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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 2 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by examiner.
Claim Objections
Claim 14 is objected to because of the following informalities: Claim 14 is objected to for missing a colon after the phrase “wherein at least one of” to indicate the list of “the determining” steps are a set of alternative limitation steps (based on the “or”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
Claim 15:
“interface”, described in ¶ [0089]-[0090] and interpreted as hardware ¶ [00150]-[00151] in Figure 4.
“computing unit”, described in ¶ [0089]-[0090] and interpreted as hardware ¶ [00150]-[00151] in Figure 4.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, each are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 16 and 17 are each rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because data per se and/or computer programs do not fall into one of the four categories of statutory invention (machine, process, manufacture, composition). More specifically, claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability (i.e., laws of nature, natural phenomena, and abstract ideas). Alice Corp. v. CLS Bank Int'l, 573 U. S. 208 (2014)
Regarding claim 16, the claim is drawn towards a “computer program product”. As described in MPEP § 2106, data per se and computer programs do not fall into one of the four statutory categories. Therefore, since claim 16 is drawn towards a program, the claim is not eligible for patent protection.
Regarding claim 17, the claim is drawn towards a “computer-readable memory medium” and it is unclear based on the specification if this is drawn to only a “non-transitory” or includes “transitory” (“determination apparatus SYS can be embodied as a virtual system” specification ¶ [00149]) and the specification appears to include “a digital signal processor” (¶ [00161]). It is not clearly defined in the claim language which embodiment is intended and therefore is presumed to include transitory signals, which is not patent eligible subject matter.
The state-of-the-art at the time the invention was made included signals, carrier waves and other wireless communication modalities (e.g., RF, infrared, etc.) as media on which executable code was recorded and from which computers acquired such code. Thus, the full scope of the claim covers "signals" and their equivalents, which are non-statutory per se. (see In re Nuijten). The examiner suggests clarifying the claim to exclude such non-statutory signal embodiments, such as (but not limited to) reciting a "non-transitory machine-readable storage medium", or equivalent, consistent with the corresponding original disclosure.
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.
Claims 1-5, 7-8, 11-17 are rejected under 35 U.S.C. 103 as being unpatentable over Rapaka et al (US 2020/0160527, as disclosed in IDS 04/25/2024) in view of Razeto et al (US 2015/0097833).
Regarding Claim 1, Rapaka et al teach a computer-implemented method for determination of a volume of calcium in an aorta (method 300 for evaluating an aorta (volume via voxel ¶ [0025]) of a patient using system 100 on computer workstation 102; Fig 1-3 and ¶ [0023]), comprising:
receiving a medical image dataset of the aorta (a medical “image” (image given broadest reasonable interpretation (BRI) as “image dataset”) 202 of a patient aorta 204 is received, S302; Fig 3 and ¶ [0024]);
determining an aorta center line of the aorta based on the medical image dataset (an aortic centerline is determined in the medical image and used for identifying the segmented aorta, S304, S506, S508; Fig 2, 3, 5 and ¶ [0025]-[0029], [0054]-[0058]);
determining landmarks on the aorta based on the medical image dataset (landmarks (anatomical locations of interest) of the aorta are identified and used to identify the measurement planes, S306, based on the segmented aorta data, S304; Fig 3 and ¶ [0026], [0030]);
determining an aorta mask of the aorta based on the medical image dataset (a mask can be used to generate the segmented aorta data of the medical image, S304, S508; Fig 3, 5 and ¶ [0025], [0030], [0058]-[0059]);
applying the aorta mask to the medical image dataset to create a masked medical image dataset (the mask is applied to the segmented aorta data to generate voxel-labeled medical image data, S304; Fig 3 and ¶ [0025]); and
determining at least one aorta segment based on the aorta mask, the aorta center line and the landmarks (the aorta is segmented from the medical image based on the mask, the centerline, and the locations of interest (landmarks), S304, S504-S508; Fig 3, 5 and ¶ [0025], [0056]-[0059]);
Rapaka et al does not teach creating a calcium mask based on the masked medical image dataset; determining the volume of calcium of the at least one aorta segment based on the calcium mask and the at least one aorta segment; and providing the volume of calcium of the at least one aorta segment.
Razeto et al is analogous art pertinent to the technological problem addressed in this application and teaches creating a calcium mask based on the masked medical image dataset (calcium (calcified regions) can be identified in non-contrast enhanced CT scan data sets when compared to contrast enhance CT scan datasets (mask), stage 20; Fig 4 and ¶ [0026]);
determining the volume of calcium of the at least one aorta segment based on the calcium mask and the at least one aorta segment (the calcium volume is determined (volume amount described as calcium scoring data sets) for the heart region (aorta) of interest, stage 20; Fig 4 and ¶ [0026]-[0027]); and
providing the volume of calcium of the at least one aorta segment (the calcium volume for a given location is determined, stage 20, which is correlated with a segment region for the vessel (aorta) structures, stage 22; Fig 4 and ¶ [0027]-[0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Rapaka et al with Razeto et al including creating a calcium mask based on the masked medical image dataset; determining the volume of calcium of the at least one aorta segment based on the calcium mask and the at least one aorta segment; and providing the volume of calcium of the at least one aorta segment. By identifying and analyzing calcium regions in the aorta, stenosis and other diseases may be identified, thereby allowing for visualization and further diagnosis/treatment options, as recognized by Razeto et al (¶ [0003]-[0004]).
Regarding Claim 2, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above), wherein the medical image dataset comprises a three-dimensional computed tomography recording (Rapaka et al, the medical images may be 3D CT images; ¶ [0019]).
Regarding Claim 3, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above), wherein the calcium mask is created via a threshold value segmentation of the masked medical image dataset (Razeto et al, the mask, for the calcification features, are determined based on a thresholding procedure (segmentation via filtering); ¶ [0030]).
Regarding Claim 4, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above), wherein the medical image dataset comprises a recording of the aorta with contrast means (Razeto et al, a first and second image datasets can be used to determine the aorta based on a contrast dye agent procedure and image analysis; ¶ [0026]-[0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Rapaka et al with Razeto et al including wherein the medical image dataset comprises a recording of the aorta with contrast means. By using a contrast agent, the areas of interest can easily be identified and analyzed, thereby improving the diagnosis and treatment planning, as recognized by Razeto et al (¶ [0004], [0027]).
Regarding Claim 5, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above), further comprising: dilating the aorta mask (Razeto et al, dilation operations may be applied to forming the aorta mask; ¶ [0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Rapaka et al with Razeto et al including dilating the aorta mask. By using a dilation operation for the aorta mask, the boundaries of the features are enhanced, thereby improving the processing analysis for quantitative accuracy, as recognized by Razeto et al (¶ [0030]).
Regarding Claim 7, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above), further comprising: filtering of the calcium mask (Razeto et al, size-dependent filters may be applied to the calcification features mask; ¶ [0030]).
Regarding Claim 8, Rapaka et al in view of Razeto et al teach the method as claimed in claim 5 (as described above), wherein the calcium mask is filtered with a median filter or a size filter (Razeto et al, size-dependent filters may be applied to the calcification features mask; ¶ [0030]).
Regarding Claim 11, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above), wherein the at least one aorta segment extends along the aorta center line between two landmarks (the aortic centerline is determined, S506, and refined based on a region-wise model based on landmarks, S508, with a segmentation determined based on the aorta and centerline; Fig 3, 5 and ¶ [0026], [0056]-[0058]).
Regarding Claim 12, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above), wherein the landmarks comprise at least one of the following landmarks: an aortic root, a sinotubular transition, a central ascending aorta, a proximal aorta arch, a central aorta arch, a proximal descending aorta, a central descending aorta, an aorta at a diaphragm, or an abdominal aorta (the claim is interpreted as a list of alterative “landmarks” based on the transition “or” before the last limitation in the list; (Rapaka et al, predefined landmarks on the aorta include, but not limited to, the aortic annulus, aortic root, sinotubular junction, tube, aortic arch, descending aorta, and abdominal aorta; ¶ [0026]).
Regarding Claim 13, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above), further comprising: creating an intervention planning based on the volume of calcium of the at least one aorta segment (Rapaka et al, a clinical treatment plan may be determined based on a risk score based on the evaluation of the aorta; ¶ [0038]); and providing the intervention planning (Rapaka et al, the clinical treatment plan may be sent to a patient management system; ¶ [0038]).
Regarding Claim 14, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above), wherein at least one of the determining the aorta mask includes a trained function to the medical image dataset (Rapaka et al, the refined aorta mask is determined using a trained deep learning model; Fig 5 and ¶ [0058]), the determining the aorta center line includes applying a second trained function to the medical image dataset, or the determining the landmarks includes applying a third trained function to the medical image dataset (the claim is interpreted as a list of alterative “determining” limitations based on the transition “or” before the third limitation in the list).
Regarding Claim 15, Rapaka et al teach a determination apparatus for determining a volume of calcium in an aorta (computer 702 to execute computer program instructions to perform method for analyzing the medical image; Fig 7 and ¶ [0065]), the determination apparatus comprising:
an interface (the I/O device 706 receives image data from other devices (the CT apparatus); Fig 7 and ¶ [0065]) configured to receive a medical image dataset of the aorta; and
a computing unit (processor 704 executes computer program instructions stored in data storage device 712, to perform method for analyzing the medical image; Fig 7 and ¶ [0065]) configured to cause the determination apparatus to perform steps identical to claim 1 (as described above),
Regarding Claim 16, Rapaka et al teach a computer program product with a computer program (computer 702 to execute computer program instructions to perform method for analyzing the medical image; Fig 7 and ¶ [0065]), when executed by a determination apparatus, cause the determination apparatus to perform the method of claim 1 (as described above).
Regarding Claim 17, Rapaka et al teach a computer-readable memory medium (non-transitory machine-readable storage device; ¶ [0064]), on which program sections able to be read and executed by a determination apparatus are stored (the computer program instructions are stored in data storage device 712; Fig 7 and ¶ [0065]), and when executed by the determination apparatus (processor 704 executes computer program instructions stored in data storage device 712, to perform method for analyzing the medical image; Fig 7 and ¶ [0065]), cause the determination apparatus to perform the method of claim 1 (as described above).
Claims 9 is rejected under 35 U.S.C. 103 as being unpatentable over Rapaka et al (US 2020/0160527) in view of Razeto et al (US 2015/0097833) and Itu et al (US 2021/0219935).
Regarding Claim 9, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above).
Rapaka et al in view of Razeto et al do not teach classifying the volume of calcium of the at least one aorta segment, wherein the providing provides the class of the aorta segment.
Itu et al is analogous art pertinent to the technological problem addressed in this application and teaches classifying the volume of calcium of the at least one aorta segment (the aorta features may be classified based on the segment and the segment may be labeled as either healthy or non-healthy based on the narrowing or dilation; ¶ [0101]), wherein the providing provides the class of the aorta segment (each coronary segment is classified based on it anatomical identification; ¶ [0101]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Rapaka et al in view of Razeto et al with Itu et al including classifying the volume of calcium of the at least one aorta segment, wherein the providing provides the class of the aorta segment. By identifying the anatomy and characteristics of calcification, a detailed analysis may be identified for abnormalities, thereby allowing for prediction of possible pathophysiology and therapeutic treatments, as recognized by Itu et al (¶ [0005], [0102]).
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Rapaka et al (US 2020/0160527) in view of Razeto et al (US 2015/0097833) and Levanon et al (US 2008/0219530).
Regarding Claim 10, Rapaka et al in view of Razeto et al teach the method as claimed in claim 1 (as described above).
Rapaka et al in view of Razeto et al do not teach wherein the providing provides the volume of calcium of the at least one aorta segment in a form of at least one of a DICOM Structured Report or a DICOM Secondary Capture.
Levanon et al is analogous art pertinent to the technological problem addressed in this application and teaches wherein the providing provides the volume of calcium of the at least one aorta segment in a form of at least one of a DICOM Structured Report or a DICOM Secondary Capture (the CT aorta images are generated as DICOM images (¶[0035], [0049]) and the analyzed data is a DICOM summary report that includes the given calcium lesions volume and scores; Fig 2, 11 and ¶ ¶ [0080]-[0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the current application to combine the teachings of Rapaka et al in view of Razeto et al with Levanon et al including wherein the providing provides the volume of calcium of the at least one aorta segment in a form of at least one of a DICOM Structured Report or a DICOM Secondary Capture. By generating a summary report that includes the DICOM data, the reports are generated with accuracy in a systematic process allowing for self-diagnosis of medical CAD systems, thereby automating the quantifying and estimation of the medial image data and resulting in reliability and efficiency, as recognized by Levanon et al (¶ [0003]-[0005]).
Allowable Subject Matter
Claim 6 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Regarding Claim 6, the prior art was not readily identified to explicitly teach all of the following limitations in combination with the claims in which it depends as claimed by the applicant:
The method of claim 5, further comprising: applying the dilated aorta mask to the medical image dataset to create a dilated masked medical image dataset; creating a dilated calcium mask based on the dilated masked medical image dataset; determining at least one dilated aorta segment based on the dilated aorta mask, the aorta center line and the landmarks; determining a dilated volume of calcium of the at least one dilated aorta segment based on the dilated calcium mask and the at least one dilated aorta segment; and selecting the volume of calcium of the at least one aorta segment to be provided between the volume of calcium of the at least one aorta segment and the dilated volume of calcium of the at least one dilated aorta segment, wherein the providing provides the selected volume of calcium of the at least one aorta segment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burris et al (US 2019/0087957) teach a system and method for cross-sectional imaging techniques as applied to CT angiography or MRI angiography to determine aortic characteristics using a 3D surface model.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN M BROUGHTON whose telephone number is (571)270-7380. The examiner can normally be reached Monday-Friday 8:00-5:00.
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/KATHLEEN M BROUGHTON/Primary Examiner, Art Unit 2661