DETAILED ACTION
Remarks
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 25 is objected to because of the following informalities: Claim 25 includes a typographical error in line 2, i.e., “(in”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 16-30 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 16 recites the limitation "a calibration module" in line 5. This term renders the claim indefinite because it recites a non-structural term with no further detail in the claim regarding any corresponding structure or functionality. The term “calibration” and “module” are non-structural terms with no plain and ordinary meaning. Further, this term is not further defined by any corresponding functionality and thus does not invoke interpretation under 35 USC 112(f). Therefore, the limitation renders the claim indefinite as it is unclear what constitutes the metes and bounds of the claimed invention. Further, dependent claims 17-30 inherit the same deficiencies as claim 16 based on their incorporation by reference of the independent claim.
Claim 26 recites the limitation "the at least one spacer module" in lines 1-2. The term “spacer module” does not have sufficient antecedent basis in the claims.
Claim Rejections – 35 USC 102 (AIA )
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:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 16-17 and 19-30 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2022/0151705 A1 to NIKOU.
Regarding claim 16, NIKOU teaches A modular surgical training platform configured to interface a virtual environment comprising at least one movable virtual surgical element, the training platform (Title: Augmented Reality Assisted Surgical Tool Alignment; Abstract: Computer-assisted surgical systems and methods for assisting with tool alignment using one or more mixed reality displays; FIG. 10A and 10B, for example) comprising:
a virtual reality display unit configured to display, to a user, the virtual environment (par. 0006: a system that improves and enhances the ability of a surgeon to perform an ongoing surgery in real time including the ability to provide additional information in an augmented reality display system; par. 0057: surgical staff may wear an Augmented Reality (AR) Head Mounted Device (HMD)(see par. 0003 defining Augmented Reality (AR) as an interactive experience by which objects that reside in the real world are “augmented” by computer-generated information); par. 0091: instructions may be provided on the…AR HMD 155 instructing the Surgeon 111 how to move the component),
a calibration module connected to the virtual reality display unit (par. 0171: a plate that comprises a trackable image (e.g., a QR code or known symbol) may be used to calibrate the tracking system.),
at least one training module, each training module including a haptic controller (par. 0092: Effector Platform 105…In some embodiments, the Surgical Computer 150 provides the Effector Platform 105 with instructions defining how to react when a component of the Effector Platform 105 deviates from a surgical plan. These commands are referenced in FIG. 5A as “haptic” commands. For example, the End Effector 105B may provide a force to resist movement outside of an area where resection is planned. Other commands that may be used by the Effector Platform 105 include vibration and audio cues),
a control system configured to: identify the different modules connected together, generate the virtual environment, interface each movable virtual surgical element of the virtual environment with a corresponding real element (par. 0003: objects that reside in the real world are “augmented” by computer-generated information; par. 0171: Specifically, in some embodiments, the plate, surface, object, etc. may comprise both a trackable image 901 and one or more infrared reflective tracking markers 902. The location of the trackable image and reflective markers may be known, both alone and in relation to each other. Accordingly, in some embodiments, a conversion method may be provided between image tracking coordinates and other tracking objects (e.g., infrared reflective markers, etc.). Thus, as long as the augmented reality system can locate (e.g., see) the plate with its camera(s), and the secondary tracking methodology can also locate its tracking markers, an embodiment can co-register the two different methodologies. Because two or more tracking modalities can be co-registered, a system may also display (e.g., in an augmented reality device) any stored or previously registered 3D models as well as an image of one or more surgical tools (e.g., the acetabular cup in alignment with the cup at the end of the impactor); par. 0176: control system 1201 can include one or more computing devices configured to coordinate information received from the tracking systems 1202 and 1203 and provide augmented reality in a video-see-through format to the near-eye display device 1204.),
wherein all of the modules are configured to be reversibly attached to each other in a known configuration (par. 0059: Various techniques generally known in the art can be used for connecting the Surgical Computer 150 to the other components of the CASS 100. Moreover, the computers can connect to the Surgical Computer 150 using a mix of technologies. For example, the End Effector 105B may connect to the Surgical Computer 150 over a wired (i.e., serial) connection. The Tracking System 115, Tissue Navigation System 120, and Display 125 can similarly be connected to the Surgical Computer 150 using wired connections; par. 0180: In an embodiment, the communication interface 1201D facilitates communication between the control system 1201 and external systems and devices. The communication interface 1201D can include both wired and wireless communication interfaces, such as Ethernet, IEEE 802.11 wireless, or Bluetooth, among others. In some embodiments, external systems connected via the communication interface 1201D include the tracking systems 1202 and 1203. Although not shown, the database 1205 and the display device 1204, among other devices, may also be connected to the control system 1201 via the communication interface 1201D. In an example, the communication interface 1201D communicates over an internal bus to other modules and hardware systems within the control system 1201.),
wherein each haptic controller includes a connection system configured to reversibly mechanically connect a surgical training tool, each haptic controller being further, configured to measure each movement in space of the surgical training tool once the latter is connected to the haptic controller (par. 0037: An Effector Platform 105 positions surgical tools relative to a patient during surgery. The exact components of the Effector Platform 105 will vary, depending on the embodiment employed. For example, for a knee surgery, the Effector Platform 105 may include an End Effector 105B that holds surgical tools or instruments during their use. The End Effector 105B may be a handheld device or instrument used by the surgeon (e.g., a NAVIO hand piece or a cutting guide or jig) or, alternatively, the End Effector 105B can include a device or instrument held or positioned by a Robotic Arm 105 A. While one Robotic Arm 105 A is illustrated in FIG. 1, in some embodiments there may be multiple devices; par. 0092: the End Effector 105B may provide a force to resist movement outside of an area where resection is planned; par. 0104: , the Surgical Computer 150 may serve as the central point where CASS data is collected. The exact content of the data will vary depending on the source. For example, each component of the Effector Platform 105 provides a measured position to the Surgical Computer 150. Thus, by comparing the measured position to a position originally specified by the Surgical Computer 150 (see FIG. 5B), the Surgical Computer can identify deviations that take place during surgery; par. 0106: For AR applications, the measured position and displacement of the HMD may be sent to the Surgical Computer 150 so that it can update the presented view as needed; par. 0159: the location and orientation of surgical tools may be simultaneously tracked),
wherein the control system further includes a system for recognising each surgical training tool configured to obtain identification information specific to the connected surgical training tool, and communicating the identification information to the control system, so that the control system recognises each surgical training tool connected to the haptic controller (par. 0053: In some embodiments, certain markers, such as fiducial marks that identify individuals, important tools, or bones in the theater may include passive or active identifiers that can be picked up by a camera or camera array associated with the tracking system. For example, an IR LED can flash a pattern that conveys a unique identifier to the source of that pattern, providing a dynamic identification mark. Similarly, one or two dimensional optical codes (barcode, OR code, etc.) can be affixed to objects in the theater to provide passive identification that can occur based on image analysis.),
wherein the control system generates a virtual image of each surgical training tool connected to the haptic controller (par. 0171: Because two or more tracking modalities can be co-registered, a system may also display (e.g., in an augmented reality device) any stored or previously registered 3D models as well as an image of one or more surgical tools (e.g., the acetabular cup in alignment with the cup at the end of the impactor).),
wherein the control system is configured to receive and analyse the data related to the movement(s) of each surgical training tool connected to the haptic controller, and reproducing each movement of the surgical training tool connected to the haptic controller into a corresponding virtual movement of its virtual image in the virtual environment (par. 0144: as the surgeon moves resection tools around the planned resection area, the process display can be updated so that the surgeon can see how his or her actions are affecting the other aspects of the surgery; par. 0159: The present disclosure describes example systems and methods of tracking specific portions of a patient's skeletal structure during surgery using an surgical navigation system enhanced by an augmented reality system. In addition, the location and orientation of surgical tools may be simultaneously tracked. By intraoperatively tracking the skeletal structure, appropriate measures can be taken to ensure proper joint function; par. 0171: as long as the augmented reality system can locate (e.g., see) the plate with its camera(s), and the secondary tracking methodology can also locate its tracking markers, an embodiment can co-register the two different methodologies. Because two or more tracking modalities can be co-registered, a system may also display (e.g., in an augmented reality device) any stored or previously registered 3D models as well as an image of one or more surgical tools (e.g., the acetabular cup in alignment with the cup at the end of the impactor)),
wherein each virtual movement is made visible to the user by the display unit (par. 0106: monitor is used as part of the Display 125, the Surgeon 111 may interact with a GUI to provide inputs which are sent to the Surgical Computer 150 for further processing; par. 0144: display can be updated so that the surgeon can see how his or her actions are affecting the other aspects of the surgery; par. 0164: augmented reality displays as a way to bring a GUI directly into the line of sight of the surgeon. Such embodiments may include projecting a virtual screen wherever the surgeon is looking (e.g., directly over the surgical site). Using augmented reality, the GUI can be projected on a virtual display in or adjacent to the surgeon's line of site during surgery, and thus, the surgeon does not have to turn from the surgical site while operating).
Regarding claim 17, NIKOU further teaches wherein the control system includes:
a measurement unit configured to: identify the connected surgical training tools and/or modules, gather the movement data of the connected surgical training tool (par. 0052: By tracking fiducial marks associated with that tool or bone structure, or by using other conventional image tracking modalities, a processor may track that tool or bone as it moves through the environment in a three-dimensional model),
a central unit configured to: generate the virtual environment, receive and analyse the data related to the movement(s) of each connected surgical training tool, interface each movable virtual surgical element of the virtual environment with a corresponding surgical training tool (par. 0144: as the surgeon moves resection tools around the planned resection area, the process display can be updated so that the surgeon can see how his or her actions are affecting the other aspects of the surgery; par. 0159: The present disclosure describes example systems and methods of tracking specific portions of a patient's skeletal structure during surgery using an surgical navigation system enhanced by an augmented reality system. In addition, the location and orientation of surgical tools may be simultaneously tracked. By intraoperatively tracking the skeletal structure, appropriate measures can be taken to ensure proper joint function; par. 0171: as long as the augmented reality system can locate (e.g., see) the plate with its camera(s), and the secondary tracking methodology can also locate its tracking markers, an embodiment can co-register the two different methodologies. Because two or more tracking modalities can be co-registered, a system may also display (e.g., in an augmented reality device) any stored or previously registered 3D models as well as an image of one or more surgical tools (e.g., the acetabular cup in alignment with the cup at the end of the impactor); par. 0167: To place virtual objects into a scene, a video-see through augmented reality system may superimpose graphical renderings of various virtual objects into a video image. However, if the virtual objects are to be perceived as part of the actual scene, they must be anchored to the scene by tracking real objects in the actual scene. Video based augmented reality systems generally use markers that are recognizable by some form of image processing software. The video frames are then analyzed by an algorithm that identifies one or more markers and calculates how the marker must be oriented and positioned relative to the camera's location based on how it appears in the video image. Using these markers, an augmented reality system can track objects within the purview of the video tracking system; par. 0168: Accordingly, in some embodiments, if at least one bone is being tracked and a surgical plan is known, the surgical augmented reality system can display the surgical plan superimposed directly onto whatever the operation room staff are looking at, relative to the tracking markers' position on the bone and tool as opposed to an abstraction of the plan displayed on a virtual GUI screen.).
Regarding claim 19, NIKOU further teaches wherein the control system is further configured to generate a feedback signal enabling the haptic controller to generate a haptic signal when at least two virtual elements interact in the virtual environment (par. 0092: In some embodiments, the Surgical Computer 150 provides the Effector Platform 105 with instructions defining how to react when a component of the Effector Platform 105 deviates from a surgical plan. These commands are referenced in FIG. 5A as “haptic” commands. For example, the End Effector 105B may provide a force to resist movement outside of an area where resection is planned. Other commands that may be used by the Effector Platform 105 include vibration and audio cues; par. 0148: the acetabular reamer may be configured to provide haptic feedback to the surgeon when he or she reaches the floor).
Regarding claim 20, NIKOU further teaches at least one anatomical module configured to represent or reproduce all or part of a human anatomical portion (par. 0154: 3D model is developed during the pre-operative stage based on 2D or 3D images of the anatomical area of interest; par. 0179: the visual animations can include a real-time 3-D representation of a patient's anatomy and/or an implant, among other things (e.g., information related to the surgical plan).).
Regarding claim 21, NIKOU further teaches wherein the anatomical module is configured to generate a haptic signal in response to a stimulation of the control system or an action of the user (par. 0092: In some embodiments, the Surgical Computer 150 provides the Effector Platform 105 with instructions defining how to react when a component of the Effector Platform 105 deviates from a surgical plan. These commands are referenced in FIG. 5A as “haptic” commands. For example, the End Effector 105B may provide a force to resist movement outside of an area where resection is planned. Other commands that may be used by the Effector Platform 105 include vibration and audio cues; par. 0148: the acetabular reamer may be configured to provide haptic feedback to the surgeon when he or she reaches the floor).
Regarding claim 22, NIKOU further teaches at least one complementary tooling module configured to represent or reproduce all or part of a tooling likely to be present in an operating room or all or part of a surgical tool required during a surgical procedure but not intervening directly on the body of a patient (par. 0037: surgical tools or instruments; par. 0171: a system may also display (e.g., in an augmented reality device) … an image of one or more surgical tools (e.g., the acetabular cup in alignment with the cup at the end of the impactor)).
Regarding claim 23, NIKOU further teaches wherein the complementary tooling module is configured to generate a haptic signal in response to a stimulation of the control system or an action of the user (par. 0092: “haptic” commands; par. 0148: For example, the acetabular reamer may be configured to provide haptic feedback to the surgeon when he or she reaches the floor or otherwise deviates from the surgical plan).
Regarding claim 24, NIKOU further teaches a storage module configured to enable storage of one or more surgical training tool(s) (FIG. 1, ref. 150, cart).
Regarding claim 25, NIKOU further teaches at least one spacer module configured to connect two modules (in an indirect manner (FIG. 1, structure connecting 105A to 105C in an indirect manner, structure connecting 125 to 150 in an indirect manner, for example).
Regarding claim 26, NIKOU further teaches wherein the at least one spacer module is configured to arrange two modules on distinct horizontal planes (FIG. 1, structure connecting 105A to 105C on a horizontal plane, i.e., the table).
Regarding claim 27, NIKOU further discloses wherein each module comprises a base having a specific shape, the shapes of the different bases of the different modules being complementary to each other, so as to obtain a stable and adapted interlocking of the different modules (par. 0038: there may be one Limb Positioner 105C on each side of the operating table T or two devices on one side of the table T. The Limb Positioner 105C may be mounted directly to the table T, be located next to the table T on a floor platform (not shown), mounted on a pole, or mounted on a wall or ceiling of an operating room).
Regarding claim 28, NIKOU further teaches wherein the connection system of the haptic controller allows connecting at least two different surgical training tools (par. 0039: Effector Platform 105 may include tools, such as a screwdriver, light or laser, to indicate an axis or plane, bubble level, pin driver, pin puller, plane checker, pointer, finger, or some combination thereof; par. 0092: Surgical Computer 150 provides the Effector Platform 105 with instructions defining how to react when a component of the Effector Platform 105 deviates from a surgical plan. These commands are referenced in FIG. 5A as “haptic” commands. ).
Regarding claim 29, NIKOU further teaches wherein the haptic controller of the training module comprises a swing arm robot, the swivel arm robot having a free end intended to cooperate with the connection system (FIG. 1, ref. 105A: robotic arm).
Regarding claim 30, NIKOU further teaches A surgical training kit comprising the modular surgical training platform according to claim 16 and at least one surgical training tool configured to be connected to the haptic controller of the platform (see claim 16 above).
Claim Rejections - 35 USC § 103 (AIA )
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 18 is rejected under 35 U.S.C. 103 as being obvious over NIKOU.
Regarding claim 18, NIKOU teaches the elements above, but does not disclose wherein the measuring unit is part of the training module. However, combining several parts into a single unit is considered an obvious engineering choice. See In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”) Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the measurement unit with the training module, as taught by NIKOU, as doing so would have been on obvious engineering choice. One of ordinary skill would find it obvious to combine these components in order to lower costs while simplifying manufacturing and assembly.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, including:
US 2025/0221772 A1 to BABY et al (Abstract: A 3-dimensional tracking and navigation simulator system for image guided neuro-endoscopy, said system comprising: a fiducial based physical model of an anatomic region associated with neuro-endoscopy, wherein the physical model is mapped with CT/MRI slices of the anatomy; a virtual model of the anatomic region associated with neuro-endoscopy; at least one surgical instrument operable to perform neuro-endoscopy, said at least one surgical instrument is associated with a 3-D tracking component; a camera unit for tracking a location of the at least one surgical instrument with the 3-D tracking component, relative to a reference unit of the physical model; one or more displays for displaying the location of the at least one surgical instrument in the CT/MRI slices and endoscopic output, a computer work-station operably coupled to the physical model, and the camera unit, said work-station comprising: a localization and tracking module having configured to track the tasks performed by a user with the at least one surgical instrument, and estimate the position and rotation of the at least one surgical instrument in 6 degrees of freedom; a virtual space mapping module configured to map a location to a corresponding anatomic position in the virtual model to give a navigation of the surgical instrument in the virtual model; an evaluation module configured to evaluate the 3D tracking of tasks performed based on a localization metric and a 3D tracking metric, and provide feedback to the user based on the performance using machine learning and AI based algorithms).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Hull whose telephone number is 571-272-0996. The examiner can normally be reached on Monday-Friday from 8:00am to 5:00pm MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xuan Thai, can be reached at telephone number 571-272-7147. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES B HULL/Primary Examiner, Art Unit 3715
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