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 .
Claims 1-14 are present for examination.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 8-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Publication No. 20190320878 A1 to Duindam et al.
Regarding claim 1, Duindam discloses A method for representing at least one medical instrument in a hollow organ (Duindam, Fig. 6A, showing at least one medical instrument in a hollow organ), the method comprising:
obtaining instrument parameters relating to mechanical properties of the at least one medical instrument (Duindam, para. [0006], disclosing obtaining a three-dimensional image of a patient anatomy and a portion of a medical instrument disposed therein, the three-dimensional image includes image information characterizing a shape of the portion of the medical instrument, shape data is obtained from the portion of the medical instrument while the portion is positioned within the patient anatomy, para. [0047], disclosing a history of the distal end pose of flexible body 216 can be used to reconstruct the shape of flexible body 216 over the interval of time, para. [0048], disclosing using history of data from sensors to represent the shape of the elongate device, para. [0062], disclosing obtaining three-dimensional image data of a patient anatomy, para. [0063], disclosing obtaining three-dimensional data representing at least a portion of a medical instrument positioned within the anatomy of the patient, para. [0072], disclosing the shape sensor reference frame or instrument reference frame is registered to the image reference frame or anatomical model reference frame or vice versa, indicating the shape data, history data from sensors, and/or shape sensor reference frame or instrument reference frame can include instrument parameters relating to mechanical properties of the at least one medical instrument);
obtaining hollow organ parameters relating to mechanical properties of the hollow organ (Duindam, para, [0037], disclosing images of a surgical site recorded preoperatively or intraoperatively using image data from imaging technology, the preoperative or intraoperative image data may be presented as two-dimensional, three-dimensional, or four-dimensional (including e.g., time based or velocity based information) images and/or as images from models created from the preoperative or intraoperative image data sets, para. [0062], disclosing obtaining three-dimensional image data of a patient anatomy, para. [0072], disclosing the shape sensor reference frame or instrument reference frame is registered to the image reference frame or anatomical model reference frame or vice versa, indicating the preoperative or intraoperative image data and/or the anatomical model reference frame can include hollow organ parameters relating to mechanical properties of the hollow organ);
generating a model of the at least one medical instrument in the hollow organ dependent upon the instrument parameters and the hollow organ parameters (Duindam, para. [0063], disclosing a three-dimensional model of the shape of the elongate device may be generated as part of the segmentation process, para. [0064], disclosing converting the intraoperative three-dimensional image data into an intraoperative model of a partial or an entire anatomic organ or anatomic region, like a torso including the lungs, para. [0065], disclosing constructing one or more models of the medical instruments, para. [0066], disclosing utilizing the shape information obtained from the elongate device, para. [0068], disclosing a three-dimensional mesh may be formed around the isolated data and/or a centerline may be determined that represents a centerline of the medical instrument, para. [0069], disclosing the three-dimensional mesh may be rendered in a display as a model, the model may be rendered opaquely or semi-transparently, one or more other models of anatomy may also be generated during a segmentation process, FIG. 6A depicts a rendered three-dimensional image 600, which is a filtered image that shows bronchial passageways 602 of the lungs and a flexible elongate medical instrument 604, which may be the elongate device 310 of the medical instrument 304, para. [0072], disclosing registration between the intraoperative model and instrument frames of reference, para. [0074], disclosing registering the three-dimensional image and shape data, displaying the registered information in a display, indicating registration with the rendered three-dimensional image with bronchial passageways and the medical instrument can correspond to a model of the at least one medical instrument in the hollow organ dependent upon the instrument parameters (such as shape information obtained from the elongate device) and the hollow organ parameters);
obtaining at least one image of the at least one medical instrument in the hollow organ (Duindam, para. [0036], disclosing an image of the surgical site and medical instruments captured by the visualization system, para. [0074], disclosing registering the three-dimensional image and shape data, displaying the registered information in a display, para. [0075], disclosing capturing additional three-dimensional image of patient anatomy, obtaining a two-dimensional image of the patient anatomy while the portion of the medical instrument is positioned within the patient anatomy); and
generating a representation of the at least one medical instrument in the hollow organ dependent upon the at least one image and the model (Duindam, para. [0074], disclosing registering the three-dimensional image and shape data, displaying the registered information in a display, para. [0075], disclosing capturing additional three-dimensional image of patient anatomy, obtaining a two-dimensional image of the patient anatomy while the portion of the medical instrument is positioned within the patient anatomy, the shape information may be used to register the three-dimensional image and the two-dimensional image, para. [0077], disclosing a composite image produced from the registration of the segmented shape of the portion of the medical instrument with the shape data from the same portion of the medical instrument, including a surface model of the bronchial passages, para. [0078], disclosing the composite image includes the instrument model, indicating the composite image can correspond to a representation of the at least one medical instrument in the hollow organ dependent upon the at least one image (to update registration) and the model (bronchial passageways of the lungs and a flexible elongate medical instrument)).
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Regarding claim 8, Duindam discloses the method of claim 1, wherein a position to be observed in the hollow organ is obtained (Duindam, para. [0078], disclosing an image of a target, which may be a tumor or growth present in the lungs of the patient, the three-dimensional image data may include data characterizing and defining a position and shape of the tumor, which can be segmented or filtered so that its location can be determined and so that it can be selectively displayed, indicating the location of the target can correspond to a position to be observed in the hollow organ), and wherein the representation of the at least one medical instrument is generated dependent upon the obtained position to be observed (Duindam, para. [0078], disclosing the target may be rendered as an opaque object while other tissues are rendered to be semi-transparent, calculating a position and orientation of the distal tip of the instrument model 804 and may determine a vector extending from the distal tip of the instrument model 804 to the target 806, the vector may be referred to as a trajectory vector 808 and may indicate a direction in which the operator O should steer the actual medical instrument in order to access the actual target for a biopsy or for treatment, indicating the representation of the at least one medical instrument is generated dependent upon the obtained position to be observed, also see FIG. 8).
Regarding claim 9, Duindam discloses the method of claim 1, wherein the at least one mechanical instrument parameters comprise wire parameters regarding mechanical properties of a guide wire for guiding the at least one medical instrument in the hollow organ (Duindam, para. [0045], disclosing the medical instrument system includes elongate device which includes a flexible body having a proximal end and distal end, para. [0047], disclosing sensors tracking distal end and/or segments of the elongate device, para. [0070], disclosing calculating a position and orientation of the distal tip of the instrument, para. [0071], disclosing receiving position/shape information from an optical fiber shape sensor or other sensor system such as electromagnetic position sensors positioned along the elongate device, obtaining a collection of measured points that describe the shape of the elongate device, indicating the elongate device can correspond to a guide wire for guiding the medical instrument in the hollow organ, and the shape data obtained from shape sensors as the at least one mechanical instrument parameters can correspond to wire parameters regarding mechanical properties of a guide wire), and wherein the model is generated dependent upon the wire parameters (Duindam, para. [0066], disclosing utilizing the shape information obtained from the elongate device, para. [0068], disclosing a three-dimensional mesh may be formed around the isolated data and/or a centerline may be determined that represents a centerline of the medical instrument, para. [0069], disclosing the three-dimensional mesh may be rendered in a display as a model, the model may be rendered opaquely or semi-transparently, one or more other models of anatomy may also be generated during a segmentation process, FIG. 6A depicts a rendered three-dimensional image 600, which is a filtered image that shows bronchial passageways 602 of the lungs and a flexible elongate medical instrument 604, which may be the elongate device 310 of the medical instrument 304, para. [0072], disclosing registration between the intraoperative model and instrument frames of reference, para. [0074], disclosing registering the three-dimensional image and shape data, displaying the registered information in a display, indicating the model can be generated dependent upon the shape data corresponding to wire parameters).
Regarding claim 10, Duindam discloses the method of claim 1, wherein the at least one medical instrument comprises a stent or a vascular catheter (Duindam, para. [0045], disclosing the medical instrument includes elongate device such as catheters).
Regarding claim 11, Duindam discloses the method of claim 1, wherein the instrument parameters of the at least one medical instrument comprise a geometrical form, a diameter, a length, a stiffness, an elasticity, a surface lubricity, or a combination thereof (Duindam, para. [0060], disclosing shape of the elongate device can be measured by the shape sensors, para. [0063], disclosing the data representing at least a portion of a medical instrument positioned within the anatomy of the patient may include a representation of the shape of the elongate device of the medical instrument, indicating the data corresponding to instrument parameters of the at least one medical instrument can comprise shape data as a geometrical form).
Regarding claim 12, Duindam discloses the method of claim 1, wherein the at least one image is at least one X-ray image (Duindam, para. [0037], disclosing the image data can be obtained by X-ray imaging, para. [0057], disclosing a three-dimensional imaging system 330 is arranged near the patient P to obtain three-dimensional images of the patient while the elongate device 310 is extended within the patient, the three-dimensional imaging system 330 may provide real-time or near real-time images of the patient P using imaging technology such as CT, fluoroscopy, thermography, ultrasound, OCT, thermal imaging, impedance imaging, laser imaging, nanotube X-ray imaging, and/or the like, para. [0075], disclosing an additional two-dimensional image of the patient anatomy may be captured while the portion of the medical instrument is positioned within the patient anatomy, indicating the two-dimensional image as the at least one image can be obtained by X-ray imaging thus can be at least one X-ray image).
Regarding claim 13, it recites similar limitations of claim 1 but in a data processing apparatus form. The rationale of claim 1 rejection is applied to reject claim 13. In addition, Duindam discloses at least one computing unit (Duindam, para. [0035]).
Regarding claim 14, it recites similar limitations of claim 1 but in an imaging system form. The rationale of claim 1 rejection is applied to reject claim 14. In addition, Duindam discloses a data processing apparatus having at least one computing unit (Duindam, para. [0035]) and an imaging modality (Duindam, para. [0037], disclosing the image data can be obtained by X-ray imaging).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam in view of US Patent Publication No. 20210290310 A1 to Laby et al.
Regarding claim 2, Duindam discloses the method of claim 1, wherein the representation comprises an artificial representation of the at least one medical instrument (Duindam, FIG. 8, showing an artificial representation of the at least one medical device), and wherein the artificial representation is generated dependent upon the model (Duindam, para. [0077], disclosing a composite image produced from the registration of the segmented shape of the portion of the medical instrument with the shape data from the same portion of the medical instrument, including a surface model of the bronchial passages, para. [0078], disclosing the composite image includes the instrument model, indicating the artificial representation of the medical instrument is generated dependent upon the surface model and the instrument model as the model). However, Duindam does not expressly disclose wherein the representation comprises the at least one image overlaid with an artificial representation of the at least one medical instrument.
On the other hand, Laby discloses wherein the representation comprises the at least one image overlaid with an artificial representation of the at least one medical instrument (Laby, FIGs. 29A-29C, showing at least one image of the catheter in the hollow organ overlaid with an artificial representation of the catheter, para. [0452], disclosing a 2D fluoro image and the 3D virtual image of the catheter correspond in the 3D workspace, the indicating the catheter, the fluoro image may include an actual image of an actual catheter in the patient, a virtual 2D image of 3D virtual catheter may be projected onto the fluoro image, indicating the fluoro image can correspond to the at least one image, the virtual 2D image of 3D virtual catheter can correspond to an artificial representation of the at least one medical instrument (the catheter), and the representation shown in FIG. 29C can correspond to the representation comprises the at least one image overlaid with an artificial representation of the at least one medical instrument).
Before the invention was effectively filed, it would have been obvious for a person skilled in the art to combine Duindam and Laby. The suggestion/motivation would have been to provide hybrid display formats which can take advantage of a combination of 2D image components and 3D image components in an overall 3D display space to enhance 3D situational awareness, as suggested by Laby (see Laby, para. [0008]).
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Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam in view of US Patent Publication No. 20140125695 A1 to Lodron et al.
Regarding claim 3, Duindam discloses the method of claim 1. However, Duindam does not expressly disclose wherein the at least one image comprises at least two images, wherein an image region of the at least two images is selected, wherein, dependent upon the model, a deformation field is generated for the selected image region, and wherein the representation is generated dependent upon the deformation field.
On the other hand, Lodron discloses the at least one image comprises at least two images (Lodron, para. [0037], disclosing obtaining at least first and second CT images of an object), wherein an image region of the at least two images is selected (Lodron, para. [0037], disclosing performing a non-rigid registration of the first and second images to determine a deformation field describing a deformation of the object from the first CT image to the second CT image; using the deformation field to determine a transformation of first image portions associated with the first CT image into second image portions associated with the second CT image, wherein the first and second image portions may represent selected contours and/or dosages, indicating the image portions can correspond to an image region of the at least two images being selected), wherein, dependent upon the model, a deformation field is generated for the selected image region (Lodron, para. [0037], disclosing performing a non-rigid registration of the first and second images to determine a deformation field describing a deformation of the object from the first CT image to the second CT image; using the deformation field to determine a transformation of first image portions associated with the first CT image into second image portions associated with the second CT image, wherein the first and second image portions may represent selected contours and/or dosages, indicating the deformation field is generated for the image portions as the selected image region dependent upon the object corresponding to the model), and wherein the representation is generated dependent upon the deformation field (Lodron, para. [0037], disclosing generating one or more images to visualise the deformation field, wherein the one or more images may be superimposed on the first and/or second CT images, indicating the generated images can correspond to the representation dependent upon the deformation field).
Before the invention was effectively filed, it would have been obvious for a person skilled in the art to combine Duindam with Lodron. The suggestion/motivation would have been to enable a differentiation between changes in the patient and changes, in particular errors in the patient's position, as suggested by Lodron (see Lodron, Abstract).
Regarding claim 4, Duindam in view of Lodron discloses the method of claim 3, wherein the deformation field for the image region defines how the image region is rotated when the representation is generated and/or how a size of the image region is changed (Lodron, para. [0037], disclosing a deformation field describing a deformation of the object from the first CT image to the second CT image, indicating the deformation can correspond to a size of the image region is changed because of deformation). Before the invention was effectively filed, it would have been obvious for a person skilled in the art to combine Duindam with Lodron. The suggestion/motivation would have been to enable a differentiation between changes in the patient and changes, in particular errors in the patient's position, as suggested by Lodron (see Lodron, Abstract).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam in view of US Patent Publication No. 20210030474 A1 to Pointeck et al.
Regarding claim 5, Duindam discloses the method of claim 1. However, Duindam does not expressly disclose wherein the generating of the model comprises carrying out a finite element simulation.
On the other hand, Pointeck discloses the generating of the model comprises carrying out a finite element simulation (Pointeck, para. [0094], disclosing the endoprosthesis assembly is modelled in the form of a finite element model, in which each stent is modelled by a beam element and the stents are connected to each other by small beam elements).
Before the invention was effectively filed, it would have been obvious for a person skilled in the art to combine Duindam with Pointeck. The suggestion/motivation would have been to make it possible to take into consideration at the same time the constraints within the stent and the interaction between the stent and the aorta, as suggested by Pointeck (see Pointeck, para. [0113]).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Duindam in view of US Patent Publication No. 20220395230 A1 to Athanasiou.
Regarding claim 6, Duindam discloses the method of claim 1. However, Duindam does not expressly disclose wherein allocation data that allocates a contour of the at least one medical instrument in the hollow organ to predetermined combinations of the instrument parameters and the hollow organ parameters is obtained, and wherein the model is generated dependent upon the allocation data.
On the other hand, Athanasiou discloses allocation data that allocates a contour of the at least one medical instrument in the hollow organ to predetermined combinations of the instrument parameters and the hollow organ parameters is obtained (Athanasiou, para. [0040], disclosing using stent contours and corresponding lumen contours to generate 3D volumes of the stent and lumen, para. [0042], disclosing using the lumen contours and translate each contour set 9lumen and stent) in the 3D space, creating for each contour set a volume and calculating the stent apposition as their volume difference, para. [0115], disclosing generating an object for each of the images that correspond to the stent based on respective struts, each object representing a respective surface segment of the endovascular device, an object is generated for each of the image(s) identified in step S608 where the contours of each object are based on respective struts detected in step S1006 for each image, indicating the contours of each object can correspond to a contour of the stent as the at least one medical instrument in the lumen as the hollow organ allocated to the combined image data including lumen and stent contours corresponding to predetermined combinations of the instrument parameters and the hollow organ parameters), and wherein the model is generated dependent upon the allocation data (Athanasiou, para. [0130], disclosing translating a contour set in the 3D space and the contours points are connected and constructing a triangle mesh and its volume, para. [0131], disclosing presenting the representation of the 3D shape of the stent superimposed on the representation of 3D shape of the lumen, indicating the 3D shapes of the stent superimposed on the lumen can correspond to the model generated dependent upon the contour data as the allocation data).
Before the invention was effectively filed, it would have been obvious for a person skilled in the art to combine Duindam and Athanasiou. The suggestion/motivation would have been for detecting an endovascular device, such as a stent, and measuring endovascular device apposition (see Athanasiou, para. [0001]).
Regarding claim 7, Duindam in view of Athanasiou discloses the method of claim 6, wherein the allocation data is interpolated dependent upon the instrument parameters and the hollow organ parameters (Athanasiou, para. [0040], disclosing interpolating missing data along a surface of the stent, para. [0115], disclosing generating an object for each of the images that correspond to the stent based on respective struts, each object representing a respective surface segment of the endovascular device, an object is generated for each of the image(s) identified in step S608 where the contours of each object are based on respective struts detected in step S1006 for each image, para. [0121], disclosing interpolating one or more missing struts of the object using one or more struts of a second object and one or more struts of a third object, para. [0122], disclosing generating portions of the object by interpolation, indicating the contour sets as the allocation data can be interpolated dependent upon the images including the instrument parameters and the hollow organ parameters), and wherein the model is generated dependent upon the interpolated allocation data (Athanasiou, para. [0122], disclosing generating portions of the object by interpolation, para. [0127], disclosing translating contours of objects for a stent, para. [0130], disclosing translating a contour set in the 3D space and the contours points are connected and constructing a triangle mesh and its volume, para. [0131], disclosing presenting the representation of the 3D shape of the stent superimposed on the representation of 3D shape of the lumen, indicating the 3D shapes of the stent superimposed on the lumen can correspond to the model generated dependent upon the contour data as the allocation data). Before the invention was effectively filed, it would have been obvious for a person skilled in the art to combine Duindam and Athanasiou. The suggestion/motivation would have been for detecting an endovascular device, such as a stent, and measuring endovascular device apposition (see Athanasiou, para. [0001]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication No. 20120289777 A1 to Chopra et al., disclosing a medical system provides navigation assistance to a surgeon so that the surgeon may navigate a flexible medical device through linked passages of an anatomical structure to a target in or adjacent to the anatomical structure.
US Patent Publication No. 20240148464 A1 to Freeman et al., disclosing a spatially sensitive augmented reality system for providing resuscitative feedback in a mixed reality environment to an acute care provider during occurrence of a cardiac event in a patient, and generation of a virtual representation of the insertable medical instrument, and wherein the generation of the image of the virtual representation of the insertable medical instrument on the visual display is based, at least in part, on information determined from the tag or code associated with the insertable medical instrument.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HAIXIA DU whose telephone number is (571)270-5646. The examiner can normally be reached Monday - Friday 8:00 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kee Tung can be reached at 571-272-7794. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HAIXIA DU/Primary Examiner, Art Unit 2611
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