Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “sensing means,” “data transmission means,” and “viewing means” in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
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) 1-5 and 7-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (U.S. PGPUB 20170151027) in view of Sinha et al. (U.S. PGPUB 20250318877).
With respect to claim 1, Walker et al. disclose a system for setting the orientation of a 3d model of an anatomical part (paragraph 42, Disclosed herein are robot-assisted, image-guided instrument driving systems and methods for navigating a medical instrument through an anatomical three-dimensional space where no direct line of sight is available to a medical practitioner, paragraph 50, The various components of the robotically-assisted instrument driving system 10 are further visible in FIG. 3), the system comprising:
a 3d model of an anatomical part having a model reference frame (paragraph 54, a pre-operative 3-D anatomical model reference frame AMF for the model depicted on the visual display 35);
a tracker device configured to be attached to a surgical instrument active on a surgical object having a surgery reference frame (paragraph 46, the tracking subsystem 36 includes one or more sensors placed on or in the medical instrument 18 to enable tracking of the instrument 18, paragraph 54, a patient reference frame PRR for the patient 14), the tracker device comprising:
sensing means configured to detect the orientation of the tracker device in a fixed reference frame to define a tracker device reference frame (paragraph 46, The term “localization” is used in the art in reference to systems and methods for determining and/or monitoring the position (i.e., location and/or orientation) of objects, such as medical instruments or tools in a reference coordinate system, paragraph 54, the robotic surgical system 10 is designed to relate a coordinate system of the tracking sensor FRF of the elongate member 18 to either a fluoroscopy coordinate system FF or a pre-operative 3-D coordinate system AMF, as shown in FIG. 5),
data transmission means configured to emit an orientation signal representative of the orientation of the tracker device reference frame (paragraph 53, A communication link 32 transfers signals between the user workstation 31, the controller 34, and the robotic instrument driver 22, paragraph 55, As the instrument 18 moves through the patient, the tracking information of the sensor can be used to update the position of the elongate instrument 18 relative to the anatomy, image, or model such that the representation of the elongate instrument can be displayed moving in real-time in an anatomical image or model);
a processing unit (paragraph 51, The controller 34 is a computing device. As shown in FIG. 4, the controller 34 includes electronics, including a processor 50, and memory 52 having instructions stored thereon) comprising:
a video output module configured to be placed in signal communication with viewing means to display the 3d model in a viewing reference frame (paragraph 50, The user workstation 31 includes a computer, a control console having a user input device 33, and a visual display 35. The visual display 35 may be a touch screen, LCD screen, or any other suitable display configured to present one or more images to a user);
a memory module configured to hold the 3d model (paragraph 52, The memory 52 may be any suitable computer-readable medium that stores computer-readable instructions for execution by computer-executable components. The software, when executed by the processor 50, causes the processor 50 to perform one or more operations described elsewhere herein, software comprises 3D models);
a signal acquisition module configured to be placed in signal communication with the tracker device to receive the orientation signal (paragraph 53, A communication link 32 transfers signals between the user workstation 31, the controller 34, and the robotic instrument driver 22). However, Walker et al. do not expressly disclose a viewpoint shift module configured to adjust the viewing reference frame as a function of the orientation signal so that the orientation of the viewing reference frame with respect to the model reference frame is the same as the orientation of the tracker device reference frame with respect to the surgical reference frame.
Sinha et al., who also deal with medical imaging, disclose a method for including a viewpoint shift module configured to adjust the viewing reference frame as a function of the orientation signal so that the orientation of the viewing reference frame with respect to the model reference frame is the same as the orientation of the tracker device reference frame with respect to the surgical reference frame (paragraph 5, The data input is configured to provide 3D image data of a hollow structure in a region of interest of a subject, wherein the 3D image data comprises a coordinate space. The data input is also configured to provide a current pose of a tool with a tool tip inserted in the hollow structure. The data processor is configured to transfer the estimated current pose of the tool tip to the coordinate space of the 3D image data based on the registration of the tool tip within the coordinate space of the 3D image data. The data processor is also configured to generate, from the 3D image data, a rendered image showing a scene inside the hollow structure relating to the transferred estimated current pose of the tool tip). The viewing reference frame is based on the tracker device reference frame (pose of the tool tip).
Walker et al. and Sinha et al. are in the same field of endeavor, namely computer graphics.
Before the effective filing date of the claimed invention, it would have been obvious to apply the method wherein a viewpoint shift module configured to adjust the viewing reference frame as a function of the orientation signal so that the orientation of the viewing reference frame with respect to the model reference frame is the same as the orientation of the tracker device reference frame with respect to the surgical reference frame, as taught by Sinha et al., to the Walker et al. system, because now the user can get a view of what the tool would see (tool-centric view) by means of the rendered image generated from the 3D image data (paragraph 6 of Sinha et al.).
With respect to claim 2, Walker et al. as modified by Sinha et al. disclose the system according to claim 1, wherein the orientation signal is updated substantially in real time (Walker et al.: paragraph 55, the position or shape tracking sensors incorporated into the medical instrument 18 allow for real-time sensing of the instrument's position (i.e., location, orientation, and/or shape)).
With respect to claim 3, Walker et al. as modified by Sinha et al. disclose the system according to claim 1, wherein the tracker device is configured to also emit a translation signal representative of a translation of the tracker device with respect to the fixed reference frame, the viewpoint shift module being configured to adjust a position of the viewing reference frame with respect to the model reference frame as a function of the translation signal (Sinha et al.: paragraph 141, The tool 212 with a tool tip 214 reaches further into the hollow anatomical structure. The hollow anatomical structure is shown having a first path 216 and a second path 218 branching of and separated by a wall structure 220). As the tool tip reaches further, this corresponds to a translation movement of the tracker device.
With respect to claim 4, Walker et al. as modified by Sinha et al. disclose the system according to claim 3, wherein the viewpoint shift module is configured to adjust a zoom factor of the viewing means as a function of either the translation signal or either an optical or digital zoom of image acquisition means connected to or part of the surgical instrument (Walker et al.: paragraph 82, the first and second view may be shown at different magnifications. For example, the first view may show an image at a lower magnification so that more of the instrument and anatomy is seen to help the user understand the global position in the patient whereas the second view may be a zoomed in or magnified view of an area of interest, usually in a different projection from the first view). Walker et al. teach zooming; thus, it would have been obvious to apply the teachings of Walker et al. for adjusting a zoom factor of the viewing means to the viewpoint shift module taught by Sinha et al.
With respect to claim 5, Walker et al. as modified by Sinha et al. disclose the system according to claim 1, wherein the viewpoint shift module is configured to update the viewing reference frame substantially in real time (Sinha et al.: paragraph 90, Several of these navigated interventional imaging devices may also be equipped with EM trackers or shape sensed devices, e.g. Fiber Optic RealShape “FORS”, that require registration once e.g. at the start of the procedure and can then be tracked in preoperative image space in real-time throughout the procedure).
With respect to claim 7, Walker et al. as modified by Sinha et al. disclose the system according to claim 1, wherein the data transmission means is wireless (Walker et al.: paragraph 53, A communication link 32 transfers signals between the user workstation 31, the controller 34, and the robotic instrument driver 22. The communication link 32 may be a wired or wireless communication link).
With respect to claim 8, Walker et al. as modified by Sinha et al. disclose the system according to claim 1, further comprising input means configured to emit an input signal representative of the state of the input means, the viewpoint shift module being configured to adjust the viewing reference frame as a function of the input signal (Sinha et al.: paragraph 120, a current pose of a tool with a tool tip inserted in the hollow structure is provided. In a third step 108, the estimated current pose of the tool tip is transferred to the coordinate space of the 3D image data based on the registration of the tool tip with the coordinate space of the 3D image data). The input signal from the tool tip is transferred to adjust the viewing reference frame.
With respect to claim 9, Walker et al. as modified by Sinha et al. disclose the system according to claim 8, wherein the input means comprises one or more buttons placed on the tracker device (Walker et al.: paragraph 120, icons to the side of the virtual instrument or lighting on the user input device may indicate when various assisted driving buttons are enabled, Walker et al.: paragraph 122, motion stops when the user stops actuating an automated driving button or other user input device). It would have been obvious to apply the teachings of Walker et al. for including one or more buttons on the tracker device because this would allow for additional user control over the image viewing process.
With respect to claim 10, Walker et al. as modified by Sinha et al. disclose the system according to claim 8, wherein the input means comprises a 3d pointing device (Walker et al.: paragraph 122, the system fully controls navigation of the medical instrument including one or more of the articulation, roll, and translation, which infers a 3d pointing device for controlling multiple degrees of freedom).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Walker et al. (U.S. PGPUB 20170151027) in view of Sinha et al. (U.S. PGPUB 20250318877) and further in view of Rawat et al. (U.S. PGPUB 20120182291).
With respect to claim 6, Walker et al. as modified by Sinha et al. disclose the system according to claim 1. However, Walker et al. as modified by Sinha et al. do not expressly disclose the 3d model comprises a plurality of layers each representative of a respective anatomical structure part of the surgical object, the processing unit being configured to show/hide each layer on the viewing means.
Rawat et al., who also deal with medical imaging, disclose a method wherein the 3d model comprises a plurality of layers each representative of a respective anatomical structure part of the surgical object, the processing unit being configured to show/hide each layer on the viewing means (paragraph 66, Body Layers can be shown or hidden by changing the information that is contained within the 3D scene. That is, removing the 3D model representing the Body Layer's structure from the scene can hide a Body Layer that is visible on the display. Conversely, a Body Layer that was previously hidden can be brought back into display by adding its 3D model to the virtual scene).
Walker et al., Sinha et al., and Rawat et al. are in the same field of endeavor, namely computer graphics.
Before the effective filing date of the claimed invention, it would have been obvious to apply the method wherein the 3d model comprises a plurality of layers each representative of a respective anatomical structure part of the surgical object, the processing unit being configured to show/hide each layer on the viewing means, as taught by Rawat et al., to the Walker et al. as modified by Sinha et al. system, because user input entered via a Graphical User Interface (GUI) element, such as a menu, can change which layers are displayed. The menu allows a user to communicate information about which Body Layers to display and which Body Layers to hide to the processor 101. Then, the processor can alter objects in memory, such as the virtual 3D scene, in a manner that complies with the user's intent (paragraph 66 of Rawat et al.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW GUS YANG whose telephone number is (571)272-5514. The examiner can normally be reached M-F 9 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kent Chang can be reached at (571)272-7667. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW G YANG/Primary Examiner, Art Unit 2614
5/30/26
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