DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Applicant claims the benefit of US Provisional Application No. 63/221,063 filed July 13, 2021. Claims 1-20 have been afforded the benefit of this filing date.
Information Disclosure Statement
The IDS dated September 5, 2023 has been considered and placed in the application file.
The IDS dated July 13, 2022 has been considered and placed in the application file. The Foreign reference CN110464505A on the IDS filed July 13, 2022 was not considered. See 37 CFR 1.98 (a) (2) for the requirements for a foreign patent or publication cited on an IDS. MPEP 609.
Claim Objections
Claims 2, 9, 38, and 194 are objected to because of the following informalities:
Claim 2 which is after claim 3 will be referred to as “claim 4” hereinafter to eliminate confusion with the other previous “Claim 2”.
Claim 9, “Error! Reference source not found.”, is acknowledged that it should be read as, “The method of claim 1,”.
Claim 38 is a typo and will be referred to as “claim 18” hereinafter.
Claim 194 is a typo and will be referred to as “claim 19” hereinafter.
Appropriate correction is required.
Claim Interpretation
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.
The following terms in the claims have been given the following interpretations in light of the specification:
Vector map: claim 7; paragraph [0021], “…a ‘vector map’ is a geometric structure spanned by a set of vectors.”
Thus, a vector map is a geometric structure spanned by a set of vectors. This definition is used for purposes of searching for prior art, but cannot be incorporated into the claims.
Should applicant wish different definitions, Applicant should point to the portions of the specification that clearly show a different definition.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being obvious and unpatentable over US Patent Application Publication US 2019/0231220 A1, (Refai et al.) (hereinafter Refai) in view of US Patent Application Publication US 2019/0269822 A1, (Williams et al.) (hereinafter Williams).
Regarding claim 1, Refai teaches A method comprising: allowing at least one user to obtain, using at least one camera of at least one device, a real-time representation of at least one portion of a patient's abdominal cavity; (Refai Abstract, Fig. 12, “[0045] …optical hardware system 12”; “[0129] …control signals to guide the endoscope through the procedure in either an autonomous or semi-autonomous manner, or to generate augmented displays which assist the operator in guiding current endoscopic tools during a procedure.”; “[0140] …on the second end 136a of the tubular sleeve 132a such that all optical source/camera pairs point forward out of the second end 136 of the tubular sleeve 132a.”; “[0143] …one or more cameras 144…”; “[0076] Given the relatively large size of the abdominal cavity compared to the colon or esophagus investigated during endoscopic procedures, the optical hardware systems 12a and 12b may utilize cameras with larger FOV to record data from larger areas of tissue.”; “[0128] …the image reconstruction system 14 provides an operator with the ability to perform highly accurate, real-time measurements of the three-dimensional surgical environment…”; “[0122]”; and “[0134] …the system 10, 10a, 10b, 10c or 10d can provide options for assisting the surgeon in quickly and confidently making precise cuts. One possible option utilizes object recognition algorithms and real-time processing of scanned images to track the position of the cutting tool with time and providing real-time data on length of the cut or the position of the cutting tool with respect to the edge of the diseased area.”)
displaying the real-time representation of the at least one portion of the patient's abdominal cavity on at least one screen; (Refai “[0076] Given the relatively large size of the abdominal cavity compared to the colon or esophagus investigated during endoscopic procedures, the optical hardware systems 12a and 12b may utilize cameras with larger FOV to record data from larger areas of tissue.”; “[0108] …outputs of the system 14 can include, but are not limited to: (1) a three-dimension model for display on a screen or other visual device for the purpose of further physical inspection by the surgeon and/or the surgical support team…”; “[0043] …Data…one or more dynamic three dimensional measurements of one or more features (e.g., polyp(s) in the colon or hernia dimension(s)), one or more three-dimensional reconstructions of a surgical or endoscopic environment for analysis, patient baseline medical data, augmented reality displays configured for guiding a surgeon and/or operator through each part of a procedure, one or more warnings of surgical or endoscopic instruments endangering surrounding tissues and organs.”; and “[0134]”)
allowing the at least one user of the least one device to create a topographical map of a contour of the at least one portion of the patient's abdominal cavity; and (Refai Figs. 5-7, “[0050]”; “[0106-0108] In a step 116, the system 14a may detect geometric components. It should be noted that the following process may be generalized to the system 10 including the image reconstruction system 14 and is not limited to the embodiments of systems 14a and 14b. In some embodiments, the system 14 may utilize input from an operator regarding the shapes and geometries that the operator may want to highlight or identify within the continuous model of the point cloud generated in the previous step. For example, in colonoscopies, the operator may be interested in identifying polyps growing within the colon. Most polyps have predictable shapes and sizes, and the operator can input this information through an interface of the image reconstruction system 14. The image reconstruction system 14 may attempt to correlate components of the scanned model with the geometries of interest to identify and mark potential candidates for the operator to further examine either during the procedure or post-operatively…”; “[0152] …the image reconstruction system 14 provides an interactive interface 164 that may allow the surgeon or member of the surgeon's surgical team to interact with the system 14. In one example, the interface 164 may allow a user to select points on the surface model and subsequently provides a measurement of the distance between the points. The interface 164 may include, but is not limited to, a variety of graphics to aid in point selection, visualization of the distance measured, and display of the resulting measurement. The interface 164 may have both touch-screen and standard mouse-keyboard interaction modes to accommodate the computer systems and operating system platforms in use at the operator's site. The interface may incorporate control inputs, which include but are not limited to, controls for adjusting aspects of the system (source power, for example), selection of specific objects or scenes for further analysis...”; and “[0129-0131]”)
instructing a custom fitted mesh based on the topographical map, where the custom fitted mesh conforms to the contour of the at least one portion of the patient's abdominal cavity (Refai “[0128] …the image reconstruction system 14 provides an operator with the ability to perform highly accurate, real-time measurements of the three-dimensional surgical environment, Examples include, but are not limited to, measurements of the herniated area for determining patch dimensions and the placement of stitches when sewing up incisions. At the next level of functionality, the system 14, 14a, 14b, 14c, or 14d can utilize the data to identify the three-dimensional position, orientation, and movement of surgical instruments within the surgical environment for a variety of purposes…providing measurement information directly on a feature of interest, identifying or highlighting features within the environment, and placing virtual targets on positions to guide suturing, cutting or incisions made by the surgeon.”; “[0131] …the system 10, 10a, 10b, 10c or 10d may provide measurements of key distances or features within the scanned volume, including lateral, perimeter, area, and depth measurements, including the circumference and shape of herniated tissue to ensure proper patch overlap. In hernia repair surgeries and similar procedures, the surgeon selects the correct-sized patch needed to perform the repair. Proper size selection requires accurate measurement of both the lateral dimensions and the depth dimensions of the area into which the patch will be placed. The system 10, 10a, 10b, 10c or 10d may provide these measurements to the operator, and the interface can allow the operator to interact virtually with the target area to ensure that the selected patch will fit before continuing the procedure.”; “[0159]”; and “[0165-0168]”)
However, Refai is silent about at least one machine to form.
Williams teaches at least one machine to form (Williams Abstract, Fig. 1, “[0017] …the implants are made by 3D printing compositions comprising poly(butylene succinate) and copolymers thereof. In a particularly preferred embodiment, the implants made by 3D printing have porous structures, and even more preferably lattice structures.”; “[0171] A 3D printed mesh was prepared from succinic acid-1,4-butanediol-malic acid copolyester (Tepha lot 180333), with weight average molecular weight of 184 kDa, Tm=115° C., using melt extrusion deposition according to the following method. The mesh was printed using an ARBURG Free-Former machine consisting of a horizontal extruder feeding into a vertical ram extruder fitted with motion controlled needle plunger, 200 micron spinneret nozzle and a movable stage table. The extruder hopper was charged with 1½×3 mm sized polymer pellets with a moisture content of less than 2,000 ppm. The pellets were purged with dry nitrogen in the extruder hopper to maintain dryness. The temperature profile of the extruder was set between 45°−180° C., and the residence time of the polymer in the extrusion system was maintained at less than 15 min/cm. The conditions resulted in the formation of very high quality printed mesh as shown in FIG. 1.”)
Refai and Williams are analogous art as both of them are related to hernia repair.
Therefore, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Refai by at least one machine to form as taught by Williams and use that within Refai’s surgical system.
The motivation for the above is for creating a more suitable mesh for a patient thus, effective hernia recovery.
Claim 15 is directed to a system (Refai “[0048] The image reconstruction systems 14 are able to embody and/or execute the logic of the processes described herein. Logic embodied in the form of software instructions and/or firmware may be executed on dedicated system or systems, on distributed processing computer systems, and/or the like. In some embodiments, the logic may be implemented in a stand-alone environment operating on a single system and/or logic may be implemented in a networked environment such as a distributed system using multiple computers and/or processors. For example, microprocessors of the image reconstruction systems 14a may work together or independently to execute processor executable code using one or more memories 32.”) and its scope and functions are substantially similar to the steps performed by the method claim 1 and therefore claim 15 is also rejected with the same rationale as specified in the rejection of claim 1.
Claim 20 is directed to a non-transitory computer readable medium storing code, the code comprising instructions executable by a processor (Refai Claim 5, “[0048] The image reconstruction systems 14 are able to embody and/or execute the logic of the processes described herein. Logic embodied in the form of software instructions and/or firmware may be executed on dedicated system or systems, on distributed processing computer systems, and/or the like. In some embodiments, the logic may be implemented in a stand-alone environment operating on a single system and/or logic may be implemented in a networked environment such as a distributed system using multiple computers and/or processors. For example, microprocessors of the image reconstruction systems 14a may work together or independently to execute processor executable code using one or more memories 32.”) and its scope and functions are substantially similar to the steps performed by the method claim 1 and therefore claim 20 is also rejected with the same rationale as specified in the rejection of claim 1.
Regarding claim 2, Refai teaches where the at least one camera is at least one surgical camera (Refai Abstract, “[0053] The single high resolution camera 18a may be sensitive to infrared light, and possibly both infrared and visible light. The single high resolution camera 18a may be configured to capture one or more images of tissue(s) within the surgical or endoscopic environment illuminated by the optical source 16a.”), where the at least one device is at least one surgical robot (Refai “[0010] Auris Surgical Robotics recently introduced the Monarch Platform, a flexible robotic endoscopic system that received FDA approval for bronchoscopic procedures.”; “[0041] Referring now to the Figures, and in particular to FIG. 1A, shown therein and designated by reference numeral 10 is an exemplary medical scanning and mapping system 10 in accordance with the present disclosure. Generally, the medical scanning and mapping system 10 may be used as a stand-alone system or a system integrated into currently used and future envisioned medical systems (e.g., endoscopic systems currently used). In some embodiments, the medical scanning and mapping system 10 may be used in minimally invasive surgical procedures such as endoscopic surgery, robotic surgery, and/or the like.”; “[0042] …with and/or augmentation of robotic, laparoscopic, and endoscopic surgical systems.”), and where obtaining the real-time representation comprises:
inserting the at least one surgical camera into the patient using the at least one surgical robot; (Refai “[0126-0127] …The system 10, 10a, 10b, 10c or 10d may at least impact the medical scanning and mapping system in common applications including, but not limited to endoscopy, laparoscopic and robotic surgical application. In laparoscopic and robotic surgical applications, the surgeon inserts the surgical tools through small holes or incisions and relies on optical source 16, 16a, 16b, 16c or 16d and camera(s) 18, 18a, 18b, 18c or 18d, respectively, inserted through the same or other incisions to visualize the surgical space and direct the instruments to perform the procedure.”; and “[0144]”)
using the at least one surgical robot, navigating the at least one surgical camera toward the at least one portion of the patient's abdominal cavity; and (Refai “[0129-0130]”; “[0076] Given the relatively large size of the abdominal cavity compared to the colon or esophagus investigated during endoscopic procedures, the optical hardware systems 12a and 12b may utilize cameras with larger FOV to record data from larger areas of tissue.”; “[0135] …robotic systems utilize a variety of technologies to steer the surgical head around tissue and anatomy to make minimally invasive surgery a real option for procedures that typically require invasive procedures to perform. For example, flexible robotic endoscopes can be driven by the operator or surgeon…driven along the colon to perform a colonoscopy.”; and “[0156]”)
capturing, using the at least one surgical camera, the real time representation of the at least one portion of the patient's abdominal cavity (Refai “[0076] Given the relatively large size of the abdominal cavity compared to the colon or esophagus investigated during endoscopic procedures, the optical hardware systems 12a and 12b may utilize cameras with larger FOV…”; “[0122]”; “[0134]”; “[0127] In laparoscopic and robotic surgical applications, the surgeon inserts the surgical tools through small holes or incisions and relies on optical source 16, 16a, 16b, 16c or 16d and camera(s) 18, 18a,
18b, 18c or 18d, respectively, inserted through the same or other incisions to visualize the surgical space and direct the instruments to perform the procedure.”; “[0128] …the image reconstruction system 14 provides an operator with the ability to perform highly accurate, real-time measurements of the three-dimensional surgical environment, Examples include, but are not limited to, measurements of the herniated area for determining patch dimensions and the placement of stitches when sewing up incisions.”; “[0136] …a robotic hernia surgery typically requires sewing of the hernia within the abdomen using the robotic systems. In a semi-autonomous mode of operation, the system 10, 10a, 10b, 10c, or 10d would provide a three-dimensional mapping and measurement of the space within the abdomen, including the section of tissue to be sewn together. The mapping may provide the operator with information on the range of movements possible without injuring the patient, the location of blood vessels and tissues the operator must avoid, and continually update imagery of the hernia throughout the surgery, so that the operator can ensure that all parts of the herniated area are sewn correctly.”)
Regarding claim 3, Refai teaches where the at least one screen is part of the at least one device (Refai “[0108]”; “[0048] To that end, in some embodiments, the image reconstruction system 14 may be integral to the optical hardware system 12 and/or communicate via one or more networks 13. For example, in some embodiments, a single processor may be positioned external to the optical hardware system 12 and communicate via a wired or wireless network 13 such that the processor may be external to a patient body during use. In some embodiments, multiple processors of the image reconstruction system 14 may be positioned internal and/or external to the patient body during use. For example, at least one processor of the image reconstruction system 14 may be positioned with the optical hardware system 12 and communicate with an external processor of the image reconstruction system 14 during use.”; “[0152] Referring to FIG. 1, in some embodiments, the image reconstruction system 14 provides an interactive interface 164 that may allow the surgeon or member of the surgeon's surgical team to interact with the system 14. In one example, the interface 164 may allow a user to select points on the surface model and subsequently provides a measurement of the distance between the points. The interface 164 may include, but is not limited to, a variety of graphics to aid in point selection, visualization of the distance measured, and display of the resulting measurement. The interface 164 may have both touch-screen and standard mouse-keyboard interaction modes to accommodate the computer systems and operating system platforms in use at the operator's site. The interface may incorporate control inputs, which include but are not limited to, controls for adjusting aspects of the system (source power, for example), selection of specific objects or scenes for further analysis, and controls related to overall processing speed such as desired modeling accuracy and acquisition rates.”)
Regarding claim 4, Refai teaches where the at least one screen is at least one external screen (Refai “[0108] …outputs of the system 14 can include, but are not limited to: (1) a three-dimension model for display on a screen or other visual device for the purpose of further physical inspection by the surgeon and/or the surgical support team…”; and “[0134] Possible interactions between the surgeon and the system 10, 10a, 10b, 10c, or 10d may include, but are not limited to, (1) planning the cut graphically on the display using the measurement data to ensure the correct length or distance, and then effectively cutting along the line, and (2) providing real-time measurement data on the screen next to the tracked instrument to allow the surgeon to adjust or end the procedure with precision.”)
Regarding claim 5, Refai teaches where the topographical map is virtually overlaid over the real-time representation of the at least one portion of the patient's abdominal cavity (Refai Fig. 5-6, “[0008]”; “[0134]”; “[0128]”; “[0043] Data may include, but is not limited to, one or more dynamic three dimensional measurements of one or more features (e.g., polyp(s) in the colon or hernia dimension(s))…”; “[0055] The image reconstruction system 14a may perform one or more matching operations, wherein each part of a projected pattern is subsequently matched to a component of the original pattern stored in the software memory 32a (associate components of the pattern recorded in the camera image with the corresponding point in the original projected pattern). In this way, the software determines which part of the original pattern illuminated each section of tissue within the surgical or endoscopic environment. The image reconstruction system 14a may use the matching information, along with information about the geometrical arrangement of the camera and source, as input to sophisticated triangulation algorithms. The triangulation algorithms use the information to calculate a location in 3D space for each segment of the surgical or endoscopic environment. Repeating the process for two different patterns projected on the same section of tissue may increase the accuracy of the triangulation process and allows the system to produce highly accurate 3D spatial reconstructions of the illuminated environment.”; and “[0121] Different optical sources 16d can project different patterns over the same area, allowing the system to take advantage of the strengths of the different patterns to improve the overall reconstructed image.”)
Regarding claim 6, Refai teaches where the topographical map is created by:
selecting a pre-set topographical template using the at least one screen; (Refai “[0010]”; “[0087-0089] In a step 58, the system 14a performs pattern matching. At this stage, the image reconstruction system matches elements of the pattern detected by the camera 18a to a reference image, in preparation for performing triangulation. Generally, pattern matching includes three steps. In a step 60, sets of neighboring dots may be grouped together into “words” of the captured pattern. For example, a “word” may include a 4-by-4 configuration of dots (4 dots roughly along the vertical direction and 4 dots roughly along the horizontal direction). Other groups can include, but are not limited to, all of the dots in a subsection of the image (for example, dividing the image into a grid of squares, with each square comprising a subsection of the image)…”; “[0108]”; and “[0129]”)
overlaying, using the at least one screen, the pre-set topographical template over the real-time representation of the at least one portion of the patient's abdominal cavity; and (Refai “[0129]”; “[0134] …measurement data may overlay from the scanner onto the visual image of the surgical space provided by the visible-light camera, effectively creating an augmented reality operating environment…providing real-time measurement”; “[0108]”; and “[0075-0076]”)
warping the pre-set topographical template to match the contour of the at least one portion of the patient's abdominal cavity (Refai “[0093] The system then warps the image with processes including, but not limited to, rotation, scaling, and shifting, with the goal of aligning the recorded images of the two cameras 18b. The alignment process aims to make the rows of the two images parallel to each other and to likewise make the columns of the two images parallel to each other…the matching process may not attempt to search through the entire image of each camera 18b to find the best match between pixels. The alignment process performed during the line description step and the highly calibrated nature of the optical system limit the set of points in the second image, also called the reference image, which can potentially match the description of the considered point in the first image…”; “[0105] In step 114, the system 14a may mesh objects. The system 14a follows processes such as generalization, fusion, and optimization for constructing a continuous approximation of the point cloud.”; and “[0128] …providing measurement information directly on a feature of interest, identifying or highlighting features within the environment, and placing virtual targets on positions to guide suturing, cutting or incisions made by the surgeon. The detailed information produced by the system 14, 14a, 14b, 14c, or 14d may allow for the generation of control signals to guide the robotic and laparoscopic systems to perform surgical procedures or parts of procedures in an autonomous or semi-autonomous manner. Examples include, but are not limited to, precise suturing for closing incisions or hernias, and guiding instruments to perform precise or difficult movements.”)
Regarding claim 7, Refai teaches where the topographical map is a vector map, where the vector map is created by:
defining fixed point on the real-time representation of the at least one portion of the patient's abdominal cavity; (Refai “[0076] …abdominal cavity…”; “[0087-0088] …Generally, pattern matching includes three steps. In a step 60, sets of neighboring dots may be grouped together into “words” of the captured pattern. For example, a “word” may include a 4-by-4 configuration of dots (4 dots roughly along the vertical direction and 4 dots roughly along the horizontal direction). Other groups can include, but are not limited to, all of the dots in a subsection of the image (for example, dividing the image into a grid of squares, with each square comprising a subsection of the image)…the system 14a encodes each group or “word” of dots into a descriptive vector of byte. Examples of descriptors include, but are not limited to, the number of dots within the group or “word” and the inner distances (the distances between dots). Another option is to construct a tiny graph, where the dots are vertices linked by lines drawn between the dots, and characterize or encode each group by the properties of the resulting geometric figure.”; “[0094-0095]”; “[0098] …aim is to match a pixel or feature description from the image captured by the first camera 18b to a pixel or feature description from the image captured by the second camera 18b”; and “[0100] The registration process establishes the relationships among point clouds and helps merge the multitude of point clouds into a single cohesive point cloud for modeling the object.”)
defining a plurality of end points on the real-time representation of the at least one portion of the patient's abdominal cavity; (Refai “[0076] …abdominal cavity…”; “[0087-0088] …Generally, pattern matching includes three steps. In a step 60, sets of neighboring dots may be grouped together into “words” of the captured pattern. For example, a “word” may include a 4-by-4 configuration of dots (4 dots roughly along the vertical direction and 4 dots roughly along the horizontal direction). Other groups can include, but are not limited to, all of the dots in a subsection of the image (for example, dividing the image into a grid of squares, with each square comprising a subsection of the image)…the system 14a encodes each group or “word” of dots into a descriptive vector of byte. Examples of descriptors include, but are not limited to, the number of dots within the group or “word” and the inner distances (the distances between dots). Another option is to construct a tiny graph, where the dots are vertices linked by lines drawn between the dots, and characterize or encode each group by the properties of the resulting geometric figure.”; “[0094-0095]”; “[0098] …aim is to match a pixel or feature description from the image captured by the first camera 18b to a pixel or feature description from the image captured by the second camera 18b”; and “[0100] The registration process establishes the relationships among point clouds and helps merge the multitude of point clouds into a single cohesive point cloud for modeling the object.”)
defining a plurality of vectors, where the plurality of vectors starts at the fixed point and terminates at one of the end points; and (Refai “[0076] …abdominal cavity…”; “[0087-0088] …Generally, pattern matching includes three steps. In a step 60, sets of neighboring dots may be grouped together into “words” of the captured pattern. For example, a “word” may include a 4-by-4 configuration of dots (4 dots roughly along the vertical direction and 4 dots roughly along the horizontal direction). Other groups can include, but are not limited to, all of the dots in a subsection of the image (for example, dividing the image into a grid of squares, with each square comprising a subsection of the image)…the system 14a encodes each group or “word” of dots into a descriptive vector of byte. Examples of descriptors include, but are not limited to, the number of dots within the group or “word” and the inner distances (the distances between dots). Another option is to construct a tiny graph, where the dots are vertices linked by lines drawn between the dots, and characterize or encode each group by the properties of the resulting geometric figure.”; “[0094-0095]”; “[0098] …aim is to match a pixel or feature description from the image captured by the first camera 18b to a pixel or feature description from the image captured by the second camera 18b”; and “[0100] The registration process establishes the relationships among point clouds and helps merge the multitude of point clouds into a single cohesive point cloud for modeling the object.”)
calculating the vector map, where the vector map is calculated by determining a vector space defined by the plurality of vectors (Refai “[0076]”; “[0087-0088]”; “[0094-0095]”; “[0100]”; “[0050] The image reconstruction system 14 may include one or more processors having analysis software configured to convert image data recovered from the light detecting array 24, perform calculations to extract depth information, and construct one or more three dimensional models of the scene of interest. Images recovered from adjacent lenses in the microlens array 22 may show the same point in space from slightly different positions, The software uses information about the power and period of the microlens array 22, the position of the microlens array 22 with respect to the imaging lens system 20 and the light detecting array 24, and the period and size of the pixels within the light detecting array 24 to perform calculations that determine the three-dimensional position of each point within the scene. The software uses the three-dimensional position information from all of the points to construct one or more three-dimensional depth maps of the entire image. The software combines the three-dimensional depth map with raw two-dimensional image data from the light detecting array 24 to construct a three-dimensional mapping or view of the scene.”; “[0098] …one of several accepted triangulation algorithms may be implemented to perform calculations to locate depth in each of the data points collected by the optical hardware system 12a and 12b. For the system 10b illustrated in FIG. 3, the aim is to match a pixel or feature description from the image captured by the first camera 18b to a pixel or feature description from the image captured by the second camera 18b, The matching process may include, but is not limited to, the use of a similarity function to achieve best matches between descriptions and matching of vectors to within a minimum geometrical distance.”; “[0099]”; “[0122] The triangulation algorithm produces a unique set of points and corresponding coordinate data for each source-camera pair, and then passes all point/coordinate sets to the remaining steps of the image reconstruction process to build and measure the 3D model. For the systems 10, 10a, 10b, 10c and 10d, a similar process would occur, wherein the software would combine the 3D position data produced by analysis of data from each pair of camera 18 and optical source 16 to build and measure the 3D model.”)
Regarding claim 8, Refai teaches where allowing at least one user of the at least one device to create the topographical map of the at least one portion of the patient's abdominal cavity comprises: allowing the at least one user to determine a location and dimensions of at least one hernia defect; and (Refai “[0075]”; “[0131] …the system 10, 10a, 10b, 10c or 10d may provide measurements of key distances or features within the scanned volume, including lateral, perimeter, area, and depth measurements, including the circumference and shape of herniated tissue to ensure proper patch overlap. In hernia repair surgeries and similar procedures, the surgeon selects the correct-sized patch needed to perform the repair. Proper size selection requires accurate measurement of both the lateral dimensions and the depth dimensions of the area into which the patch will be placed. The system 10, 10a, 10b, 10c or 10d may provide these measurements to the operator, and the interface can allow the operator to interact virtually with the target area to ensure that the selected patch will fit before continuing the procedure.”; “[0159]”)
allowing the at least one user to modify the topographical map of the at least one portion of the patient's abdominal cavity to omit the at least one hernia defect (Refai “[0096]”; “[0136] …a robotic hernia surgery typically requires sewing of the hernia within the abdomen using the robotic systems. In a semi-autonomous mode of operation, the system 10, 10a, 10b, 10c, or 10d would provide a three-dimensional mapping and measurement of the space within the abdomen, including the section of tissue to be sewn together. The mapping may provide the operator with information on the range of movements possible without injuring the patient, the location of blood vessels and tissues the operator must avoid, and continually update imagery of the hernia throughout the surgery, so that the operator can ensure that all parts of the herniated area are sewn correctly…In a fully-autonomous mode of operation, the system 10, 10a, 10b, 10c or 10d may utilize the three-dimensional mapping and measurement to accurately locate the target site for sewing, monitor the movements of the robotic systems performing the sewing operation, and monitor the sewing site to allow the system and the operator to verify that the sewing process is correct and complete. In some embodiments, the operator could override the autonomous systems to provide corrections, modify operations, or inspect the work of the robotic systems as needed.”; and “[0159]”)
Regarding claim 9, Refai is silent about 3D printing.
Williams teaches 3D printing (Williams Abstract, Fig. 1, “[0017] …the implants are made by 3D printing compositions comprising poly(butylene succinate) and copolymers thereof. In a particularly preferred embodiment, the implants made by 3D printing have porous structures, and even more preferably lattice structures.”; “[0171] A 3D printed mesh was prepared from succinic acid-1,4-butanediol-malic acid copolyester (Tepha lot 180333), with weight average molecular weight of 184 kDa, Tm=115° C., using melt extrusion deposition according to the following method. The mesh was printed using an ARBURG Free-Former machine consisting of a horizontal extruder feeding into a vertical ram extruder fitted with motion controlled needle plunger, 200 micron spinneret nozzle and a movable stage table. The extruder hopper was charged with 1½×3 mm sized polymer pellets with a moisture content of less than 2,000 ppm. The pellets were purged with dry nitrogen in the extruder hopper to maintain dryness. The temperature profile of the extruder was set between 45°−180° C., and the residence time of the polymer in the extrusion system was maintained at less than 15 min/cm. The conditions resulted in the formation of very high quality printed mesh as shown in FIG. 1.”; and “[0027-0028]”)
Refai and Williams are analogous art as both of them are related to hernia repair.
Therefore, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Refai by 3D printing as taught by Williams and use that within Refai’s surgical system.
The motivation for the above is for creating a more suitable mesh for a patient thus, effective hernia recovery.
Claim 10 is rejected under 35 U.S.C. 103 as being obvious and unpatentable over Refai and Williams as applied to claims 1-20, and further in view of US Patent Application Publication US 2013/0253545 A1, (Massen).
Regarding claim 10, Refai and Williams are silent about obtaining a standardized mesh; and pressing, the standardized mesh into.
Massen teaches obtaining a standardized mesh; and pressing, the standardized mesh into (Massen “[0030-0035] …a standard mesh material made of strong synthetic, or biologic, fabric-like material can be utilized for the back portion of the mesh. As depicted at block 525, the mesh can be placed into the hernia defect such that the front portion fills the hernia sac and the back portion covers normal tissue and fascia. Finally, the mesh adheres to the tissues of hernia sac and repairs the hernia, as depicted at block 530…The mesh can be pressed down small enough to allow the mesh to be rolled up and deployed through a small laparoscopic port. Then the mesh is unrolled inside the inflated abdomen and fitted into the exposed hernia sac spaces. The foam described herein can be biocompatible, expansile over time, and bacteria resistant…”)
Refai, Williams, and Massen are analogous art as all of them are related to hernia repair.
Therefore, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Refai modified by Williams by obtaining a standardized mesh and pressing the standardized mesh into as taught by Massen and use that within Refai’s surgical system.
The motivation for the above is for creating a more suitable mesh for a patient thus, effective hernia recovery.
Regarding claim 11, Refai teaches where the at least one portion of the patient's abdominal cavity was previously dissected (Refai “[0134] …the system 10, 10a, 10b, 10c or 10d can provide options for assisting the surgeon in quickly and confidently making precise cuts. One possible option utilizes object recognition algorithms and real-time processing of scanned images to track the position of the cutting tool with time and providing real-time data on length of the cut or the position of the cutting tool with respect to the edge of the diseased area...These and other possible options would enable the surgeon to become adept at making precision cuts or incisions without prolonged times for training or gaining experience, other than the expected short training period in operation of the software interface.”; “[0144]”; and “[0148]”)
Regarding claim 12, Refai is silent about a monofilament macroporous mesh.
Williams teaches a monofilament macroporous mesh (Williams “[0127] The mesh preferably has pores with average diameters ranging from 5 μm to 5 mm, and more preferably 50 μm to 1 mm. The width of the mesh is preferably from 1 mm to 20 mm, more preferably 1 mm to 10 mm, and even more preferably 1 mm to 7.8 mm.”; and “[0027] …and monofilament products made from polydioxanone (PDO).”)
Refai and Williams are analogous art as both of them are related to hernia repair.
Therefore, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Refai by a monofilament macroporous mesh as taught by Williams and use that within Refai’s surgical system.
The motivation for the above is for creating a more suitable mesh for a patient thus, effective hernia recovery.
Regarding claim 13, Refai is silent about a myopectineal orifice and pelvic floor.
Williams teaches a myopectineal orifice and pelvic floor (Williams “[0024]”; “[0139]”; “[0146]”; “[0128]”; and “[0145]”).
Refai and Williams are analogous art as both of them are related to hernia repair.
Therefore, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Refai by a myopectineal orifice and pelvic floor as taught by Williams and use that within Refai’s surgical system.
The motivation for the above is for creating a more suitable mesh for a patient thus, effective hernia recovery.
Regarding claim 14, Refai is silent about a myopectineal orifice and pelvic floor.
Williams teaches a myopectineal orifice and pelvic floor (Williams “[0024]”; “[0139]”; “[0146]”; “[0128]”; and “[0145]”).
Refai and Williams are analogous art as both of them are related to hernia repair.
Therefore, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Refai by a myopectineal orifice and pelvic floor as taught by Williams and use that within Refai’s surgical system.
The motivation for the above is for creating a more suitable mesh for a patient thus, effective hernia recovery.
Regarding claim 16, Refai teaches where the at least one device is at least one surgical robot (Refai “[0010] Auris Surgical Robotics recently introduced the Monarch Platform, a flexible robotic endoscopic system that received FDA approval for bronchoscopic procedures.”; “[0041] Referring now to the Figures, and in particular to FIG. 1A, shown therein and designated by reference numeral 10 is an exemplary medical scanning and mapping system 10 in accordance with the present disclosure. Generally, the medical scanning and mapping system 10 may be used as a stand-alone system or a system integrated into currently used and future envisioned medical systems (e.g., endoscopic systems currently used). In some embodiments, the medical scanning and mapping system 10 may be used in minimally invasive surgical procedures such as endoscopic surgery, robotic surgery, and/or the like.”; “[0042] …with and/or augmentation of robotic, laparoscopic, and endoscopic surgical systems.”)
Regarding claim 17, Refai teaches where the at least one camera is present on the at least one surgical robot (Refai “[0144]”; “[0126-0127]”; “[0045] …optical hardware system 12”; “[0129] …control signals to guide the endoscope through the procedure in either an autonomous or semi-autonomous manner, or to generate augmented displays which assist the operator in guiding current endoscopic tools during a procedure.”; “[0140] …on the second end 136a of the tubular sleeve 132a such that all optical source/camera pairs point forward out of the second end 136 of the tubular sleeve 132a.”; “[0143] …one or more cameras 144…”; and “[0122]”)
Regarding claim 18, Refai is silent about where the at least one machine comprises a 3D printer.
Williams teaches where the at least one machine comprises a 3D printer (Williams Abstract, Fig. 1, “[0017] …the implants are made by 3D printing compositions comprising poly(butylene succinate) and copolymers thereof. In a particularly preferred embodiment, the implants made by 3D printing have porous structures, and even more preferably lattice structures.”; “[0171] A 3D printed mesh was prepared from succinic acid-1,4-butanediol-malic acid copolyester (Tepha lot 180333), with weight average molecular weight of 184 kDa, Tm=115° C., using melt extrusion deposition according to the following method. The mesh was printed using an ARBURG Free-Former machine consisting of a horizontal extruder feeding into a vertical ram extruder fitted with motion controlled needle plunger, 200 micron spinneret nozzle and a movable stage table. The extruder hopper was charged with 1½×3 mm sized polymer pellets with a moisture content of less than 2,000 ppm. The pellets were purged with dry nitrogen in the extruder hopper to maintain dryness. The temperature profile of the extruder was set between 45°−180° C., and the residence time of the polymer in the extrusion system was maintained at less than 15 min/cm. The conditions resulted in the formation of very high quality printed mesh as shown in FIG. 1.”; and “[0027-0028]”)
Refai and Williams are analogous art as both of them are related to hernia repair.
Therefore, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Refai by where the at least one machine comprises a 3D printer as taught by Williams and use that within Refai’s surgical system.
The motivation for the above is for creating a more suitable mesh for a patient thus, effective hernia recovery.
Regarding claim 19, Refai is silent about where the at least one machine comprises a press machine.
Williams teaches where the at least one machine comprises a press machine (Williams “[0016] The surgical meshes are prepared from oriented fibers of poly(butylene succinate) and copolymers thereof. The improved meshes prevent additional tension being placed on tissues at the implant site, and maintain the original area of reinforcement or repair.”; “[0139] The three-dimensional implant may be formed by draping the mesh over the inwardly curving half of the metal form, placing the outwardly curving half of the metal form other the mesh, clamping the split metal form together to form a block, and heating the block to mold the mesh. In another process, the three-dimensional implants may be plugs, preferably hernia plugs, made from meshes of poly(butylene succinate) and copolymers thereof.”; “[0127]”; “[0163] …the block, metering pump and the spinneret die were maintained at a constant temperature, preferably 180° C. Pump discharge pressure was kept below 1500 psi by controlling the temperatures and the speed of the metering pump. The resulting spun extrudate filament was free from all melt irregularities.”)
Refai and Williams are analogous art as both of them are related to hernia repair.
Therefore, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Refai by where the at least one machine comprises a press machine as taught by Williams and use that within Refai’s surgical system.
The motivation for the above is for creating a more suitable mesh for a patient thus, effective hernia recovery.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
US Patent Application Publication US 2021/0046212 A1 to Williams et al. discloses mesh for hernia repair.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA VELAZQUEZ VALENCIA whose telephone number is (571)272-7418. The examiner can normally be reached M-F, 8:30AM-5:00PM.
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/A.V.V/Examiner, Art Unit 2612
/Said Broome/Supervisory Patent Examiner, Art Unit 2612
Date: 3/4/2026