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 .
Response to Amendment
The amendment filed on 06/18/2026 has been entered. Claims 1-11 are pending. Claim 15 is cancelled. Claims 12-14 are withdrawn.
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 do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
3D modeling unit, recited in claims 1, 4; and comparison unit, recited in claims 6, 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend 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 avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 4, 9, 11, is/are rejected under 35 U.S.C. 103 as being unpatentable over Popovic (US 20170172663) in view of Thomas (US 20160070436).
Regarding claim 1, Popovic discloses a cavity modeling system (FIG. 1) for an intraoperative creation of a three-dimensional model of a cavity during a surgical intervention, the cavity modeling system comprising:
a visual displaying device (Display 118);
a visualization unit (imaging device 105; FIG.1; para [0026]) with a distal imaging head, which is adapted to be inserted intracorporeally into the patient and to create and to digitally provide an intracorporeal image of at least a partial region of the cavity of the patient via the distal imaging head (FIG. 1);
a 3D modeling unit (The operative images 135 are employed to build a three-dimensional model 136; para [0029]) adapted to create a digital 3D model of an inner surface of the cavity in the patient during the surgical intervention by using a first image in a first image pose and by using at least one second image in a second image pose (Plurality of view images are taken and a composite image is generated. Para [0030]), the 3D modeling unit being further adapted to output a view of the digital 3D model of the cavity via the visual displaying device to provide a user with a real-time intraoperative visualization of the cavity (The images from the imaging device are stitched to form a composite image and registered with a digital three dimensional model; Para [0011]; The composite endoscope image 206 is registered with the 3D renderings, 3D model with the internal camera images; Para [0044]; Live image; Para [0030]); and to output a comparison, via the visual displaying device, superimposing the 3D model of the inner surface of the cavity and the pre-operative 3D image of the tissue (Overlay is generated by comparing the 3D model of IMA (preoperative image) and internal view of the IMA using the camera of the endoscope, the endoscope image; Overlay 107; Para [0034]; Also see FIG. 1; System 100; para [0028]-[0029], [0032], [0030], [0039]) and output a comparison, via the visual displaying device (See the panoramic composite image 206, FIG. 1).
Popovic is silent about generating image of the cavity created by the resection of the tissue.
Thomas is directed to planning, navigation and simulation systems (abstract) and teaches a storage unit that stores preoperative 3D images comprising at least an intervention region with a tissue to be resected prior to resection (The system comprises a storage device to store at least one pre-operative 3D imaging volume; Para [0023], [0142]); and
a comparison unit adapted to compare the digital 3D model of the inner surface of the cavity with a pre-operative 3D image of the tissue to be resected prior to resection (Pre-operative and intra-operative images are analyzed and surgical plan is updated. Imaging involves only the regions of interest that are important at that point of the surgical procedure; imaging to update tissue maps after resection, as well as imaging to resect maximal tumor while limiting damage to healthy or recoverable tissue. Para [0016], [0057], [0063], [0066], [0141]; To evaluate the impact of brain and tissue shift as a result of tissue resection prior to actual resection; para [0205]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Popovic to include preoperative imaging data prior to resection for the image comparison in accordance with the teaching of Thomas so that images before and after resection are compared.
Regarding claim 4, Popovic discloses wherein the 3D modeling unit is adapted to calculate a three-dimensional inner surface of a region of the cavity (A three-dimensional model 136 including virtual internal cross-section or internal view images along the anatomical target 131. Para [0029]) or of an entirety of the cavity via a picture analysis based on the first image in the first image pose and the at least one second image in the second image pose (FIG. 2; Para [0033]).
Regarding claim 9, Popovic discloses a robot with a robot arm (robotic 108; FIG. 1) to which the visualization unit is connected as an end effector (imaging device 105; FIG. 1; Para [0026]), and a control unit of the cavity modeling system is adapted to control the robot and thus a position of the distal imaging head of the visualization unit (FIG. 1; para [0026]).
Regarding claim 11, Popovic discloses wherein the visualization unit (an imaging device 105) is configured as an endoscope and has a camera (device 102; FIG. 1).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Popovic (US 20170172663) in view of Thomas (US 20160070436) and further in view of Shmayahu (US 20210386491).
Regarding claim 2, Popovic does not expressly disclose a tracking system adapted to track a position and an orientation of the distal imaging head of the visualization unit in space in order to determine an image pose of the intracorporeal image.
Shmayahu is directed to a system for endoscopic surgery (abstract) and teaches a tracking system adapted to track a position and an orientation of the distal imaging head of the visualization unit in space in order to determine an image pose of the intracorporeal image (At least one controller is configured to track the pose of the endoscopic camera and the pose of the surgical end effector; 3D navigational coordinate system 505; Para [0025], [0099]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Popovic to include a tracking system in accordance with the teaching of Shmayahu so that distal portion of the endoscope could be tracked during surgery.
Regarding claim 3, Popovic as modified teaches wherein the tracking system comprises at least a navigation unit (3D navigational coordinate system 505) with an external navigation camera (endoscopic camera 40; para [0099], [0102]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Popovic (US 20170172663) in view of Thomas (US 20160070436) and further in view of Hiereth (US 20190099612).
Regarding claim 5, Popovic does not expressly disclose wherein the visualization unit comprises a fluorescence imaging unit with a spotlight of a predefined wavelength for excitation and an image sensor for detection of a particular fluorescence.
Hiereth is directed to an endoscope (abstract) and teaches wherein the visualization unit comprises a fluorescence imaging unit (Endoscope 2; Sensitizer molecules are made to fluoresce; Para [0054]) with a spotlight of a predefined wavelength (A spotlight can be generated by light of certain wavelengths, e.g. light for Narrow Band Imaging (NBI) and/or light for the excitation of a photosensitizer for Photodynamic Diagnostics (PDD). Para [0015]) for excitation and an image sensor for detection of a particular fluorescence (An image sensor picks up the radiation reflected by the tissue; abstract; Para [0058]; The illumination light such as Narrow Band Imaging (NBI) is used for imaging. Fluorescence is generated. Para [0054], [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Popovic to include a fluorescence imaging unit/sensor in accordance with the teaching of Hiereth so that a florescence could be detected during surgery.
Claim(s) 6, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Popovic (US 20170172663) in view of Thomas (US 20160070436) and further in view of Nagata (US 20200243184).
Regarding claim 6, Popovic discloses wherein the comparison unit is further adapted to compare the digital 3D model of the inner surface of the cavity with a pre-operative three-dimensional outer- surface model of a tissue of the preoperative image (Overlay is generated by comparing the 3D model of IMA (preoperative image) and internal view of the IMA using the camera of the endoscope, the endoscope image; Overlay 107; Para [0034]; Also see FIG. 1; System 100; para [0028]-[0029], [0032], [0030], [0039]; Panoramic stitching of 3D model of Internal Mammary Artery (IMA) images and the internal view of the IMA by the endoscope is performed (see, e.g., FIG. 2, image 206). Para [0034]).
Popovic does not expressly disclose outputting a comparison via the visual displaying device, so that regions of under or over-resection of the tissue to resected are indicated to the user.
Nagata is directed to medical image processing apparatus for visualizing a tissue and teaches outputting a comparison via the visual displaying device, so that regions of under or over-resection are indicated to the user (Generate a rendering image including the tissue cut along the cut surface; Para [0065] and displaying on a display unit display information including the rendering image in which a contour line of the tissue on the cut surface is highlighted. A surface rendering image GZ3 including a bronchus 31, a pulmonary artery 32, and a pulmonary vein 33; Abstract; Para [0065], [0093]; Display of highlighted cut surfaces F3 of an organ Z1 to be cut. Para [0068], FIG. 10, annotated below.).
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Thomas teaches that the tissue is the tissue to be resected (Pre-operative and intra-operative images are analyzed and surgical plan is updated. Imaging involves only the regions of interest that are important at that point of the surgical procedure; imaging to update tissue maps after resection, as well as imaging to resect maximal tumor while limiting damage to healthy or recoverable tissue. Para [0016], [0057], [0063], [0066], [0141]; To evaluate the impact of brain and tissue shift as a result of tissue resection prior to actual resection; para [0205]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Popovic in accordance with the teaching of Nagata and Thomas so that cut surface of the tissue to be resected is displayed during surgery and could be compared with the original image.
Regarding claim 7, Popovic disclose wherein the comparison unit is adapted to compare a three-dimensional shape of the digital 3D model of the inner surface of the cavity and of the preoperative three-dimensional outer-surface model (The composite image 124 can be used to register the endoscope image (134) and preoperative or intraoperative 3D imaging (3D model 136). Para [0038]) in order to illustrate a resection via a shape comparison in a cavity changing due to soft tissue (Popovic: When the preoperative or intraoperative 3D images are compared, they will automatically compare a resection in the area. Nagata: Cut area is shown in the image; FIG. 10) as a superimposed representation of the digital 3D model of the inner surface of the cavity and of the pre-operative three-dimensional outer-surface model.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Popovic (US 20170172663) in view of Thomas (US 20160070436) and further in view of Jafari (US 20230060639).
Regarding claim 10, Popovic does not expressly disclose wherein the control unit is adapted to control the position of the distal imaging head via three position parameters and an orientation of the distal imaging head via three orientation parameters, wherein a first subset of the three position parameters and the three orientation parameters is assigned to an automatic control and is automatically executed by the control unit and a second subset of the three position parameters and the three orientation parameters is assigned to a manual control and is controllable by the user via an input unit.
Jafari is directed to robotic systems and apparatuses (abstract) and teaches wherein the control unit is adapted to control the position of the distal imaging head via three position parameters (The systems provide advanced three-dimensional micro robotic navigation with artificial intelligence support and real-time endoluminal imaging to decrease the need for fluoroscopy; para [0030]) and an orientation of the distal imaging head via three orientation parameters, wherein a first subset of the three position parameters and the three orientation parameters is assigned to an automatic control and is automatically executed by the control unit and a second subset of the three position parameters and the three orientation parameters is assigned to a manual control and is controllable by the user via an input unit (3D coordinates are controlled; AI incorporation will allow the operator to switch between AI-guided navigation mode and a manual control mode for surgery interventions. Para [0060]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Popovic to include artificial intelligence (AI) in accordance with the teaching of Popovic so that AI could be used during surgery to assist with surgical procedure.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Popovic (US 20170172663) in view of Thomas (US 20160070436) and further in view of Wang (US 20160163091).
Regarding claim 8, Popovic discloses wherein the visual displaying device displays a view of the digital 3D model of the inner surface of the cavity with detected regions with intraoperative images via the visual displaying device in real time and with remaining regions that have not yet been detected (When composite image and real time image are displayed, detected and undetected images are displayed. A three-dimensional model 136 including virtual internal cross-section or internal view images along the anatomical target 131 are provided. FIGS. 1-3; Para [0029]).
Popovic does not expressly disclose providing the user with instructions for detecting regions still to be detected, in order to provide the user with an intuitive, complete detection of the cavity.
Wang is directed to electronic apparatus and a method for incremental pose estimation and photographing (abstract) and teaches providing the user with instructions for detecting regions still to be detected, in order to provide the user with an intuitive, complete detection of the cavity (Projection module 752 re-projects the images captured by the electronic apparatus onto the new surface to identify the covered regions and the uncovered regions on the new surface, so as to implement the subsequent prompting; para [0078]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Popovic to provide user assistance with an intuitive detection of new regions in accordance with the teaching of Wang so the new area could be detected.
Response to Arguments
Applicant' s arguments submitted on 06/18/2026 have been fully considered. In view of amendment, a new rejection has been made.
Newly cited art teaches comparing the digital 3D model of the inner surface of the cavity with a pre-operative 3D image of the tissue to be resected prior to resection (Pre-operative and intra-operative images are analyzed and surgical plan is updated. Imaging to update tissue maps after resection, as well as imaging to resect maximal tumor while limiting damage to healthy or recoverable tissue. Para [0016], [0057], [0063], [0066], [0141]; To evaluate the impact of brain and tissue shift as a result of tissue resection prior to actual resection; para [0205]; These facts indicate that the imaging is made with the tissue to be resected and imaging is compared after resection).
Accordingly, claim 1 is rejected. See 103 rejection set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHANKAR R GHIMIRE whose telephone number is (571)272-0515. The examiner can normally be reached 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHANKAR RAJ GHIMIRE/Examiner, Art Unit 3795
/ANHTUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
7/11/26
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