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 .
Claim Status:
Claims 10 and 22 are canceled.
Claims 1-9, 11-21, and 23-24 are pending and examined below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 2, 9, 13, 14, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US2013/0155064 to Grbic et al. “Grbic”, in view of US2016/0300351 to “Gazit”, further in view of Non-Patent Literature (NPL): “Model-Based 3-D LV Shape Recovery in Biplane X-Ray Angiography: A-Priori Information Learned from CT” to Swoboda et al. “Swoboda”, and further in view of US7,149,331 to Kaufman et al. “Kaufman”.
Regarding claims 1 and 13, Grbic teaches a method and system for assessing calcification of an aortic valve (Title, Abstract, “method and system for automatic aortic valve calcification evaluation”), wherein the system comprises:
a processor (“ automated aortic valve calcification evaluation may be implemented on a computer using well-known computer processors”, Paragraph 0028); and
a memory storing processor-executable instructions (The computer program instructions may be stored in a storage device 712 (e.g., magnetic disk) and loaded into memory 710 when execution of the computer program instructions is desired”, Paragraph 0028), wherein the instructions configure the processor to, and the method comprising:
receiving computed tomography (CT) images (Paragraph 0017, Fig. 1, Step 102, receive 3D medical image volume, that is a 3D CT volume of a cardiac region of a patient) of the aortic valve (Fig. 1, Step 104, Paragraph 0018, “patient-specific aortic valve model is detected in the 3D medical image; thus the received CT image must be of the aortic valve);
pre-processing the received images to have a field of view focused on an aortic root corresponding to the aortic valve (As show in Fig. 2, and Paragraphs 0018-19, when the aortic valve model detection is performed on the CT image 200 of Fig. 2, as seen in Ref. 210, the aortic valve region, which includes the aortic root, is at the focus of the field of view; also see the claim language of claim 3: “detecting surface aortic valve surface structures in the 3D medical image”, and claim 4: the aortic valve surface structures include an aortic root; therefore the aortic root must be in the field of view of the CT image);
segmenting the aortic valve from the surrounding tissue in the pre-process image (the volumetric region defined by the boundaries of the detected aortic valve model can be cropped in order to define a region of interest in the 3D medical image volume, Paragraph 0021; wherein the cropping would be broadly interpreted as segmenting);
define a local coordinate system relative to leaflets of the aortic valve (Paragraph 0024, mapping points to one of three aortic valve leaflets in the aortic valve model, wherein each point of the aortic valve model is represented with coordinates (u,v), which would read on a local coordinate system relative to the leaflets);
generating a calcification model based on the pre-processed images and the aortic root model (Fig. 1, Ref. 108, determining the calcification regions in the aortic valve model, Paragraph 0023, using a graph cuts segmentation algorithm or intensity-based thresholding) and
generating an indicator quantifying calcification of the aortic valve based on the calcification model, the principal axes and the landmark points (a 2D plot of the calcifications is generated, Paragraph 0024, Fig. 1, Ref. 110; Paragraph 0025, wherein the 2D calcification plot depicts the calcifications detected in the volumetric region of a 3D CT image defined by the aortic valve model; and outputting the 2D plot of calcification, Fig. 1, Ref. 112).
Grbic also teaches extracting an aortic valve model from the CT image, wherein the aortic valve model comprises structures including the aortic root (Paragraph 0018).
However, Grbic does not teach wherein the received images are contrast-enhanced CT images and implementing a fast-marching method for the pre-processed images to segment the aortic valve from surrounding tissue to generate an aortic root model.
Gazit teaches in a similar field of endeavor of image processing of medical images comprising an organ (Abstract) such as a heart with features such as the heart valves (Paragraph 0242). Gazit teaches wherein the received images are contrast-enhanced (Paragraph 0087; Paragraph 0241, wherein the CT image includes contrast materials such as barium) CT images (Paragraph 0130, the images can be CT images), and implementing a fast-marching method for the pre-processed images to segment the target organ from surrounding tissue (Paragraph 0161, Fig. 8 shows a flow chart 800 for the method of segmenting the one or more target organs; Paragraph 0181 and Fig. 8 step 824, using a fast marching algorithm to grow a more accurate segmentation of the target organ).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Grbic's invention wherein the system and method includes receiving contrast-enhanced CT images and implementing a fast-marching method for the pre-processed images to segment the target organ from surrounding tissue, as taught by Gazit, in order to produce images wherein the internal intensity of the lumens would be more predictable (Gazit, Paragraph 0241 ) and improve the accuracy of the segmentation (Gazit, Paragraph 0181).
However, the modifications of Grbic and Gazit does not disclose determining multiple principal axes and multiple landmark points based on the pre- processed images and the aortic root model to define the local coordinate system.
Swoboda teaches in a similar field of endeavor of determining/recovering the 3D shape of the left ventricle from 2D x-ray images (angiograms). Swoboda teaches determining multiple principal axes and multiple landmark points based on the pre- processed images (Page 102, Methods, Section 2.1 Statistical Shape Models, and section 2.2 Modeling of LV anatomy, wherein Swoboda teaches creating a statistical shape model, SSM, from back-propagation of landmarks, and performing a principle component analysis to yield the principle axes of the distribution of the shape of the model. Then a transform is determined from the model space to the image space, Section 2.3, which would read on defining the local coordinate system).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Grbic and Gazit, wherein system and method includes determining multiple principal axes and multiple landmark points based on the pre- processed images and a model, to define the local coordinate system as taught by Swoboda, in order to recover a 3D shape information from the images (Swoboda, Abstract).
However, the modifications of Grbic, Gazit, and Swoboda do not teach generating a calcification model based in part on an image-specific calcific Hounsfield (HU) threshold, the image-specific calcific HU threshold determined by iteratively changing an initial estimate of the calcific HU Hounsfield (HU) threshold until a minimum false positive rate (FPR) criterion is reached for that image.
Kaufman teaches an image-specific calcific Hounsfield (HU) threshold (Col. 3, Paragraph starting at line 31, create a slice-specific signal threshold for calcium scoring of each slice image of an image scan of a patient; Fig. 1 and Col. 6, Paragraph starting at line 41, select a region of interest in each slice or selected image slice…generate an individualized signal threshold for each of the slice images, Fig. 1, step 106; where the threshold is in HU units, Col. 8, Paragraph starting at line 23), the image-specific calcific HU threshold determined by iteratively changing an initial estimate of the calcific HU Hounsfield (HU) threshold until a minimum false positive rate (FPR) criterion (Col. 7, lines 1-15, and Fig. 2, step 110, operator sets the acceptable number of false positives, wherein the acceptable level can be 0, 1, 2, 3, 4 . . . or other integers; ) is reached for that image (Fig. 4 and Col. 8, lines 23-55, selecting a first signal threshold HU, step 122, applying the first threshold to the region of interest of the slice image, step 124, count the number of false positives in the region of interest, step 126, compare the counted number of false positives to the operator set acceptable number, step 128, if the counted number exceeds the acceptable number, adjust the signal threshold HU until the signal threshold is found that provides the acceptable number of false positives or less, step 130).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system and method as described by Grbic, Gazit, and Swoboda, to have modified Grbic’s segmentation method of using an intensity-based thresholding, which is used to generate the calcification model, to include an image-specific calcific Hounsfield (HU) threshold, the image-specific calcific HU threshold determined by iteratively changing an initial estimate of the calcific HU Hounsfield (HU) threshold until a minimum false positive rate (FPR) criterion is reached for that image, as taught by Kaufman, in order for the maximum sensitivity available from any one CT scanner to become available for the detection of small lesions so that a more accurate coronary calcium score can be obtained, by using a slice specific signal threshold for calcium scoring (Kaufman, Col. 3, Paragraph starting at line 31).
Regarding claims 2 and 14, the modifications of Grbic, Gazit, Swoboda, and Kaufman disclose all the features of claim 1 or 13 above.
As disclosed in the claim 1 rejection above, Grbic discloses wherein generating the indicator includes generating one or more maps quantifying calcification of the aortic valve (a 2D plot of the calcifications is generated, Paragraph 0024, Fig. 1, Ref. 110; Paragraph 0025, wherein the 2D calcification plot depicts the calcifications detected in the volumetric region of a 3D CT image defined by the aortic valve model; and outputting the 2D plot of calcification, Fig. 1, Ref. 112).
Regarding claims 9 and 21, the modifications of Grbic, Gazit, Swoboda, and Kaufman disclose all the features of claim 1 or 13 above.
As disclosed in claim 1 rejection above, Grbic discloses wherein the one or more maps quantifying calcification include one or more of a calcification intensity map (a 2D plot of the calcifications is generated, Paragraph 0024, Fig. 1, Ref. 110; Paragraph 0025, wherein the 2D calcification plot depicts the calcifications detected in the volumetric region of a 3D CT image defined by the aortic valve model; and outputting the 2D plot of calcification, Fig. 1, Ref. 112; wherein the amount of calcification at each point on the 2D plot is encoded with the alpha channel, and small amounts of calcification will appear transparent, while severe calcifications will appear solid in the 2D plot, Paragraph 0024, and would read on an intensity map).
Claim(s) 3, 4, 11, 12, 15, 16, 23 and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grbic, in view of Gazit, further in view of Swoboda, and further in view of Kaufman, as applied to claims 2 or 14 above, and further in view of US2017/0076014 to “Bressloff”.
Regarding claims 3, 4, 15, and 16, the modifications of Grbic, Gazit, Swoboda, and Kaufman disclose all the features of claims 2 or 14 above.
However, the modifications of Grbic, Gazit, Swoboda, and Kaufman do not disclose measuring one or more local and/or global geometric parameters quantifying calcification of the aortic valve based on the one or more maps.
Bressloff teaches in a similar field of endeavor of providing a map of a characteristic in the region (Paragraph 0019), wherein the characteristic is the degree of calcification in an artery or aortic root (Paragraph 0041). Bressloff teaches measuring one or more local and/or global geometric parameters quantifying calcification of a region based on the one or more maps (Paragraph 0215, determining the degree of calcification by measuring a specific volume that correspond to a percentage of the total volume that is calcified; wherein the amount of calcification is determined by maps derived from the medical images such as shown in Fig. 6b, Paragraph 0137, that depict the boundaries of the artery, and also the area of calcification; measuring the specific volume of calcification for each region would read on the geometric parameters including one or more of a physical volume).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Grbic, Gazit, Swoboda, and Kaufman, wherein the system and method includes measuring one or more local and/or global geometric parameters quantifying calcification of the aortic valve based on the one or more maps, as taught by Bressloff, in order to quantify and visualize the variation of the disease (i.e. calcification) in the region of interest (Bressloff, Paragraph 0161). In addition, such quantification and visualization could be used to design a stent that is optimized for disease variation in a specific patient (Bressloff, Paragraph 0162).
Regarding claims 11 and 23, the modifications of Grbic, Gazit, Swoboda, Kaufman and Bressloff disclose all the features of claims 3 or 15 above.
Bressloff further teaches monitoring or prognosing aortic valve stenosis (AS) in a subject based on the one or more local and/or global geometric parameters (monitoring or diagnosing a disease, Paragraph 0046; wherein the disease is plaques or lesions formed on the artery walls which cause narrowing, Paragraphs 0007, 0130, which reads on stenosis; wherein monitoring, the characteristic is the degree of calcification in an artery or aortic root is characterized, Paragraph 0041; therefore, the monitoring of the disease would be interpreted as stenosis found in the aortic root, which is part of the aortic valve, and would read on aortic valve stenosis)
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Grbic, Gazit, Swoboda, Kaufman and Bressloff, wherein the system and method includes monitoring or prognosing aortic valve stenosis (AS) in a subject based on the one or more local and/or global geometric parameters, as taught by Bressloff, in order to be able to determine the progression of the disease or disorder, or assess treatment (Bressloff, Paragraph 0274).
Regarding claims 12 and 24, the modifications of Grbic, Gazit, Swoboda, Kaufman and Bressloff disclose all the features of claims 11 or 23 above.
Grbic teaches wherein a procedural risk assessment and/or a complication/event prediction is conducted prior to a transcatheter aortic valve replacement (TAVR) (Paragraph 0027, using the mapping of the calcifications to the 2D plot enables comprehensive calcium analysis, which can then be used as data to train a classifier for risk assessment to predict the likelihood that a TAVI procedure will result in the patient having a stroke, wherein a TAVI procedure is defined as transcatheter aortic valve implant, Abstract)
Claim(s) 5 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grbic, in view of Gazit, further in view of Swoboda, and further in view of Kaufman as applied to claims 1 or 13 above, and further in view of NPL: “Anatomical and Procedural Features Associated With Aortic Root Rupture During Balloon-Expandable Transcatheter Aortic Valve Replacement” to Barbanti et al. “Barbanti”.
Regarding claims 5 and 17, the modifications of Grbic, Gazit, Swoboda, and Kaufman disclose all the features of claim 1 or 13 above.
However, modifications of Grbic, Gazit, Swoboda, and Kaufman do not disclose wherein the received images are pre-processed to have the field of view include an interface between the aortic valve and a left ventricular outflow tract (LVOT), and a part of the ascending aorta after a Sino-tubular junction (STJ); and to have the field of view exclude any other surrounding structures.
Barbanti teaches wherein the received images are pre-processed to have the field of view include an interface between the aortic valve and a left ventricular outflow tract (LVOT), and a part of the ascending aorta after a Sino-tubular junction (STJ); and to have the field of view exclude any other surrounding structures (Page 245, Section: MDCT Image Analysis, using double-oblique transverse “reformats” to take measurements of the LVOT/subannular and ascending aortic dimensions, along with dimensions from the insertion of the aortic valve cusps to the ostia of the coronary arteries and to the sinotubular junction; wherein the reformat reads on reformatting the views or reconstruction to include the structures mentioned above for measurements).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Grbic, Gazit, Swoboda, and Kaufman, wherein the received images are pre-processed to have the field of view include an interface between the aortic valve and a left ventricular outflow tract (LVOT), and a part of the ascending aorta after a Sino-tubular junction (STJ); and to have the field of view exclude any other surrounding structures, as taught by Barbanti, in order to be able to obtain the necessary measurements needed to predict potential aortic root rupture during a Transcatheter Aortic Valve Replacement (TAVR) (Barbanti, Page 245, left column, paragraph before “Methods”).
Claim(s) 6 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grbic, in view of Gazit, further in view of Swoboda, and further in view of Kaufman as applied to claims 1 or 13 above, and further in view of US2017/0065242 to Chirvasa et al. “Chirvasa”.
Regarding claims 6 and 18, the modifications of Grbic, Gazit, Swoboda, and Kaufman disclose all the features of claims 1 or 13 above.
As disclosed in the claim 1 rejection above, Grbic teaches generating a model of the aortic valve that includes the aortic root (Paragraph 0018), and Gazit teaches generating the model using a fast marching method.
However, the modifications of Grbic, Gazit, Swoboda, and Kaufman do not disclose performing morphological operations to obtain a smoothed surface of the model.
Chirvasa teaches performing morphological operations to obtain a smoothed surface of the model (Paragraphs 0243-0246, performing smooth surface modeling using pseudo thin plate splines defined on a sphere, and optimizing a modeled expression that approximates boundary points of the model as closely as possible while resulting in a smooth surface).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Grbic, Gazit, Swoboda, and Kaufman, wherein the system and method include morphological operations are performed to obtain a smoothed surface of the model, as taught by Chirvasa, in order to obtain an accurate model of tissue, such as that of the heart myocardium, to identify abnormalities (Chirvasa, Paragraph 0096).
Claim(s) 7 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grbic, in view of Gazit, further in view of Swoboda, and further in view of Kaufman as applied to claims 1 or 13 above, and further in view of NPL: “Three-Dimensional Echocardiography and En Face Views of the Aortic Valve: Technical Communication” to Kim et al. “Kim”.
Regarding claims 7 and 19, the modifications of Grbic, Gazit, Swoboda, and Kaufman disclose all the features of claims 1 or 13 above.
However, the modifications of Grbic, Gazit, Swoboda, and Kaufman do not disclose wherein the multiple principal axes correspond to an anatomical short axis view, and two long axis views that are perpendicular to the "En-face" short axis view (“en face view”, Page 376, right column,
Kim teaches wherein the multiple principle principal axes correspond to an anatomical short axis view, and two long axis views that are perpendicular to the "En-face" short axis view (Page 376, defining the en face view of aortic valve, which as seen in Fig. 3, and therefore one of ordinary skill in the art would understand that en-face defines the x-y plane, which in the definition of the aortic valve would be a short axis plane, then the two other coordinate axes would have to be long axis views, as seen based on the anatomical picture of Fig. 2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Grbic, Gazit, Swoboda, and Kaufman, wherein the multiple principal axes correspond to an anatomical short axis view, and two long axis views that are perpendicular to the "En-face" short axis view, as taught by Kim, in order to clearly define a uniform description of the 3D anatomy of the aortic valve.
Claim(s) 8 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grbic, in view of Gazit, further in view of Swoboda, and further in view of Kaufman as applied to claims 1 or 13 above, and further in view of Bressloff.
Regarding claims 8 and 20, the modifications of Grbic, Gazit, Swoboda, and Kaufman disclose all the features of claims 1 or 13 above.
Bressloff teaches generating an anatomical N region average intensity map quantifying calcification of the aortic valve (Paragraph 0248, generating a contour map of the first metric, wherein the first metric an average value of the characteristic, Paragraph 0249, wherein the characteristic is the degree of calcification in an artery or aortic root Paragraph 0041, wherein the contour map, such as Fig. 14, depicts the degree of calcification against location along the artery, Paragraph 0214, which would read on N anatomical regions).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as described by Grbic, Gazit, Swoboda, and Kaufman, wherein the system and method includes generating an anatomical N region average intensity map quantifying calcification of the aortic valve, as taught by Bressloff, in order to be able to visualize the degree of calcification against location along the artery (Bressloff, Paragraph 0214).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-9, 11-21, and 23-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments are directed towards prior art to Tzolos et al. Due to applicant’s amendments Tzolos et al. is no longer used in the rejections. Newly found prior art to Kaufman is used to address the newly amended limitation of an image-specific calcific Hounsfield (HU) threshold, the image-specific calcific HU threshold determined by iteratively changing an initial estimate of the calcific HU Hounsfield (HU) threshold until a minimum false positive rate (FPR) criterion is reached for that image.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US2005/0195936 to Raman et al. is direct to quantification of vessel calcification using computed tomographic angiography (Paragraph 0016), and determines a threshold for determining calcification based on an intensity standard deviation of the intensities found in the image (Paragraph 0019), which is then used to determine which voxels in the image represent calcium fragments (Paragraph 0019).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MT/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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