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 .
DETAILED ACTION
The United States Patent & Trademark Office appreciates the application that is submitted by the inventor/assignee. The United States Patent & Trademark Office reviewed the following application and has made the following comments below.
Priority
This application claims benefit of foreign priority under 35 U.S.C. 119(a)-(d) of 2024900612, filed in Australia on 03/08/2024, and 2024902678, filed in Australia on 8/27/2024.
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.
Claims 5 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.
The term “if” in claim if a condition is determined is a relative term which renders the claim indefinite. The term “if” is defined by the claim, however, if none of condition are met the then claim become indefinite. Ex parte Schulhauser, PTAB Appeal No. 2013-007847 (2016). Additional information can be found in MPEP §2111.04(II). The PTAB found, “If the condition for performing a contingent step is not satisfied, the performance recited by the step need not be carried out in order for the claimed method to be performed.” Schulhauser at 10. As a result, if there is a possibility that the condition is not met, then the Examiner need not find prior art addressing the corresponding element. In regards to Claim 5, “if” both conditions are not met, the Examiner finds that the claim would be indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Or
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 3, 4, 6, 7, 8, 9, 11, 12, 13, 14, 16, 17, 18, 20, 21, 23, 24, 25, 26 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Min et al (U.S. Patent Pub. No., 2024/0233954, hereafter referred to as Min).
In regards to Claim 1, Min teaches A method of automatically determining a plaque score for coronary arteries of a patient, the method comprising:
receiving cardiac CT data indicative of a cardiac CT scan carried out on the patient (paragraph 58, Min teaches using a CT image for high-risk plaque volume characterization.);
analyzing the cardiac CT data to identify plaque volumes to be included in the plaque score (paragraph 58, Min teaches using a CT image to determine a volumetric characterization of the coronary plaque and perivascular adipose tissue), the plaque volumes located on the coronary arteries (paragraph 58, Min teaches using a CT image to determine a volumetric characterization of the coronary plaque and perivascular adipose tissue);
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determining locations of the identified plaque volumes on the coronary arteries (paragraph 120, paragraph 140, paragraph 141, paragraph 264, Min teaches determining the size and location and ratio of the plaque build up in the imaging system, the system determines by using CNN on a set of medical images.);
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applying machine learning to the cardiac CT data to identify a plurality of primary key points on the coronary arteries (paragraph 120, paragraph 140, paragraph 141, paragraph 264, Min teaches determining a calcium score and determining score using a AI or ML, which is not know as Super-intelligence, in addition, the system determine the wall of the arteries therefore, edge points are determined.);
determining a distance between each identified plaque volume and an associated primary key point (the Examiner finds that the claim does not define what a “primary key point” is and therefore POSITA can interpret to be any features on the heart or organ, paragraph 138, paragraph 140, paragraph 141, Min using the vascular morphology parameters, which can be interpreted to be primary key point.); and
determining a plaque score based on a heart dimension value and, for each identified plaque volume (paragraph 138, paragraph 140, paragraph 141, Min using the vascular morphology parameters that is used to determine the score of the plaque-by-plaque), the determined distance from the identified plaque volume to the associated primary key point (paragraph 251, Min teaches determining the one or more distances between plaque and vessel wall and distance between plaque and lumen walls.).
In regards to Claim 2, Min teaches wherein the locations of the identified plaque volumes on the coronary arteries are determined using machine learning (paragraph 138, paragraph 140, paragraph 141, Min teaches using CNN or ML).
In regards to Claim 3, Min teaches wherein the key points include at least one primary key point corresponding to an ostium location at which a coronary artery connects to a patient's aorta (paragraph 169, Min teaches analyzing the aorta).
In regards to Claim 4, Min teaches wherein the key points include at least one secondary key point corresponding to a location on a coronary artery associated with a coronary artery branch location (paragraph 368, paragraph 369, paragraph 370, Min teaches using multiple points from multiple images to determine the different of the plaque score).
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In regards to Claim 6, Min teaches wherein the distance is determined from a centroid of an identified plaque volume (paragraph 56, paragraph 168, Min).
In regards to Claim 7, Min teaches wherein the heart dimension value includes a maximum heart diameter value (paragraph 56, paragraph 168, Min).
In regards to Claim 8, Min teaches wherein the plaque score is determined based on volume magnitude of the plaque volumes (paragraph 56, paragraph 168, Min).
In regards to Claim 9, Min teaches wherein the cardiac CT data is non-contrast CT data and the plaque volumes are calcified volumes (paragraph 56, paragraph 168, Min).
In regards to Claim 11, Min teaches wherein the cardiac CT data is contrast CT data and the plaque volumes include non-calcified volumes (paragraph 113, Min).
In regards to Claim 12, Min teaches comprising filtering CT data using defined filtering characteristics to identify the plaque volumes to be included in the plaque score (paragraph 141, paragraph 121, Min).
In regards to Claim 13, Min teaches wherein the defined filtering characteristics include HU values, and/or plaque volume characteristics, and/or plaque composition (paragraph 121, Min).
In regards to Claim 14, Min teaches wherein the plaque score is determined based on a stenosis severity parameter; and/or based on an amount of high-risk plaque features, wherein each high risk plaque feature has an associated scaling factor (paragraph 144, Min teaches the risk factor).
In regards to Claim 16, Min teaches a system for automatically determining a plaque score for coronary arteries of a patient, the system comprising: a plaque volume identifier arranged to receive cardiac CT data indicative of a cardiac CT scan carried out on a patient (paragraph 58, Min teaches using a CT image of high-risk plaque volume characterization.),
analyse the cardiac CT data to identify plaque volumes located on the coronary arteries to be included in the plaque score (paragraph 58, Min teaches using a CT image to determine a volumetric characterization of the coronary plaque and perivascular adipose tissue), and
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determine locations of the identified plaque volumes on the coronary arteries (paragraph 120, paragraph 140, paragraph 141, paragraph 264, Min teaches determining the size and location and ratio of the plaque build up in the imaging system, the system determines by using CNN on a set of medical images.);
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a key point determiner arranged to apply machine learning to the cardiac CT data to identify a plurality of primary key points on the coronary arteries (paragraph 120, paragraph 140, paragraph 141, paragraph 264, Min teaches determining a calcium score and determining score using a AI or ML, which is not know as Super-intelligence.); a key point distance determiner arranged to determine a distance between each identified plaque volume and an associated primary key point (the Examiner finds that the claim does not define what a “primary key point” is and therefore POSITA can interpret to be any features on the heart or organ, paragraph 138, paragraph 140, paragraph 141, Min using the vascular morphology parameters, which can be interpreted to be primary key point.); and
a plaque score calculator arranged to determine a plaque score based on a heart dimension value and, for each identified plaque volume (paragraph 138, paragraph 140, paragraph 141, Min using the vascular morphology parameters that is used to determine the score of the plaque-by-plaque), the determined distance from the identified plaque volume to the associated primary key point (paragraph 251, Min teaches determining the one or more distances between plaque and vessel wall and distance between plaque and lumen walls.).
In regards to Claim 17, Min teaches wherein the key points include at least one primary key point corresponding to an ostium location at which a coronary artery connects to a patient's aorta (paragraph 169, Min teaches analyzing the aorta).
In regards to Claim 18, Min teaches wherein the key points include at least one secondary key point corresponding to a location on a coronary artery associated with a coronary artery branch location (paragraph 368, paragraph 369, paragraph 370, Min teaches using multiple points from multiple images to determine the different of the plaque score)
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In regards to Claim 20, Min teaches wherein the plaque score is determined based on volume magnitude of the plaque volumes (paragraph 56, paragraph 168, Min).
In regards to Claim 21, Min teaches wherein the cardiac CT data is non-contrast CT data and the plaque volumes are calcified volumes (paragraph 56, paragraph 168, Min).
In regards to Claim 23, Min teaches wherein the cardiac CT data is contrast CT data and the plaque volumes include non-calcified volumes (paragraph 113, Min).
In regards to Claim 24, Min teaches comprising a plaque filter for filtering CT data using defined filtering characteristics to identify the plaque volumes to be included in the plaque score (paragraph 141, paragraph 121, Min).
In regards to Claim 25, Min teaches wherein the defined filtering characteristics include HU values, and/or plaque volume characteristics, and/or plaque composition (paragraph 121, Min).
In regards to Claim 26, Min teaches wherein the plaque score is determined based on a stenosis severity parameter; and/or based on an amount of high risk plaque features, wherein each high risk plaque feature has an associated scaling factor (paragraph 144, Min teaches the risk factor).
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 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(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 5 & 19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Min et al (U.S. Patent Pub. No., 2024/0233954, hereafter referred to as Min) in view of Lang et al (U.S. Patent Pub. No. 2021/0137634, hereafter referred to as Lang).
Regarding Claim 5, Min teaches computer system that determine the plaque score of a patient.
Min does not explicitly disclose if an identified plaque volume is on a coronary artery that connects directly to the aorta at an ostium, then the method comprises determining the distance by determining a straight line distance from the plaque volume to a primary key point associated with the ostium; and
if an identified plaque volume is on a coronary artery that connects indirectly to the aorta at an ostium through a branch, then the method comprises determining the distance by determining a straight line distance from the plaque volume to a secondary key point associated with the branch plus a straight line distance from the secondary key point to a primary key point associated with the ostium.
Lang is in the same field of art of medical image of the heart. Further, Lang teaches (the Examiner interprets that the limitation only need to be meet “if” the condition is meet and therefore, only one conditions needs to met) if an identified plaque volume is on a coronary artery that connects directly to the aorta at an ostium, then the method comprises determining the distance by determining a straight line distance from the plaque volume to a primary key point associated with the ostium (paragraph 1130-paragraph 1144, Lang teaches the determining the plaque change and dimension when in the between the aorta and a renal artery); and
if an identified plaque volume is on a coronary artery that connects indirectly to the aorta at an ostium through a branch, then the method comprises determining the distance by determining a straight line distance from the plaque volume to a secondary key point associated with the branch plus a straight line distance from the secondary key point to a primary key point associated with the ostium (paragraph 1130-paragraph 1144, Lang teaches the determining the plaque change and dimension when in the between the aorta and a renal artery).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Min by incorporating the feature image processing of aorta that is taught by Lang, to make the invention that captures image of the patient, using the CT image and image processing to determine the shape and blockage size of the plaque and determine the shape and size near the aorta; thus, one of ordinary skilled in the art would be motivated to combine the references since the interventional field and vascular access is in a different location and has a different view coordinate system for the surgeon or interventionalist's eyes than the external computer monitor, hand-eye coordination can be challenging for the surgeon or interventionalist (paragraph 3. Lang) .
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 19, Min teaches computer system that determine the plaque score of a patient.
Min does not explicitly disclose if an identified plaque volume is on a coronary artery that connects directly to the aorta at an ostium, then the method comprises determining the distance by determining a straight line distance from the plaque volume to a primary key point associated with the ostium, and if an identified plaque volume is on a coronary artery that connects indirectly to the aorta at an ostium through a branch, then the method comprises determining the distance by determining a straight line distance from the plaque volume to a secondary key point associated with the branch plus a straight line distance from the secondary key point to a primary key point associated with the ostium.
Lang is in the same field of art of medical image of the heart. Further, Lang teaches (the Examiner interprets that the limitation only need to be meet “if” the condition is meet and therefore, only one conditions needs to met) if an identified plaque volume is on a coronary artery that connects directly to the aorta at an ostium, then the method comprises determining the distance by determining a straight line distance from the plaque volume to a primary key point associated with the ostium (paragraph 1130-paragraph 1144, Lang teaches the determining the plaque change and dimension when in the between the aorta and a renal artery);
and if an identified plaque volume is on a coronary artery that connects indirectly to the aorta at an ostium through a branch, then the method comprises determining the distance by determining a straight line distance from the plaque volume to a secondary key point associated with the branch plus a straight line distance from the secondary key point to a primary key point associated with the ostium (paragraph 1130-paragraph 1144, Lang teaches the determining the plaque change and dimension when in the between the aorta and a renal artery).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Min by incorporating the feature image processing of aorta that is taught by Lang, to make the invention that captures image of the patient, using the CT image and image processing to determine the shape and blockage size of the plaque and determine the shape and size near the aorta; thus, one of ordinary skilled in the art would be motivated to combine the references since the interventional field and vascular access is in a different location and has a different view coordinate system for the surgeon or interventionalist's eyes than the external computer monitor, hand-eye coordination can be challenging for the surgeon or interventionalist (paragraph 3. Lang) .
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Allowable Subject Matter
Claims 10, 15, 22, 27 are 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ONEAL R MISTRY whose telephone number is (313)446-4912. The examiner can normally be reached on 9am-5pm.
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/ONEAL R MISTRY/
Examiner, Art Unit 2665
