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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ) as being indefinite because the recitation that the slice images are “parallel to a first plane parallel to a first direction” together with the subsequent recitation of “a second plane parallel to a second direction different from the first direction” does not clearly define the geometric relationship between the first and second planes. A single plane may be parallel to multiple different directions; therefore, merely requiring the second direction to differ from the first direction does not establish that the second plane differs in orientation from the first plane. It is consequently unclear whether the claim requires the first and second WMH-to-ventricle positional relationships to be determined on differently oriented planes.
Additionally, the “first plane” is initially introduced as a plane to which the plurality of source slice images are parallel but is subsequently recited as the plane on which the first WMH-to-ventricle positional relationship is determined. The specification separately describes source-image planes and planes selected from the reconstructed 3D medical model, including selected planes that may form an angle with a source image plane. Accordingly, it is unclear whether the claimed “first plane” refers to the source slice image or a plane selected from the 3D medical model.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 7-14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Khademi et al. (US 20210158523 A1) and Avasarala et al. NPL “The first 3D printed multiple sclerosis brain: Towards a 3D era in medicine” in view of DeCarli et al. NPL “Anatomical Mapping of White Matter Hyperintensities (WMH) Exploring the Relationships Between Periventricular WMH, Deep WMH, and Total WMH Burden” and further in view of Paskavitz (US 9808175 B1).
Regarding claim 1, Khademi et al. teaches a method for providing diagnostic assistance information related to a 3D medical model performed by a diagnostic assistance information providing device (see para [0246]; “the standardized image processing system may be used as a computer-aided diagnosis tool, that helps radiologists diagnose and measure pathology in images”, see also para [0134]; “Since MR images generally correspond to a volume of an anatomy, the pixels within an MR image volume may be regarded to be voxels that are arranged in three dimensions such that an image volume can be defined as Y(x.sub.1, x.sub.2, x.sub.3)”), comprising: obtaining a plurality of slice images related to the brain (see para [0007]; “separating the scaled digital MR image volume into a plurality of scaled digital MR image slices”, see also para [0014]; “the digital MR image volume is of a brain”), wherein the plurality of slice images include a plurality of cells (see para [0152]; “The value β is the image slice shifting factor and it may be added to the pixel values for the corresponding image slice”, see also para [0046]; “separating the digital MR image volume into a plurality of digital MR image slices”), labeling at least two brain regions in the plurality of cells, wherein the at least two brain regions include a WMH region and a ventricle region (see para [0167]; “The WML segmentation algorithm can be used to quantify PVA in an image …..retains all pixels containing WML”, and para [0224]; “the ventricles can be segmented…. This yielded an approximate segmentation of the ventricles. The two largest remaining connected volumes were then labelled as ventricular CSF”, and para [0235]; “In particular, FIGS. 16A-16L show sample results of midline plane estimation, as well as WML and ventricle segmentation… FIGS. 17A-17L show sample results of midline plane estimation, as well as WML and ventricle segmentation”). However, Khademi e al does not teach and the slice images are parallel to a first plane parallel to a first direction, obtaining a 3D medical model based on the plurality of slice images labeled with the two or more brain regions; and providing diagnostic assistance information related to a positional correlation between a WMH region and a ventricle region from the three-dimensional medical model; wherein the WMH region includes a first WMH region and a second WMH region, and the correlation includes a positional relationship between the first WMH region and the ventricle region on the first plane and a positional relationship between the second WMH region and the ventricle region on a second plane parallel to a second direction different from the first direction.
In the same field of endeavor, Avasarala et al. teaches obtaining a 3D medical model based on the plurality of slice images labeled with the two or more brain regions (see page 4, right col. 2nd para; “The imaging study was then segmented into regions and surface rendered to achieve 3D virtual reconstructions in addition to 3D printable files of the desired structures of interest – the brain, ventricles and white matter lesions… The ventricles of the brain and lesions were also segmented… After the images were segmented into the defined regions of interest in the images, 3D tessellated surface models were calculated and rendered from the segmented regions”); wherein the WMH region includes a first WMH region and a second WMH region (see page 5, Fig. 2 and Fig. 3; “Figure 2. Reconstructed 3D brain images depicting axial, sagittal and coronal views with amalgamated lesions shown in pink and ventricles displayed in blue…, Figure 3. A 3D brain, modeled to size. Ventricles are shown in blue and white matter lesions are depicted in pink”). Accordingly, it would have been obvious to one of ordinary skills in the art before the effective filling date of the claimed invention to modify a method of for processing a digital magnetic resonance (MR) image volume in an image data set using intensity standardization to provide standardized MR image slices of Khademi et al. in view of a method of a 3D printed patient specific brain model to scale of Avasarala et al. in order to demonstrate that 3D depiction of chronic neurological diseases is possible in a printable model while serving a fundamental need for patient education (see page 4, right col. 2nd para).
However, the combination of Khademi e al and Avasarala et al.as a whole does not teach and the slice images are parallel to a first plane parallel to a first direction; and providing diagnostic assistance information related to a positional correlation between a WMH region and a ventricle region from the three-dimensional medical model; and the correlation includes a positional relationship between the first WMH region and the ventricle region on the first plane and a positional relationship between the second WMH region and the ventricle region on a second plane parallel to a second direction different from the first direction.
In the same field of endeavor, DeCarli et al. teaches and providing diagnostic assistance information related to a positional correlation between a WMH region and a ventricle region from the three-dimensional medical model (see Fig. 4, page 51, right col. 1st para; determine the exact distance between each WMH voxel and the ventricular ependymal surface for all subjects”, see page 52, “Discussion”; “Use of image segmentation, 3D anatomical mapping of WMH voxels”); and the correlation includes a positional relationship between the first WMH region and the ventricle region on the first plane and a positional relationship between the second WMH region and the ventricle region on a second plane parallel to a second direction different from the first direction (see Fig. 4, page 51, right col. 1st para; determine the exact distance between each WMH voxel and the ventricular ependymal surface for all subjects”, Abstract; “spatial localization of each WMH voxel”, see also page 52, left col. 3rd para; “When viewed axially, as is common in studies of WMH,33 ,34 DWMH appear present. However, the sagital and coronal orientations show that these WMH are actually contiguous with the ventricular lining” and see page 52, “Discussion”; “Use of image segmentation, 3D anatomical mapping of WMH voxels” Note; 3D WMH mapping, relationship to ventricle, and axial view versus differently oriented sagittal/coronal view). Accordingly, it would have been obvious to one of ordinary skills in the art before the effective filling date of the claimed invention to modify a method of for processing a digital magnetic resonance (MR) image volume in an image data set using intensity standardization to provide standardized MR image slices of Khademi et al. in view of a method of a 3D printed patient specific brain model to scale of Avasarala et al. and further in view of a method for anatomical mapping of white matter hyperintensities (WMH) of Decarli et al. in order to assess evidence in support of categorical distinctions between periventricular white matter hyperintensities (PVWMH) and deep WMH (DWMH).
However, the combination of Khademi et al. Avasarala et al. and Decarli et al. as a whole does not teach the slice images are parallel to a first plane parallel to a first direction.
In the same field of endeavor, Paskavitz teach the slice images are parallel to a first plane parallel to a first direction (see col. 7, lines 9-12; “That 3-dimensional representation may be a series of parallel planes, each representing a slice through a portion of the brain”, see also col. 5, lines 52-53; “a slice in a plane perpendicular to the scan direction, D”). Accordingly, it would have been obvious to one of ordinary skills in the art before the effective filling date of the claimed invention to modify a method of for processing a digital magnetic resonance (MR) image volume in an image data set using intensity standardization to provide standardized MR image slices of Khademi et al. in view of a method of a 3D printed patient specific brain model to scale of Avasarala et al. and further in view of a method for anatomical mapping of white matter hyperintensities (WMH) of Decarli et al. and a technique for reliably measuring brain atrophy based on image data of Paskavitz in order to determine disease progression and useful for diagnosis or evaluation of treatments (see col. 7, lines 9-12).
Regarding claim 2, the rejection of claim 1 is incorporated herein.
DeCarli et al. in the combination further teach wherein the correlation includes the distance between the first WMH region and the ventricle region and the distance between the second WMH region and the ventricle region (see Abstract; “the basis of distance from the lateral ventricles and correlations, with total WMH volume determined. Periventricular distance histograms of WMH voxels were also calculated”, see also page 52, right col. last para; “WMH were divided into PVWMH and DWMH on the basis of a 1-cm distance from the ventricular surface”).
Regarding claim 3, the rejection of claim 1 is incorporated herein.
DeCali et al. in the combination further teach wherein the diagnostic assistance information includes the volume of the WMH region included in the three-dimensional medical model (see Abstract; “included quantification of WMH volume…. with total WMH volume determined”).
Regarding claim 7, the rejection of claim 1 is incorporated herein.
Khademi et al. in the combination further teach wherein the diagnostic assistance information is related to Alzheimer's disease (see para [0104]; “The prevalence of these lesions can be associated with ischemic stroke [3], Alzheimer's Disease (AD) [2] and multiple sclerosis (MS) [4]”).
Regarding claim 8, the rejection of claim 1 is incorporated herein.
Khademi et al. in the combination further teach wherein the slice images are T2-FLAIR MRI images (see para [0117]; “an image standardization framework for MR images that can be used to reduce the variability of MR images obtained from MC studies. For example, the image standardization framework may be applied to FLAIR, T1-weighted, T2-weighted”).
Regarding claim 9, the rejection of claim 1 is incorporated herein.
Khademi et al. in the combination further teach wherein the 3D medical model is a 3D image including a plurality of brain regions distinguished by a plurality of 3D boundaries (see para [0155]; “the preferred or predetermined intensity range may be selected to correspond to the boundaries of the brain class (e.g. at least one of WM and GM tissues depending on the imaging modality) in the atlas image volume, to which all image volumes are aligned”, see also para [0164]; “An increase in local contrast may indicate that the boundaries of the WML have been preserved, yielding edges that can allow for discrimination between WML and GM/WM tissue classes”).
Regarding claim 10, the rejection of claim 1 is incorporated herein.
DeCali et al. in the combination further teach wherein the second plane is set to minimize the distance between the second WMH region and the ventricle region (see page 52, left col.,4th para; “the peak of the WMH distribution widens continuously from the lowest WMH quintile, where the median distance is 3.5 mm, to highest quintile, where the median distance is 6.0 mm. One exception to this general observation is at the lowest quintile, where a small second peak occurs at 30 mm from the ventricular surface”).
Regarding claim 11, the rejection of claim 1 is incorporated herein.
Khademi et al. in the combination further teach a non-transitory computer-readable medium storing instructions that in response to being executed, cause performance (see para [0026]; “a non-transitory memory; at least one processor operable to execute instructions stored in the non-transitory memory”)
Regarding claim 12, the scope of claim 12 is fully incorporated in claim 1, and the
rejection of claim 1 is equally applicable here.
Regarding claim 13, the rejection of claim 12 is incorporated herein.
DeCali et al. in the combination further teach wherein the correlation includes the distance between the first WMH region and the ventricle region and the distance between the second WMH region and the ventricle region (see Abstract; “the basis of distance from the lateral ventricles and correlations, with total WMH volume determined. Periventricular distance histograms of WMH voxels were also calculated”, see also page 52, right col. last para; “WMH were divided into PVWMH and DWMH on the basis of a 1-cm distance from the ventricular surface”).
Regarding claim 14, the rejection of claim 12 is incorporated herein.
DeCali et al. in the combination further teach wherein the diagnostic assistance information includes the volume of the WMH region included in the three-dimensional medical model (see Abstract; “included quantification of WMH volume…. with total WMH volume determined”).
Regarding claim 18, the rejection of claim 12 is incorporated herein.
Khademi et al. in the combination further teach wherein the slice images are T2-FLAIR MRI images (see para [0117]; “an image standardization framework for MR images that can be used to reduce the variability of MR images obtained from MC studies. For example, the image standardization framework may be applied to FLAIR, T1-weighted, T2-weighted”).
Regarding claim 19, the rejection of claim 12 is incorporated herein.
Khademi et al. in the combination further teach wherein the 3D medical model is a 3D image including a plurality of brain regions distinguished by a plurality of 3D boundaries (see para [0155]; “the preferred or predetermined intensity range may be selected to correspond to the boundaries of the brain class (e.g. at least one of WM and GM tissues depending on the imaging modality) in the atlas image volume, to which all image volumes are aligned”, see also para [0164]; “An increase in local contrast may indicate that the boundaries of the WML have been preserved, yielding edges that can allow for discrimination between WML and GM/WM tissue classes”).
Regarding claim 20, the rejection of claim 12 is incorporated herein.
Khademi et al. in the combination further teach wherein the second plane is set to minimize the distance between the second WMH region and the ventricle region (see page 52, left col.,4th para; “the peak of the WMH distribution widens continuously from the lowest WMH quintile, where the median distance is 3.5 mm, to highest quintile, where the median distance is 6.0 mm. One exception to this general observation is at the lowest quintile, where a small second peak occurs at 30 mm from the ventricular surface”).
Claims 4-5, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Khademi et al. and Avasarala et al. in view of DeCarli et al. and Paskavitz and further in view of Meyer et al. (US 20180344161 A1).
Regarding claim 4, the rejection of claim 1 is incorporated herein.
The combination of Khademi et al. and Avasarala et al., DeCarli et al. and Paskavitz does not teach wherein the diagnostic assistance information is obtained based on the number of cells labeled with WMH included in the three-dimensional medical model.
In the same field of endeavor, Meyer et al. teaches wherein the diagnostic assistance information is obtained based on the number of cells labeled with WMH included in the three-dimensional medical model (see para [0025]; “the parameter may comprise the volume of a lesion, the total volume of the identified lesions, the number of identified lesions and/or a ratio of a white matter lesion volume to cortical area”, see also para [0038]; “the first lesions comprises white matter lesions, and the examination area comprises a brain”). Accordingly, it would have been obvious to one of ordinary skills in the art before the effective filling date of the claimed invention to modify a method of for processing a digital magnetic resonance (MR) image volume in an image data set using intensity standardization to provide standardized MR image slices of Khademi et al. in view of a method of a 3D printed patient specific brain model to scale of Avasarala et al. and further in view of a method for anatomical mapping of white matter hyperintensities (WMH) of Decarli et al. and a technique for reliably measuring brain atrophy based on image data of Paskavitz and a medical instrument for automatically detecting affected regions in an examination area of a subject of Meyer et al. in order to automatically detecting affected regions in an examination area of a subject (see para [0025]).
Regarding claim 5, the rejection of claim 1 is incorporated herein.
Meyer et al. in the combination further teach wherein the two or more brain regions further include white matter regions (see para [0071]; “In case the examination area comprises the brain, the tissues of the segmented first anatomical image may be at least one of white matter, gray matter, cerebrospinal fluid (CSF), edema and tumor tissue”), and the diagnostic assistance information includes a volume ratio of the WMH region and the white matter region (see para [0016]; “the first parameter comprises at least one of size, voxel intensity, number, fractional volume of the identified lesions”, see also para [0025]; “the parameter may comprise the volume of a lesion, the total volume of the identified lesions, the number of identified lesions and/or a ratio of a white matter lesion volume to cortical area (e.g. ratio of the first lesion's volume to the first cortical area and/or ratio of the second lesion's volume to the second cortical area)”, and para [0099]; “a label is assigned to the determined white matter tracts indicating the anatomical region of the corresponding white matter lesion”).
Regarding claim 15, the rejection of claim 12 is incorporated herein.
Meyer et al. in the combination further teach wherein the diagnostic assistance information is obtained based on the number of cells labeled with WMH included in the three-dimensional medical model (see para [0025]; “the parameter may comprise the volume of a lesion, the total volume of the identified lesions, the number of identified lesions and/or a ratio of a white matter lesion volume to cortical area”, see also para [0038]; “the first lesions comprises white matter lesions, and the examination area comprises a brain”).
Regarding claim 16, the rejection of claim 12 is incorporated herein.
Meyer et al. in the combination further teach wherein the two or more brain regions further include white matter regions (see para [0071]; “In case the examination area comprises the brain, the tissues of the segmented first anatomical image may be at least one of white matter, gray matter, cerebrospinal fluid (CSF), edema and tumor tissue”), and the diagnostic assistance information includes a volume ratio of the WMH region and the white matter region (see para [0025]; “the parameter may comprise the volume of a lesion, the total volume of the identified lesions, the number of identified lesions and/or a ratio of a white matter lesion volume to cortical area”, see also para [0038]; “the first lesions comprises white matter lesions, and the examination area comprises a brain” and para [0099]; “a label is assigned to the determined white matter tracts indicating the anatomical region of the corresponding white matter lesion”).
Claim 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Khademi et al. and Avasarala et al. in view of DeCarli et al. and Paskavitz and further in view of Li (US 20090003676 A1).
Regarding claim 6, the rejection of claim 1 is incorporated herein. The combination of Khademi et al. and Avasarala et al., DeCarli et al. and Paskavitz does not teach wherein the second plane is set to have the largest number of cells corresponding to the WMH region located on the second plane.
In the same field of endeavor, Li teaches wherein the second plane is set to have the largest number of cells corresponding to the WMH region located on the second plane (see para [0014]; “the reference slice image determination device determines a slice image containing a maximum lesion area in the first slice image group”). Accordingly, it would have been obvious to one of ordinary skills in the art before the effective filling date of the claimed invention to modify a method of for processing a digital magnetic resonance (MR) image volume in an image data set using intensity standardization to provide standardized MR image slices of Khademi et al. in view of a method of a 3D printed patient specific brain model to scale of Avasarala et al. and further in view of a method for anatomical mapping of white matter hyperintensities (WMH) of Decarli et al. and a technique for reliably measuring brain atrophy based on image data of Paskavitz and an image diagnosis supporting apparatus of Li in order to accurately comparing and interpreting images of lesion areas included in slice image groups at different photographing (see para [0025]).
Regarding claim 17, the rejection of claim 12 is incorporated herein.
Li in the combination further teach wherein the second plane is set to have the largest number of cells corresponding to the WMH region located on the second plane (see para [0014]; “the reference slice image determination device determines a slice image containing a maximum lesion area in the first slice image group”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WINTA GEBRESLASSIE whose telephone number is (571)272-3475. The examiner can normally be reached Monday-Friday9:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Bee can be reached at 571-270-5180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WINTA GEBRESLASSIE/Examiner, Art Unit 2677
Prosecution Insights