of Casas and Bowling teaches the limitations of claim 1 as outlined above. Casas alone may not explicitly teach the following limitations in combination. However, in the cited combination, Bowling also teaches
wherein the one or more controllers generate the response to account for the obstacle by being configured to
generate a virtual boundary that is associated with the object,
wherein the virtual boundary provides a constraint on motion of a surgical tool.
(Bowling - [0059] … The manipulator controller 54 may also continuously track movement of the virtual constraint boundary and continuously adjust a path and/or orientation of the surgical instrument 22 as the virtual constraint boundary moves, to avoid the virtual constraint boundary.
[0061] Models of the objects being tracked may be displayed on displays 28, 29 to show the location of the objects. Representations of the virtual boundaries and the anatomy being treated may also be shown on displays 28, 29. )
Claim 18
As stated above, Casas's teachings primarily relate to a non-robotic surgical system. However, Casas indicates that their teachings apply equally to a fully automated robotic device.
(Casas - [0176] The same principles described above are used in case of a fully automated robotic device, where the surgeon 128 may operate without physically being in the same room as the patient 118.)
Bowling illustrates an exemplary robot, and thus teaches
further comprising a robotic manipulator including a base and robotic arm coupled to the base, wherein the robotic arm is configured to support and move the surgical tool to manipulate the surgical site,
(Bowling - [0051] As a result, coordinate transformer 102 generates data indicating the position and orientation of the working end of the surgical instrument 22 relative to the tissue (e.g., bone) against which the instrument working end is applied. Image signals representative of these data are forwarded to displays 28, 29 enabling the surgeon and staff to view this information. In certain embodiments, other signals representative of these data can be forwarded to the manipulator controller 54 to guide the manipulator 56 and corresponding movement of the surgical instrument 22.)
EXAMINER NOTE: See Annotated Fig. 1 below
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and wherein the one or more controllers account for the obstacle by being configured to control the robotic manipulator to control motion of the surgical tool to avoid the object.
(Bowling - [0059] … The manipulator controller 54 may also continuously track movement of the virtual constraint boundary and continuously adjust a path and/or orientation of the surgical instrument 22 as the virtual constraint boundary moves, to avoid the virtual constraint boundary.)
Claim 19
The combination of Casas and Bowling teaches the limitations of claim 16 as outlined above. As discussed above, Casas states that their vision system is applicable to robotic systems, but does not mention the specific structure of the robotic system. Casas does not disclose a hand-held robotic device, but Bowling teaches
a hand-held robotic device configured to support and move the surgical tool to manipulate the surgical site,
(Bowling - [0080] In other systems, the instrument 22 has a cutting tool that is movable in three degrees of freedom relative to a handheld housing and is manually positioned by the hand of the surgeon, without the aid of cutting jigs, guide arms or other constraining mechanism. )
and wherein the one or more controllers account for the obstacle by being configured to control the hand-held robotic device to control motion of the surgical tool to avoid the object.
(Bowling - [0081] … The navigation system 20 communicates with the control system of the hand held surgical cutting instrument. The navigation system 20 communicates position and/or orientation data to the control system. The position and/or orientation data is indicative of a position and/or orientation of the instrument 22 relative to the anatomy. This communication provides closed loop control to control cutting of the anatomy such that the cutting occurs within a predefined boundary (the term predefined boundary is understood to include predefined trajectory, volume, line, other shapes or geometric forms, and the like))
Bowling demonstrates that a hand held cutting tool is also capable of performing surgeries in the context of a vision guided system. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute Casas's robot with Bowling's hand-held device to achieve the same result of performing vision guided surgery.
Claim 20
The combination of Casas and Bowling teaches the limitations of claim 1 as outlined above. As discussed above, and further elaborated below, Bowling’s contribution to the combination teaches
wherein the one or more controllers are configured to control identify that the object presents the obstacle to a planned trajectory of the surgical tool; and control the surgical tool to account for the obstacle by being configured to adjust the planned trajectory.
(Bowling - [0059] … The manipulator controller 54 may also continuously track movement of the virtual constraint boundary and continuously adjust a path and/or orientation of the surgical instrument 22 as the virtual constraint boundary moves, to avoid the virtual constraint boundary.)
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Casas and Bowling as applied to claim 1 above, and further in view of Macklowski (US-20170189125-A1).
Claim 11
The combination of Casas and Bowling teaches the limitations of claim 1 as outlined above. Casas further teaches
a display device,
(Casas - [0112] In embodiments, the display 126 may be a simple stereoscopic video display, or alternatively it may be a stereoscopic virtual reality display, that allows for interaction of the surgeon 128 or other users with the virtual environment created by computer means 100, e.g. through motion tracking and gesture recognition. In embodiments, as shown in FIG. 2, the stereoscopic display 214 is head-mounted 213, and it may include headphones 219 and a microphone, to receive information in audio format and be able to communicate with other users.)
and wherein the one or more controllers generate the response to account for the obstacle by being configured to:
… track movement of the object with the vision device; and
(Casas - [0081] … Alternatively, 3D scans are made whenever computer means 100 detect movement of the portion of the patient 118 (i.e. determining patient pose 318), e.g. by comparing a surface reconstruction obtained from the stereoscopic video 116 to the last surface reconstruction 112 of the 3D scanner 110, or by marker-based optical tracking, or by IMU tracking, or any other tracking means 136.)
Casas alone may not explicitly teach the following limitations in combination. However, Malackowski teaches
and wherein the one or more controllers generate the response to account for the obstacle by being configured to:
present, on the display device, a position of the object relative to the surgical site and a suggestion or instruction to clear the object;
(Malackowski - [0003] A representation of the virtual object can be displayed to the user during surgery to assist the user in visualizing placement of a treatment end of the instrument relative to the target site. For instance, the target site may be associated with a bone of the patient and the virtual object may define a volume of the bone to be removed by the treatment end of the instrument.
[0018] The target sites to be treated by the surgical instrument 30 are defined by virtual objects. In the embodiment shown, a femur target site TS is shown, which is associated with the femur F. Of course, several other target sites, such as a target site for the tibia T, are also possible, with each being defined by its own separate virtual object. The virtual objects representing the target sites are pre-operatively set by the user and/or automatically generated to define volumes of material to be treated, trajectories for the surgical instrument 30, planes to be cut by the surgical instrument 30, bores to be drilled, and the like. In the embodiment shown, a virtual object VB (see FIG. 4) defines the volume of material to be removed from the femur F. In some cases, the virtual objects are set or re-set intraoperatively, i.e., during the surgical procedure. It should be appreciated that although the description set forth herein relates to orthopedic surgical procedures, the systems and methods described herein are likewise suitable for any type of surgical procedure.)
EXAMINER NOTE: A visualization of the area to be remove is a display of a suggestion of a specific volume to remove, or an instruction of the specific volume to remove.
update the display device to inform that the obstacle has been cleared.
(Malackowski - [0036] The navigation processor 62 also generates image signals that indicate the relative position of the treatment end to the target sites. These image signals are applied to the displays 36, 38. Displays 36, 38, based on these signals, generate images that allow the surgeon and staff to virtually view the relative position of the treatment end to the target sites. In most cases, the images illustrate the treatment end with respect to one target site at a time. For instance, in a surgical procedure in which the femur F and the tibia T are both being treated, the femur target site TS and the relative position of the treatment end of the surgical instrument 30 to the femur target site TS may be visually represented while material is being removed from the femur F. Likewise, when the user is finished removing material from the femur F and is ready to remove material from the tibia T, the display 36, 38 may only illustrate placement of the treatment end of the surgical instrument 30 with respect to the target site associated with the tibia T.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further modify Casas with Malackowski's suggestion to display boundaries of volumes to be removed in order to assist the user in visualizing the surgical area.
(Malackowski - [0003] Navigation systems assist users in precisely locating objects. For instance, navigation systems are used in industrial, aerospace, and medical applications. In the medical field, navigation systems assist surgeons in precisely placing surgical instruments relative to a target site in a patient. The target site usually requires some form of treatment, such as tissue removal. In some cases, the target site is defined in the navigation system using a virtual object, such as a 3-D model. A representation of the virtual object can be displayed to the user during surgery to assist the user in visualizing placement of a treatment end of the instrument relative to the target site. )
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES MILLER WATTS whose telephone number is (703)756-1249. The examiner can normally be reached 7:30-5:30 M-TH.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Mott can be reached at 571-270-5376. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES MILLER WATTS III/Examiner, Art Unit 3657
/ADAM R MOTT/Supervisory Patent Examiner, Art Unit 3657
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