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 .
Priority
The instant application claims benefit to provisional application No. 63431539 filed on December 09, 2022. Domestic benefit is acknowledged. Thus, the effective filing date of Claims 1-17 is December 09, 2022.
Drawings
The 26 page drawings have been considered and placed on record in the file.
Status of Claims
Claims 1-17 are currently pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent Claim 1 is directed to determining a region of interest of the patient and the location of a commissure in said region of interest.
Step 1:
With regard to Step 1, the instant claim 1 is directed to a method among the statutory categories of invention.
Step 2A – Prong 1:
With regard to Step 2A – Prong 1, for example in method Claim 1, the limitations “determining, based on a representation of a first tissue, a region of interest of the patient” and “determining, based on the region of interest, an estimate of a location of a commissure within a representation of second tissue of the patient”, as recited, are a method that, under its broadest reasonable interpretation, covers performance of the limitation in the mind/observation of a person inspecting an image of a patient. That is nothing in the claim steps preclude the limitations from practically being performed in the mind or through observation/judgement of a person inspecting an image of a patient. If a claim limitation, under its broadest reasonably interpretation covers performance of the limitation in the mind then it falls within the "Mental processes" grouping of the abstract idea, which include concepts performed in the human mind, including an observation, evaluation, judgement, opinion. Accordingly, the claim recites an abstract idea
Step 2A – Prong 2:
The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception. In the instant case, there are no additional elements in the claims, which may apply, rely on, or use the judicial exception.
Step 2B:
Because the claim fails under Step 2A, the claim is further evaluated under Step 2B. The claim herein do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Accordingly, the claim is not patent eligible.
Further, with regard to dependent Claims 2-17 viewed individually, these additional elements are under their broadest reasonable interpretation, cover performance of the limitation in the mind and do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Accordingly, Claims 1-17 are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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) 1-2, 6-7, 10-16 is/are rejected under 35 U.S.C 102 (a)(1) as being anticipated by Shirai (US 2022/0198652).
Consider Claim 1, Shirai discloses “A method comprising: treating a patient diagnosed by a process” (Shirai, Paragraph [0001], “The present invention relates to an image analysis device that provides a diagnostic index of a disease or the like based on an image acquired by a medical imaging device”) “comprising: determining, based on a representation of a first tissue, a region of interest of the patient;” (Shirai, Paragraph [0028], “a slice location determining unit 240 that determines a slice location in the diagnostic image after standardization based on a feature of the notable tissue”) “and determining, based on the region of interest, an estimate of a location of a commissure within a representation of second tissue of the patient. ” (Shirai, Paragraph [0005], “With respect to the corpus callosum angle, a corpus callosum angle in an MRI coronal section perpendicular to anterior commissure and posterior commissure passing through the posterior commissure is steep (90 degrees or less), which becomes a diagnostic index” (emphasis added)). Examiner notes Shirai teaches the anterior and posterior commissure is identifies in a coronal section to calculate the corpus callosum angle. Shirai also teaches the segmentation and extraction of a notable tissue; i. e. a brain ventricle, is used to determine the coronal section. Examiner notes the extraction of the brain ventricle is interpreted as the representation of a second tissue disclose in Claim 1.
Consider Claim 2, Shirai discloses “The method of claim 1, wherein determining the region of interest of the patient comprises: segmenting, based on the representation of the second tissue of the patient, the first tissue.” (Shirai, Paragraph [0033], “the area dividing unit 230 extracts an area of a notable tissue by segmentation from the image after standardization”).
Consider Claim 6, Shirai discloses “The method of claim 1, wherein the commissure is a posterior commissure. ” (Shirai, Paragraph [0041], “As for the corpus callosum angle, one index of the iNPH diagnosis is that the corpus callosum angle in an MRI coronal section … passing through the posterior commissure is steep, specifically 90 degrees or less.” (emphasis added)).
Consider Claim 7, Shirai discloses “The method of claim 6, further comprising: selecting a portion of the representation of the second tissue of the patient;” (Shirai, Paragraph [0041], “For the corpus callosum angle, the slice location is determined in a coronal cross section, and the brain ventricle is extracted.” (emphasis added)) “and segmenting, based on the portion of the representation of the second tissue of the patient, a first ventricle of the representation of the second tissue of the patient. ” (Shirai, Paragraph [0041], “For the corpus callosum angle, the slice location is determined in a coronal cross section, and the brain ventricle is extracted.” (emphasis added)).
Consider Claim 10, Shirai discloses “The method of claim 7, further comprising: determining a second ventricle;” (Shirai, Paragraph [0069], When the notable tissue is also extracted for the neighboring slices, for the neighboring slices as well, first a maximum width between anterior horns of bilateral ventricles is calculated, a slice having the largest maximum width among a predetermined slice and slices in the vicinity thereof is determined as a measurement target”) Examiner notes Shirai teaches determining a measurement target and maximum width between the anterior horns of the bilateral ventricles to determine the location of the second bilateral ventricle from the extracted first lateral ventricle segment location. “and determining, based on a focal point,” (Shirai, Paragraph [0072], “An angle formed by the two line segments calculated based on the point P is calculated to obtain the corpus callosum angle”) “a maximum angle between contours of the first ventricle and the second ventricle. ” (Shirai, Paragraph [0070], “In the case of the corpus callosum angle, … a center line along a sulcus of brain … and a nearest contact point between the left and right ventricles (a point P in FIG. 4B) are determined…and two line segments are calculated. …a contour of the ventricle meet can be determined as the tangent line.” (emphasis added)).
Consider Claim 11, Shirai discloses “The method of claim 7, wherein the first ventricle is a lateral ventricle. ” (Shirai, Paragraph [0070], “In the case of the corpus callosum angle, with respect to the ventricle extracted in the coronal cross section, … a nearest contact point between the left and right ventricles (a point P in FIG. 4B) are determined” (emphasis added)). Examiner notes the left and right brain ventricles are defined as bilateral ventricles in Shirai, Paragraph [0072].
Consider Claim 12, Shirai discloses “The method of claim 1, wherein the commissure is an anterior commissure. ” (Shirai, Paragraph [0041], “ As for the corpus callosum angle, one index of the iNPH diagnosis is that the corpus callosum angle in an MRI coronal section (a cross section perpendicular to a straight line connecting an anterior commissure and a posterior commissure)” (emphasis added)).
Consider Claim 13, Shirai discloses “The method of claim 1, wherein the first tissue is a ventricle. ” (Shirai, Paragraph [0041], “ the slice location is determined in a coronal cross section, and the brain ventricle is extracted.”).
Consider Claim 14, Shirai discloses “The method of claim 1, wherein the representation of the second tissue comprises the representation of the first tissue. ” (Shirai, Fig. 4B (see image below); Paragraph [0070] “In the case of the corpus callosum angle, with respect to the ventricle extracted in the coronal cross section, a center line along a sulcus of brain (a dotted line L in FIG. 4B) and a nearest contact point between the left and right ventricles (a point P in FIG. 4B) are determined…”). Examiner notes Shirai teaches that the coronal cross section is determined by identifying and extracting a brain ventricle. FIG. 4B is interpreted as containing and identifying two tissues; the extracted ventricle and the other bilateral ventricle, from the extracted ventricle segment location.
PNG
media_image1.png
287
440
media_image1.png
Greyscale
Consider Claim 15, Shirai discloses “The method of claim 1, wherein the representation of the second tissue is based on computed tomography scan. ” (Shirai, Paragraph [0026], “The medical imaging device 300 is not limited to a single device…may be a plurality of types of devices having different modalities. Examples of devices having different modalities include…a CT device…”).
Consider Claim 16, Shirai discloses “The method of claim 7, further comprising: determining, based on the estimate of the location of the commissure, a condition of the patent, wherein the condition is Normal Pressure Hydrocephalus. ” (Shirai, Paragraph [0041], “As for the corpus callosum angle, one index of the iNPH diagnosis is that the corpus callosum angle in an MRI coronal section (a cross section perpendicular to a straight line connecting an anterior commissure and a posterior commissure) passing through the posterior commissure is steep, specifically 90 degrees or less.” (emphasis added)). Examiner notes Shirai teaches (Shirai, Paragraph [0005], “idiopathic normal pressure hydrocephalus (iNPH) included in the normal pressure hydrocephalus”).
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.C103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.C102(b)(2)(C) for any potential 35 U.S.C102(a)(2) prior art against the later invention.
Claims 3 and 8-9 are rejected under 35 U.S.C 103 as being unpatentable over Shirai (US 2022/0198652) in view of Nowinski (US 20150206300).
Consider Claim 3, Shirai discloses “ and denoising the representation of the first tissue. ” (Shirai, Paragraph [0044], “the image standardizing unit 220 performs FOV adjustment (S21), resolution adjustment (S22), and subject location adjustment (S23)…. The FOV is adjusted by performing processing of cutting off an excess area or zero filling a periphery according to the standard value (S21).” (emphasis added)). Examiner notes denoising an image is broadly interpreted as removing unwanted noise or artifacts. Examiner has interpreted the removal of excess area in Shirai as denoising the image.
Shirai does not explicitly disclose “The method of claim 2, wherein segmenting the first tissue comprises: isolating, based on a Hounsfield range, the representation of the first tissue…”. However, in an analogues field, Nowinski teaches (Nowinski, Paragraph [0048], “The VOI extraction is based on the distribution within the scan of material which constitutes the "brain-with-a-clot" (defined as the tissues having an intensity in the brain scan which corresponds to a radio-density in a range typical of CSF. WM, GM and hemorrhage…” (emphasis added)). Examiner notes that Nowinski teaches radio density measured in Hounsfield unit.
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Shirai with the teachings of Nowinski to use radiodensity of brain tissue to assist in distinguishing between different brain structures and tissue. One of ordinary skill in the art would be motivated to combine Shirai and Nowinski to distinguish between different brain tissue in a brain scan to segment and narrow the region of interest to more efficiently determine the location of some anatomical brain structure. Accordingly, the combination of Shirai and Nowinski discloses the invention of Claim 3.
Consider Claim 8, the combination of Shirai and Nowinski disclose “The method of claim 7, further comprising: determining, based on the first ventricle, an ellipse; (Nowinski, Fig. 4 (see image below); Paragraph [0045], “The ventricular template is co-registered with the patient's scan. Any procedure can be applied to do this registration; in particular that based on ellipse fitting presented in [4,5].”) “and determining an eccentricity of the ellipse. ” (Shirai, Paragraph [0045], “a method for performing elliptic approximation of the head outer shape mask of an axial surface and obtaining a center of an ellipse as the center of the brain.”). The proposed combination as well as the motivation for combining the Shirai and Nowinski references presented in the rejection of claim 3, apply to claim 8 and are incorporated herein by reference. Thus, the method recited in claim 8 is met by Shirai and Nowinski.
PNG
media_image2.png
259
430
media_image2.png
Greyscale
Consider Claim 9, the combination of Shirai and Nowinski disclose “The method of claim 7, further comprising: determining a sagittal reconstruction of the representation of the second tissue of the patient;” (Nowinski, [0055], “Next, the method identifies the sagittal and coronal extent of the fourth ventricle region.”). Examiner notes Nowinski discloses variations of its disclosed embodiments and teaches the extraction and analysis of a ventricle region is not limited to the fourth ventricle region (Nowinski, Paragraph [0082], “For example, although in FIG. 1 the fourth ventricle is processed first, the ventricles may be processed in any other order. ”). Examiner also notes that Nowinski teaches the sagittal extent of the ventricle region is determined by sagittal segmentation of the ventricle (Nowinski, Paragraph [0055]). “determining, the representation of the second tissue of the patient and based on a Hounsfield range, slices of the representation of the second tissue of the patient determining, based on the slices, an axial plane,” (Nowinski, Paragraph [0053], “Likewise, the total number of skull voxels per axial slice is calculated (for instance, the voxels having a radio-density >120 HU) and plotted as a distribution over the axial slices. Typically, the result is as shown in FIG. 6(a). The distribution shows a peak region in the inferior slices which corresponds to the skull base… This is the region where the fourth ventricle lies.” (emphasis added)) “wherein the first ventricle of the representation of the second tissue of the patient is based on the axial plane. ” (Shirai, Paragraph [0041], “the slice location is determined in an axial cross section, and a brain ventricle and brain parenchyma are treated as the notable tissues.”). Examiner notes Shirai teaches notable tissue as tissue of interest and to be extracted during segmentation. The proposed combination as well as the motivation for combining the Shirai and Nowinski references presented in the rejection of claim 3, apply to claim 9 and are incorporated herein by reference. Thus, the method recited in claim 9 is met by Shirai and Nowinski.
Claims 4-5 are rejected under 35 U.S.C 103 as being unpatentable over Shirai (US 2022/0198652) in view of Liu, Y. , & Dawant, B. M. (“Automatic localization of the anterior commissure, posterior commissure, and midsagittal plane in MRI scans using regression forests. ”).
Consider Claim 4, Shirai does not disclose the limitations of claim 4. However, in an analogous field of endeavor, Lui teaches “The method of claim 1, wherein the estimate of the location of the commissure comprises: determining, based on the region of interest, a segment of the representation of the second tissue of the patient;” (Lui, Pg 1, Right Col, Paragraph 3, “For the AC and PC, these algorithms rely on the successful segmentation of surrounding structures, the localization of other anatomical landmarks, or image registration.”). Examiner notes Lui teaches an algorithm to locate the AC and PC that relies on identifying other structures in the brain. Anatomical landmarks and structures are interpreted to include a second tissue of the patient disclosed in Claim 4. “and determining, based on the segment, a heat map of the segment. ” (Lui, Pg 5, Fig 4-5 (see images below)).
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Shirai with the teachings of Lui to determine a segmentation of an anatomical tissue landmark when locating a commissure, and using a heat map to display the location of a commissure on the segment. One of ordinary skill in the art would be motivated to combine Shirai and Lui to narrow the area/segment of estimation of a commissure using a known anatomical tissue landmark locally associated with the commissure, and to use a heat map to better visualize the location of a commissure for diagnostic purposes. Accordingly, the combination of Shirai and Lui discloses the invention of Claim 4.
PNG
media_image3.png
506
1227
media_image3.png
Greyscale
Consider Claim 5, the combination of Shirai and Lui discloses “The method of claim 4, wherein the heat map comprises an intensity indicative of the estimate of the location of the commissure. ” (Lui, Pg 5, Fig 5 (see image above)). The proposed combination as well as the motivation for combining the Shirai and Lui references presented in the rejection of claim 4, apply to claim 5 and are incorporated herein by reference. Thus, the method recited in claim 5 is met by Shirai and Lui.
Claims 17 are rejected under 35 U.S.C 103 as being unpatentable over Shirai (US 2022/0198652) in view of Hughes (US 2023/0290039 with the effective filing date of August 31, 2021).
Consider Claim 17, Shirai discloses “The method of claim 16, wherein the condition is determined based on distinguishing the condition from Alzheimer's Dementia,” (Shirai, Paragraph [0005], “ With respect to the corpus callosum angle, a corpus callosum angle in an MRI coronal section perpendicular to anterior commissure and posterior commissure passing through the posterior commissure is steep (90 degrees or less), which becomes a diagnostic index that can determine Alzheimer's disease.” (emphasis added)) “
Shirai does not teach “Post-traumatic Encephalomalacia, and headaches. ”. However, in an analogous field, Hughes teaches the analysis and segmentation of medical images to distinguish between neurodegenerative diseases (Hughes, Paragraph [0123], “In various embodiments, the neurodegenerative disease or neurological disease is any one of …Encephalopathy… Normal Pressure Hydrocephalus… SUNCT Headache…”). Examiner notes Encephalopathy encompasses a wide range of brain dysfunction that is interpreted to include Post-traumatic Encephalomalacia.
Accordingly, before the effective filing date of the instant application, it would have been obvious to one of ordinary skill in the art to combine Shirai with the teachings of Hughes to distinguish between a number of neurodegenerative diseases. One of ordinary skill in the art would be motivated to combine Shirai and Hughes to output a more accurate diagnosis of the patient to provide the appropriate treatment. Accordingly, the combination of Shirai and Hughes discloses the invention of Claim 17.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Annie Pham whose telephone number is (571)272-1673. The examiner can normally be reached Mon - Fri: 8:30a - 5:00p.
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, Amandeep Saini can be reached on (571)272-3382. 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.
/ANNIE H PHAM/Examiner, Art Unit 2662
/Siamak Harandi/Primary Examiner, Art Unit 2662